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Archive for Medical Device Safety

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  • Consumers demand safer medical devices
    Posted 02/27/12 at 9:00 am

    To make sure elected officials hear from Americans who’ve been harmed by outdated safety laws, Consumers Union’s Safe Patient Project brought 10 activists from seven states to Washington D.C. to share their medical device experiences and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
    Posted 08/02/11 at 4:37 pm

    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

  • 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