MENTOR™ MemoryGel™ Enhance Breast Implant Receives FDA Approval for Largest Size Breast Implants for Reconstruction

IRVINE, Calif., Dec. 2, 2024 /PRNewswire/ -- Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of Johnson & Johnson MedTech, today announced the U.S. Food and Drug Administration (FDA) approved MENTOR™ MemoryGel™ Enhance Breast Implants for primary and revision reconstruction breast surgery in post-mastectomy women.

This first-of-its-kind silicone gel-filled implant line features an expanded range of base widths, projections, and volumes in an entirely new range of sizes extending from 930 cc to 1445 cc, the largest on the market. Mentor plans to commercially launch MemoryGel™ Enhance Breast Implants in the U.S. beginning in mid-2025.

More than 150,000 women in the U.S. undergo breast reconstruction annually1, and this growing patient population is becoming more diverse.2,3 An increasing number of these patients require larger breast implants due to factors such as body frame, breast size, or extensive tissue removal during mastectomy. Previously, women with larger cup sizes faced limitations to their breast reconstruction options as the largest implant available was 800 cc.In many cases, this led to compromises in achieving optimal aesthetic outcomes, as insufficiently sized implants could not adequately meet reconstruction tissue volume requirements for some women.5

“We are proud to introduce MemoryGel™ Enhance Implants, a truly meaningful innovation that reflects our commitment to inclusivity and addressing the long-standing patient need for larger breast implant options,” said Alenka Brzulja, Worldwide President, Mentor Worldwide LLC. “By expanding the choices available for breast reconstruction, we are breaking down barriers and ensuring that every woman has equal access to options tailored to her unique anatomy and preferences. Our goal is to support the overall well-being, confidence, and sense of wholeness for every woman undergoing breast reconstruction, ultimately enhancing her journey through comprehensive breast cancer care.”

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