The Safe Patient Project is a Consumers Union campaign focused on eliminating medical harm, improving FDA oversight of prescription drugs and promoting disclosure laws that give information to consumers about health care safety and quality.
My mother had hip surgery during which the doctor, unbeknownst to my mother or her rehab crew, severed a nerve. After several months of my mother not getting the mobility or correct walking gait back, the doctor insisted it would only take more rehab.
Archive for Medical Device Safety
Consumers Union Documents
- Consumer Reports Health News: J&J to stop selling troublesome surgical mesh products
A major manufacturer of the transvaginal mesh implants that we warned about in our recent report on unsafe medical devices is voluntarily halting marketing of four of the products.
- CU urges Congress to support Senate-passed medical device reforms in final FDA User Fee bill
Letter from Consumers Union highlighting important patient safety reforms from the Senate-passed version of the bill that should be included in the final version of the legislation.
- Consumer Reports Health News: Loophole in medical device governing statute puts patients at risk
As the Senate prepares to vote on a bill this week to reauthorize the statute governing medical device oversight, Consumers Union, the advocacy arm of Consumer Reports called attention to a loophole that puts patients at risk.
- Consumer Reports May 30, 2012 Op-Ed: Medical Device Loophole Leaves Patients At Risk
Op-ed by James A. Guest President & CEO, Consumer Reports, appeared in both the print and online versions of Roll Call today.
- Medical Device Loophole Leaves Patients At Risk
Consumers Union Responds to Medical Device Industry on Recalled Predicates.
- Consumers Union Medical Device Ad in Politico
Consumers Union, the policy and advocacy arm of Consumer Reports, is calling attention to a dangerous medical device loophole that puts patients at risk in an ad in Politico today. The ad is running as the Senate prepares to vote on a bill this week to reauthorize the statute governing medical device oversight.
- Consumers Union Letter to House Energy & Commerce Health Subcommittee on MDUFA
Consumers Union urges House Energy & Commerce Health subcommittee to keep consumer safety issues in mind as they are set to mark-up the Medical Device User Fee reauthorization bill.
- Consumers Union Letter to Senators Harkin and Enzi on the Food and Drug Administration Safety and Innovation Act
Consumers Union comments on the Managers Amendment in the Senate bill regarding medical device legislation.
- Consumer Reports: Senate OKs weak Safety And Innovation Act for medical devices
The Senate HELP Committee today voted to approve the Food and Drug Administration Safety And Innovation Act, and although the bill included some improvements, it lacked key medical device safety provisions.
- Consumer Reports President Jim Guest NYT Letter to the Editor: Safety of Medical Implants
The President of Consumer Reports calls for common sense reforms to medical device safety oversight in a letter to the editor of New York Times.
- Consumer Reports Press Room: Many Medical Implants Such As Surgical Mesh and Metal-On-Metal Hips Never Tested For Safety, Leaving Patients At Risk
Consumer Reports press release announcing a new investigation finding that many medical implants have never been tested for safety and manufacturers are often required to do nothing more than file paperwork and pay a user fee before bringing their products to market.
- CR Investigates: Dangerous medical devices
Most medical implants have never been tested for safety. A new investigation by Consumer Reports reveals that while tens of millions of American consumers live with medical devices implanted in their bodies, many of these implants have never been tested for safety and manufacturers are often required to do nothing more than file paperwork and pay a user fee before bringing their products to market. In fact, because of our broken regulatory system, in such cases the only safety “testing” that occurs is in the bodies of unsuspecting patients.
- Consumer Reports Consumer News: Is your implanted medical device safe?
Consumer Reports has released a new report on Dangerous Medical Devices. You might assume so, but many implanted devices, including artificial joints and surgical mesh, were never clinically tested on humans before being put on the market, according to a new Consumer Reports investigation.
- CR poll: Americans want safer medical devices
Consumer Reports: Americans support stricter safety standards for medical devices, according to a new Consumer Reports poll. More than eight of 10 people in the survey said it was more important to prevent safety problems in the devices than it was to encourage innovation or avoid delays in getting them to market.
- Consumer Reports National Research Center: Medical Implant Poll (2012)
A new Consumer Reports poll shows overwhelming public support for strong medical device safety oversight. The poll was released just as House and Senate Committees have issued draft legislation to reauthorize the statute governing medical devices and at a time when the FDA’s process for reviewing new implants has come under intense criticism.
- Consumers Union’s Safe Patient Project Recommendations for Strengthening Medical Device Safety Oversight
Improve review of devices before they enter the market.
- Consumers Union Testimony on Medical Device Safety Before U.S. House Committee on Energy and Commerce/Health Subcommittee
Consumers Union Testimony on Medical Device Safety before U.S. House Committee on Energy and Commerce/Health Subcommittee
- Improve the Safety of Medical Devices
An overview of Consumers Union’s Safe Patient Project Initiative
- Two pathways for approval of devices
Consumers Union background on device approval and recommendations to make it safer
- FDA Advisory Committee Members Should be Free of Conflicts-of-Interest
Several congressional bills have introduced bills that would relax conflict of interest rules for the Food and Drug Administration (FDA) advisory committee members.
- Consumers Union Letter to Congress Concerning the Medical Device User Fee Act (MDUFA)
Consumers Union Letter to Congress Concerning the Medical Device User Fee Act (MDUFA)
- Letter to FDA from consumer groups with recommendations for medical device
Consumer Groups preliminary MDUFA suggestions to improve the agency’s performance in terms of ensuring that consumers have access to safe and effective medical devices, and to guarantee the scientific integrity of the safety review process.
Consumers Union News Releases
- House Voting Today on FDA Reform Act
House Bill Is Weaker Than Senate-Passed Version and Fails to Include Important Patient Safety Protections
- Senate Passes FDA Safety And Innovation Act
Bill Makes Some Improvements to Medical Device Oversight But Important Patient Safety Protections Still Missing
- Dangerous Medical Device Loophole Puts Patients At Risk
Consumers Union Ad Focuses on Need to Close Loophole as Senate Prepares to Vote on FDA User Fee Act
- Senate HELP Committee to Vote on Food and Drug Administration Safety And Innovation Act On Wednesday, April 25
Bill Includes Important Improvements Over Current Law But Lacks Critical Medical Device Patient Safety Provisions
- Consumers Union: Medical Device Bills Missing Critical Protections For Patients
Medical Device User Fee Bills Face Key Votes in Congress Next Week
- Consumer Reports Poll: Americans Overwhelmingly Support Strong Medical Device Safety Oversight
Industry Pressure Stymies Patient Protections In Draft House and Senate Medical Device Bills
- Patient Safety Coalition Protests FDA’s Approval Of Device Used For Treating Aneurysms
FDA Should Do More Rigorous Testing To Prove Medical Device Is Safe & Effective
- CU testifies for stronger medical device oversight at House Hearing Today
Congress Shouldn’t Sacrifice Patient Safety In The Drive to Speed Up Medical Device Approvals, CU Says
- Consumers Union steps up campaign to improve medical device safety
Consumers Union’s Safe Patient Project teams up with eight patient safety activists from around the country to Washington, D.C. to meet with lawmakers in Congress and press for improvements in the Medical Device User Fee Act (MDUFA).
- Lax oversight of medical devices puts patients at risk, Consumers Union says
Consumers Union, the advocacy arm of Consumer Reports, urged Congress to strengthen the law governing approval of medical devices.
- Consumers Union Urges Congress to Strengthen Medical Device Oversight
Consumers Union urged Congress today to strengthen the law that governs the approval of medical devices to ensure
- Consumers Union Statement on IOM Medical Device Study
The medical device industry lobby has criticized a report on medical device regulation before it was published.
- Consumers Union: IOM Report Urges More Consumer Protection for Medical Devices
The report that found thousands of medical devices are allowed to go on the market without proper testing for safety.
Blog Posts
- Consumer advocates attend FDA panel on safety of metal-on-metal hip implants
The FDA will examine the risks and benefits of metal-on-metal hip implants in a 2-day panel in Maryland tomorrow and Thursday (June 27-28). The agency is convening the meeting of scientific and medical experts in light of evidence that metal-on-metal hip implants fail at a higher rate than implants made of ceramic or plastic. As part Continue Reading
- House passes compromise FDA funding bill leaving important medical device safety provisions in the recycle bin
The FDA Safety and Innovation Act passed the House Wednesday on a voice vote. Consumer advocates had mixed reactions since the bill left out some critical patient safety protections but could have been a lot worse given the political muscle of medical industry lobbyists. For Consumers Union, the most disturbing issue that was left unaddressed Continue Reading
- Real People, Real Medical Device Stories
This week, we sent congressional staffers a person’s medical device story each morning asking them to keep real people in mind as they reconcile the differences between the House and Senate versions of the medical device bill.
- Problem Medical Devices: Read Avery’s story
“Almost one year after being implanted, the defibrillator lead broke in half inside of my daughter Avery and caused her to have 9 defibrillation shocks. To any adult, this is scary. My three year old daughter Avery was convinced for months that there were monsters attacking her and was scared to move.” – Molly deGroh, mother of Avery, McHenry, IL
- Congress passes FDA user fees law, speeds up drug/device approvals; slows down safety
It was a case of good and bad — last week the Senate passed legislation to oversee medical device safety, and while Senators agreed to increase fees to help fund some safety oversight, they missed the opportunity to include important medical device safety provisions that thousands of activists helped support. This week, the House passed their Continue Reading
- #SPPChat: What Consumers Need to Know About Medical Device User Fee Bills
The intent of our Twitter chat on May 17 was to debunk industry claims about the FDA’s device approval process and explain what consumers really need to know about the medical device user fee bills.
- Join Our Twitter Chat on May 17: “What Consumers Need To Know About Medical Device User Fee Bills”
Consumers Union’s Safe Patient Project will host its second Twitter chat on Thursday, May 17 at 1pm EST to debunk industry claims about the FDA’s device approval process and explain what consumers really need to know about the medical device user fee bills. In the wake of several high profile, device-related public health disasters–such as Continue Reading
- Consumers Gaining Momentum in the Senate on Safety In Medical Device Legislation Debate, Congress Feeling the Pressure
Last week Senators on a key committee voted on a bill that will determine the safety of a medical device you or a member of your family may need someday. Learn how consumers are taking action and what the Senate bill does and doesn’t do to improve patient safety.
- Twitter chat on Medical Device Safety
Consumers Union’s Safe Patient Project team hosted a Twitter chat on medical device safety issues on March 30 from 1-2pm ET.
- Consumers Union’s Safe Patient Project to host Twitter chat on medical devices
To help educate the public about medical device safety issues concerning Americans, Consumers Union’s Safe Patient Project will host a Twitter chat on medical devices on Friday, March 30 at 12pm CST using the hashtag #sppchat. The campaign invites any interested individuals to join the chat. The medical device industry has been pushing Congress to Continue Reading
- Consumer Reports Poll: Americans Want Strong Medical Device Safety Oversight
This week, Consumers Union issued a news release on a new Consumer Reports poll showing overwhelming public support for strong medical device safety oversight. The poll results come at a time when Congress is considering legislation that could weaken current safety standards that would make it easier for potentially unsafe devices to enter the market.
- Consumers demand safer medical devices
To make sure elected officials hear from Americans who’ve been harmed by outdated safety laws, Consumers Union’s Safe Patient Project brought 10 activists from seven states to Washington D.C. to share their medical device experiences and demand improvements. And it had a huge impact!
- Institute of Medicine report scrutinizes medical device approval process
The IOM released a report last week reviewing the 510(k) medical device approval process. The report finds that the current FDA process “lacks the legal basis to be a reliable premarket screen of the safety and effectiveness” of devices.
News Articles
- Medical Bed Mattresses: FDA Safety Communication - Damaged or Worn Covers Pose Risk of Contamination and Infection Source: FDA (Friday April 19, 2013)
From January 2011 to January 2013, the FDA received 458 reports associated with medical bed mattress covers failing to prevent blood and body fluids from leaking into the mattress (fluid ingress). Fluid ingress may occur if mattress covers become worn or damaged from small holes or rips in the fabric or from incorrect cleaning, disinfecting and laundering procedures. The zipper on the cover may also allow fluid to penetrate the mattress. Some reports indicate that if blood and body fluids from one patient penetrate a mattress, they can later leak out from the mattress when another patient is placed on the bed. Patients are at risk for infection if they come into contact with blood and body fluids from other patients.
- J&J Jury Urged to Award $5 Million for Failed Metal Hip Source: Bloomberg (Monday April 15, 2013)
J&J Jury Urged to Award $5 Million for Failed Metal Hip
- St. Jude Hit by Suits Source: Wall Street Journal (Thursday April 4, 2013)
A raft of lawsuits filed Thursday against St. Jude Medical Inc. over an implanted heart device could challenge the broad liability protection that medical-device makers have enjoyed since a key Supreme Court ruling in 2008. “What the judges are recognizing now is that there’s no recourse for consumers, and that’s changing,” said Reza Torkzadeh, a Los Angeles attorney representing the plaintiffs in the new cases.
- New York Times Editorial: One Industry’s Hold on the Senate Source: New York Times (Monday April 1, 2013)
Medical device makers are lobbying Congress to repeal the medical device tax, which is a source of revenue in the health care law that would expand health coverage to 30 million uninsured people. “The industry claims the tax will hurt demand for its products, but, in fact, sales of these devices, which are not purchased directly by consumers, are unlikely to be affected by price, especially by a small tax increase. As more people receive health coverage that pays for devices, the industry will more than make up the cost of the tax.”
- Joint pain, function not always better after surgery Source: MedCity News (Wednesday March 27, 2013)
Only about half of people who have a knee or hip replaced see meaningful improvements in pain and disability in the months after surgery, a new study from Canada suggests.
- Salesmen in the Surgical Suite Source: New York Times (Monday March 25, 2013)
New York Times story on a man who suffered a cascade of complications after receiving robotic surgery for a prostatectomy. He eventually died and his wife is suing the device maker. NYT reports on emails sent from device maker sales reps to hospitals urging them to switch their surgeries to robotic ones.
- Intuitive Surgical Loses Bid to Throw Out Robot Lawsuit Source: Bloomberg (Tuesday March 26, 2013)
The device maker must face claims that it did not providing proper training on their robotic devices.
- Illinois Hospital’s Experience with DePuy ASR Metal-on-Metal Hip Implant Underscores its Problems Source: Bad Medical Devices Blog (Friday March 22, 2013)
The high failure rate of the DePuy ASR metal-on-metal hip implant seen among the patients at one Illinois hospital underscores the dangers posed by this and other similar hip implants.
- How Much is that Hip Replacement in the Hospital? Source: Forbes (Tuesday February 12, 2013)
A study in the New England Journal of Medicine finds the cost of a hip replacement is difficult to determine.
- Medical Devices and Malware: The Latest Hospital-Acquired ‘Infection’ Source: Healthcare Informatics (Thursday March 21, 2013)
In recent months, the potential impact of malware on medical devices—and, ultimately, patient safety—has garnered considerable attention.
- FDA warns Stryker on quality issues, marketing practices Source: MedCity News (Tuesday March 12, 2013)
Orthopedic implant maker Stryker Corp said it received a warning letter from the U.S. Food and Drug Administration related to quality concerns at its Portage, Michigan facility.
- Metal-on-Metal Hips Still a Problem Doc Says Source: Medpage Today (Wednesday March 20, 2013)
“More than 2 years after the metal-on-metal Articular Surface Replacement XL system was taken off the market, rates of repeat surgery continue to rise, experience at one facility indicates.”
- Bacteria Clog Medical Devices Very Quickly, Study Shows Source: Infection Control Today (Friday March 1, 2013)
A new study examines how bacteria clog medical devices, and the result isn’t pretty. The microbes join to create slimy ribbons that tangle and trap other passing bacteria, creating a full blockage in a startlingly short period of time.
- Morning Joe video: Medical device malfunction in women Source: MSNBC (Monday March 18, 2013)
PBS medical correspondent discusses medical device malfunction in women on MSNBC’s Morning Joe show.
- Robosurgery Suits Detail Injuries as Death Reports Rise Source: Bloomberg (Tuesday March 5, 2013)
Bloomberg reporter: Intestines fall out of woman’s vagina after robot surgery. A review of adverse incident reports sent to the Food and Drug Administration since 2009 shows an increase. As the popularity of robot surgery has grown, injury reports involving the procedures jumped to at least 115 in 2012 from 24 in 2009, while deaths rose to 30 from 11.
- Intuitive Robot Probe Threatens Trend-Setting Surgeries Source: Bloomberg (Friday March 1, 2013)
The safety of robots made by Intuitive Surgical Inc. (ISRG) is being probed by U.S. regulators, raising questions about the prospects of one of the hottest technologies in health care.
- Improved Access to Device Information: What a UDI System Can Do for Patients and Consumers Source: Brookings Institution (Tuesday February 26, 2013)
Lisa McGiffert, director of Consumers Union’s Safe Patient Project participated in a Brookings Institution webinar for consumers on the Unique Device Identifier system for medical devices. UDIs when fully implemented would improve tracking of medical devices and allow patients and doctors to be better notified about device recalls.
- Johnson & Johnson Confirms Inquiry Into Hip Devices Source: New York Times (Friday February 22, 2013)
NYT: “Federal prosecutors are investigating Johnson & Johnson’s practices in marketing a line of hip replacements recalled in 2010 because many had to be replaced within a few years — part of a string of more than 30 product recalls by the company in the last three and a half years.”
- Johnson & Johnson discloses government probe of hip implants, surgical mesh Source: NJ.com (Friday February 22, 2013)
Johnson & Johnson disclosed government probes into two of its troubled products today.
- Journalists, Patient Advocates and Whistle blowers… Oh my! Source: The Peggy Lillis Memorial Foundation (Saturday February 23, 2013)
Christian Lillis shares highlights and stories of people he met at the Selling Sickness conference in DC.
- J&J Failed to Warn of Vaginal Mesh Risks, Jury Says Source: Bloomberg (Monday February 25, 2013)
Bloomberg: “Johnson & Johnson (JNJ)’s Ethicon unit failed to properly warn of the risks of a vaginal mesh implant and made fraudulent misrepresentations to a South Dakota nurse who sued, a New Jersey jury ruled in the first verdict in more than 2,100 lawsuits filed over the device.”
- Study: Hip implants more likely to fail in women Source: Associated Press (Monday February 18, 2013)
Associated Press reports: “Hip replacements are slightly more likely to fail in women than in men, according to one of the largest studies of its kind in U.S. patients. The risk of the implants failing is low, but women were 29% more likely than men to need a repeat surgery within the first three years.”
- Why Doctors Remain Silent Source: New York Times (Friday February 15, 2013)
“It might not be surprising to find that [Johnson & Johnson] executives acted to protect a company’s bottom line. Still, the Johnson & Johnson episode is also illuminating a broader medical issue: while experts say that doctors have an ethical obligation to warn their peers about bad drugs or medical devices, they often do not do so.”
- Johnson & Johnson recalls more metal hip implants Source: Chicago Tribune/Reuters (Thursday February 14, 2013)
Depuy, a unit of J&J that has already recalled their ASR metal on metal hip implants has issued another product recall. This recall is for Adept modular heads, a component of the metal-on-metal hip replacement device.
- New Questions About The Safety Of Hip Replacements Source: The Diane Rehm Show (Tuesday February 14, 2012)
The Food and Drug Administration recently issued new warnings on the safety of some hip replacements. As part of our occasional series, “Mind and Body,” Diane and her guests discuss what patients need to know about safety and cost of hip replacements. Full transcript here: http://thedianerehmshow.org/shows/2013-02-14/new-questions-about-safety-hip-replacements/transcript
- NYT Editorial: What a Company Knew About Its Metal Hips Source: New York Times (Sunday February 10, 2013)
NYT: Manufacturer of all-metal hips that failed and harmed many patients has a lot of explaining to do, now that there is evidence that the manufacturer knew of a serious problem with one of its models yet failed to alert patients or doctors and continued to market it aggressively.
- Price for a New Hip? Many Hospitals Are Stumped Source: New York Times (Monday February 11, 2013)
Health care prices are often hidden from consumers.
- Tim’s Horror Story regarding a ceramic on metal hip implant Source: Earl's View (Sunday February 10, 2013)
Tim’s Horror Story regarding a ceramic on metal hip implant
- Thousands of women sue over surgical mesh Source: Associated Press (Friday February 8, 2013)
Thousands of women harmed by surgical mesh implanted for pelvic organ prolapse sue manufacturers of pelvic mesh products for failing to disclose potential risks and fraudulently promoting the mesh as a safe medical device.
- Hollywood cardiologist’s ties with St. Jude sales rep raises red flags Source: Miami Herald (Saturday February 2, 2013)
Hollywood doctor regularly implants St. Jude pacemakers in his patients, generating more than half a million sales for the company last year. This doctor also happens to be a business partner with a St. Jude sales rep in two corporations that run yogurt shops. This raises some conflict of interest questions in the ongoing debate over a pending disclosure policy in Congress that would more clearly reveal financial ties between doctors and the healthcare industry.
- NYT Op-ed: Health Care’s Trick Coin Source: New York Times (Friday February 1, 2013)
Ben Goldacre writes an op-ed published in New York Times commenting on the “casual lack of transparency” in medicine as evidenced by the Johnson & Johnson metal hip lawsuits, where internal documents showed that executives had known of flaws in their device for some time, but had failed to make them public.
- During Trial, New Details Emerge About Hip Maker Source: New York Times (Wednesday January 30, 2013)
“Details about the involvement of an executive with the DePuy all-metal hip implant emerged Wednesday in Los Angeles Superior Court during the trial of a patient lawsuit against the DePuy Orthopaedics division of Johnson & Johnson. More than 10,000 lawsuits have been filed against DePuy in connection with the device — the Articular Surface Replacement, or A.S.R. — and the Los Angeles case is the first to go to trial. The information about the depth of the executive’s involvement with the implant may raise questions about DePuy’s ability to put the ASR episode behind it.”
- A Call to Prevent Unsafe, High-Risk Medical Devices From Reaching Patients Source: UCSF News (Monday January 28, 2013)
Commentary Sheds Light on FDA Approval Process for Implantable Body Parts
- J&J Failed Own Safety Test in Hip Design, Witness Says Source: Bloomberg (Tuesday January 29, 2013)
Witness testified in a suit against Johnson & Johnson that the company changed their test instead of the design of the device because a redesign would be too costly.
- A Call to Prevent Unsafe High-Risk Medical Devices from Reaching the Marketplace Source: Science Daily (Tuesday January 22, 2013)
“Some “high risk” surgical devices that have been approved by the U.S. Food and Drug Administration (FDA) are not required to go through clinical trials, where a product is tested to determine its safety and effectiveness.”
- Maker Aware of 40% Failure in Hip Implant Source: New York Times (Tuesday January 22, 2013)
NYT: “An internal analysis conducted by Johnson & Johnson in 2011 not long after it recalled a troubled hip implant estimated that the all-metal device would fail within five years in nearly 40 percent of patients who received it, newly disclosed court records show.”
- FDA Metal-on-Metal Hip Implants: Safety Communication
Updated safety information for metal on metal hips.
- FDA Clamps Down on Metal-on-Metal Hips Source: Medpage Today (Thursday January 17, 2013)
Metal on Metal hips are the subject of an FDA proposal to require pre-market safety testing which is currently not required.
- Doctors Weigh Risks of Metal Hips as FDA Tightens Reviews Source: Bloomberg (Thursday January 17, 2013)
Makers of all-metal, total-hip replacement products will now have to file approval applications for the strictest level of agency device review, the FDA said today in a statement on its website.
- F.D.A. Seeks to Tighten Regulation of All-Metal Hip Implants Source: New York Times (Wednesday January 16, 2013)
FDA is proposing new regulations that makers of metal-on-metal hip implants would have to prove the devices were safe and effective before they could continue selling existing ones or obtain approval for new all-metal designs.
- Dr Tower writes to Senator re concerns about the regulatory malfeasance at the FDA – Metal-on-Metal hip replacement debacle Source: Earl's View (Sunday January 6, 2013)
Letter by Alaskan orthopedic surgeon Dr. Tower to his Senator re concerns about the regulatory malfeasance at the FDA – Metal-on-Metal hip replacement debacle. Dr. Tower was injured by the same metal-on-metal hip he implanted in patients. Dr. Tower’s story was featured in Consumer Reports’ medical device May 2012 article, “Dangerous Medical Devices.”
- Patient safety: Kiani "blown away" by pledges to open up healthcare data Source: Mass Device (Monday January 14, 2013)
Medical device company CEO plans today to unveil a list of medical device companies who signed a pledge to make data gathered by their devices accessible to the public.
- Ninth Circuit Backs Plaintiffs in Medical Device Litigation Source: The Recorder (Thursday January 10, 2013)
A ruling on a state lawsuit concerning medical devices found that federal law will not pre-empt or prevent the case from moving forward.
- Rochester woman in bellwether case on hip implants Source: Rochester Business Journal (Monday January 7, 2013)
A Rochester area woman’s court complaint has been selected to be heard as one of two bellwether cases that will help decide the outcome of several thousand suits targeting DePuy Orthopaedics Inc. and Johnson & Johnson for selling allegedly defective hip implants.
- Should You Have Unfettered Access to Your Implanted Medical Device Data? Source: IEEE (Friday December 7, 2012)
- J&J's first vaginal mesh trial revs up this week Source: Fierce Medical Devices (Monday January 7, 2013)
Fierce Medical Devices reports: “For Johnson & Johnson ($JNJ), jury selection is scheduled to begin Jan. 7 for one of 1,800 lawsuits in New Jersey state court accusing the company of selling unsafe vaginal mesh implants without warning patients of the dangers.”
- What's the deal with those bad hip replacements? Source: Doctor Skeptic (Tuesday January 1, 2013)
“Most people are aware that a year or two ago there were some new hip replacements that were recalled. The story behind it has all the ingredients to suit this blog: overestimation of benefit, underestimation of harm, regulation failure, and conflict of interest up the wazoo.”
- Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments Source: FDA (Monday January 28, 2013)
Report any problems you might have with a Zimmer spine to your physician and the FDA at www.fda.gov/MedWatch/report.htm.
- Reporting complications from medical devices to the FDA Source: FDA (Friday December 21, 2012)
FDA’s MedWatch
- ‘Redo’ joint replacement surgeries on rise in Western Pa. Source: Pittsburgh Tribune-Review (Sunday November 25, 2012)
- YES, YOU CAN HACK A PACEMAKER (AND OTHER MEDICAL DEVICES TOO) Source: Singularity HUB (Sunday December 9, 2012)
“For years, researchers have been exposing enormous vulnerabilities in internet-connected implanted medical devices.”
- FDA pledges to work with medical device industry consortium to speed up product approvals Source: Associated Press (Monday December 3, 2012)
AP: The Food and Drug Administration said Monday it will collaborate with medical device manufacturers on a public-private partnership designed to speed up the development of new medical technology.
- Heart Gadgets Test Privacy-Law Limits Source: Wall Street Journal (Wednesday November 28, 2012)
A recent swell of digital-medical data collected on devices outside of a doctor’s office is raising some thorny questions: Who owns the rights to a patient’s digital footprint and who should control that information? WSJ’s Linda Blake reports.
- Consumer Agency Finds Most Adult Bedrail Deaths Are Among Those 60 and Older Source: New York Times (Thursday November 29, 2012)
New Consumer Product Safety Commission report cited 155 deaths involving bedrails from January 2003 to this past September. About 126 of those who died were 60 or older.
- A Female Surgical Nightmare Source: In These Times (Wednesday June 13, 2012)
How a problematic medical device has escaped FDA regulation. A look at surgical mesh used on women for a prolapsed uterus.
- Podcast: Dead On the Operating Table: A Q&A with journalist Mina Kimes Source: ProPublica (Tuesday November 27, 2012)
ProPublica interviews journalist Mina Kimes of Fortune Magazine. Her report, “Bad to the Bone: A Medical Horror Story,” lays out in detail how a medical device company navigated around Food and Drug Administration rules meant to inform and protect patients.
- A Name Blacked Out, a Reputation at Risk Source: New York Times (Monday November 26, 2012)
NYT’s Barry Meier reports on a medical device company whose executives blacked out the name of a heart device component when they released a critical federal report involving the product. This is the latest development in the controversy involving the component, an electrical wire that connects an implanted defibrillator to a patient’s heart.
- After Dozens of Deaths, Inquiry Into Bed Rails Source: New York Times (Sunday November 25, 2012)
Since those first warnings in 1995, about 550 bed rail-related deaths have occurred, a review by The New York Times of F.D.A. data, lawsuits, state nursing home inspection reports and interviews, found. Last year alone, the F.D.A. data shows, 27 people died.
- Companies go surgery shopping Source: Los Angeles Times (Saturday November 17, 2012)
Employers are sending workers on all-expenses-paid trips to top-performing hospitals that agree to low, fixed rates for surgeries, such as hip and knee surgeries.
- Unnecessary surgery show Source: White Coat, Black Art (Saturday November 3, 2012)
30 minute program about unnecessary surgery, including hip and knee replacements.
- As Sales Fall, Allergan Seeks a Buyer for Lap-Band Source: New York Times (Tuesday October 30, 2012)
Allergan said Tuesday that it was looking to divest itself of its Lap-Band, the once-popular weight-loss device that has experienced several years of falling sales, loss of market share and controversies about its safety and effectiveness.
- Going Virtual To Improve Patient Safety Source: iHealthBeat (Monday October 29, 2012)
Created using computer-aided design to comprise FDA’s “Virtual Family Tool,” the models are being used to assess the safety and efficacy of medical implants and devices, and radiologic imaging.
- Ethicon Endo-Surgery Circular Stapler Sets: Class I Recall - User Difficulty With Firing Stapler Devices Source: FDA (Friday October 26, 2012)
FDA notified healthcare professionals of a Class I Recall of these products because of difficulty users have firing the stapler devices, resulting in incomplete firing stroke and incomplete staple formation.
- Medtronic's pull influenced Infuse articles, report finds Source: Star Tribune (Thursday October 25, 2012)
U.S. Senate panel alleges that Medtronic was heavily involved in shaping the content of medical journal articles about one of its bone graft devices, downplaying its risks.
- Senate report finds Medtronic manipulated studies on its products Source: The Hill (Thursday October 25, 2012)
Leaders with the Senate Finance Committee are charging medical device maker Medtronic with manipulating studies on its spine-fusion product and failing to disclose significant financial ties to the studies’ authors.
- Analysis: When implanted medical devices go wrong, who pays? Source: Reuters (Monday October 8, 2012)
As the number of costly, high-profile recalls rises, along with pressure to cut their own spending, insurers are starting to pin more of the responsibility on manufacturers.
- “Mesh: Definitely risky for POP, but for SUI? Eh? It might be ok still, right?” Source: Mesh Medical Device News (Wednesday October 10, 2012)
Deb wonders when the FDA will issue something on Stress Urinary Incontinence (SUI) mesh.
- Hundreds of NZ hip replacements are faulty Source: New Zealand Herald (Thursday October 4, 2012)
A victim of a faulty hip replacement is not confident an inquiry will be launched into metal-on-metal implants, despite another 400 patients this week finding out their replacements could be faulty.
- GAO: Medical Devices Vulnerable to Hacking, Oversight Needed Source: iHealthBeat (Friday September 28, 2012)
GAO report warns of dangers of medical devices that rely on software to operate such as pacemakers and insulin pumps could be vulnerable to hacking.
- Smith & Nephew issues failure warning on all-metal hips Source: Fierce Medical Devices (Wednesday September 26, 2012)
Smith & Nephew has issued a warning on its Birmingham metal-on-metal hip implants, telling regulators that new data reveals higher rates of failure for the devices.
- Bad to the bone: A medical horror story Source: Forbes (Tuesday September 18, 2012)
Patients getting spine surgery became unwitting participants in clinical trials testing the off label use of a cement that is injected in the spine. After reported deaths from the off label use, the company, Synthes now owned by J&J, continued to urge orthopedic surgeons to use it on patients.
- Unpredictable Danger Looms Close to the Heart Source: New York Times (Friday September 7, 2012)
Years after her 4-year-old daughter’s heart device had a faulty wire that needed to be removed, mother of Avery de Groh worries about what to do with her daughter’s replacement wire that was recalled in December. As many as 20 percent of 128,000 patients worldwide with the Riata device may be affected. Some patients have elected to remove the Riata lead but there are risks involved with either decision.
- Shared Decision Making for Hip and Knee Replacement Candidates Source: The Doctor Weighs In (Thursday September 6, 2012)
Hip and knee replacement candidates could benefit from shared decision making to guide their health care decisions.
- Solicitor Says DePuy Case May Affect 600 In Cork Source: Earl's View (Saturday September 1, 2012)
Up to 3,500 Irish people were fitted with the faulty ‘metal on metal’ hip replacement implants, recalled by DePuy worldwide on August 24th, 2010 in the face of data gathered by UK academics and medics that showed higher than expected failure rates of the devices.
- Feds notify hospitals of liability for wrongly implanted heart devices Source: Modern Healthcare (Thursday August 30, 2012)
“In what experts say is a novel legal tactic to resolve hundreds of ongoing investigations simultaneously, the Justice Department is e-mailing hospitals across the country today with instructions to examine questionable implantable defibrillator surgeries on Medicare patients and estimate potential penalties under the False Claims Act.”
- "Steel Standing" : Metal allergy causes woman's muscles to wither Source: ABC 3340 (Monday July 30, 2012)
Alabama woman develops muscular problems after receiving metal implants.
- Markey, Merkley Call on FDA to Reform Medical Devices Databases Source: U.S. Congressman Ed Markey (Wednesday August 15, 2012)
Today, Representative Edward J. Markey (D-Mass.) and Senator Jeff Merkley (D-Ore.) sent a letter to the Food and Drug Administration (FDA) calling on the agency to overhaul and streamline the federal databases that provide information to the public about the safety of medical devices that rarely undergo clinical trials in humans before being sold on the market. In the absence of legislation that would close the current loophole in federal law that allows defective devices to enter the market and jeopardize patient safety, the lawmakers are urging reforms be made immediately to the FDA’s main medical device databases.
- Congressmen Ask FDA to Update Database to Improve Medical Device Safety Source: New York Legal Examiner (Monday August 27, 2012)
In an effort to make the data concerning medical devices more available to the public, Representative Edward Markey (D-Massachusetts) and Senator Jeff Merkley (D-Oregon) have sent a letter to the FDA. In the letter, they ask about the FDA’s willingness to make changes to the 510(k) premarket notification database. The lawmakers requested answers to their questions by September 19, 2012.
- Fat-Melting Device a Weighty Matter for FDA Source: Fair Warning (Wednesday July 11, 2012)
For several years, doctors and medical spas around the country have touted a fat-melting device called the LipoTron 3000, or Lipo-Ex, as a revolutionary way for people to slim down. But the device has never been cleared or approved by the FDA, which would make it illegal under federal law to sell or promote it for weight loss.
- Over 123 Million Medical Device Units Recalled in Second Quarter of 2012, Reaching an Eight-Quarter High, According to the ExpertRECALL Index Source: Wall Street Journal Market Watch (Tuesday August 21, 2012)
More than 123 million units in the medical device category – which includes products like knee replacements, syringes, gels used in ultrasound procedures, dental implants, and products used in heart surgery – were recalled during the second quarter of 2012, according to the quarterly ExpertRECALL(TM) Index released today.
- ‘Toxic’ hip replacement fears – Health – Belfast Newsletter Source: Earl's View (Wednesday August 22, 2012)
Earl’s View blog reports that UK media outlets are reporting a new warning for metal on metal hip implants, claiming that the risk from the devices is greater than previously thought, with greater failure rates.
- Covidien recalls, discontinues device tied to deaths Source: Fierce Medical Devices (Wednesday August 22, 2012)
Covidien recalls its surgical tools after its products were linked to serious injuries and deaths.
- J&J's Synthes recalls bone putty over fire risk Source: Fierce Medical Devices (Tuesday August 21, 2012)
Johnson & Johnson’s ($JNJ) Synthes unit launched a recall of its Hemostatic Bone Putty, warning that the implant could catch fire if exposed to cauterization systems during surgery, and the FDA has slapped its most serious label on the affair.
- FDA warns Medtronic on manufacturing guideline violations Source: Reuters (Tuesday August 21, 2012)
The U.S. health regulator warned Medtronic Inc that certain devices manufactured by the company violated manufacturing and quality regulations that could lead to patient injuries.
- FDA warns Medtronic over implantable drug infusion pump snafu Source: Fierce Medical Devices (Tuesday August 21, 2012)
The FDA slapped Medtronic ($MDT) with a warning letter over a faulty implantable drug infusion pump that appears susceptible to corrosion, a fatal flaw that could injure patients.
- Trouble for St. Jude as study flags Durata failures Read more: Trouble for St. Jude as study flags Durata failures Source: Fierce Medical Devices (Tuesday August 21, 2012)
St. Jude Medical ($STJ) has been working to distance its Durata line of leads from the recalled Riata devices, but a new study reports that some of newer techs suffer from the same problem.
- St. Jude Heart Defibrillator Recipients Need X-Rays To Check For Abnormalities: FDA Source: Reuters (Thursday August 16, 2012)
Patients implanted with certain heart defibrillators made by St. Jude Medical Inc should have X-rays or other imaging tests to check for abnormalities, the U.S. Food and Drug Administration said on Thursday.
- St. Jude’s Defibrillator Leads: Information for Patients Source: Wall Street Journal Health Blog (Monday August 16, 2010)
The FDA advised doctors to begin routinely screening the nearly 80,000 U.S. patients who have Riata defibrillator leads in their chests with X-rays to search for signs that a device’s insulation is wearing away.
- Doctors Grapple With FDA Advice For Troubled Heart Wire Source: Wall Street Journal Health Blog (Friday August 17, 2012)
When U.S. regulators advised doctors to routinely X-ray patients with a flawed St. Jude Medical Inc. heart device Thursday, top heart doctors asked, “why?” The agency doesn’t recommend that doctors treat patients any differently if they detect flaws, potentially subjecting thousands of people to unneeded medical tests.
- FDA recommends X-ray or other imaging on implanted heart defibrillators with St. Jude Medical Riata leads to help guide treatment Source: FDA (Thursday August 16, 2012)
The U.S. Food and Drug Administration recommended today that patients who have implantable heart defibrillators with Riata and Riata ST leads, manufactured by St. Jude Medical, should have X-rays or other imaging alternatives to check for abnormalities in the insulation surrounding the lead, which is a wire attached to the device that is inserted into the heart.
- Wright subpoenaed over metal hip implants Source: Fierce Medical Devices (Wednesday August 8, 2012)
Wright Medical hit with subpoena over metal-on-metal hip replacement.
- Use Of 13 Disease Registries In 5 Countries Demonstrates The Potential To Use Outcome Data To Improve Health Care’s Value Source: Health Affairs (Thursday December 1, 2011)
Abstract only. Authors of a study published in Health Affairs Dec 2011 calculate that if the United States had a registry for hip replacement surgery comparable to one in Sweden that enabled reductions in the rates at which these surgeries are performed a second time to replace or repair hip prostheses, the United States would avoid $2 billion of an expected $24 billion in total costs for these surgeries in 2015.
- Two Arms, Two Choices: If Only I’d Known Then What I Know Now Source: Health Affairs (Wednesday August 1, 2012)
Disabled by faulty arm surgery and harmed by a hospital-acquired infection, a patient wishes he’d been better informed. Article by Colorado patient safety advocate Kerry O’Connell for Health Affairs.
- Pennsylvania woman to address FDA panel on husband's hip-replacement recall Source: The Philly Inquirer (Wednesday June 27, 2012)
Pennsylvania woman travels to DC to share her husband’s story about problems with his recalled metal on metal hip.
- The FDA Is Spying on Its Own Scientists Source: Mother Jones (Wednesday August 1, 2012)
Tom Philpott: “It looks like the FDA knowingly chose to expose untold thousands of people to unnecessary cancer risk to apparently to appease General Electric and other medical-device makers.”
- Couple wins landmark trial against medical company Source: KGET (Monday July 23, 2012)
California woman harmed by vaginal mesh wins case against medical device company
- Congress Gives FDA 2 Years to Issue Social Media Guidance. All Bark, No Bite. Source: Pharma Marketing Blog (Friday July 20, 2012)
Congress Gives FDA 2 Years to Issue Social Media Guidance. All Bark, No Bite.
- FDA investigating how device-approval files leaked Source: Fierce Medical Devices (Monday July 16, 2012)
The FDA is already facing a lawsuit from 5 current and former investigators after the agency monitored their email communications. Now the regulator has another problem: About 75,000 pages of related confidential documents ended up posted online for all to see.
- CORRECTED-St. Jude's Riata large-diameter leads have most problems-study Source: Reuters (Monday July 16, 2012)
St. Jude Medical Inc said on Monday initial findings from a study on its Riata defibrillator leads, which were recalled in late 2011, showed that lead erosion that occurred from the inside out happened most frequently in larger diameter leads.
- St. Jude: Riata erosion more common in large leads Source: Fierce Medical Devices (Monday July 16, 2012)
St. Jude Medical ($STJ) is investigating the dangers of its now-recalled Riata leads, and the company says larger-diameter models are more likely to suffer from erosion.
- Vast F.D.A. Effort Tracked E-Mails of Its Scientists Source: New York Times (Saturday July 14, 2012)
“F.D.A. officials defended the surveillance operation, saying that the computer monitoring was limited to the five scientists suspected of leaking confidential information about the safety and design of medical devices.”
- Reports From F.D.A. Surveillance Operation Source: New York Times (Saturday July 14, 2012)
These documents were reports from a surveillance operation by the Food and Drug Administration against a group of its own scientists. For privacy reasons, the Times redacted the names of several scientists and others named in the memo who have not been publicly identified.
- As lawsuits climb, J&J may have new hip trauma Source: Fox News (Thursday July 12, 2012)
Johnson & Johnson has another metal hip problem. After recalling the ASR hip, it appears the “Pinnacle hip replacement” which was manufactured by J&J after the ASR hip is showing similar problems.
- Replay of FDA teleconference on sterilizer product recall available Source: AHA News (Friday July 6, 2012)
The Food and Drug Administration yesterday held an informational teleconference on the voluntary recall of a product used by hospitals and surgical centers to monitor the effectiveness of certain sterilization systems.
- U.S. plans IDs to track medical device safety Source: Reuters (Tuesday July 3, 2012)
“While these codes are already present for most consumer goods, in the ubiquitous barcodes scanned at the grocery store, they have been absent from life-sustaining medical devices.”
- Medical devices will begin getting special codes to help improve patient safety Source: New Jersey Star Ledger (Tuesday July 3, 2012)
FDA is developing a system to identify each medical device with a special code to help notify patients of recalls and other problems under a new rule proposed by the FDA.
- Obama Signs FDA User Fee Bill Into Law Source: Regulatory Focus (Monday July 9, 2012)
US President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law on 9 July 2012—12 days after the Senate approved the bill and 17 days after the House of Representatives passed the bill.
- Stryker recalls certain hip implant products Source: Reuters (Friday July 6, 2012)
Orthopedic implant maker Stryker Corp said it has begun to recall certain modular-neck stems used to correct hip biomechanics, due to potential risks associated with fretting and corrosion.
- Stryker recalls metal hip implants over corrosion risk Source: Fierce Medical Devices (Monday July 9, 2012)
Stryker is recalling two metal-on-metal hip implants, halting worldwide production of the devices amid concerns of fretting and corrosion.
- MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA Source: HealthLeaders Media (Thursday July 5, 2012)
Cheryl Clark for HealthLeaders Media reports: Metal-on-metal hips — an FDA panel renews concern. Should implants be suspended until safety experts figure this out?
- FDA alerts hospitals, surgical centers to sterilizer product recall Source: AHA News (Thursday July 5, 2012)
The Food and Drug Administration Tuesday announced the voluntary recall of a product used by hospitals and surgical centers to monitor the effectiveness of certain sterilization systems.
- FDA Recalls Baby Breathing Device Source: MedPage Today (Thursday July 5, 2012)
The FDA has elevated the recall of an infant breathing circuit to Class I due to the potential formation of a crack that can reduce tidal volume in therapy and may cause death.
- Delays and Difficulties in Assessing Metal-on-Metal Hip Implants Source: NEJM (Thursday July 5, 2012)
The FDA ordered manufacturers to conduct post market studies on these devices a year ago but few have even started studies much less supply FDA with useful data on their performance.
- FDA seeks unique device ID code Source: Minneapolis Star Tribune (Tuesday July 3, 2012)
The proposed identifiers would make high-risk medical devices easier to track and recall, the agency says, improving patient safety. Article quotes Consumers Union.
- FDA lays out new system to track medical devices Source: McClatchy Newspapers (Thursday July 5, 2012)
On Tuesday, the U.S. Food and Drug Administration proposed a new system to better track high-risk medical devices after they have gone public, giving patients, doctors, regulators and consumer advocates access to information about specific products. Consumers Union quoted in the article.
- Medical devices will begin getting special codes to help improve patient safety Source: NJ Star-Ledger (Tuesday July 3, 2012)
Medical devices will start being manufactured with a special code to help identify them in the event of recalls and other problems under a new rule passed by federal regulators. Consumers Union quoted in the article.
- Medical Devices To Get Unique Identification Numbers In FDA Plan Source: Bloomberg (Tuesday July 3, 2012)
Medical devices including catheters, defibrillators, heart stents and artificial joints will carry unique identification numbers under a plan proposed by the U.S. Food and Drug Administration to improve patient safety.
- FDA says device-ID plan a 'game-changer' Source: Fierce Medical Devices (Thursday July 5, 2012)
The FDA has released its plan to track medical devices by requiring each to feature a unique identification system, which the agency hopes will improve accuracy of reporting and keep patients safe, The Wall Street Journal reports.
- FDA proposes unique device identification system for medical devices Source: FDA (Tuesday July 3, 2012)
The U.S. Food and Drug Administration proposed that most medical devices distributed in the United States carry a unique device identifier, or UDI.
- Metal Hip Replacements Could Cause Chronic Pain, Should Be Avoided Source: The Christian Post (Saturday June 30, 2012)
Reporting on FDA’s 2-day panel on the safety of metal-on-metal hip implants.
- Study: iPad use could muddle shunt settings Source: Fierce Medical Devices (Friday June 29, 2012)
The small magnets in iPads can scramble the settings on implantable shunts, a new study reports, and researchers are cautioning parents to keep a distance between the mobile devices and kids with the hydrocephalus-treating techs.
- FDA panel recommends against metal-on-metal hip implants Source: Fierce Medical Devices (Friday June 29, 2012)
Reporting on FDA’s 2-day panel examining the safety of metal-on-metal hip implants.
- FDA user fee bill passes Senate, 92-4 Source: Politico (Wednesday June 27, 2012)
Next stop-the President.
- Hip, Hip, Delay Source: Gooznews (Wednesday June 27, 2012)
Metal hip hearing comes after passage of the FDA user fee bill which fails to address inadequate safety testing crucial to safe hip implants.
- F.D.A. Hearing to Focus on Replacement Hips Source: New York Times (Tuesday June 26, 2012)
“Why were these devices implanted in 500,000 people without adequate testing?”
- FDA panel sees little use for metal-on-metal hips Source: Associated Press (Friday June 29, 2012)
Report on the FDA panel examining the safety of metal-on-metal hips.
- F.D.A. Hearing to Focus on Replacement Hips Source: New York Times (Tuesday June 26, 2012)
The Food and Drug Administration will start a two-day hearing on Wednesday meant to help doctors find ways to better monitor the risks posed by all-metal replacement hips.
- J&J Sold Vaginal Mesh Implant After Sales Halt Ordered Source: Bloomberg (Tuesday June 26, 2012)
On June 5, J&J said it will stop selling four vaginal mesh implants including the Prolift in response to lawsuits. The company will not withdraw the Prolift before its “planned discontinuation” of the mesh products over the next three to nine months.
- Hip Implant Concerns Reached 16,800 In A Decade, FDA Says Source: Bloomberg (Thursday June 21, 2012)
Almost 16,800 adverse events associated with metal-on-metal hip implants were reported in the U.S. from 2000-2011, FDA said.
- House rushes through approval of new PDUFA legislation Source: Fierce Biotech (Thursday June 21, 2012)
Next stop-the Senate and then the President’s desk.
- House Passes Compromise FDA Reauthorization Measure Source: Bloomberg (Wednesday June 20, 2012)
The House passed the drug and medical device user fee bill that came out of conference that ironed out the differences between the House and Senate bills passed earlier.
- Kidney-donor deaths linked to surgical clips raise issues of alerts, warnings Source: CNN (Thursday June 21, 2012)
Tiny surgical clips were linked to the death of a woman who donated a kidney. Hospitals are alerted against using clips in laparascopic kidney donor surgery. But at least five deaths raise issues about whether stronger warnings are needed.
- Podcast: Talking Mesh with Amanda Marcotte of RH RealityCast Source: In These Times (Monday June 18, 2012)
Lindsay Beyerstein spoke with Amanda Marcotte of RH RealityCast about “A Female Surgical Nightmare,” her new feature about how one flawed women’s health product reveals the shortcomings of the FDA’s medical device regulation system.
- A Female Surgical Nightmare Source: In These Times (Wednesday June 13, 2012)
How a problematic medical device has escaped FDA regulation. Lindsay Beyerstein reports on problems experienced by women who use mesh products for transvaginal repair of pelvic organ prolapse.
- House cheers, approves FDA reform bill Source: The Hill (Wednesday June 20, 2012)
House approves FDA User Fee compromise bill.
- Medical-device spokesman's claim on heart disease termed 'overstated,' 'outlandish' Source: MinnPost (Monday June 18, 2012)
Dale Wahlstrom of LifeScience Alley (medical device industry trade group) recently claimed that medical devices had cut the death rate from heart disease by 50% and for strokes by 30%. Those estimates have been criticized for being wildly overblown since therapeutic drugs and lifestyle changes are the main reason deaths from heart disease and strokes have dropped in recent years:
- Kera News NPR report on knee replacement surgery Source: Kera News (Monday June 18, 2012)
Kera News interviews a North Texas doctor discussing custom fit knee implants. Unfortunately, this doctor makes no mention of patient safety risks of these new knee implants.
- Knee implants: more evidence needed? Source: Biggleswade Chronicle (Monday June 18, 2012)
BBC reports on a new report in The Lancet that said more evidence is needed on long-term safety of knee implants. New implants are often introduced with little or no evidence of their effectiveness.
- Bundled Payments and Joint Replacement Source: HealthLeaders Media (Wednesday June 13, 2012)
To reduce expenses for medical devices, healthcare systems are getting involved with bundled payments, and joint replacement is seen as an important niche for such programs.
- Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry Source: New York Times (Thursday June 14, 2012)
The Food and Drug Administration is investigating whether the nation’s largest operator of dialysis centers violated federal regulations by failing to inform customers of a potentially lethal risk connected to one of its products, an F.D.A. official said.
- Consumers Union Urges Congress to Adopt Stronger Medical Device Patient Safety Source: Clarksville Online (Wednesday June 13, 2012)
Consumers Union, the policy and advocacy arm of Consumer Reports, urged House and Senate leaders today to adopt a number of provisions from the Senate’s FDA User Fee Act that would better protect patients from potentially dangerous medical devices than the version passed by the House.
- More Women Need To Be Involved In Medical Device Trials Source: CT Health I Team (Friday June 8, 2012)
Only recently has the FDA proposed guidelines to improve the representation of women in clinical device trials, but these guidelines are nonbinding and experts are skeptical that the medical device industry will comply.
- Congress leaves dangerous medical device loophole intact Source: The Orange County Register (Tuesday June 5, 2012)
Despite heavy lobbying by consumer groups, Congress last week declined to close a loophole that allows medical devices based on flawed predecessors to make it to market. Article quotes Lisa McGiffert, head of the Safe Patient Project for Consumers Union.
- Report: J&J To Stop Selling Controversial Vaginal Mesh Implants Source: Common Health (Tuesday June 5, 2012)
Common Health of Boston’s NPR news station reports on J&J’s decision to halt sales of several vaginal mesh implants that many women say have led to painful and debilitating long-term complications.
- Surgery Under Scrutiny: What Went Wrong With Vaginal Mesh Source: Common Health (Friday November 4, 2011)
Common Health of Boston’s NPR news station interviews women who have been seriously injured by vaginal mesh implants and details how these devices are cleared for sale through the FDA’s fast-track process.
- J&J To Halt Sales Of Vaginal Mesh Implants Source: Pharmalot (Tuesday June 5, 2012)
Pharmalot reports on Johnson & Johnson’s unexpected move to halt marketing of four vaginal mesh implants that have harmed women.
- Congress leaves dangerous medical device loophole intact Source: Orange County Register (Tuesday June 5, 2012)
Both House and Senate failed to include an amendment that would stop the practice of using faulty devices as predicates used in order to get a new device on the market.
- J&J To Halt Sales Of Vaginal Mesh Implants Source: Pharmalot (Tuesday June 5, 2012)
The decision involves four Gynecare products – TVT Secur; Prosima Pelvic Floor Repair System, Prolift Pelvic Floor Repair System and the Proflit MTM Pelvic Floor Repair System.
- Report: J&J To Stop Selling Controversial Vaginal Mesh Implants Source: WBUR Boston (Tuesday June 5, 2012)
J & J has stopped production of 4 vaginal mesh products: TVT Secur; Prosima Pelvic Floor Repair System, Prolift Pelvic Floor Repair System and the Proflit MTM Pelvic Floor Repair System. All four have been the subject of lawsuits involving serious patient harm.
- House affirms FDA user fee in sweeping bipartisan vote Source: MassDevice (Wednesday May 30, 2012)
House passes medical device bill, which fails to includes important provisions needed to protect patients from unsafe medical devices, according to Consumers Union, the policy and advocacy arm of Consumer Reports.
- Consumer groups unhappy with bill easing medical device FDA review process Source: Minnesota Public Radio (Tuesday May 29, 2012)
Minnesota Public Radio reports on the medical device legislation pending in Congress.
- U.S. Senate passes bipartisan FDA funding bill Source: Reuters (Thursday May 24, 2012)
Update from Reuters on the medical device user fee bill. “Congress is missing the opportunity to fix a broken system that lets too many unsafe medical devices on the market,” said Lisa McGiffert, director of the Safe Patient Project at Consumers Union.
- FDA user fee bill passed by Senate Source: Politico (Thursday May 24, 2012)
Senate passes FDA user fee bill but misses important patient safety protections. Lisa Swirsky, senior policy analyst at Consumers Union, quoted.
- White House statement on Senate medical device bill Source: White House (Thursday May 17, 2012)
The White House issues a statement endorsing the S. 3187, the Food and Drug Administration Safety and Innovation Act.
- FDA rule clears medical devices without human testing Source: The Orange County Register (Saturday May 19, 2012)
The Orange County Register reports on dangerous flaws in the fast-track 510k medical device regulatory process. Lisa McGiffert, Director of Consumers Union’s Safe Patient Project quoted.
- Bipartisanship in Congress, in Support of Pharma and Device Industries Source: Hooked: Ethics, Medicine, and Pharma (Tuesday May 15, 2012)
Howard Brody, MD, PhD writes about the bipartisan support in Congress for approving FDA user fee bills that fail to address the concerns of consumer advocates.
- Consumer Reports on the Device Mess Source: Hooked: Ethics, Medicine, and Pharma (Wednesday April 4, 2012)
Coverage on the Consumer Reports investigation of dangerous medical devices by Howard Brody, MD, PhD.
- Video: Questionable medical bill passes through House committee Source: KGO-TV San Francisco ABC7 (Wednesday May 16, 2012)
Medical device bills in Congress fail to address a dangerous loophole that allows FDA fast-track approval of medical devices as long as they resemble devices that have already been approved, even if the original devices have been recalled for safety defects.
- Medical Device Recalls Soar During First Quarter, ExpertRECALL Index Shows Source: Wall Street Journal (Monday May 14, 2012)
Medical device recalls increased more than 160 percent in the first quarter of 2012, affecting more than five times as many units than the previous quarter, according to the quarterly ExpertRECALL(TM) Index.
- Medical Implant Recalls Raises Questions About 510k Review Process Source: U.S. PIRG (Thursday May 10, 2012)
The huge increase in recalls and repeat surgeries calls into question if the 510 (k) review process is really protecting consumer’s health.
- Agonizing Choices for Heart Patients Source: Wall Street Journal (Friday May 11, 2012)
Patient with recalled defibrillator lead decides he wants to have his leads removed to avoid the device failing. The removal surgery can be damaging as well, but a growing number of patients are making the difficult decision to remove the leads. 79,000 U.S. patients are implanted with the troubled Riata defibrillator lead.
- FDA user fee bill appears safe from GOP poison pills Source: Politico (Sunday May 6, 2012)
“There’s a bipartisan push to get the FDA bill — negotiated with the medical device and pharmaceutical industries — enacted ahead of the Supreme Court ruling on the health reform law expected in June, which could quickly pull a relatively bipartisan health-related bill into a swamp of political grandstanding.”
- MDUFMA: FDA user fee agreements survive partisan fray in the House Source: MassDevice (Monday May 7, 2012)
Lawmakers are motivated to maintain bipartisan momentum on FDA user fee bills. A U.S. House version of a bill reauthorizing FDA user fees for medical devices and pharmaceuticals, posted just before the weekend, will head to the House Energy & Commerce Subcommittee tomorrow for an open markup session.
- How Does the FDA Monitor Your Medical Implants? It Doesn’t, Really Source: ProPublica (Thursday May 3, 2012)
How many Americans get medical implants each year? The FDA doesn’t know either.
- More women describe transvaginal mesh problems Source: CTV News (Tuesday May 1, 2012)
Since CTV News first reported on a class action lawsuit filed on behalf of women who say they have had life-altering complications from something called transvaginal surgical mesh sling, more women have come forward with similar complaints.
- Four Medical Implants That Escaped FDA Scrutiny Source: ProPublica (Monday April 30, 2012)
ProPublica takes a closer look at four types of implantable medical devices that have drawn the most criticism: hip implants, surgical mesh, heart valve rings and defibrillator leads.
- Practical steps to help the device industry Source: Star Tribune (Sunday April 29, 2012)
StarTribune’s Howard Root writes that the industry needs a better prepared labor force. It can’t all be blamed on regulations.
- New York Times Editorial: Cozy Deal Source: New York Times (Saturday April 28, 2012)
“The best approach would be for the government to fully finance the F.D.A. That is unlikely to happen. So before it ratifies any new deal on “user fees,” Congress must ensure that patient safety is the first priority.”
- Senate panel adds safety measures to FDA user fee act Source: MassDevice (Wednesday April 25, 2012)
The U.S. Senate’s Health, Education, Labor & Pensions Committee passes the “Food & Drug Administration Safety and Innovation Act,” but fails to include provisions consumer advocates insist are necessary to protect patients from unsafe medical devices.
- FDA Plans ID-Tag System to Detect Faulty Devices Source: Wall Street Journal (Wednesday April 25, 2012)
FDA’s unique identifier system will tap medical and billing records from hospitals and insurance companies that could potentially allow the agency to know more precisely the rate at which a device is failing, and which patients have devices prone to malfunctions. Five years ago, Congress authorized the creation of Unique Device Identifiers but we still don’t have them.
- Michigan Lawmaker Wants FDA Promoting Jobs, Industry Source: Mesh Medical Device Newsdesk (Friday April 20, 2012)
Jane Akre reports on the medical device user fee debate in Congress. One Michigan lawmaker has proposed a legislative amendment that would change the FDA’s mission to include job creation.
- FDA rips Europe's system for medical device reviews Source: Star Tribune (Sunday April 22, 2012)
Under pressure by the medical device industry to speed up device approvals in the upcoming reauthorization of medical device user fees, an FDA report sheds light on the safety issues associated with the device approval process in the European Union.
- House Energy & Commerce Health Subcommittee April 18, 2012 Hearing on FDA User Fees Source: U.S. House Energy & Commerce Committee (Tuesday April 17, 2012)
House Energy & Commerce Subcommittee on Health will hold a hearing on April 18, 2012 at 10:15am to discuss FDA User Fees, including the Medical Device User Fee Act (MDUFA). The hearing will also be webcast on the committee website.
- Jim Guest Letter to the Editor: Safety of Medical Implants Source: New York Times (Friday April 13, 2012)
The President of Consumer Reports calls for common sense reforms to medical device safety oversight in a letter to the editor of New York Times.
- Australia, New Zealand, recall J&J hip implant components Source: Fierce Medical Devices (Monday April 16, 2012)
Johnson & Johnson is facing more bad news over its metal-on-metal artificial hip implant products, this time in New Zealand and Australia.
- Ex-Medicare chief Berwick lauds medical device industry Source: MassDevice (Friday April 6, 2012)
“Erstwhile Centers for Medicare & Medicaid Services chief Dr. Donald Berwick tells MassDevice.com that, despite a clutch of headline-grabbing recalls, medical device makers are doing good work for patients.”
- Bad Wire in Heart Device Led to 22 Deaths, Study Says Source: New York Times (Tuesday March 27, 2012)
A defect in wires that connect hearts to defibrillators caused at least 22 deaths, possibly as a result of a short circuit that is difficult to detect during routine monitoring, according to a study in the journal Heart Rhythm.
- St. Jude to Stop Selling Certain Device Wires Source: New York Times (Wednesday April 4, 2012)
Following news coverage of flawed St. Jude heart devices, St. Jude Medical will stop selling two types of wires used in devices that treat heart failure because conductive wires in some cases were sticking out of their insulation.
- Troubling Flaws in a Heart Device Shake Implant Makers Source: New York Times (Friday April 6, 2012)
The St. Jude Riata defibrillator is the latest example of a medical implant without proper safety review that harmed a patient.
- More questions about testing, FDA approvals of medical-device implants Source: Dallas Morning News (Friday March 30, 2012)
The Dallas Morning News reports on the new Consumer Reports investigation on Dangerous Medical Devices.
- Untested medical devices, treatments dangerous: Consumer Reports Source: ABC KABC (Wednesday March 28, 2012)
ABC news coverage of Consumer Reports’ Dangerous Medical Devices report, which found that some medical devices may not be clinically tested at all.
- FDA to discuss risks and benefits of metal-on-metal hip replacements Source: FDA (Thursday March 29, 2012)
FDA announces two-day panel to address risks and benefits of metal-on-metal hip replacements
- Probe: Many medical devices not safety-tested Source: Newsday (Wednesday March 28, 2012)
“Despite requirements for pre-marketing review, the investigation found few devices undergo rigorous clinical testing and the standards themselves haven’t changed in a generation.”
- Consumer Reports blasts implant safety Source: Fierce Medical Devices (Wednesday March 28, 2012)
Fierce Medical Devices reports on a new Consumer Reports investigation of untested medical devices that puts patients at risk.
- Report: Medical implants rarely tested Source: CBS News (Wednesday March 28, 2012)
CBS News coverage of Consumer Reports medical devices investigation. A new Consumer Reports investigation shows artificial hips and some other medical devices are rarely rigorously tested to make sure they’re safe.
- Consumer Reports targets medical devices' safety Source: Los Angeles Times (Wednesday March 28, 2012)
The Lap-Band, surgical mesh, metal hips and certain cardiac devices are cited by Consumer Reports, which says the government allows some products to be sold with little or no advance safety testing.
- How Much Will the Medical Device Tax Hurt? Source: Bloomberg (Thursday March 22, 2012)
This Bloomberg article offers a good critique of the medical industry’s claim that the medical device tax included in the health reform law will lead to big industry losses and cause jobs to move overseas.
- Hip Device Phaseout Followed F.D.A. Data Request Source: New York Times (Thursday March 22, 2012)
FDA asked DePuy for safety data just before hip implants phaseout
- Markey targets vaginal mesh manufacturers in new bill Source: Boston Globe (Thursday March 22, 2012)
The Boston Globe reports on Representative Ed Markey’s press conference in DC who stood alongside injured vaginal mesh patient who was left permanently disabled and lives in pain.
- [VIDEO]: March 22, 2012: Victims Speak Out about Dangerous Loophole, Unsafe Medical Devices on the Market Source: Representative Ed Markey (Friday March 23, 2012)
Rep. Markey joined victims, patients, and advocates in a press conference calling for the end of a dangerous loophole at the Food and Drug Administration which has allowed faulty devices to stay on the market.
- Senators Introduce Bipartisan Effort to Make Medical Devices Safer Source: Senator Jeff Merkley (Thursday March 15, 2012)
Today, Oregon’s Senator Jeff Merkley, with Senators Chuck Grassley (R-IA), Michael Bennet (D-CO) and Herb Kohl (D-WI), introduced the bipartisan Ensuring Safe Medical Devices for Patients Act. The bill would give the Food and Drug Administration the tools it needs to improve oversight of medical devices. Defective medical devices have been associated with thousands of deaths in recent years.
- Prone To Failure, Some All-Metal Hip Implants Need To Be Removed Early Source: NPR (Monday March 19, 2012)
NPR story about Susy Mansfield, who had a metal hip implanted and had to get it removed 3 years later because it was eating away at the surrounding bone and soft tissue.
- Markey Calls for Closure of Dangerous Medical Device Loophole Source: Representative Ed Markey (Tuesday March 20, 2012)
Joined by injured patient and surgeon, Markey to release new report highlighting faulty FDA approval process that enables defective medical devices to be implanted in patients, causing serious injury and death
- Consumer Group Says House Draft Bill on Device Fees Should Be Rejected Source: Bloomberg BNA (Wednesday March 21, 2012)
According to Consumers Union, the policy and advocacy arm of Consumer Reports, the House Energy and Commerce Health Subcommittee’s draft bill would significantly weaken device safety oversight and should be rejected.
- Markey, Waxman, Schakowsky, DeLauro Introduce Legislation To Close Loophole In Flawed Medical Device Approval Process Source: Congressman Ed Markey (Wednesday February 1, 2012)
To protect patients from defective devices, Reps. Edward J. Markey (D-Mass.), Henry A. Waxman (D-Calif.), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.), introduced H.R. 3847, the Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act). This bill closes a major loophole in the device approval process known as the 510(k) by ensuring that a new device is not cleared by the FDA if it is based on an earlier product that was pulled from the market for causing serious harm to patients.
- Believe It Or Not, People Want More Oversight Of Implanted Medical Devices Source: The Consumerist (Tuesday March 20, 2012)
“It seems almost silly to think that anyone would want to scale back the amount of regulatory control on the safety of medical devices, and a new [Consumer Reports] poll shows that an overwhelming number of Americans believe in strong oversight of these products.”
- White House OKs medical device act Source: Cardiovascular Business (Friday March 16, 2012)
White House oks medical device act one month after Consumers Union warned Congress that reauthorizing MDUFMA could lead to a significant increase in the number of unsafe medical devices entering the market.
- For Drugs and Medical Devices, It's Still a Jungle Out There Source: Union of Concerned Scientists (Tuesday March 13, 2012)
The regulation of prescription drugs and medical devices presents new challenges for FDA. Giving FDA the resources it needs to protect the public health will require pressure on Congress from all of us.
- Merkley Backs Bill to Make Medical Devices Safer Source: KTVZ (Thursday March 15, 2012)
U.S. Senators introduce a bipartisan bill that would give the FDA more tools to improve oversight of medical devices. The bill has been endorsed by a number of organizations, including Consumers Union.
- Metal hip joints not worth risk Source: Associated Press (Wednesday March 14, 2012)
British experts at the world’s biggest artificial joint registry said doctors should stop using metal-on-metal hip replacements, citing an analysis showing they have to be fixed or replaced more often than other implants.
- Consumer Reports taps ire over bad medical devices Source: Reuters (Monday March 12, 2012)
Reuters covers Consumers Union’s campaign to improve medical device safety and interviews patients who have had faulty medical devices.
- Artificial hip brings only pain Source: Star Tribune (Monday March 12, 2012)
The artificial devices were thought to be a more durable option for hip replacements, but failure rates are forcing doctors to rethink the option. Terry Wagner-Morley, whose faulty metal-on-metal artificial hip was removed in December, talked about her worries from her hospital room. An infection has forced a delay in implanting a replacement hip, leaving her unable to walk.
- A flawed device brings a tough choice for Riata patients Source: Star Tribune (Saturday March 10, 2012)
Patients weigh what to do about a St. Jude Medical defibrillator with wiring problems. Unlike a defective toaster or recalled automobile, implanted medical devices aren’t easy to take back.
- Report: Hundreds of thousands exposed to toxic compounds from metal-on-metal hip implants Source: MassDevice (Tuesday February 28, 2012)
Hundreds of thousands of patients may have been exposed to toxic chromium and cobalt particles as their metal-on-metal hip implants wear, according to a joint investigation by the British Medical Journal and BBC Newsnight.
- Britain Extends Monitoring for People With Metal Hips Source: New York Times (Tuesday February 28, 2012)
British health regulators said Tuesday that patients in Britain who received a specific type of all-metal artificial hip — one that was also used widely in the United States — should undergo annual examinations for as long as they have the device to make sure they are not suffering tissue damage or other problems.
- Consumer groups protest approval of medical device Source: Washington Post (Wednesday February 29, 2012)
Consumer groups, including Consumers Union, wrote FDA protesting the agency’s approval of a medical device used to address complications from aneurysm treatments on the market. This device carries high risk to patients since it is surgically implanted and potentially life-saving, which is why it should have undergone the FDA’s most rigorous safety testing before it was approved. The safety groups say the device was reviewed under a process that did not require as comprehensive an evaluation and clinical study as other devices that carry low and moderate risks to patients.
- How The Medical Device Industry Lobbies Source: GoozNews (Wednesday February 29, 2012)
Congress is hearing a lot from the medical device industry. Consumers Union is making sure they hear from consumers, too. Merrill Goozner reporting on the recent Public Citizen report entitled “Substantially Unsafe,” about 30 facts that medical device industry lobbyists will probably neglect to tell Congress.
- FDA device regulator calls for more authority Source: Fierce Pharma Manufacturing (Tuesday February 28, 2012)
“Without specifically endorsing legislation introduced by House Democrats, the FDA’s top dog on medical devices has thrown his support behind tougher regulations for approving products that have designs traceable to recalled items.”
- Medical Device Loophole Needs Closing by Congress, FDA Device Chief Says Source: Bloomberg (Tuesday February 28, 2012)
“House Democrats introduced legislation this month to let the FDA reject devices that have designs based on past products that were recalled for safety flaws. The agency now lacks that authority in many cases, creating a ‘loophole’ that’s challenged the credibility of some device approvals, said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.”
- Consumer safety proponents press for tougher standards while firms want faster approvals. Source: StarTribune (Monday February 27, 2012)
Article on the medical device debate in Congress that features Consumers Union’s Safe Patient Project and the stories of real people who have been affected by medical devices that were untested: Steven Baker and Jim Shull.
- Consumer groups, medical device makers spar during MDUFMA III hearings Source: MassDevice (Wednesday February 15, 2012)
Consumer advocates challenged the medical device industry’s calls for speedier clearance pathways at the FDA during a sometimes contentious U.S. House hearing on reauthorizing FDA user fees, arguing that device makers left device safety out of the negotiations with the FDA.
- Consumer Advocates Push House Panel For Stronger Oversight of Device Approvals Source: Bloomberg (Wednesday February 22, 2012)
Consumer advocates told a House panel Feb. 15 that stronger medical device safety oversight is needed, especially now that the Food and Drug Administration has a potential new user fee agreement with industry. Includes quotes by Lisa Swirsky, senior health policy analyst for Consumers Union.
- Hip Maker Discussed Failures Source: New York Times (Tuesday February 21, 2012)
Flawed Depuy hip implant had early FDA notice
- How dirty medical devices expose patients to infection Source: iWatch News (Wednesday February 22, 2012)
An outbreak of infections at a Texas hospital prompted an investigation of the surgical tools used and raised concerns about dirty devices, including possible design flaws that make them difficult to clean.
- Consumer group clashes with medical device industry on Capitol Hill Source: Cardiovascular Business (Tuesday February 21, 2012)
Some coverage of the medical device U.S. House hearing. Features quotes by Consumers Union and Jim Shull, who told about his experience as a patient harmed by synthetic mesh used for a hernia operation.
- Controversy over medical device safety Source: WOAI (Wednesday February 15, 2012)
San Antonio’s WOAI reports on the medical device debate in Congress, including the story of Mike McReynolds who can barely walk these days, because the hip implants he received in 2009 are causing excruciating pain. He recently learned those implants, made by a company called DePuy, were never subjected to clinical trials to prove their safety.
- Consumer Groups: Medical Devices Need More Oversight Source: Fowler Tribune (Monday February 20, 2012)
Colorado publication: Patient safety advocates are asking Congress to step up the regulation of such medical devices as hip replacements and heart stents. Comments by Lisa McGiffert, Director of Consumers Union’s Safe Patient Project.
- St. Jude Device Exposes Safety Monitoring Failures, Doctor Says Source: Bloomberg Businessweek (Thursday February 16, 2012)
Bloomberg story on a defective cable used in heart defibrillators. It is based on an article in the New England Journal of Medicine, which says that the cable is the latest example of a defective medical device that wasn’t spotted quickly enough because U.S. surveillance systems are lacking.
- Hip Implant U.S. Rejected Was Sold Overseas Source: New York Times (Tuesday February 14, 2012)
Background info on the Johnson & Johnson ASR metal hip implant. In March 2010, The Times disclosed that F.D.A. records showed that the agency had received 300 complaints about the ASR, virtually all of them involving patients who had to undergo replacement operation just a few years after getting the device. That number has since reached into the thousands.
- Faulty hip implants may cause long-term health, joint damage Source: USA TODAY (Wednesday February 8, 2012)
Faulty hip joints implanted in tens of thousands of Americans pose adverse health effects in some patients even after removal, according to new research.
- Austin woman, injured by device, lobbying Congress on law Source: Austin American-Statesman (Tuesday February 7, 2012)
Lana Keeton, an Austin woman injured by a medical device, went to Washington DC to meet with her Congress members asking for safety improvements for medical devices. Lana had a synthetic mesh bladder sling implanted in 2001 and has had 17 surgeries and procedures to remove the mesh and has had ongoing medical problems,
- Lawmakers Bid to Close Loopholes on Malfunctioning Med Devices Source: California Progress Report (Wednesday February 15, 2012)
Substantially Unsafe Medical Devices Pose Great Threat to Patients; Safeguards Must be Strengthened, Not Weakened
- Secrecy on medical-device prices hurts buyers, GAO says Source: MN Star Tribune (Saturday February 11, 2012)
The report from the U.S. General Accounting Office — which turned up a difference of more than $8,000 for one cardiac device alone — found that confidentiality clauses in sales contracts keep even the physicians who decide which devices to use in the dark about prices. A study of device charges has been requested by Sen. Max Baucus.
- Special Report: The French breast implant scandal Source: Reuters (Thursday February 2, 2012)
Reuters story about a defective silicone gel breast implant manufactured by a now defunct French company.
- U.K. regulators launch metal hip investigation Source: Fierce Medical Devices (Monday January 30, 2012)
Britain’s Sunday Telegraph writes about the details, including the stark finding that failure rates for the metal-on-metal full hip replacement could be even higher than the estimated 17% national figure.
- Plaintiffs allege 'gruesome conditions' at Lap-Band clinics Source: Los Angeles Times (Tuesday January 17, 2012)
At least five patients have died since 2009 after Lap-Band procedures at clinics in Beverly Hills and West Hills that are affiliated with the 1-800-GET-THIN marketing campaign, according to autopsy reports, lawsuits and other public records.
- FDA Misses Deadline in Clash With Device-Makers Over Reviews Source: Bloomberg (Thursday January 19, 2012)
Industry will not agree to sufficient fees required for FDA to adequately review devices.
- J&J Mesh Approved by FDA Based on Recalled Device Source: Bloomberg (Thursday October 27, 2011)
Bloomberg covers safety issues with vaginal mesh implants which the FDA continued approving based on similarity to a device pulled from the market more than a decade ago for safety reasons. The FDA is under increasing pressure to improve medical device safety and oversight.
- New Models of Implants Not Better, Study Finds Source: New York Times (Thursday December 22, 2011)
A new study suggests that the recent technology for artificial hips and knees did not perform any better than older, less expensive designs. Many of the new designs, like metal-on-metal hips, are widely used in the U.S. Those implants are expected to fail prematurely in tens of thousands of patients rather than lasting 15 years or more as artificial joints are supposed to do.
- Changes in medical device information pose lawsuit risks for doctors Source: American Medical News (Monday December 19, 2011)
Kentucky surgeon sued after using a pain pump for an off-label purpose that allegedly injured a patient. The case raises questions about whether doctors are responsible for seeking information about changes to medication instructions or whether device manufacterers should announce updates to physicians.
- Blumenthal Sponsors Bill To Protect Patients From Unsafe Medical Devices Source: Connecticut Health I-Team (Wednesday January 18, 2012)
U.S. Sen. Richard Blumenthal has joined two other senators introducing legislation designed to protect patients from unsafe medical devices. “This bill will help the FDA to get unsafe devices out of the market more quickly and improve tracking and recall procedures,” said Charles Bell, program director with Consumers Union.
- FDA probing J&J delays in reporting serious injuries among users of its Animas insulin pump Source: Associated Press (Wednesday January 11, 2012)
The FDA ordered an insulin pump medical device company to explain by Jan. 20 why it kept selling pumps known to fail and also to submit a plan to rectify its failure to promptly report cases where its device might have caused or contributed to death or serious injury. FDA warned the company that it could face fines and other sanctions if it doesn’t promptly correct the violations.
- F.D.A. Orders Surgical Mesh Makers to Study Risks Source: New York Times (Wednesday January 4, 2012)
The FDA issued an order requiring makers of implantable surgical mesh used to treat urinary incontinence in women to study its risks. This agency move is similar to one it took last year when it ordered producers of all-metal artificial hips to undertake patient studies. The mesh products and the hips belong to a class of implantable devices that manufacturers don’t have to study in patients before they are marketed or closely follow in patients afterward.
- J&J, C.R. Bard Must Study Safety of Vaginal Mesh, FDA Says Source: Bloomberg (Thursday January 5, 2012)
The FDA sent a letter to vaginal mesh device makers ordering them to study rates of organ damage and complications linked to their devices. An FDA report in July found a fivefold jump in deaths, injuries or malfunctions tied to the products.
- It's about time that FDA took action against Lap-Band billboards Source: Los Angeles Times (Wednesday December 14, 2011)
The FDA warned marketing company and clinics that they’re in violation of federal law by promoting the Lap-Band, a weight loss device that has been implanted in thousands of patients, through “false or misleading” advertising.
- Bill Would Require More Monitoring of Implants Source: NY Times (Thursday December 15, 2011)
New bipartisan bill would require postmarket surveillance of medical devices approved through 510(k), the FDA’s fast track approval process that requires no testing on humans and only needs to be similar to a device already on the market.
- Medical devices maker Medtronic agrees to pay $23.5 million to settle kickback allegations Source: Associated Press (Monday December 12, 2011)
Medtronic Inc., the world?s largest maker of medical devices, has agreed to pay $23.5 million to settle allegations that it paid kickbacks to doctors to implant its pacemakers and defibrillators, the U.S. Justice Department said Monday.
- Ventilator errors are linked to 119 deaths Source: Boston Globe (Sunday December 11, 2011)
An analysis of federal safety reports by the Globe shows that at least 119 people died nationwide between 2005 and May 2011 because of such alarm-related problems. And a separate review by the US Food and Drug Administration uncovered about 800 alarm-related adverse events involving ventilator patients in 2010 alone. Many were deemed ?preventable?? or due to ?human error.?? An unknown number resulted in injuries or deaths.
- Analysis: Court tests liability of healthcare executives Source: Reuters (Tuesday December 6, 2011)
3 former medical device executives receive prison sentences for their role in an illegal test of a bone-cement product
- Hospitals Tumble on Medicare Order for Heart Procedure Audit Source: San Francisco Chronicle (Sunday December 4, 2011)
“The Center for Medicare and Medicaid Services will require pre-payment audits on hospital stays for cardiac care, joint replacements and spinal fusion procedures, according to the American College of Cardiology in a letter to members. The program means hospitals won’t receive payment for stays that involve cardiac care or orthopedic treatment until auditors have examined the patient records and confirmed that the care was appropriate.”
- Update: Two ex-Synthes executives, Michael Huggins and Thomas Higgins, get 9 months in prison Source: Philly Pharma (Monday November 21, 2011)
Executives with the device company were sentenced to 9 months jail and $100,000 for sponsoring a clinical trial not approved by the FDA. The illegal clinical tests of bone cements intended for back surgeries. Three study participants died on the operating table.
- 10 HEALTH TECHNOLOGY HAZARDS FOR 2012
10 HEALTH TECHNOLOGY HAZARDS FOR 2012
- Drugs better than stents at preventing 2nd stroke Source: Reuters (Wednesday September 7, 2011)
Stroke patients in a large study who were treated with drugs and a brain stent had more than twice the rate of strokes and death in the month after surgery compared with those treated with drugs alone, researchers said.
- The Money Trail: Erik Paulsen gets financial jolt from medical tech industry Source: The Minnesota Independent (Friday October 21, 2011)
“As co-chair of the House Medical Technology Caucus, U.S. Rep. Erik Paulsen has battled for the medical devices industry since he took office in 2009. Industry Political Action Committees (PACs) and executives have responded to his advocacy with a deluge of campaign donations, helping to make Paulsen the lead fundraiser in Minnesota’s House delegation.”
- Report: Growth in Medical Device Adverse Events Outpaces Industry Growth Source: ASC Review (Wednesday November 2, 2011)
The medical device industry grew 9% annually from 2001-2009; serious harm grew 17% during that same time period, according to an FDA report.
- Venture Capitalists Put Money on Easing Medical Device Rules Source: New York Times (Tuesday October 25, 2011)
As Congress considers reauthorizing a law that sets the fees for medical device makers, venture capitalists are emerging as a rich and influential ally of device companies eager to remove what they say are regulatory roadblocks in the approval process.
- Warning about pelvic mesh Source: WCAX.com (Friday July 15, 2011)
Lana Keeton shares her story about being in constant pain since doctors used plastic mesh on her during pelvic surgery. The FDA approved this medical device for pelvic organ prolapse in 2002, but since it was similar to devices used for decades it did not undergo safety testing.
- Risky pelvic mesh highlights worries about FDA process Source: msnbc.com (Tuesday July 26, 2011)
The FDA has received thousands of adverse event reports related to the mesh in women treated for pelvic organ prolapse or stress urinary incontinence. Janet Holt shares her story about how surgical mesh led to more pain and seven more operations to remove the mesh that had eroded her insides.
- Stenting's Steep Learning Curve Linked to High Mortality Rates Source: HealthLeaders Media (Friday September 30, 2011)
Inexperienced physicians performing carotid artery stenting have alarmingly higher rates of 30-day mortality than more seasoned operators, according to a new report published in the Journal of American Medical Association.
- Remedy Is Elusive as Metallic Hips Fail at a Fast Rate Source: NYT (Friday September 30, 2011)
Metal on metal may be the issue with these implants but research has yet to definitively prove why these artificial hips are failing. But researchers warned more than a decade ago that they release medal debris into the blood system.
- Dangerous Medical Devices: A Personal Story Source: Bioethics Forum blog (Thursday August 25, 2011)
This is an example of a medical device that has been approved through the FDA’s 510(k) fast track process which allows devices that are of “moderate risk” and similar to previously approved devices to go to the market without a rigorous pre-market examination.
- Insight: DePuy's handling of hip recall sparks questions Source: Reuters (Monday August 22, 2011)
“In a highly unusual move, DePuy has hired a third party — Broadspire Services Inc, which manages workers compensation and other medical claims on behalf of insurance companies and employers — to administer patient claims for out-of-pocket medical costs associated with the recall.”
- If Insulin Pump Can Be Hacked, What Else? Lawmakers Ask Source: ABC (Monday August 22, 2011)
Two lawmakers are requesting a review of the government’s security standards for wireless medical devices after a diabetic discovered how to remotely reprogram his and other people’s insulin pumps.
- Hip Implant Complaints Surge, Even as the Dangers Are Studied Source: New York Times (Monday August 22, 2011)
An analysis of federal data by The New York Times indicates that the Food and Drug Administration has received more than 5,000 reports since January about several widely used devices known as metal-on-metal hips, more than the agency had received about those devices in the previous four years combined.
- How Safe Are Medical Devices? Source: New York Times (Thursday August 4, 2011)
New York Times editorial on medical devices, following the Institute of Medicine report released last week that found that the FDA process for approving medical devices to market is flawed and does not ensure the safety or effectiveness of most devices.
- FDA is urged to revamp its review process for medical devices Source: Los Angeles Times (Friday July 29, 2011)
“The National Academy of Sciences says in an FDA-commissioned report that thousands of medical devices are allowed to go on the market without proper testing for safety. The FDA disputes the finding.”
- Study of Medical Device Rules Is Attacked, Unseen Source: New York Times (Wednesday July 27, 2011)
The medical device industry is crawling over Washington in an attempt to discredit an upcoming Institute of Medicine report that could propose a tougher approval process for a wide range of devices like hip implants, hospital pumps and external heart defibrillators.
- Health News: Medical devices debated in Congress; controversies surface; Oregon connection Source: The Oregonian (Tuesday July 5, 2011)
A sampler of articles on the issue of fees for medical device manufacturers, a debate heating up in Washington DC.
- More Scrutiny for Doctors Profiting From Medical Devices They Use Source: ProPublica (Friday June 10, 2011)
Five senators are calling for an investigation into a system that gives surgeons a financial stake in the devices they use on their patients.
- The Markingson Files: Conflicts of interest in clinical trials should be transparent Source: Reporting on Health (Monday June 6, 2011)
Conflicts of interest in clinical trials should be transparent.
- Heart-valve rings slip through FDA loophole Source: Chicago Tribune (Tuesday March 22, 2011)
Permanently implanted devices OK’d without clinical studies
- Data raise questions on FDA oversight Source: Chicago Tribune (Saturday May 21, 2011)
Flawed statistics paint murky picture of rings’ safety record
- Metal Artificial Hips May Need A Hip Check Source: NPR (Wednesday May 25, 2011)
Consumers want to be informed about the longevity and error rate of joint implants.
- After five hip replacement surgeries, Travis County woman sues company Source: American-Statesman (Monday May 2, 2011)
Jane Rogers has had hip replacement surgery five times in four years. The financial analyst says she thinks the manufacturer knew about a high failure rate by the time of her second surgery.
- Medical device recalls come from devices through the 510(k) process Source: MedCity News (Tuesday February 15, 2011)
Nearly three-quarters of medical device recalls that could have caused injury or death from 2005-2009 went through the 510(k) pre-market notification process at the Food & Drug Administration, according to a new report from the Archives of Internal Medicine.
Research and Reports
- FDA Should Expand Its Consideration of Information Security for Certain Types of Devices Source: GAO (Friday September 28, 2012)
GAO report on the dangers of hacking into medical devices that require software with wireless connections. Hacking into a device could, for instance, stop a pacemaker from operating.
- FDA Public Meeting on Medical Device Postmarket Surveillance System, September 10, 2012 Source: FDA (Tuesday September 4, 2012)
The Food and Drug Administration (FDA) is announcing a public meeting entitled: “Strengthening the National Medical Device Postmarket Surveillance System.” The purpose of this meeting is to solicit public feedback regarding FDA’s proposal to strengthen the national medical device postmarket surveillance system. The meeting will be webcast.
- Congressman Ed Markey and Senator Merkley Letter to FDA on 510(k) database Source: U.S. Congressman Ed Markey (Wednesday August 15, 2012)
U.S. Rep. Ed Markey and U.S. Sen. Jeff Merkley write a letter to FDA asking them to update the 510(k) medical device database to provide better information about devices recalled for serious design flaws and to help avoid future injuries.
- 2012 Meeting Materials of the FDA Metal on Metal Hip Panel Source: FDA (Monday July 30, 2012)
Meeting materials from the FDA’s metal on metal hip panel, June 27-28, 2012.
- Patient Access to Medical Devices — A Comparison of U.S. and European Review Processes Source: New England Journal of Medicine (Thursday August 9, 2012)
A study comparing how high-risk devices are approved in the US versus Europe.
- California Joint Replacement Registry Source: California Joint Replacement Registry (Tuesday August 7, 2012)
The California Joint Replacement Registry (CJRR) is an effort by the California HealthCare Foundation (CHCF), Pacific Business Group on Health (PBGH), and the California Orthopaedic Association (COA) to collect and share information about hip and knee replacement surgeries performed in the state.
- Failure rates of stemmed metal-on-metal hip replacements Source: The Lancet (Tuesday March 13, 2012)
Analysis of data from the National Joint Registry of England and Wales. Findings: Metal-on-metal total hip replacement systems failed at high rates. Interpretation: Metal-on-metal stemmed articulations give poor implant survival compared with other options and should not be implanted. Comments on this study can be found at http://www.thelancet.com.
- Fact Sheet: Medical Device User Fee Amendments of 2012
List and brief description of medical device amendments contained in the FDA Safety and Innovation Act.
- FDA Safety and Innovation Act Source: FDA (Monday July 9, 2012)
Includes FDA’s description of MDUFA III.
- Statement of Dr. Diana Zuckerman Regarding Metal on Metal Hip Implants Source: Diana Zuckerman (Wednesday June 27, 2012)
Diana Zuckerman (president of the National Research Center for Women & Families) statement before the FDA June 27, 2012 panel on metal-on-metal hip implants.
- NEJM: Delays and Difficulties in Assessing Metal-on-Metal Hip Implants Source: New England Journal of Medicine (Wednesday June 20, 2012)
NEJM reports on unanswered safety questions about metal-on-metal hip implants and foreseeable challenges for stakeholders.
- Video: FDA 2012 Patient Network Annual Meeting Source: FDA (Friday May 18, 2012)
4-part video series of the May 18, 2012 FDA event to get patient input on perceived risks and benefits related to medical products.
- Video: Health Subcommittee Hearing on FDA User Fees Source: Committee on Energy & Commerce (Wednesday April 18, 2012)
Webcast video of Subcommittee on Health hearing on Wednesday, April 18, 2012, at 10:15 a.m. in 2123 Rayburn House Office Building entitled “FDA User Fees 2012: How Innovation Helps Patients and Jobs.”
- House Energy & Commerce Health Subcommittee April 18, 2012 Hearing on FDA User Fees Source: U.S. House Energy & Commerce Committee (Tuesday April 17, 2012)
House Energy & Commerce Subcommittee on Health will hold a hearing on April 18, 2012 at 10:15am to discuss FDA User Fees, including the Medical Device User Fee Act (MDUFA). The hearing will also be webcast on the committee website.
- The Eleven Most Implanted Medical Devices In America Source: 24/7 Wall St (Monday July 18, 2011)
24/7 Wall St. has examined National Health Survey data, multiple professional physician services, peer-reviewed journals, and SEC filings to complete a list of the most frequently implanted medical devices today. While many of these are life saving, controversy swirls around several others.
- Congressman Edward Markey report: Defective Devices, Destroyed Lives SOUND Act Report Source: Representative Ed Markey (Thursday March 22, 2012)
Congressman Ed Markey issued a report highlighting faulty FDA approval process that enables defective medical devices to be implanted in patients, causing serious injury and death.
- Support for the SOUND Act of 2012 Source: Congressman Ed Markey (Wednesday February 1, 2012)
Consumers Union signs on to legislation introduced in Congress that will protect the public from avoidable harms caused by unsafe devices that should never have been cleared for sale in the first place. It will also help to ensure that decisions on device safety are based on more reliable information.
- Survey: Despite Progress, FDA Scientists Feel Political and Industry Pressure Source: Union of Concerned Scientists (Wednesday March 7, 2012)
Despite progress, FDA scientists feel political and industry pressure
- FDA Scientist Survey Shows Progress, But Problems Remain Source: Union of Concerned Scientists (Wednesday March 7, 2012)
The survey shows FDA scientific reviewers trusted the latest leaders of the FDA but still feel the agency is overly influenced by special interests. “FDA scientists express concern on several fronts, including their right to publish research and communicate with the public, the degree of corporate and political influence on regulatory decisions, and the overall transparency and accountability of the agency’s decision making.”
- Ongoing problems with metal-on-metal hip implants Source: BMJ (Tuesday February 28, 2012)
Authors examine what has gone wrong with hip implants
- Lifelong checks are needed for patients fitted with dangerous hip implants Source: BMJ (Wednesday February 29, 2012)
Access requires subscription or payment. UK health agency announced that around 49 000 UK patients with metal-on-metal hip implants will need follow-up tests for the rest of their lives. A BMJ investigation found problems with metal-on-metal implants caused by metal ions leaking into the body.
- Watchdog group says “massive lobbying effort” by medical device industry threatens public health Source: BMJ (Tuesday February 28, 2012)
Access requires subscription or payment. Public Citizen says that the medical device industry has lavished millions of dollars on US politicians in a “massive lobbying effort” to promote legislation that will weaken oversight of the industry and endanger the public.
- How safe are metal-on-metal hip implants? Source: BMJ (Tuesday February 28, 2012)
Deborah Cohen examines the evidence of risk from metal-on-metal hips, the manufacturers’ inadequate response, and how the regulatory bodies failed to give doctors and patients the information they need to make informed decisions
- 30 Things You Need to Know About Medical Devices: Approvals, the Industry, and Safety Source: Public Citizen (Monday February 27, 2012)
All of the facts below and additional information are compiled in the Public Citizen report, Substantially Unsafe, available at http://pubc.it/rMDUFA.
- NEJM: Regulation of Medical Devices in the United States and European Union Source: New England Journal of Medicine (Tuesday February 14, 2012)
“In our view, the greatest challenge facing U.S. device regulation is the evaluation of high-risk devices through pathways intended for lower-risk devices, such as the 510(k) process.”
- NEJM: Postmarketing Surveillance of Medical Devices — Filling in the Gaps Source: New England Journal of Medicine (Tuesday February 14, 2012)
- Substantially Unsafe: Medical Devices Pose Great Threat to Patients
Public Citizen report on dangers of poorly regulated medical devices.
- Testimony of James Shull Before U.S. House Committee on Energy and Commerce/Subcommittee on Health
James Shull of Brown Mills, NJ testifies before U.S. House Energy and Commerce Committee, Health Subcommittee on medical devices
- FDA Should Enhance Its Oversight of Recalls Source: GAO (Tuesday June 21, 2011)
GAO report on medical device recalls
- FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process Source: GAO (Thursday January 1, 2009)
GAO report on Class III medical devices and the 510(k) process.
- Shortcomings in FDA's Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments Source: GAO (Wednesday February 18, 2009)
GAO found that FDA does not review all class III devices through its most stringent premarket review process.
- FDA's Premarket Review and Postmarket Safety Efforts Source: GAO (Wednesday April 13, 2011)
Government Accountability office report
- Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years
IOM report: Thousands of medical devices are allowed to go on the market without proper testing for safety. FDA should develop a new framework for ensuring the safety and effectiveness of these devices.
- Pharmaceutical and Medical Device Manufacturer Code of Conduct
This page provides information relating to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (PCOC) regulation. Reports on drug and medical device industry gifts to physicians.
- FDA Safety Alerts for Drugs and Devices
FDA Medwatch Safety Information
- GAO report on hospital infections related to medical devices
The GAO determined the scope and collection of available data limited the agencies ability to determine a national estimate of hospital associated infecdtions related to medical devices. However, experts report medical staff practices as a significant factor.
- GAO study: reprocessed single use medical devices
No definitive evidence that reuse of “single use devices” presents risk to patients.
Stories about Medical Device Safety
My family experienced a surgical error in 2007. We filed a complaint with the state department of public health over this incident. In the single issue of exposing an IgE latex allergic patient to a medical device containing latex, it should have been very easy for DPH to find that the surgeon and hospital provided our daughter with negligent care. The device was clearly labeled as containing latex, the hospital and surgeon identified our daughter, Kelly, as a latex allergic patient before surgery, standard of care at the hospital was the strict avoidance of all latex products in an surgical/medical procedure for an identified latex allergic patient, and the Informed Consent for this procedure does not give the hospital or surgeon permission to treat our daughter with a medical device containing latex.
Lesley of Stamford, Connecticut
To Delay is Deadly
98,000 people die each year needlessly because of preventable medical harm. Efforts to reduce this are few and fragmented. With little transparency and no public reporting (except where hard fought state laws now require it), scarce data does not paint a picture of real progress.
In this report (PDF) we give the country a failing grade on progress on select recommendations we believe necessary to create a health-care system free of preventable medical harm.