Nearly three-quarters – or 12,137 – of complaints made to the Food and Drug Administration (FDA) in 2011 regarding artificial hips involved a recalled metal-on-metal hip implant made by Johnson & Johnson subsidiary DePuy Orthopaedics, the agency reported.
The recall, issued in 2010, involved the DePuy ASR XL Acetabulator Hip Replacement System. But that wasn’t the only metal-on-metal hip implant to cause problems. Metal-on-metal artificial hips from all manufacturers generated about twice the number of complaints in 2011 than implants made with plastic or ceramic parts.
The report was announced this week during a review of all-metal hip implants by an expert panel charged by the FDA to draw up guidelines for the medical devices. The 18-member panel reviewed the data and said they found few reasons why all-metal hip implants should continue to be marketed to doctors and patients.
The report showed that more than 14,000 people who received artificial hip implants required revision surgery to remove and/or replace a defective device. About 8,700 people reported pain.
The FDA advisory panel did note that fewer metal-on-metal devices were being used since DePuy recalled its device. The panel also recommended those who have the all-metal devices and experience problems visit with their doctors to ensure their implant isn’t failing or causing other problems.
The FDA does not always follow the advice of its expert panels, but it often does.
DePuy now faces about 6,000 lawsuits from people who claim the implants were defective and caused them pain and disability.