Are Silicone Breast Implants Safe Again?

Breast surgery is one of the most popular plastic surgery procedures available in today’s world. According to the American Society of Plastic Surgeons National Clearinghouse of Plastic Surgery Procedural Statistics, there were 296,203 breast augmentations and an additional 93,083 breast reconstruction procedures completed in the United States in 2010. Of these procedures, approximately half used silicone gel-filled implants. Advantages of silicone implants include a more natural look and feel without the tendency of visible wrinkling and rippling of the implant. Silicone implants have long been considered controversial. Banned between 1992 and 2006, silicone gel-filled breast implants were unavailable in the United States to those seeking breast implants due to important restrictions implemented by the FDA. Critics of silicone contend that the devices can leak, potentially causing a variety of health problems. In June 2011, the Food and Drug Administration issued an Update on the Safety of Silicone Gel-Filled Breast Implants. Although this report was not intended to provide a comprehensive clinical update, some of the most frequent complications and adverse outcomes in patients with silicone gel-filled breast implants include capsular contracture, or when the pocket of "scar tissue" that forms around the implant when placed in the body contracts and constricts around the implant causing the implant to be “squeezed” inside the body, requiring secondary implant removal. Additionally, studies have shown that women with implants may have a very small but increased possibility of being diagnosed with anaplastic large-cell lymphoma. In 2006 the FDA approved silicone gel-filled implants made by two manufacturers, Allergan and Mentor, for reconstructive breast surgery and for breast augmentation in women aged 22 and older. On March 9, 2012, the FDA approved the third such implant. The newest silicone implant is manufactured by Sientra of Santa Barbara, California. The approval of this implant is conditioned on continued studies on the longer-term safety and health risks. However, the FDA believes that "when used properly, silicone gel-filled implants have a reasonable assurance of safety and effectiveness." The approval of Sientra’s latest implant is based on clinical studies that produced three years of data from a population of approximately 1,800 patients. According to an agency news release, Dr. William Maisel, deputy director for science in the FDA’s Center for Devices and Radiological Health, stated that “Data on these and other approved silicone gel-filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness.