FDA Releases Updated Information on Silicone Gel-filled Breast Implants: Are You at Risk for Serious Complications?

The U.S. Food and Drug Administration (FDA) announced new clinical and scientific information in a June 22 news release regarding the complications surrounding silicone gel-filled breast implants. Whether you or someone you care about has silicone gel-filled breast implants or is considering getting them, it is important for women and their loved ones to know this information.

The report asserts that silicone gel-filled breast implants are safe and effective when used as intended; however, the report confirms certain risks of these implants in relation to breast augmentation and reconstruction.

The longer a woman has had silicone gel-filled breast implants, the greater her chances are of experiencing complications. The most common complications and results of silicone gel-filled breast implants include:

• capsular contracture (hardening of the region surrounding the implant);
• additional surgeries;
• implant removal;
• implant rupture;
• wrinkling;
• asymmetry;
• scarring;
• pain; and
• infection.

The report also emphasizes that breast implants are not a one-time deal. One in 5 patients who received implants for breast augmentation will need them taken out within 10 years of implantation. As many as 1 in 2 patients who received implants for breast reconstruction will require removal 10 years after implantation. While preliminary data does not link silicone gel-filled breast implants with breast cancer, reproductive problems, or connective tissue disease, more extensive studies have been noted as being needed to determine whether these complications as well as others can be ruled out.

The two breast implant manufacturers Allergan and Mentor have reportedly informed the FDA that it is difficult to effectively monitor women who have received silicone gel-filled breast implants. The FDA is expected to work with these manufacturers to address these difficulties and improve patient participation as well as follow-up procedures.

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