The mission of Washington Advocates for Patient Safety (WAPS) is to promote accountability, quality, safety, and responsibility in patient care. As the voice of patients, their goals are to eliminate medical errors and harm and to save more lives.
Hip and Knee Replacement
More and more people are getting hip and knee replacements to feel better, play longer. And if the hip or knee implant fails, it likely will require revision surgery, which is both painful and costly. Implants don’t come with a warranty. Consumers Union is calling on the top manufacturers of hip and knee implants to begin offering warranties for their products and take responsibility for the associated costs if they fail due to a product defective.
Consumers Union Documents
- Consumers Union Ad for USA Today on hip and knee warranties Source: Consumers Union (Monday March 10, 2014)
Consumers Union ad for USA Today on our campaign to get manufacturer warranties for hip and knee implants.
- Background: Warranties for Hip and Knee Implants Source: Consumers Union (Wednesday February 26, 2014)
Background paper on Consumers Union’s call to medical device makers to provide a warranty for hip and knee replacements
- Answers to Your Questions about Warranties for Hip and Knee Replacements Source: Consumers Union (Wednesday February 26, 2014)
Answers and recommendations for hip and knee implant warranties
- What To Ask Your Surgeon Before Getting Hip or Knee Replacement Surgery Source: Consumers Union (Thursday February 6, 2014)
13 Things to Ask Your Surgeon Before Getting Hip or Knee Replacement Surgery (by Consumers Union’s Safe Patient Project)
- Artificial hips and knees need a lemon law, says Consumer Reports Source: Consumer Reports (Monday February 3, 2014)
Consumer Reports video explains Consumers Union’s campaign to get the top hip and knee implant makers to warranty their products for 20 years. Joint replacements often fail, while consumers and insurers are left with the bill
Consumers Union News Releases
- Consumers Union Takes Push for Hip and Knee Implant Warranties To Orthopaedic Surgeons Conference in New Orleans
Consumers Union, the policy and advocacy division of Consumer Reports, is taking its campaign to convince medical device companies to provide warranties for hip and knee implants directly to the doctors who perform hundreds of thousands of these operations each year. The campaign has launched an ad campaign and will be conducting outreach activities this week during the American Association of Orthopaedic Surgeons (AAOS) conference in New Orleans.
- Consumers Union calls on medical device makers to provide warranties for hip & knee implants
Consumers Union, the policy arm of Consumer Reports, is calling on the top manufacturers of hip and knee implants to provide warranties that would entitle patients to have defective devices replaced at no cost.
- Johnson & Johnson Settlement Resolves Metal Hip Lawsuits But Weak Oversight Of Medical Device Industry Leaves Patients Vulnerable
Consumers Union Calls for Stricter Safety Testing & Warranties for Implants.
- Consumers Union To Hold “Ending Medical Harm” Conference at Columbia University On November 6th
CONSUMERS UNION NEWS RELEASE For Immediate Release: Tuesday, October 29, 2013 Contact: Michael McCauley, email@example.com or 415-902-9537 (cell) or Ross Moonie, firstname.lastname@example.org or 917-690-5713 or Joe Duraes, email@example.com or 914-293-0100 Consumers Union To Hold “Ending Medical Harm” Conference at Columbia University On November 6 Conference To Focus on Tackling The 3rd Leading Cause of Death Continue Reading
- Consumers Union Urges FDA To Require Safety Testing of Metal on Metal Hips and Other High Risk Implants
Consumers Union urged the U.S. Food and Drug Administration today to adopt a proposed rule requiring metal hip implants to be reviewed through the agency’s premarket approval (PMA) process to prove that the devices are safe and effective.
- Q & A for Surgeons on Warranties for Hip and Knee Replacements
Consumers Union’s Safe Patient Project will be talking to surgeons attending the AAOS 2014 Annual Meeting in New Orleans and hope to get their feedback on our warranty campaign. Here’s our answers to frequently asked questions on our campaign for hip and knee warranties.
- Docs for Hip and Knee Warranties?
We’ve started asking orthopedic surgeons who implant hip and knee devices what they think about our warranty idea. Next month, we’re going to New Orleans to talk with surgeons attending an annual orthopedic surgeons meeting.
- [Guest post] Does Your Joint Replacement Have a Warranty? By Brian Hatten, M.D.
Dr. Brian Hatten, an orthopedic surgeon, shares his perspective on warranties for hip and knee implants.
- Go Team! Advocates Deliver Patient Safety Message in Washington State
Last week, the Safe Patient Project traveled to Washington State to team up with Washington Advocates for Patient Safety to give a voice to the health care crisis of preventable medical harm
- NPR features CU’s Safe Patient Project and story sharer harmed by hip implant
Our Safe Patient Project Director, Lisa McGiffert, was on NPR’s Morning Edition yesterday about a story on the Johnson and Johnson metal hip settlement.
- Medtronic Sued by 1,000 Infuse Patients Source: MedPage Today (Wednesday March 5, 2014)
1,000 patients sue Medtronic over Infuse spine product. Many more lawsuits may be coming and state AGs investigating. Independent studies have found that Infuse offered little benefit over conventional spine surgery and raised questions about the possibility that the product was linked to serious adverse events including cancer and sterility in men.
- Dr. Steven Tower, MD: The Dangers of Metal-on-Metal Hip Implants Source: Health Watch USA (Wednesday February 19, 2014)
Video presentation by Dr Steven Tower, MD: The Dangers of Metal-on-Metal Hip Implants (Health Watch USA Meeting – From Alaska over Adobe Connect, Feb. 19, 2014)
- Congressional report slams FDA's treatment of employees who disclosed device approval concerns Source: Fierce Medical Devices (Wednesday February 26, 2014)
“The FDA may have gone too far and violated federal law when it chose to monitor 6 scientists who made public their safety concerns about medical devices approved at the agency, a congressional investigation has concluded.”
- Another reason to keep the weight off: knee pain and the risk of surgery Source: National Research Center for Women & Families (Sunday December 1, 2013)
This December 2013 article on knee replacement from NRC includes information from CU’s Safe Patient Project on the lack of warranties for artificial knees. From NRC: “New research finds that obesity can be worse for knee health than old age. More people are getting knee surgery at younger ages, and younger patients are much more likely to be obese than older patients.”
- When a University Hospital Backs a Surgical Robot, Controversy Ensues Source: Truthout (Tuesday February 18, 2014)
ProPublica’s Charles Ornstein writes this op-ed describing a full-page ad for the da Vinci surgical robot featuring members of a surgery team at an IL university hospital. This ad was spotted a couple Sundays ago by former hospital executive, Paul Levy, in the New York Times magazine. Following controversy, the university asked the robot device maker to suspend the ad.
Research and Reports
- 2014-2015 Targeted Medication Safety Best Practices for Hospitals Source: ISMP (Thursday December 12, 2013)
Institute for Safe Medication Practices report on medication safety best practices for hospitals.
- Patient Safety America Newsletter (April 2013) Source: Patient Safety America (Sunday March 31, 2013)
Summary by John James: “Changes are long overdue in American healthcare as pointed out by the Institute of Medicine and National Research Council in their new book “The US health Disadvantage Relative to Other High-income Countries.” My first newsletter article attempts to summarize this report. In the second article I discuss the risks associated with sleeping pills. The third article considers legislation that often has collateral damage. The fourth involves one doctor’s view of how he was led into care that was not patient centered. My next two articles deal with mental health: 1) As we age, we all fear the loss of mental capabilities, but a new study has linked mid-life fitness with a reduction in the risks of dementia. 2) Young people often do not have access to mental health facilities as pointed out by experts writing in the JAMA. The next articles deal with unintended death from pharmaceuticals and with loss of confidence in drug companies. The newsletter concludes with a short piece on the vanishingly small value of robotic surgery for those who might need a hysterectomy.”
- Patient Safety America Newsletter (March 2013) Source: Patient Safety America (Monday March 4, 2013)
John James, Ph.D., Patient Safety America: “This month I’ve tried to put some important things in perspective for you. Ben Goldacre’s book called “Bad Pharma,” which I reviewed, is a worth-while read. Gun violence is compared with “medical violence” as far as they affect our children’s lives. The cheap, effective medical care received in Cuba is summarized as a lesson for us, and then I pound on the dangers of drugs and the unstoppable overpricing of medical care in our country. Finally, you’ll learn what post-hospital syndrome is and how to manage it to remain out of the hospital.”
- FDA Safety Communication: Metal-on-Metal Hip Implants Source: FDA (Thursday January 17, 2013)
Today the U.S. Food and Drug Administration (FDA) issued a Safety Communication on metal-on-metal hip implants which includes recommendations on imaging a patient with a metal-on-metal hip implant.
- NEJM Perspective: The 510(k) Ancestry of a Metal-on-Metal Hip Implant Source: New England Journal of Medicine (Thursday January 10, 2013)
Using FDA documents obtained from the agency’s database and Freedom of Information Office, authors traced the ancestry of the ASR XL back more than five decades, through a total of 95 different devices (including femoral stems), including 15 different femoral heads and sleeves and 52 different acetabular components (see figure, and the interactive graphic, available with the full text of this article at NEJM.org).