Mentor Worldwide LLC, the U.S. market leader in breast aesthetics, today announced the U.S. Food and Drug Administration (FDA) has approved four additional styles of the MENTOR® MemoryShape® Breast Implants, expanding its suite of silicone breast implant products. MemoryShape® Implants are supported by unsurpassed 10-year prospective clinical data. With the addition of these styles, the MemoryShape® Implant product line will better meet the wide spectrum of patient needs.
"This product line demonstrates our commitment to meet the needs of plastic surgeons and their patients with an expanded range of shaped styles and sizes of implants that have demonstrated excellent patient satisfaction and safety in our long-term study," said David J. Wilson, Worldwide President, Mentor Worldwide LLC. "Our growing portfolio can now more effectively meet the needs of patients undergoing either breast reconstruction or augmentation surgery by allowing a better match between the patient and the implant on height, width and desire for optimal projection."
"Breast reconstruction and breast augmentation patients have varying desires, specifically with regard to projection. These approved implants address those needs," said Dennis Hammond, M.D. of Partners in Plastic Surgery of West Michigan, and lead investigator of the MENTOR® MemoryShape® Breast Implant clinical trial. "Expansion of the product line, in combination with Mentor's unique imprint texturing, limits implant rotation allowing surgeons to achieve consistent, long-term, optimal outcomes for their patients."
The FDA approval is supported by clinical studies including a core study of 955 patients implanted with MemoryShape® Implant Style MM (FDA approved in 2013) and a study of all five MemoryShape® Implant styles consisting of 3,637 patients. In the core study, patients with MemoryShape® Implants expressed high satisfaction with their breast appearance and 97 percent reported they would make the same decision again to have breast implant surgery.