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Consumers Union Urges FDA To Require Safety Testing of Metal on Metal Hips and Other High Risk Implants
Date:4/18/2013

ven though they were classified as "high risk."

We also strongly support the proposal's requirement for makers of hip implants in this category that are already on the market to provide critical safety information to the agency within 90 days. However, it is troublesome that MoM hips can continue to be commercially distributed up to 90 days after the FDA order.

This order will finally require manufacturers to demonstrate clinical testing for safety and effectiveness before approval of new metal on metal hips. But at this time we are skeptical that any metal on metal hip implant could be safe for patients. Because of that, we urge the FDA to push all manufacturers of metal-on-metal hips to remove their products from the market, because of the high failure rates and high numbers of adverse events, especially experienced by women.

While the FDA has issued an alert about possible adverse events to the public, this does not guarantee that all affected patients have been given advice on monitoring their metal hips for problems. As was done in the UK, all patients with these implants should be notified about their risks and advised to get yearly tests for cobalt poisoning. Unless the FDA confirms that each manufacturer has done due diligence to notify every patient with these MoM hips, the problem has not been properly addressed.

The New York Times recently reported that a MoM hip sold by Johnson and Johnson had a 40% failure rate but the company continued to sell the remainder of their inventory, despite the knowledge of the failure rate. This kind of irresponsible behavior must stop. Requiring a more thorough review up front, as the current order proposes, will help to keep flawed devices from the market.

In addition, we strongly encourage the FDA to review and re-classify to PMA status all Class III implantable medical devices. Other high risk implanted medical devices like surgical mesh should also be put into the PMA approval tr
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SOURCE Consumers Union
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