Faulty French breast implants may reverse US device approval debate.

FDA And Breast Implants Standards

Jan 19. 2012
Poly Implant Prothese

Poly Implant Prothese

U.S. medical device makers have complained for years about slow reviews and inconsistent standards at the Food and Drug Administration

They have spent the last year urging U.S. officials to approve high-risk products faster, like their European counterparts.

A recent scandal over leaking breast implants made in France may make the argument harder.

French and German officials last month recommended thousands of women have surgery to remove implants made by Poly Implants Protheses SA, after reports the products were leaking industrial silicone inside patients.

While the devices were never approved for use in the U.S., they may alter the debate over regulations.

Congress faces a September deadline over whether to revamp U.S. device rules, and industry allies in both parties have pointed to Europe’s speedier reviews as a model to follow.

The FDA, acknowledging industry concerns about U.S. regulation, defends its system as better for patients.

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