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Drugs & Medical Devices

FDA May Require More Information from Metal-on-Metal Hip Makers

— January 18, 2013

Once again, the FDA arrives late to the party:

Jan 17 (Reuters) – The U.S. Food and Drug Administration has issued a proposal calling on companies that make all-metal hip replacements to provide additional information proving they are safe and effective before being allowed to continue selling them.

The move follows years of concern within the medical community over the metal-on-metal implants, which the FDA said on Thursday can cause soft-tissue damage, potentially leading to further surgery to replace the devices.

Source: UPDATE 1-FDA moves to tighten controls on all-metal hip implants | Reuters

Recall of course that trial lawyers have for years been filing lawsuits against the makers of metal-on-metal hips.  DePuy, for example. faces over 2,000 lawsuits from individuals who received DePuy ASR hip implants that may be defective.

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