All-Metal Hip Implant Approval Process May Be Altered By The FDA

Posted on January 18, 2013

Yesterday we brought you word of the first trial involving the DePuy ASR hip implant, which is set to begin next week.  Panish Shea & Boyle is involved in the proceedings, and thousands more lawsuits akin to this one are currently pending in California State Court.  Now, the Food and Drug Administration has made a move that could have longterm implications for metal on metal hip implants and the way they’re approved by regulators.

Previously, the manufacturers of metal on metal hip implants were not required to submit the devices to clinical trials which might have illuminated certain safety defects and inordinate failure rates.  Thanks to a loophole in the 1976 Medical Device Amendments, these types of implants only had to be shown as being similar to products already on the market.

So even though the metal hip implants were widely thought to be high risk, some versions were already on the market, and lawmakers granted the devices temporary status as a moderate risk device, with the thought being that legislators would come back and rule on a final designation later.  Such a classification was never made, and when device manufacturers began to unfurl a new series of devices about ten years ago, they only had to be compared to items already on the market to receive approval.

Clinical trials were never required, a fact that’s held in stark contrast when you consider the high failure rates of such devices and the impact said failure can have on the patient.  Persons implanted with metal on metal hip implants that fail must put up with a marked decrease in mobility and all the pain and hindrances to their way of life that go along with that.  In addition, it’s also become apparent that metal shavings can rub off of the device when the components grind against one another.  If these shavings enter the bloodstream, it could cause a host of other issues, such as bone and tissue damage.  This has led the FDA to call for increased monitoring of metallic ion levels in the blood should the patient experience pain or other side effects.

The FDA has now issued a proposal that would require device makers to put the implants through the rigors of clinical trials and thus demonstrate both the safety and the efficacy of the items.  However, it’s likely that lobbyists could push back against the ruling in some way.  Even if passed as is, it will be up to a year before the comment period is even opened up.

In the meantime, the thousands of lawsuits filed against DePuy and parent company Johnson & Johnson are coming to trial, so stay tuned to the latest developments in this story.

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