Approval of Silicone-filled Breast Implant Makes Three

Breast silicone filled implant receives FDA approval

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) The U.S. Food and Drug Administration (FDA) has approved a silicone gel-filled breast implant for breast augmentation and reconstruction. This is only the third gel filled implant approved in the United States.

The product, manufactured by California-based Sientra, Inc., has been approved to increase bust size in women 22 years and older. It may also be used in women of any age for reconstructive purposes to rebuild breast tissue following breast cancer or injury.

"Ask your plastic surgeon about all the cosmetic and reconstructive options."

Silicone gel-implants are surgically placed under existing breast tissue or beneath the chest muscle. 

For reconstruction, these implants are used to replace tissue that has been removed due to breast cancer, trauma or abnormal breast development.

The FDA approval requires that Sientra conduct post-approval studies. The objective of these studies is to determine long-term safety and effectiveness, along with risks of rare disease outcomes.

The approval is based on three years of clinical trial data involving 1,788 participants. Complications and side effects are similar to those of other breast implants previously studied and include: tightening in the area around the implant, the need for one or more additional operations, removal of the implant, uneven appearance and infection.

William Maisel, M.D., M.P.H., deputy director for science in the FDA’s Center for Devices and Radiological Health, said in a statement, “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.”

The Director of Breast Plastic Surgery at Johns Hopkins, Gedge Rosson, M.D., told dailyRx, "I think it's wonderful for women and their surgeons to have a greater degree of choice when it comes to reconstruction."

"Competition is healthy and typically leads to quality improvements and cost decreases over time," Dr. Rosson said.

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.

There are now three silicon gel implants approved in the United States. In addition to Sientra, Allergan and Mentor offer these products.

In 1992, silcone-filled implants were removed from the market following lawsuits suggesting an association between the implants and various diseases. The FDA re-approved the devices in 2006.

Reviewed by: 
Review Date: 
March 12, 2012
Last Updated:
September 27, 2012