FDA, Congress Examine Saline Implant Data; Silicone PMA Expected In 2002
This article was originally published in The Gray Sheet
Executive Summary
Mentor and Inamed should reconvene focus groups to review patient labeling changes for saline-filled breast implants, FDA's General and Plastic Surgery Devices Panel recommended July 9 at its meeting in Gaithersburg, Maryland
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Breast implants
FDA posts Mentor and Inamed saline breast implant five-year labeling data on its website. The firms presented the updated data at a July 9 meeting of the agency's General and Plastic Surgery Devices Panel (1"The Gray Sheet" July 15, 2002, p. 3). Inamed showed a re-operation rate of 26% for augmentation patients and 44.5% for reconstruction patients, while Mentor re-operation rates were 20% and 43%, respectively...