Sientra announces FDA approval of silicone breast implants.

SientraMar 11 2012

Today, Sientra announced that it has received FDA approval of its portfolio of Silimed-brand silicone breast implants.

“The rigorous FDA regulatory approval process, coupled with Silimed's 33-year successful worldwide manufacturing record, provides assurance of safety, quality and reliability to surgeons and patients in the U.S. when choosing from Sientra's portfolio of silicone breast implants.”

"We are elated to receive FDA approval of our flagship portfolio of silicone breast implants," said Hani Zeini, founder and chief executive officer of Sientra. "This represents two significant milestones. Namely, for the first time in 20 years, Sientra has successfully broken the existing duopoly in the U.S. by offering surgeons and patients a new choice. And today, Sientra becomes the first and only company in the U.S. to provide a full portfolio of commercially-available breast implants, including shaped implants in addition to standard round implants."

Until now, and in contrast to the rest of the world, the only approved breast implants in the U.S. market have been round implants with no other choices for surgeons or patients. Sientra now fills this gap by offering an innovative portfolio of breast implants, including shaped implants, with a broad selection of sizes, profiles, projections, and implant surfaces.

Mr. Zeini also emphasized, "The rigorous FDA regulatory approval process, coupled with Silimed's 33-year successful worldwide manufacturing record, provides assurance of safety, quality and reliability to surgeons and patients in the U.S. when choosing from Sientra's portfolio of silicone breast implants."