The U.S. Food and Drug Administration (FDA) approved a silicone gel-filled breast implant manufactured by Sientra Inc. (known as Silimed in the UK) to increase breast size in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. London Bridge Plastic Surgery uses Silimed breast implants as part of our commitment to providing patients with the safest and best options for their augmentation.

With this approval, there are now three FDA-approved silicone gel-filled breast implants in the U.S. manufactured by Allergan, Mentor and Sientra(Silimed).

As a condition of approval, Sientra(Silimed) 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.

“Data on these and other approved silicone gel-filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness,” said William Maisel, M.D., M.P.H., 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. Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.” said Maisel.

In addition to other post-approval conditions, Sientra(Silimed) 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(Silimed) 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 (Silimed) 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 (Silimed) 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.”

Here at London Bridge Plastic Surgery, we constantly evaluate evidence and keep up to the minute with the latest information so that we can make the best choices for our patients