FDA approves new silicone breast implants

June 17, 2013
FDA approves new silicone breast implants
MemoryShape breast implants have been approved by the U.S. Food and Drug Administration for breast augmentation in women 22 and older, and for breast reconstruction, the FDA said Friday.

(HealthDay)—MemoryShape breast implants have been approved by the U.S. Food and Drug Administration for breast augmentation in women 22 and older, and for breast reconstruction, the FDA said Friday.

In a news release, the manufacturer, Mentor Worldwide LLC, said the implants have been approved outside of the United States for more than a decade. The product is available in a range of sizes and is tear-drop shaped to mimic the natural shape of a breast.

The product has been clinically studied among 955 augmentation and reconstruction patients participating in an ongoing 10-year study, Mentor said. After six years, the study has found a low rate of "adverse events," including rupture, the company added.

The FDA said in a news release that the approval was based on six years of data from 955 women showing a reasonable assurance of safety and effectiveness for this implant. Mentor's MemoryShape Breast Implant showed similar rates of complications and outcomes as previously approved breast implants. These complications included tightening of the area around the implant, re-operation, implant removal, an uneven appearance (asymmetry), and wrinkling. Fissures or cracks were observed in the gel of some MemoryShape Breast Implants, a characteristic called gel fracture.

"It's important to remember that breast implants are not lifetime devices. Women should fully understand the risks associated with breast implants before considering augmentation or , and they should recognize that long-term monitoring is essential," Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, said in a statement.

Breast implant surgery should not be performed on women with any active infection, untreated cancer, or who are pregnant or nursing, Mentor said.

With Friday's approval, there are now five FDA-approved -filled available in the United States manufactured by three companies: Allergan, Mentor, and Sientra.

Explore further: Consumer group questions review of breast implants

More information: More Information

Related Stories

Consumer group questions review of breast implants

January 5, 2012

(AP) -- Consumer safety advocates are questioning the Food and Drug Administration about seemingly incomplete and erroneous data used to affirm the safety of silicone breast implants last year.

FDA approves new silicone gel-filled breast implant

February 21, 2013

(HealthDay)—The Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant has been approved by the U.S. Food and Drug Administration for breast augmentation in women aged 22 years or older and ...

Recommended for you

Sustaining biomedical research: Med school deans speak out

May 27, 2015

Cuts in federal support and unreliable funding streams are creating a hostile work environment for scientists, jeopardizing the future of research efforts and ultimately clinical medicine, according to leaders of the nation's ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.