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Cracking Down On Silicone Implants


In Business This Week

CRACKING DOWN ON SILICONE IMPLANTS

The controversy over silicone-filled breast implants has taken a new turn. On Aug. 22, the Food & Drug Administration notified three manufacturers that data they had submitted for safety reviews was insufficient. The three are Bioplasty, California doctor Joseph F. Cavon, and Bristol-Myers Squibb's Surgitek unit. The ruling could signal the end of their implants. Surgitek stopped marketing its implant in April after the FDA found that foam used in its manufacture could decompose into a carcinogenic material.

The FDA also told four companies that their applications had "significant problems" but that the agency would continue its review of the products. These companies are McGahan Medical, Mentor, Dow Corning Wright, and Bioplasty, which submitted two applications.EDITED BY PETER FINCH


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