FDA approves MENTOR MemoryShape Breast Implants

Mentor Worldwide LLCJun 15 2013

Mentor Worldwide LLC, the U.S. market leader in breast aesthetics, today announced the U.S. Food and Drug Administration (FDA) has approved MENTOR® MemoryShape™ Breast Implants, providing new options for women looking for a more natural shape and youthful feel from breast enhancement or reconstruction surgery.

"We understand each woman has different needs and specific, personal reasons for choosing to undergo breast surgery," said David J. Wilson, Worldwide President, Mentor Worldwide LLC. "As the U.S. market leader in breast aesthetics, Mentor constantly strives to develop products that celebrate a woman's uniqueness. 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."

Unlike round implants, MENTOR® MemoryShape™ Breast Implants have a teardrop shape, much like the silhouette of a natural breast. They have been approved for more than a decade outside of the U.S. and are filled with a uniquely formulated cohesive gel that enables shape retention, while providing a natural silhouette and youthful firmness. The combination of teardrop shape and distinct gel formulation creates the optimal balance of shape and feel. MENTOR® MemoryShape™ Breast Implants are indicated for breast augmentation in women at least 22 years old and for breast reconstruction.

"I knew that I wanted to have breast augmentation because I came to a point in my life where I was self-conscious about my appearance, and I wanted to change that," said Jessica White-Hatinger, a 30-year-old breast augmentation clinical trial participant. "I really wanted a natural result, and after speaking with my surgeon, we decided on the MENTOR® MemoryShape™ Breast Implants. I am very happy with my new look and the confidence the implants have given me."

"Over the past 25 years, we have been exploring opportunities to improve breast implants. MENTOR® MemoryShape™ Breast Implants incorporate several new design features, such as the cohesive gel that allows the implant to be formed into a teardrop shape to fit each individual patient," said Dennis Hammond, M.D. of Partners in Plastic Surgery of West Michigan, and lead investigator of the MENTOR® MemoryShape™ Breast Implants clinical trial. "I am pleased women in the U.S. now have an implant that offers an enhanced yet subtle breast appearance with a proven safety profile."

To help surgeons find the ideal size and fit for their patients, MemoryShape™ Breast Implants are available in a range of sizes. Like all breast implants in the company's product portfolio, MENTOR® MemoryShape™ Breast Implants can be sized using the BodyLogic® System, an innovative implant sizing system. The BodyLogic® System helps surgeons determine the right breast implants for their patients, by providing selection tools and materials to identify a range of implants for the patient, which will ultimately increase the patient's level of satisfaction.