Navigation Links
Consumers Union Calls On Medical Device Makers to Provide Warranties for Hip & Knee Implants

AUSTIN, Texas, Sept. 10, 2013 /PRNewswire-USNewswire/ -- 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.    

Consumers Union is pushing device makers to equip patients with warranties so they will have a better understanding of how long an implant is expected to last and a clear process to follow in the event that it fails prematurely.  Ultimately, warranties will encourage companies to make their devices safer and more durable, according to Consumers Union. 

"Patients have a right to know how long medical device manufacturers are willing to stand by their products," said Lisa McGiffert, director of Consumers Union's Safe Patient Project (  "While patients may be told by their surgeon how long a device can be expected to last, they rarely get a guarantee in writing since most hip and knee implants do not come with a warranty." 

Biomet is the only company that provides a warranty and it covers just one partial knee implant.  Consumers Union's warranty campaign is being launched at a time when hip and knee replacement surgeries have become increasingly common.  In 2011, there were nearly 1.2 million of these surgeries in the U.S.  The demand for hip and knee replacement surgeries is expected to reach 4 million a year by 2030, and more than half of those patients will be under 65 years old. 

A Consumers Union review of hip and knee implant recalls found that all major manufacturers have recalled a product or line of products for defects over the past decade.   These recalls underscore how devices can fail prematurely and harm patients.  

Over 750,000 Americans got metal on metal hip implants during the past decade, which were supposed to last longer than devices made with ceramic and plastic.  But unusually high failure rates have been documented in metal hip implants in Australia, England, and Wales where devices are tracked through national registries.  The data from these countries showed that the failure rate of the Johnson & Johnson DePuy ASR XL metal hip implant was one in eight within five years. 

Some patients have experienced debilitating symptoms from metal debris that flakes off the device over time, including cardiomyopathy and neurological problems.   Due to the significant problems experienced with metal on metal hip implants, the FDA has proposed that they be subject to a more rigorous review process.

Hundreds of knee implant components have been recalled since 2003, frequently because they were shipped with the wrong part, a wrong size part, a missing part, or a part built for the left side etched as a "right" (or vice versa).  These kinds of errors can have serious implications for patients and sometimes require additional surgery to correct.  Other knee components have been recalled because they simply weren't manufactured to spec or started to fail once installed in patients.  

Most hip and knee implants are allowed on the market without being reviewed for safety and effectiveness by the Food and Drug Administration (FDA).  Instead, under current law, the companies simply have to demonstrate that the devices are "substantially equivalent" to a product already being sold.  Since most new hip and knee implants are similar to ones already on the market, manufacturers are able to gain approval through the FDA's fast track 510(k) clearance process without having to prove the device is safe and effective. 

Consumers Union and other patient safety groups urged Congress to require more pre-market testing of devices like hip and knee implants during last year's reauthorization of the Medical Device User Fee Act.  But those efforts were blocked by the politically powerful medical device industry. 

"Medical device companies claim that current law provides adequate protection for patients and that their implants are dependable and safe," said McGiffert.  "If that's the case, they should have no objection to offering warranties to back up those claims.  Patients and taxpayers shouldn't be on the hook for the cost of replacing devices when they fail."

When implants turn out be defective, the cost for additional surgery and a replacement device is now largely paid by patients or their insurance companies, including Medicare.  Revision surgery costs more, results in longer hospital stays and can often lead to additional surgeries.  An estimated 18 percent of hip replacements and 8 percent of knee replacements in the U.S. are for revisions and the cost for these procedures is likely in the hundreds of millions of dollars per year.  

In letters sent to Biomet, Inc., DePuy Synthes, Smith & Nephew, Stryker Corporation, Wright Medical Technology, Inc, and Zimmer Holdings Inc., earlier this summer, Consumers Union urged the companies to provide a 20 year warranty and outlined the terms of a model warranty, including:

  • Covers the full cost of replacing the flawed device, including the device, surgeon and hospital costs as well as related patient out-of-pocket costs
  • Establishes a clear system for patients to use, including a toll-free phone line and a registration number to track the claims process, with physicians charging the device company, not the patient.
  • Does not eliminate the patient's right to sue if they use a warranty.
  • Provides the patient with a full explanation if a warranty claim is denied and an appeals process for denials
  • Does not disqualify patients across the board if they have specific diseases or illnesses that are not related to the failure of the device

SOURCE Consumers Union
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Consumers Are Advised to Be Aware of Hidden Costs in Some Discount Dental Plans
2. NABP Applies for New .PHARMACY Generic Top-Level Domain to Provide a Secure Destination for Consumers
3. Consumers Choosing Organic Alternatives to Traditional Pharmaceuticals
4. New Study Finds Use of Generic Prescription Drugs Saved Consumers and the U.S. Health Care System $1 Trillion over Past Decade
5. MedVantx Achieves Significant Milestone of Providing Over $600 Million of Specialty Pharmacy Prescription Medications to Consumers
6. iPad Altering Interaction between Pharma Sales Forces, Physicians, & Consumers
7. FastMed Urgent Care and MedVantx Offer Consumers First Ever Access to Free Samples of Medications through an Automated Medication Cabinet Across North Carolinas Largest Network of Urgent Care Centers
8. PCMA: New Report Shows Anti-PBM Laws Could Raise Health Care Costs for Oklahoma Businesses, Consumers, Government Programs
9. Healthrageous Unveils Accountable Health The Missing Piece To Engage Consumers In Their Health And Achieve Accountable Care Goals
10. Consumers Union Urges FDA To Require Safety Testing of Metal on Metal Hips and Other High Risk Implants
11. Supreme Court Ruling on Rx Industrys Pay-to-Delay-Generics Good News for NY Consumers
Post Your Comments:
(Date:11/30/2015)... , Nov. 30, 2015  Kevin Smith ... Sensium Healthcare, a global pioneer in wireless monitoring ... Boston, MA , Mr. Smith will ... Sensium,s global commercial strategy.  He will also directly ... to build clinical evidence for SensiumVitals, the first ...
(Date:11/30/2015)... , Nov. 30, 2015  The fee-for-service ... in U.S. medical imaging is on its ... accountable care payer-provider contracts are set to ... their wake, alter provider-vendor relationships. The shift ... push forward new purchasing frameworks in the ...
(Date:11/30/2015)... WOODCLIFF LAKE, N.J. and SAN ... Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA ) ... (FDA) has accepted for filing the New Drug Application ... approved, the extended release formulation will offer patients a ... ® ) is currently approved as ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... November 30, 2015 , ... Using a combination of two blood ... children and adults, according to a new study by researchers at the School of ... Children and Adults: Using Combinations of Blood Glucose Tests ,” published in Frontiers in ...
(Date:11/30/2015)... ... November 30, 2015 , ... Newly reviewed and approved “NJ Top ... from Tufts School of Dental Medicine in 1935. His father graduated from NYU ... being in dentistry as well as their commitment and passion to the Practice of ...
(Date:11/30/2015)... York, NY (PRWEB) , ... November 30, 2015 , ... ... York Times,” will be released on December 1, 2015, to coincide with World AIDS ... about the groundbreaking journalist who covered the AIDS epidemic as he was dying of ...
(Date:11/30/2015)... ... November 30, 2015 , ... The American Society for ... honor of World AIDS Day 2015. On Nov. 30, ASCP shared its “Give a ... about World AIDS Day and the importance of getting tested for HIV. , ASCP ...
(Date:11/30/2015)... ... 30, 2015 , ... California-based i2i Systems, a pioneer defining ... Michigan-based Family Health Center (FHC) has selected i2iTracks as their population health management ... the largest Affordable Care Act grant for Federally Qualified Health Centers in the ...
Breaking Medicine News(10 mins):