Mentor: 10-Year Data Show Safety, High Satisfaction

Wednesday, February 21, 2018 | FDA Approval/Clearance , Research and Publications


Data from a 10-year clinical study involving 955 patients in the US suggests that  Mentor® MemoryShape Gel Breast Implants are safe and associated with high rates of physician and surgeon satisfaction. Findings appear in the journal Plastic and Reconstructive Surgery.

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. Findings show high patient and surgeon satisfaction rates with implant results and low Baker Grade III/IV capsular contracture, rupture and rotation rates. There were 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.

Additionally, Mentor has 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.

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