US-based aesthetic medical products manufacturer Mentor Worldwide has received the US Food and Drug Administration (FDA) clearance for its MemoryShape breast implants.
Indicated for breast reconstruction and breast augmentation in women who are aged at least 22 years, the MemoryShape breast implants use a teardrop shape that is similar to the silhouette of a natural breast and come with a gel formulation for optimal shape and feel.
The breast implants can be sized using the BodyLogic system, an implant sizing system that enables surgeons to determine the right breast implants for patients based on their individual requirements.
Mentor worldwide president David J Wilson said the company recognises that different patients have varying needs and reasons for choosing to undergo breast surgery.
“The FDA approval of Mentor MemoryShape breast implants allows us to meet this need by delivering the perfect balance of shape and feel to obtain the natural and youthful look patients desire,” Wilson said.
The approval was based on the open-label, multicentre MemoryShape breast implant core study, which involved 955 patients who underwent post-surgery follow up annually for ten years in order to evaluate the safety and effectiveness of the implants.
According to Mentor, during the clinical trial it was found that the breast implants were safe and effective in both reconstruction and augmentation patients at six years, with a low rate of adverse cases such as rupture and capsular contracture Baker grades III and IV.
On the whole, the patients reported high satisfaction rates with their breast appearance, with about 97% reporting that they would repeat the process.
Following the FDA approval, the company now plans to conduct studies to gather additional clinical data on the implants.