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FDA Approves Mentor’s Largest Breast Implants for Reconstruction Patients

by Alice
breast

Women seeking breast reconstruction after mastectomy now have access to a new, larger option. The U.S. Food and Drug Administration (FDA) has granted approval for Mentor’s MemoryGel Enhance breast implants, the largest silicone implants currently available. Ranging in size from 930cc to 1445cc, these implants offer considerably more volume than previous options, which topped out at 800cc. They are specifically designed for post-mastectomy reconstruction and revision surgeries, and are expected to be available in the United States by mid-2025.

Dr. Alanna Rebecca, a Phoenix-based plastic and reconstructive surgeon at Mayo Clinic, explains that women with larger frames or significant tissue loss have often faced limited options in reconstruction. “This approval addresses a long-standing need, providing a solution that helps restore symmetry and confidence for more patients,” she said.

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Prior to this approval, women who sought larger breast implants were constrained by a maximum size of 800cc, which often required compromises in both aesthetics and functionality. With the new range of sizes, surgeons can better tailor the implants to suit a patient’s body type, resulting in more balanced and natural-looking outcomes. Alenka Brzulja, President of Mentor, emphasized that the expansion of implant sizes is a step toward greater inclusivity in breast reconstruction. “This is about ensuring women have access to reconstruction options that work for their unique anatomy,” she said in a company statement.

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The approval of the MemoryGel Enhance implants marks a significant shift in breast reconstruction options. For many women, it represents not just an opportunity for more personalized results, but also a chance to rebuild their sense of self after a deeply personal and often challenging journey. By offering more volume and variety in implant sizes, this new approval helps fill a crucial gap in the reconstruction process, giving patients the freedom to choose options that align better with their bodies and personal preferences.

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