Silicone-Gel Implants Get Thumbs Up From FDA Advisory Panel
An FDA advisory panel recommended approval of Mentor’s application to sell silicone-gel breast implants.
The same panel a day earlier rejected the company’s application.
An article at Boston.com says:
Yesterday’s vote, occurring after the same panel rejected the application of Inamed Corp. by a 5 to 4 vote, gives the FDA a mixed recommendation as it grapples with the future of implants, used for breast enlargement and reconstructive surgery.
In 2003, the agency rejected an earlier advisory panel’s recommendation to allow general use of silicone gel implants, and it now has 90 days to decide whether to approve one company’s device, both companies’ implants, or none.
”We’re very gratified that the panel came to the decision they did and hopeful the agency will focus on the same things — the quality of our science and the quality of our data on safety and efficacy,” said Mentor president and CEO Joshua Levine. ”I think the panel concluded that not all breast implants are created equally and not all test methods are created equally.”
The decision made by the panel has been criticized by public interest groups.
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