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New Silicone Breast Implants Approved by FDA

On early March 2012, The US Food and Drug Administration (FDA) approved a new silicone gel–filled breast implant, bringing the number of such products in the United States to 3, but continued to warn that women who receive any of these implants require lifelong monitoring.

The new silicone breast implant, made by Sientra, is indicated to increase breast size in women aged 22 years and older, and to reconstruct breast tissue in women of any age.

Sientra’s product joins 2 other silicone-filled implants made by Allergan and Mentor that are currently on the market.

In late 2011, safety of silicone breast implants has come into sharp focus after the French version of the FDA recalled implants made by Poly Implant Prothese (PIP) in 2010. PIP had used an industrial-grade, none medical silicone that is more prone to ruptures and leakage. As many as 300,000 women worldwide received the implants, and roughly 2000 have lodged complaints about adverse events, which include 8 cases of cancer.

PIP closed in 2010, but the company’s founder, Jean-Claude Mas, continues to make headlines. Now facing charges of causing bodily harm, as well as committing fraud, Mas was jailed earlier this week by French authorities for not paying his bail.

Here in the United States, the FDA has sounded cautionary notes about silicone breast implants. Last year, it reported that 20% of women who receive implants for breast augmentation will need them removed within 10 years. That percentage goes up to almost 50% for women who receive implants for breast reconstruction. The agency advised women with silicone implants, but not saline-filled implants, to undergo MRI study for silent ruptures 3 years after implantation, and every 2 years afterward.

Nevertheless, the FDA deems the new Sientra implant and those from Allergan and Mentor as safe for patients seeking plastic surgery Beverly Hills and beyond. The FDA’s approval of the Sientra implant was based on 3 years of clinical trial data on 1788 women. Adverse events and outcomes, which resembled those for other silicone breast implants, included capsular contracture, reoperation, implant removal, asymmetry, and infection.

FDA Approved Breast Implants

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