The U.S. Food and Drug Administration recently approved a silicone-gel breast implant manufactured by Santa Barbara, CA-based firm Sientra Inc. Like other silicone-gel implants, this version comes in various shapes and sizes and is approved for breast augmentation in women 22 and older, and breast reconstruction for women of any age.
The Sientra implant is the third silicone-gel implant to hit the market along with those manufactured by Allergan and Johnson & Johnson’s Mentor. Since many plastic surgeons are already familiar with the two options currently available, it may take some time for Sientra to break into the market, as many physicians will surely wait to see how effective and safe the new brand proves to be.
As part of the approval, Sientra must conduct long-term safety and efficacy studies and follow patient outcomes. Of course, all breast implants require follow-up, as they may move or change after implantation. In fact, the FDA recommends that women with silicone implants have an MRI scan every few years.
To date, Sientra, which also makes saline breast implants and facial and body implants, has followed 1,788 clinical trial participants for three years and will continue to study those patients as well as 4,782 more women for the next 10 years. Sientra’s implant, thus far, has performed on par with the others with complications that include tightening around the implant, re-operation, removal, uneven appearance and infection.
Price points for Sientra’s implants are not yet known, but will surely play a role in how competitive they end up being in the market.
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