The Food and Drug Administration today approved a third silicone gel-filled breast implant.
The implants are approved for breast augmentation and reconstruction in women who are at least 22 years old, according to a statement from the agency.
The approval is based on three years of clinical data from 1,788 participants. Complications of the implants included tightening of the area around the implant, an uneven appearance, infections and need for re-operation or implant removal.
While data show that the implants are reasonably safe and effective, “it’s important to remember that breast implants are not lifetime devices,” said Dr. William Maisel, deputy director for science in the FDA’s Center for Devices and Radiological Health.
“Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential,” Maisel said.
The approval is conditional. The FDA is requiring implant manufacturer Sientra, Inc. to conduct further studies on the long-term safety and effectiveness of the implants.
Breast reconstruction involves replacing breast tissue that has been removed due to cancer or injury. Breast augmentation is done to increase the breast size.
Two previous silicone gel-filled breast implants are manufactured the companies Allergan and Mentor.
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