Mentor MemoryShape Breast Implants Get FDA Approval

Posted on June 28, 2013 | by

FDA Approval of Mentor MemoryShape Breast Implants On June 14, 2013, the Food and Drug Administration (FDA) approved a new silicone-gel breast implant for use in the United States. The MemoryShape Breast Implant will now be available for breast reconstruction and breast augmentations in women at least 22 years old.

MemoryShape Cohesive Silicone-Gel Breast Implants

MemoryShape is the third cohesive silicone gel breast implant to be approved by the FDA in the last two years. It is also, now the fifth FDA-approved silicone gel-filled implant on the U.S. market.

The MemoryShape breast implant is made by Mentor Worldwide, LLC, and is one of three approved breast implant manufacturers in the United States.

The new implants feature a teardrop shape and a more cohesive silicone-gel than previous Mentor implants. The new cohesive gel better enables the implant to retain its shape, and mimic the look and feel of a natural breast.

The FDA’s Approval of Mentor’s MemoryShape Breast Implant

According to the press release issued by Mentor, the implants have been available outside the U.S. for more than a decade. However, the approval is based on six years of data from 955 women who were a part of the pre-approval study.

Part of the FDA’s approval is for Mentor to conduct a number of post-approval studies to look further into the safety and effectiveness of the breast implant.

Commenting on the FDA’s approval, David J. Wilson, Worldwide President of Mentor, said: “We understand each woman has different needs and specific, personal reasons for choosing to undergo breast surgery. The FDA approval of [the] 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.”

For more information about the Mentor MemoryShape Breast Implant, visit the Mentor webpage. Or if you’re interested in learning more about your breast augmentation or breast reconstruction options, contact Dr. Fouad Samaha, or visit our Quincy, MA location.