FDA approves new silicone-gel breast implant
The Food and Drug Administration (FDA) on March 9 approved a silicone gel-filled breast implant manufactured by Sientra Inc., to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) 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 ability to offer our patients a wider variety of treatment options is good for everyone," says ASPS President Malcolm Z. Roth, MD. "Innovation and patient safety drive our specialty, so we welcome the opportunity to provide yet another FDA-approved alternative for both breast augmentation and reconstruction patients."
With today's approval, there are now three FDA-approved silicone gel-filled breast implants in the United States; they are manufactured by Allergan, Mentor and Sientra.
"Data on these and other approved silicone gel-filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness," says William Maisel, MD, MPH, deputy director for science in the FDA's Center for Devices and Radiological Health.
"It's important to remember that breast implants are not lifetime devices," Dr. Maisel adds. "Women should fully understand [the] risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential."
The FDA based its Sientra approval on three years of clinical data from 1,788 participants. Complications and outcomes reflected those found in previous studies of other breast implants and included capsular contracture, re-operation, implant removal, asymmetry and infection.
In June 2011, the FDA released a report that included preliminary safety data from post-approval studies from earlier breast implant approvals. The experience collecting and analyzing data from these studies informed the design and structure of post-approval studies for Sientra breast implants.
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 seven 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 potential 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," says Dr. Maisel. "The FDA is committed to working with breast implant manufacturers to collect useful post-market data on long-term safety and effectiveness.