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PIP Saline Implant Deemed "Not Approvable" Due To Paucity Of Data

This article was originally published in The Gray Sheet

Executive Summary

Poly Implants Prostheses' premarket approval application for a prefilled saline breast implant included clinical data on only 6.4% of the number of patients deemed necessary by FDA for approval, the agency's General and Plastic Surgery Devices panel determined March 2.

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Panel Urges McGhan To Recharacterize "Inflated" Complication Rates

Inamed's McGhan Medical unit should eliminate non-significant risks from its risk characterization of saline breast implants as a condition for FDA approval, the agency's General and Plastic Surgery Devices advisory panel concluded March 2 in Gaithersburg, Maryland.

Mentor, Inamed Saline Breast Implants Deemed Approvable By FDA Panel

Saline breast implants manufactured by Mentor Corp. and Inamed Corp. should remain on the U.S. market provided the device manufacturers beef up labeling and physician training to help insure that patients are fully informed of any possible adverse outcomes, FDA's General and Plastic Surgery Devices Advisory Panel recommended at a March 1 meeting in Gaithersburg, Maryland.

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