• 22
  • August
    2011

Last year DePuy Orthopaedics, a division of Johnson & Johnson, issued a recall of two hip replacement devices: the ASR XL Acetabular System and the ASR Hip Resurfacing System. The voluntary recall was due to a flaw in the design that allowed the leeching of cobalt and chromium into patients' bodies as well as the high percentage of patients who required a second surgery after their initial procedure.

Many experts blame the need for such a recall on the way these defective hip implants and other similar medical devices have been approved by the U.S. Food and Drug Administration (FDA).

Using a review process called the 510(k), these products are approved in as little as ten months due to their similarity to products already on the market. This streamlined process, used for the vast majority of medical devices, allows them to enter the market place years faster than they would if they were subjected to a traditional review process.

The Institute of Medicine has recently called for the FDA to require implant manufacturers to submit more proof of the safety and effectiveness of medical devices. The Government Accountability Office has backed up the need for increased regulation with the statistic that 83 percent of the medical devices recalled each year have entered the market place through the streamlined 510(k) approval process.

The FDA has thus far ignored the pleas for a more in depth approval process. The agency claims the streamlined approval process helps bring medical devices to those who need them, and provides necessary support for the U.S. medical device industry.

While the debate continues, patients need to advocate for themselves. Patients should look at the track record of different medical devices, and consider older more tested devices. Patients should also check the device maker's website to see if their physician is being compensated by the company whose products they are recommending (medical device makers are required by law to disclose this information). The concern is that some doctors may promote certain products at the expense of what really may be best for patients.

Source: Experts Say FDA Should Abandon Approval Process