sientra silicone impantsFor the past 20 years, only two companies have had breast implants approved by the U.S. Food and Drug Administration: Mentor and Allergan. On March 9, the FDA approved a new breast implant from Sientra, Inc, a company based in Santa Barbara, California.

The FDA has not commented on the differences among the three manufacturers silicone-gel breast implants. However, Sientra's breast implants are known by many as the coveted cohesive-gel or gummy bear implants that were previously only available to patients undergoing treatment through a clinical trail.

Despite the interest in gummy bear breast implants, neither the company nor the FDA will refer to the breast implants under that name.

"We do not condone the use of such terms," Sientra CEO Hani Zeini said in statement to ABC's Nightline.

Surgeons involved in Sientra's clinical trials say the cohesive gel is more form-stable and the implants look and feel more natural and have lower rupture rates than other implants on the market.

Sientra's silicone-gel filled breast implants are approved for use in breast augmentation patients that are at least 22 years of age, and breast reconstruction patients of any age.

The FDA's approval of Sientra's breast implants provides plastic surgeons with additional options, allowing them to tailor the size and shape of the implant to each patient. Sientra offers round breast implants, as well as shaped breast implants with a round, oval, or classic base.

The FDA approved Sientra's breast implant product after extensive clinical testing, which included three years worth of clinical data for 1,788 patients. As a condition of the FDA approval, Sientra is required to follow-up with participants in the clinical trials to further evaluate the long-term safety of the products.

To learn more about the breast implant choices available at the practice of Paul Pin, MD, contact us today. We are committed to providing our patients with breast implant options that can be customized to the individual.