Crouse Health Online: Wellness is just a click away.
Share Share
  |  Connect with Us: 
large
med
small
Text Size
 

Health News



New Silicone Breast Implants Approved

New Silicone Breast Implants Approved

06/14/13

FRIDAY, June 14 (HealthDay News) -- 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 it's 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 reconstruction surgery, and they should recognize that long-term monitoring is essential," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in the news release.

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 silicone gel-filled breast implants available in the United States manufactured by three companies: Allergan, Mentor and Sientra.

More information

The U.S. Food and Drug Administration has more about breast implants.

Health NewsCopyright © 2013 HealthDay. All rights reserved.

Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.

OF INTEREST:
 

Latest News

Crouse Hospital Appoints Chief Information Officer
more >

MedEx Bedside Prescription Delivery Service

Free service offers convenience, patient education at discharge.
more >

CrouseSports Express After-Hours Ortho Care

Immediate care of orthopedic injuries in kids and adults.
more >

Weight Loss Surgery

Is it right for you? Attend a free information seminar held twice monthly.
more >

Quality at Crouse

See how Crouse Hospital strives to provide the best in patient care.
more >

Cheer Up That Special Someone

Say get well or welcome a new arrival with a gift purchased right at Crouse.

more >

Make an Online Donation Now

Your donation of any amount helps support Crouse services & programs in a meaningful way.
more >

Shop Online Now

Say get well, thinking of you or welcome new baby with a unique gift from the Crouse Gift Shop.

more >