MENTOR MemoryGel Enhance Breast Implant gets USFDA nod for largest size breast implants for reconstruction: Mentor Worldwide

"This 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 stated.

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 annually, and this growing patient population is becoming more diverse. 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.

“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.”

"With the launch of MemoryGel Enhance Breast Implants, breast reconstruction patients in need of larger implants are afforded the same clinical benefits as those patients for whom proportionately sized implants are already available. This new implant line will enable surgeons to deliver desired results for women who were previously underserved, having limited options to regain their original breast size or achieve projection and symmetry with the unaffected breast," the release stated.

“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,” says Alanna Rebecca, M.D., plastic and reconstructive surgeon at the Mayo Clinic in Phoenix, Arizona, 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.”

This approval is supported by 3-year findings from the prospective, multicenter, ongoing 10-year ATHENA study, which demonstrated the safety and effectiveness of MemoryGel Enhance larger-volume silicone breast implants after three years, in women who underwent post mastectomy and implant-based breast reconstruction.

WARNING:

• Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery.
• Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This cancer occurs more commonly in patients with textured breast implants than smooth implants, although rates are not well defined. Some patients have died from BIA-ALCL.
• Patients receiving breast implants have reported a variety of systemic symptoms such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases and others. Individual patient risk for developing these symptoms has not been well established. Some patients report complete resolution of symptoms when the implants are removed without replacement.

The sale and distribution of Mentor Breast Implant Devices are restricted to users and/or user facilities that provide information to patients about the risks and benefits of the device prior to its use in the form and manner specified in approved labeling to be provided by Mentor Worldwide LLC.

Read also: JnJ seeks USFDA nod for Tremfya for treatment of plaque psoriasis, juvenile psoriatic arthritis in children