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Inamed Silicone Implant Patient Monitoring Plans Allay Rupture Concerns

This article was originally published in The Gray Sheet

Executive Summary

Inamed's proposal to closely follow patients implanted with silicone gel-filled breast prostheses helped sway FDA's General & Plastic Surgery Devices Panel to recommend conditional approval of the firm's PMA by a 9-6 margin

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Silicone Breast Implant Postmarket Proposals To Be Weighed By FDA Panel

FDA's General & Plastic Surgery Devices Panel is likely to place added scrutiny on Mentor's and Inamed's respective proposed silicone breast implant postmarket studies, given the controversy surrounding the devices and heightened public spotlight on the agency's postmarket data lapses

Silicone Breast Implant Postmarket Proposals To Be Weighed By FDA Panel

FDA's General & Plastic Surgery Devices Panel is likely to place added scrutiny on Mentor's and Inamed's respective proposed silicone breast implant postmarket studies, given the controversy surrounding the devices and heightened public spotlight on the agency's postmarket data lapses

Spring renewal of breast implant PMA debate

FDA General & Plastic Surgery Devices Panel will convene in April to review supplemental data on Inamed's silicone gel-filled breast implants, the firm says Dec. 6. Submitted to the agency in August, the data supports a PMA deemed "approvable with conditions" by the FDA panel in a 9-6 vote last year (1"The Gray Sheet" Oct. 20, 2003, p. 3). FDA's rejection of the PMA in January narrowed the race between Inamed and Mentor, which claims it expects a spring panel review of its own silicone implants. Like Inamed, Mentor filed supplemental data to its PMA in August, accounting for FDA guidance in January. The two firms could share a panel date...

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