FDA approves new silicone gel-filled breast implantsPosted on March 9, 2012
Today, the U.S. FDA gave approval to a third breast implant manufacturer – Sientra – to supply silicone gel-filled breast implants for both cosmetic and reconstructive patients in the U.S. Sientra joins Allergan and Mentor as FDA-approved implant manufacturers.
As a condition of approval, Sientra is also required to conduct several ollow-up studies that will assess patient outcomes and safety issues.
The FDA based the approval on a three year study of 1,788 patients. Complications and outcomes were similar to those found in previous studies of other breast implants.
The FDA has required Sientra to perform a number of additional long-term follow-up studies, as well, to maintain their approval.
Details on the product dimensions and types are not yet available on the Sientra website, but I would expect them to be similar to the current Silimed brand devices. They have both smooth and textured implants. The date of availability has not yet been announced by the company. In other countries, they also sell polyurethane-coated implants, which are not approved here.
I’ll keep you posted as details become available.