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Duopoly Broken - FDA Approves New Silicone Breast Implant

The popularity of breast augmentation has been on the rise, despite a history of lawsuits associated with the breast implants. According to the American Society of Plastic Surgeons, a total of 307,000 breast augmentation procedures were performed in 2011, an increase of 4% from 2010. Until yesterday, there were only two FDA approved silicone gel implant manufacturers namely, Allergan Inc. (AGN) and Johnson & Johnson's (JNJ) Mentor unit.

Now, one more name has been added to the list of FDA approved breast implant makers, following the regulatory approval of silicone gel-filled breast implant manufactured by privately held, aesthetics company Sientra Inc. on Friday.

Sientra's silicone gel-filled breast implant is approved to increase breast size in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. The approval is conditioned on post-approval studies that will assess long-term safety and effectiveness outcomes as well as the risks of rare disease outcomes.

The FDA approved Sientra's breast implant based on three years of clinical data from 1,788 participants.

In addition to the post-approval studies, the company is required:

* to monitor the 1788 participants for an additional 7 years.

* study 4782 women who receive the implant for 10 years and collect information on long-term local complications such as capsular contracture, rheumatoid arthritis, and breast and lung cancer; and

* conduct 5 case-control studies to evaluate the link between the silicone implants and five rare diseases namely, rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer, and lymphoma.

Sientra's portfolio of silicone gel breast implants, which includes the options for round or shaped implants, will be offered in moderate or high profile configuration, and in various sizes.

Breast implants are not lifetime devices. One in 5 patients who received implants for breast augmentation will need them removed within 10 years of implantation, and as many as 1 in 2 patients who received implants for breast reconstruction will require removal within 10 years of implantation, according to the FDA.

William Maisel, deputy director for science in the FDA's Center for Devices and Radiological Health, said that data on Sientra's and other approved silicone gel-filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness.

However, Maisel cautions that women should fully understand the risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.

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