April 2, 2012

FDA May Implement New Standards for All Metal-on-Metal Hip Implants

by Levin & Perconti

The Washington Post is reporting that the U.S. Food and Drug Administration (FDA) is considering changes to implement stricter standards for all metal-on-metal hip replacement devices. Our Illinois DePuy hip recall lawyers know that the recall of 93,000 ASR metal-on-metal hips in August of 2010 was likely a factor in the FDA reconsideration. Many patients suffered injury as a result of the failure of their DePuy ASR hips, often requiring risky revision surgery. The legal cases stemming from the hip failures are still being sorted out across the country.

The DePuy hip recall led to much more scrutiny being placed on the use of these metal-on-metal hip designs. Following the recall the FDA asked all companies producing similar devices to conduct additional research to ensure the safety of their products. However, that research request did not quell all concern about the use of these devices. Many have questioned whether the FDA’s approval process might have played a role in allowing the dangerous product to enter the market prematurely.

To address those concerns, the FDA will hold a two-day meeting in June to discuss the process that led to this latest recall and whether or not changes in the approval process might be needed to prevent a similar product malfunction from harming medical patients in the future. At the heart of the June 27th meeting will be discussion about whether more rigorous testing standards are needed for these devices.

The FDA panel will include scientists, researchers, doctors, and patients to discuss the issues and help FDA regulators determine if more rigorous safety standards are needed. The FDA’s deputy director at the Center for Devices and Radiological Health said that the agency “is asking outside scientific and medical experts to discuss recent information on these devices so that the agency can continue to make reliable safety recommendations.

Our Chicago medical malpractice lawyers have closely followed concerns about these hips as they’ve developed over the last two years. Since that time there have been many questions asked about the use of metal-on-metal hip implants. Some recent studies have found that the metal-on-metal devices are uniformly more likely to fail than traditional plastic hip implants. For example, in early March a team of British experts released a report which suggested that all metal hip joints should be pulled out of use because of their poor performance record when compared to traditional plastic devices. That study, from the National Joint Registry of England and Wales found that about 6% of all those who receive metal-on-metal hip implants need to have revision surgery within five years. That is significantly higher than the 1.7% to 2.3% replacement rate for older plastic hips.

Besides challenging the efficacy of the devices themselves, our Illinois medical malpractice lawyers have explained how others have directed criticism at the FDA approval process for these devices. The recalled DePuy hip implants were approved for use in the past via an alternative approval process through the FDA based on its similarity with devices already on the market. While this speedier process might seem more efficient at times, it also comes with the risk of allowing potentially dangerous products to enter the market before all of their risks are made apparent.

See Our Related Blog Posts:

Hip Implant Producers Ordered to Conduct More Research

Defective Medical Implants Suggest More Oversight Necessary