The Food and Drug Administration (FDA) issued an updated white paper on June 23rd, 2011 on the safety of silicone gel-filled breast implants, used in both breast augmentation and breast reconstruction. The FDA stated that “silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled.” In their announcement, the FDA declared that early findings from an analysis of safety issues and adverse events associated with silicone-gel breast implants revealed no new concerns. Therefore, the Agency decided to allow the devices to remain on the market. The FDA also indicated that despite “frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make well informed decisions about their use.” Silicone breast implants were allowed back on the market in 2006 after a 14-year hiatus, and the FDA reiterated that there is no evidence of disease associated with their use: “the current data doesn’t indicate that silicone gel-filled breast implants are linked to breast cancer, connective tissue disease or infertility.” The ongoing study, scheduled to continue until 2016, is designed to determine if the silicone implants “could leak and cause cancer, fibromyalgia, rheumatoid arthritis, and a range of other ills.” Known risks of silicone gel implants include capsular contracture, rupture, palpability, visibility and asymmetry. Silicone implants should not be expected to routinely last for a patient’s lifetime, and revision rates range from 20 to 40% within the first 10 years for breast augmentation patients and up to 70% for reconstruction patients. Despite the known risks and complications associated with silicone gel-filled breast implants, the newest data show that over 90% of patients are satisfied with the outcome of their breast implantation surgery and report an improved quality of life.
The FDA has provided the following links to related documents:
Update on the Safety of Silicone Gel-Filled Breast Implants (2011) – Executive Summary
The FDA has made available a Consumer Update that contains current and background information on breast implants, as well as other links to additional documents and Frequently Asked Questions.
If you are considering breast augmentation surgery, Dr. Olivia Hutchinson will gladly discuss the procedure, risks, benefits and alternatives with you. Please call the office at (212) 452-1400 to schedule your consultation with Dr. Hutchinson in her New York City office.
