Worldwide attention was garnered this week when Jean-Claude Mas admitted using non-approved silicone gels in Poly Implant Prosthese (PIP) breastimplants. The company was shut down in 2010, and all of its products were banned because the implants ruptured at alarmingly high rates. Although Mas admits to the use of the unapproved silicon, he claims that the substance is nontoxic and safe.
According to the New York Daily News, PIP used two different kinds of gels in its implants: One was an approved silicon gel manufactured in the United States, while the other was a “homemade” gel that was five times cheaper. Mas’s attorney, Yves Haddad, claims that the homemade gel was chemically identical to Nusil, the gel made in the U.S; however, PIP products have been banned in the U.S. since 2000, following a U.S. FDA visit to PIP.
The Daily News has reported that tens of thousands of women, mostly from South American and European countries, received implants produced by PIP. French representatives are advising women to have them removed, stating that the implants could rupture.
Despite the scare in Europe, U.S. women can be assured that breastimplants used in augmentation surgeries in the United States are completely safe. Two types of implants are approved in the U.S.: saline implants and silicone gel implants manufactured by Allergan and Mentor. The FDA recommends that women use saline-based implants, but they have approved the silicone gels because they continue to do follow-up studies to ensure the safety of the women who use them.
Women seek breast augmentation for a variety of reasons, but they should always consult with a plastic surgeon regarding what kind of implants are best for them. The FDA regularly monitors the safety of all U.S. implants and was aware of the problem at PIP ten years before European authorities took action. If you live in the Fort Worth area and are considering breast augmentation surgery, you can trust that as long as you use a board-certified plastic surgeon, your implants will be safe and FDA-approved and for you. If you have any concerns about the implants that will be used in your surgery, discuss them with your surgeon, who will be more than happy to explain the details.
