J&J’s Mentor Wins FDA Nod for MemoryGel Enhance Breast Implant

Johnson & Johnson MedTech’s Mentor company has gained U.S. Food and Drug Administration (FDA) approval for its Mentor MemoryGel Enhance breast implants for primary and revision reconstruction breast surgery in post-mastectomy patients.

The silicone gel-filled implant line, first-of its kind according to J&J, has an expanded range of base widths, projections, and volumes in a new range of sizes from 930 cc to 1445 cc—the largest on the market.

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. In the past, patients with larger cup sizes had limits on breast reconstruction options because the largest implant available was 800 cc. In some cases, this caused compromises in achieving optimal aesthetic outcomes because the insufficiently sized implants couldn’t adequately meet reconstruction tissue volume requirements.

J&J said the new implant line can allow surgeons to provide desired results for patients who were previously underserved with limited options to regain their original breast size or have projection and symmetry with the unaffected breast.

The approval was backed by three-year findings from the company’s ongoing ten-year ATHENA study. This prospective, multicenter study showed safety and effectiveness of MemoryGel Enhance larger-volume silicone breast implants after three years in patients who underwent post-mastectomy and implant-based breast reconstruction.

“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. “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.”

Mentor expects to commercially launch MemoryGel Enhance breast implants in the U.S. starting in mid-2025.

“The size of implants currently on the market is not reflective of the diverse body types of women, especially women with larger cup sizes who undergo reconstructive surgery following a breast cancer diagnosis,” said Alanna Rebecca, MD, plastic and reconstructive surgeon at the Mayo Clinic in Phoenix, Ariz., and co-author of the anticipated ATHENA study publication. “A woman’s body type should never limit her options in reconstruction, which is why this latest approval is an exciting step for the breast cancer community as we pave the way for inclusivity along the full continuum of breast cancer care.”