New publication adds to substantial clinical data demonstrating safety and effectiveness of MENTOR® Breast Implants in primary and revision augmentation and reconstruction patients
IRVINE, Calif., Feb. 14, 2018 /PRNewswire/ -- 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.1
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 results1
- Low Baker Grade III/IV capsular contracture, rupture and rotation rates1, 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 1
Further, in the Core Study at 10 years there were no reported cases of double capsule*,2 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 patients3.
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.1
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.
About Mentor Worldwide LLC
Mentor Worldwide LLC, part of Johnson & Johnson Medical Devices Companies, is a leading supplier of breast implants in the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow breast surgery patients to improve their quality of life. The company is focused on two strategic areas: breast reconstruction and breast augmentation. MENTOR® is the only manufacturer whose silicone breast implants are made in the U.S.A. For more information about MENTOR® visit: www.mentorwwllc.com
Important Safety Information:
MENTOR® MemoryGel® Breast Implants, MemoryShape® Breast Implants, and Saline-filled Breast Implants are indicated for breast augmentation – in women who are at least 22 years old for MemoryGel® Implants and MemoryShape® Implants, and at least 18 years old for Saline Breast Implants – or for breast reconstruction. Breast Implant surgery should not be performed in women with active infection anywhere in their body, with existing cancer or precancer of their breast who have not received adequate treatment for those conditions, or who are currently pregnant or nursing. The most common complications with MemoryGel® Implants, MemoryShape® Implants, and Saline-filled Breast Implants include reoperation, capsular contracture, asymmetry, breast pain, implant removal, wrinkling, ptosis, and implant rupture and deflation. Detailed information regarding the risks and benefits associated with MemoryGel® Implants, MemoryShape® Implants, and Saline-filled Breast Implants is provided in patient brochures available from your surgeon or on line at www.mentorwwllc.com. For more complete safety information click here.
*Based on the MENTOR® MemoryShape® Breast Implants Core study report of 955 patients.
- Hammond DC, Canady JW, Love TR, et al. Mentor Contour Profile Gel Implants: Clinical Outcomes at 10 Years. PlasticReconstructive Surgery 2017 Dec;140 (6): 1142-1150 .
- Mentor Worldwide, LLC. MemoryShape® Post-Approval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report. 02 June 2015.
- Mentor Warranty Information http://www.mentorwwllc.com/global- us/WarrantyInformation.aspx; Accessed 01/18/2018.
- ASPS 2016 Plastic Surgery Statistics:https://www.plasticsurgery.org/news/plastic-surgery-statistics
CONTACT: Emma Reynolds,(949) 562-2196, ereynol4@its.jnj.com