Ten Year Safety Data for MENTOR® MEMORYSHAPE® Gel Breast Implants

J&J company, Mentor Worldwide LLC, has announced the publication of a U.S. based 10-year clinical study involving 955 patients which highlights the safety of MENTOR® MemoryShape Gel Breast Implants.

Background

Every year in the U.S. there are approximately 400,000 breast procedures either for reconstruction following cancer treatment or for augmentation for personal aesthetic reasons. Over more than 30 years approximately 5 million women have chosen MENTOR® breast implants to achieve their desired outcome.

A newly published open-label, multi-center MENTOR® MemoryShape® Breast Implant Core Study was designed to assess the safety and effectiveness of these implants in primary augmentation, revision (augmentation and reconstruction), and primary reconstruction patients.

Published in Plastic and Reconstructive Surgery® the paper, entitled ‘Mentor Contour Profile Gel Implants: Clinical Outcomes at 10 Years, pointed to high patient and surgeon satisfaction rates with implant results, low Baker Grade III/IV capsular contracture, rupture and rotation rates and no reported cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
in the Core Study at 10 years there were no reported cases of so-called double capsule, where one capsule develops around the breast implant and the other connects to the surrounding tissue, potentially requiring additional surgery.

Investigator comment

“The results of this study document the important role MemoryShape® implants play in providing options in both aesthetic and reconstructive breast surgery,” said Dr. Dennis Hammond, lead author and board-certified plastic surgeon from Partners in Plastic Surgery in Grand Rapids, Michigan. “It’s affirming to see the data confirm what I have observed clinically in my own patients – these devices are a safe and effective option for patients undergoing breast implant surgery.”

Mentor has also announced Premarket Approval (PMA) for the new MemoryShape® Tall Height/High Projection (TH) Breast Implants, providing a more comprehensive implant profile range to help surgeons expand treatment to a broader patient population.

The ‘Mentor Contour Profile Gel Implants: Clinical Outcomes at 10 Years’ publication was published in December 2017 and is now available in the Plastic and Reconstructive Surgery® Journal.

Source: Mentor Worldwide, LLC

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