The U.S. Food and Drug Administration approved the new implant -- the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant -- to increase breast size in women at least age 22 and to rebuild breast tissue in women of any age. The implants are manufactured by Allergan Inc.
"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 a statement.
"The data we reviewed showed a reasonable assurance of safety and effectiveness."
The FDA based its approval on seven years of data from 941 women. Most complications and outcomes reflect those found in previous breast implant studies including: tightening of the area around the implant, re-operation, implant removal, an uneven appearance and infection.
In addition, investigators observed fissures, or cracks, in the gel of some Natrelle 410 implants -- a characteristic called gel fracture and unique to this implant, the FDA said.
As a condition of approval, Allergan must:
-- Track for an additional five years, approximately 3,500 women who received the implants.
-- Conduct a 10-year study of more than 2,000 women for long-term local complications such as implant rupture and less common potential disease outcomes such as rheumatoid arthritis, or breast and lung cancer.
-- Conduct five case control studies to evaluate the possible association between these implants, as well as other silicone gel-filled breast implants, and five rare diseases such as brain cancer or lymphoma.
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