Mentor Worldwide, part of Johnson & Johnson MedTech, has received the US Food and Drug Administration (FDA) approval for MENTOR MemoryGel Enhance Breast Implants.
MemoryGel Enhance is a silicone gel-filled breast implant line indicated for primary and revision reconstruction breast surgery in post-mastectomy women.
It features an expanded range of base widths, projections, and volumes in an entirely new range of sizes extending from 930cc to 1445cc, the largest on the market.
The FDA approval is supported by three-year findings from an ongoing ten-year ATHENA study, which showed the safety and effectiveness of larger-volume silicone breast implants.
Mentor plans to commercially launch the new line of implants in the US, in mid-2025.
Mentor Worldwide president Alenka Brzulja said: “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.
“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.”
According to Mentor Worldwide, more than 150,000 women in the US undergo breast reconstruction each year, and the number of these patients is increasing.
Previously, women with larger cup sizes faced limitations to their breast reconstruction options, which led to compromises in achieving optimal aesthetic outcomes in many cases.
Mentor Worldwide said that its MemoryGel Enhance Breast Implants enable breast reconstruction procedures for patients in need of larger implants.
The new line of breast implants would deliver desired results for women who were previously underserved, with limited options to regain their original breast size.
Mayo Clinic plastic and reconstructive surgeon and ATHENA study co-author Alanna Rebecca said: “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.
“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.”
