FDA approved Allergan’s highly cohesive “shaped” implants
There isn’t much new (that works and is legitimate) in the field of plastic surgery these days. That’s why what is going on with breast implants is really exciting. To recap, there are three breast implant companies in the U.S.: Mentor, Allergan and Sientra. For many years, only the first two of these three companies were allowed to sell implants in the U.S. Sientra did all its business outside of the U.S., primarily in Brazil and Europe. During this time, the only breast implants available were the round shaped implants. Even though all the companies made shaped implants, the FDA would not approve them until they had sufficient safety data. In my practice, the biggest problem with round implants is in the case of the post-mastectomy breast cancer patients. The round implants ripple, lack fullness in the upper part of the breast, and keep us from achieving A+ results.
Last year, the FDA approved Sientra implants in the U.S., including their limited line of shaped implants. Since then, we have been using shaped implants in most of our breast reconstruction patients with phenomenal results. The big problem is that the FDA did not approve the larger sized Sientra implants. Since a women who has had a mastectomy is “all implant and no breast tissue,” she is relying completely on the size of the implant. For many of these patients, there are no Sientra shaped implants large enough to suit their needs.
Last week, the FDA finally approved the shaped implants made by Allergan, and in the very near future they will probably also approve Mentor’s shaped implants. Fortunately, Allergan had its full line of shaped implants approved including the larger sizes needed for many breast reconstruction patients.
What does this all mean? It means that when it comes to breast implants we now have a large variety of shapes and sizes available. This is especially important for breast reconstruction patients and women with certain breast deformities that are difficult to correct with a round implant (such as a tight constricted breast). At the Kryger Institute of Plastic Surgery, we use implants made by all three companies. We do not receive any royalties or payments to use one implant over the other. Our goal is to pick the implant that is best suited to your individual needs.