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Status Quo Maintained In Implant Controversy

SATURDAY, OCT. 18, 1997

The Food and Drug Administration rejected an attempt by cancer organizations to lift federal restrictions on silicone breast implants, keeping an uneasy status quo for the controversial devices.

The FDA also rejected a call by sick implant recipients to recall and ban the implants.

But the FDA said the two petitions, rejected Wednesday, highlight a serious problem: that five years after the government demanded safety data from manufacturers, it still can’t settle the controversy.

“We do not have sufficient information to change the current regulatory policy on silicone gel-filled breast implants,” Dr. Michael Friedman, FDA’s acting commissioner, wrote the Y-Me National Breast Cancer Organization. He sent an almost identical explanation to implant critics.


 

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