New Silicone Gel-Filled Breast Implant Approved
The FDA has approved a silicone gel-filled breast implant manufactured by Sientra Inc. (sientra.com) to increase breast size in women at least 22 years old and to rebuild breast tissue in women of any age. As a condition of approval, Sientra is required to conduct post-approval studies that will assess long-term safety and effectiveness outcomes, as well as the risks of rare disease outcomes.
The FDA based its approval on three years of clinical data. Complications and outcomes reflected those found in previous studies of other breast implants and included tightening of the area around the implant, re-operation, implant removal, asymmetry, and infection.
In addition to other post-approval conditions, Sientra will:
- continue to follow the 1,788 clinical trial participants in their pre-market study for an additional 7 years;
- conduct a 10-year study of 4,782 women receiving Sientra silicone gel-filled breast implants to collect information on long-term local complications such as capsular contracture, as well as less common disease outcomes, such as rheumatoid arthritis and breast and lung cancer; and
- conduct five case-control studies that will evaluate the association between Sientra’s silicone gel-filled breast implants and five rare diseases: rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer, and lymphoma.
“The design of these post-approval studies will require Sientra to collect valuable safety information with adequate enrollment and follow-up,” said Maisel. “The FDA is committed to working with breast implant manufacturers to collect useful post-market data on long-term safety and effectiveness.”
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For more information, visit www.fda.gov.
This article was published in Coping® with Cancer magazine, May/June 2012.