FDA Considers National Registry For Silicone Breast Implants
This article was originally published in The Gray Sheet
Executive SummaryDue to lower-than-expected follow-up rates for Allergan and Johnson & Johnson/Mentor’s silicone-gel-filled breast implant post-approval studies, FDA advisory panel members last week called for a national registry to better document long-term outcomes and complications.
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After years of struggling to track breast implant patients with post-market surveillance surveys, silicone gel breast implant makers will be allowed by FDA to substitute data from two new registries to fulfill their duties on post-approval studies and device tracking, an FDA epidemiologist said recently.