-- Scott Roberts
FRIDAY, March 9 (HealthDay News) -- Sientra Inc.'s silicone
gel-filled breast implant has been approved by the U.S. Food and
Drug Administration for breast reconstruction or augmentation in
women aged 22 or older, the agency said Friday in a news
Similar products made by two other manufacturers -- Allergan and
Mentor -- were approved previously by the FDA.
Breast reconstruction includes replacing tissue removed due to
cancer or injury, while augmentation generally is used to increase
Approval of the Sientra product followed clinical testing
involving 1,788 people. Adverse reactions included tightening of
the area surrounding the implant, implant removal, uneven
appearance and infection.
As a condition of approval, Sientra will be required to follow
clinical participants for seven additional years, and to conduct a
10-year study of nearly 5,000 women to see if the implants are
associated with diseases including rheumatoid arthritis and breast
Sientra is based in Santa Barbara, Calif.
The FDA has more about
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