FACT: Both of Mentor’s
silicone gel-filled and saline-filled implants have been approved by the U.S. Food and Drug Administration (FDA) for use in breast reconstruction and augmentation patients. The recent approval of Mentor’s MemoryGel™ products marks the first time since 1992 that silicone gel breast implants have been made available, outside of a clinical study, in the United States.
The MemoryGel™ approval came after the FDA reviewed Mentor’s pre-market application (PMA) and the FDA Advisory Panel positively recommended Mentor’s MemoryGel™ breast implants for approval. At the 2005 FDA Panel Meeting, Mentor presented results from its Core Gel MRI sub-study, which yielded a very low – 1.1% – overall confirmed and suspected rupture rate by implant for MemoryGel ™ implants at three years, and a confirmed rupture rate by implant of 0.3%.
Learn more about the
differences between saline and silicone gel MemoryGel™ breast implants here.