FACT: The
FDA recently approved Mentor’s
MemoryGel™ silicone breast implants for use in
breast reconstruction and
augmentation patients.
Mentor’s silicone gel-filled breast implants first became available in the United States in April 1984. In January 1992, at the FDA’s request, Mentor agreed to a voluntary moratorium on sales of silicone gel-filled breast implants. In July of the same year, these medical devices were made available once again to reconstruction and revision patients who were willing to participate in an Adjunct study. The
Mentor Adjunct Study has been one of the largest continued access studies, with more than 128,000 patients participating.
The data collected in Mentor’s Adjunct study was reviewed by FDA as part of the approval process. The silicone gel-filled breast implants that were recently approved by the FDA contain the same material as those that, prior to this approval, were manufactured and available only to physicians participating in the Mentor Adjunct Study.
Read more about the
safety of breast implants, including links to various resources on the web.