Regulatory Focus™ > News Articles > FDA Meeting on Hip Implants Recommends Against Use

FDA Meeting on Hip Implants Recommends Against Use

Posted 29 June 2012 | By Alexander Gaffney, RAC 

A panel of experts convened on Thursday, 28 June by US regulators has recommended against the use of metal-on-metal hip implants in patients, reports the Associated Press.

The hips, cleared for use by the US Food and Drug Administration (FDA) through its 510(k) pathway which assesses products for "substantial equivalence" to existing products, have been increasingly under fire in recent months as safety concerns mount.

UK regulators recently advised surgeons to stop implanting the hips, which are characterized by a metal hip component that fits into a metal socket, in light of their high revision rate and associated adverse events including pain and swelling from metal shavings.

Similar concerns seemed to be on the minds of US regulators when they convened a panel of 18 experts to study the issue. In addition to recommending against the use of the products in patients, the panel also advised patients to receive regular blood tests to monitor blood chromium levels and the integrity of the implants.

While the Associated Press explained FDA has thus far not raised the possibility of withdrawing the products from the market, the panel's recommendations nevertheless raise the potential for future action.

Read more:

AP - FDA panel sees little use for metal-on-metal hips

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