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FDA Panel Says Yea to Mentor's Silicone-Gel Breast Implant


On Tuesday, an advisory panel to the U.S. Food and Drug Administration rejected Inamed’s application to reintroduce silicone-gel breast implants to the market. But on Wednesday, the same panel gave their stamp of approval to the application of a competitor, Mentor, and will recommend that the FDA approve release of this product. This decision comes 13 years after the agency put restrictions on this product due to safety concerns.

Mentor’s application was approved by a vote of 7-2. But this approval did not come without some warnings. The panel stressed that if the company’s implants received full approval, they must insist upon doctor’s following-up with patients. Additionally, doctors must be certified in this procedure.

The panel found Mentor’s product to be safer than that of Inamed’s and less likely to rupture. Mentor’s data indicated that 1.4 percent of the implants had ruptured over three years time, but that there were no indications of any adverse effects in any of these cases. They also used data from a British study which showed a lower projected rupture rate than that of inamed. Additionally, Inamed’s data was based more on projection than actual case studies and they only had study results for a three-year period.

18 months ago, the FDA refused to approve Inamed’s application even though an advisory panel recommended approval. At that time, the agency cited incomplete data.

D.R. Boyer



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