FDA Assumes new Method for Hip Recall

FDA Assumes new Method for Hip Recall

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FDA Assumes new Method for Hip Recall

On August 24, 2010, DePuy Orthopaedics issued a voluntary recall on its ASR XL Acetabular System and the ASR Hip Resurfacing System. This decision was also heeded by the US Food and Drug Administration. A senior FDA official urges smart regulation in the wake of the DePuy recall.

The recall was voluntarily done by DePuy Orthopaedics in response to the data presented by an independent national registry from UK. The data indicated that within five years of having an ASR resurfacing device implanted, approximately 12 percent of patients have had revision surgery. Furthermore, 13 percent of patients who had an ASR total hip replacement for the past five years had to undergo revision procedure.

The FDA has been taking measures to come up with suited interventions for the metal-on-metal hip implant crisis, like the DePuy recall. Several areas are currently worked on by FDA for them to thoroughly assess the safety and effectiveness of MoM hip implants. The agency has requested MoM hip implant manufacturers to submit device retrieval analyses. FDA constantly appraises Medical Device Reports, post-approval study reports, data from several orthopedic device registries and published literature. Through this, they can better understand the adverse events linked with metal debris on MoM hip systems.

A post-market surveillance study to be conducted by all-metal hip implant manufacturers was ordered by the FDA on May 6, 2011. The FDA will receive research protocols on specific safety issues regarding the affected devices from manufacturers. From the given data, the agency will have a clearer view on the nature and safety of the artificial hips.

Recently, a Biotech conference was conducted and as reported, the FDA official urges smart regulation in the wake of the DePuy recall. Dr. Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, remarked that the federal government needs to carry out strict policy enforcement. "We needed to move away from this pendulum-swing approach, away from the idea of it's more regulation or less regulation. It's about smart regulation," Shuren stated. He further commented “It’s not safety or innovation. It’s safety AND innovation.”

According to Dr. Shuren, the FDA must specify its role. "We needed to move away from this construct that safety and effectiveness and facilitating innovation are incompatible. They are both sides of our mission,” he added.

Follow-up visits to the health care provider should be done continuously by the recipients of the device, as recommended by the FDA. The FDA strongly suggests that patients who are and are not experiencing DePuy hip symptoms ask for help from their attending doctor.

  Article Info
Created: Feb 15 2012 at 08:45:29 AM
Updated: Feb 15 2012 at 08:45:29 AM
Category: Health
Language: English

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