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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