US-based clinical study highlights safety and effectiveness of MENTOR MemoryShape Gel Breast Implants
Mentor Worldwide LLC, a global leader in breast aesthetics and part of the Johnson & Johnson Medical Devices companies, announced today the Plastic and Reconstructive Surgery® publication of a U.S.-based 10-year clinical study involving 955 patients which highlights the safety of MENTOR® MemoryShape Gel Breast Implants.
The 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. The publication, entitled ‘Mentor Contour Profile Gel Implants: Clinical Outcomes at 10 Years,’ demonstrated MENTOR® MemoryShape® Implants, which have SILTEX®Texture, have proven performance in the following areas:
- High patient and surgeon satisfaction rates with implant results
- Low Baker Grade III/IV capsular contracture, rupture and rotation rates, complications seen as a result of breast implant surgery with these types of devices which may result in reoperation
- No reported cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), as of the date of this publication
Further, in the Core Study at 10 years there were no reported cases of double capsule,where one capsule develops around the breast implant and the other connects to the surrounding tissue, potentially requiring additional surgery.
“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.”
In addition, Mentor announced they received 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. MemoryShape® TH implants have the most projection and tallest height available in the portfolio and are backed by the MENTOR®Promise Breast Implant Warranty Program, our comprehensive product warranty program for breast implant surgery patients.
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®
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.4 Breast implants allow these women to go through their lives with increased confidence. For more than 30 years, approximately 5 million women have chosen MENTOR® breast implants to achieve their desired outcome.
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