FREE Case Review (866) 588-0600

FDA to Consider More Rigorous Testing for Metal-on-Metal Hip Implants

The FDA has scheduled a two-day meeting in June to discuss the safety of metal-on-metal hip implants, which have been increasingly associated with high rates of failure.

The U.S. Food & Drug Administration (FDA) has scheduled a two-day meeting in June to discuss the safety of metal-on-metal hip implants, which have been increasingly associated with high rates of failure. The devices have come under heavy scrutiny over the past several years due to a high number of reports of pain and swelling that have sometimes required additional revision surgeries to correct. To date, thousands of lawsuits have been filed nationwide on behalf of individuals allegedly injured by metal-on-metal hip implant devices.

DePuy Hip Update 1/23/13: Newly disclosed court documents have revealed that a 2011 internal investigation conducted by Johnson & Johnson on its much-troubled DePuy ASR hip implant estimated that the device would fail within five years in nearly 40% of recipients. For reasons still unclear, the company failed to make this information public while simultaneously downplaying the potential health complications associated with its metal-on-metal hip. Click here to learn more.

Hip Implant Recall Update 7/10/12: Michigan-based Stryker Orthopaedics is now recalling two brands of devices used in conjunction with artificial hips in hip replacement surgeries. To date, the devices in question – the Stryker Rejuvenate and ABG II Modular-Neck Stem – have been linked to at least 45 adverse event reports (AERS) submitted to the FDA by individuals who claim to have suffered severe pain and/or tissue swelling. Click here for more information.

Free Metal-on-Metal Hip Replacement Lawsuit Evaluation: If you or a loved one has suffered a serious injury after being implanted with a metal-on-metal hip replacement device, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the hip implant and we can help.

What’s the problem?

March 29, 2012 – The FDA announced today that an advisory panel of scientists, researchers and medical practitioners will meet on June 27-28 to decide whether to impose new testing standards to be met before a device can be sold in the United States.

“We are asking outside scientific and medical experts to discuss recent information on these devices so that the agency can continue to make reliable safety recommendations,” Dr. William Maisel, deputy director of science at FDA’s Center for Devices and Radiological Health, said in a statement.

According to the Maisel, the upcoming advisory panel will investigate:

  • failure rates
  • metal ion testing
  • imaging methods
  • patient risk factors
  • follow-up surgery
  • complications associated with metal-on-metal hip replacement and resurfacing systems

Hip replacement surgery is a commonly performed, expensive procedure designed to provide greater mobility to patients with joint pains and arthritis. Each year, approximately 270,000 hip replacements are performed around the country, accounting for nearly 40% of all joint replacements. The procedure typically costs around $20,000.

However, in recent years, metal hip implants have become increasingly associated with high rates of failure compared to patients implanted with older, more conventional devices. Additionally, a large number of metal-on-metal recipients have reported high concentrations of metal ions in their blood.

New research from the National Joint Registry of England and Wales found that approximately 6% of patients with metal-on-metal devices needed revision surgery to replace or repair the implants within five years, compared to about 2% of patients implanted with ceramic or plastic systems.

Need More Info?

Click on the links below if you’d like additional information about these topics from Schmidt & Clark, LLP:

Do You Have a Metal-on-Metal Hip Implant Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in metal-on-metal hip implant lawsuits. We are handling individual litigation nationwide and currently accepting new hip implant injury cases in all 50 states.

Free Metal-on-Metal Hip Implant Lawsuit Evaluation: If you or a loved one has suffered a serious injury after being implanted with a metal-on-metal hip replacement device, you should contact our law firm immediately. You may be entitled to compensation by filing a metal on metal hip implant suit and we can help.

Free Confidential Case Evaluation

Verified 100% Secure SiteTo contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (866) 588-0600.
*
*
*
Awards & recognition