-- Scott Roberts
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,
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.
The U.S. Food and Drug Administration has more about
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