Mentor Worldwide LLC, a J&J firm that’s a big name in aesthetic surgery products, won FDA approval for its MENTOR MemoryShape breast implants that feature “a more natural shape and youthful feel,” according to a press release.
The implants are shaped like a teardrop and are filled with a cohesive gel that helps maintain their 3D profile. They’re indicated for breast augmentation for women over 22 years of age, as well as for breast reconstruction procedures.
The open-label, multi-center MENTOR® MemoryShape™ (CPG™ Core) Breast Implant Core Study consists of 955 patients who undergo post-surgery follow up annually for 10 years. This study is designed to assess the safety and effectiveness of these implants in primary augmentation, revision (augmentation and reconstruction), and reconstruction patients. Effectiveness is assessed by bra and cup size, patient satisfaction, and quality of life (QoL) measurements. Safety is assessed by complications, such as implant rupture, capsular contracture, and reoperation.
In the clinical trial, MENTOR® MemoryShape™ Breast Implants were shown to be safe and effective in both reconstruction and augmentation patients at 6 years, with a low rate of adverse events, such as rupture and capsular contracture Baker grades III and IV. Overall, the Core Study patients also had high satisfaction rates with their breast appearance, and 97 percent of patients who have MemoryShape™ Implants reported they would repeat the procedure.