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FDA takes long-awaited action on all-metal joint replacements

Posted by Smiley & Smiley on Jan 18, 2013 2:07:56 PM

The Food and Drug Administration (FDA) has played a central role in the ways that all-metal hip implants and related joint replacement devices have been introduced into the marketplace and taken out of it. Despite the large-scale DePuy hip implants scandal, the FDA has yet to banish all-metal joint replacements from the market. Rather, most all-metal implant models have simply been recalled to the point that their use is declining in significance over time.

However, the FDA is finally seeing fit to propose rules that would practically disallow the manufacture of these truly dangerous implantable medical devices. This effort comes too late for the 500,000 American patients who have been outfitted with metal-on-metal hip implants alone. Yet, action now will hopefully prevent future patients from related pain and suffering.

In essence, the FDA's new proposal mandates that any medical device manufacturer who opts to include an all-metal component in hip implant designs must first prove that their current designs are effective and safe for patient use before they will be allowed to continue marketing them. Given that these designs have proven to be inherently unsafe in the past, this proposal may effectively eliminate all-metal joint implants from the market.

One of the reasons that the DePuy hip implant scandal harmed patients to the extent that it did is that the all-metal implants were insufficiently tested before they were released into the marketplace. By insisting that manufacturers guarantee the safety and effectiveness of these devices, the FDA is helping to prevent that insufficient testing will lead to patient harm in the future.

Source: New York Times, "F.D.A. Seeks to Tighten Regulation of All-Metal Hip Implants," Barry Meier, Jan. 16, 2013

Topics: defective-products, depuy-hip-implants, patient-safety

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