Doctors Say FDA Hip Implant Approach is Flawed

The Food and Drug Administration (FDA) is under fire for its approach to post-marketing studies by manufacturers of metal-on-metal hip implants by critics who say the agency needs to tighten up its protocols for the studies and push manufacturers to more quickly submit their study plans for FDA approval.

An article appearing in the online version of the New England Journal of Medicine (NEJM) warns that the required studies will be of limited use unless the FDA adopts a more stringent approach to the process, writes MedPage Today.

Last year, the FDA ordered the manufacturers of metal-on-metal hip devices -- like Johnson & Johnson’s DePuy ASR -- to carry out surveillance studies on their patients and to submit study protocols for the agency’s approval. These studies were ordered following reports of high failure rates and inflammatory reactions linked to metal-on-metal hip implants, according to MedPage Today.

Of the 104 devices ordered covered by the FDA, less than a quarter of the study protocols have been approved, according to the NEJM article by Dr. Joshua Rising of the Pew Charitable Trusts and two colleagues. And plans for 80 studies were described as either pending or overdue.

The NEJM article also charges the FDA’s requirements for the protocols weren’t tight enough and likely to result in a lack of conformity in the study results, according to MedPage Today. The FDA had, for example, failed to set specific guidelines to measure chromium and cobalt ions in blood, an important element in studying problems with metal-on-metal hip implants.

The article also called on the FDA to create comprehensive U.S. device registries, similar to what other countries have done.

The FDA meets this week to review the safety of metal-on-metal hip devices.

If you or a loved one has been harmed by an unsafe metal-on-metal hip implant, contact Sokolove Law for a free legal consultation and to find out if a product liability lawyer may be able to help you.

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