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The U.S. FDA posted a proposed order today that will be published in the Federal Register tomorrow addressing metal on metal hip implants. Metal hip implants made by all manufacturers have been failing at an unacceptable rate for several years. The DePuy ASR was the first metal hip recalled in 2010. The Smith & Nephew R3 was recalled in 2013. Other implants such as the Biomet Magnum, the DePuy Pinnacle, the Encore, the Wright Profemur Converse, the Wright Dynasty, the Wright Lineage, and the Zimmer Tribecular are still on the market.

The new 2013 proposed metal on metal hip implant Order, if approved, will require hip implant manufacturers to go through the Premarket Approval Process to keep any metal on metal hip implant on the market or to put a new metal on metal product on the market. The Premarket Approval process, the PMA, requires extensive and expensive clinical studies to prove that the products are safe and effective.

It is unlikely that any of these manufacturers will spend the money to go through the PMA process because the metal hip design has already proven over the last ten years that it is not safe or effective. A PMA application for a metal on metal hip would probably not be approved by the FDA because of the high failure rates of all of these hips. The metal hips are failing because they shed metal debris that raises cobalt and chromium levels in the blood. The cobalt and chromium are toxic to the tissues in the hip compartment and cause pain, swelling, and failure of the implant. This usually requires an expensive and painful revision surgery.

It is possible that this is a brokered deal between the FDA and the medical device industry. This Order would allow the manufacturers to discontinue marketing these products citing the expense of preparing a PMA application. This would avoid the necessity of the FDA ordering a recall. A recall would be an admission that there is a safety problem with the metal hips.This proposed rule could take up to a year to take effect and remove the products from the market.

Most of these manufacturers still deny the obvious: that these metal hips are a bad idea. Avoiding a recall will help the manufacturers defend the lawsuits that have been brought against them. In every one of the thousands of the lawsuits that have been filed against DePuy, Zimmer, Biomet, Wright, and Encore the companies claim that the products are not defective and that the companies are not responsible to pay any compensation to anyone for all the pain and revision surgeries that metal implant patients have suffered.

Once we begin presenting these lawsuits to juries I think they will agree that these products never should have been sold to the public and should have been recalled long ago.

Here is the link to the proposed Order.

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