U.S. Food and Drug Administration released an updated safety data on silicone gel-filled breast implants, including preliminary data culled from studies conducted by two breast implant manufacturers (Allergan and Mentor) as a condition of their November 2006 approval. Included in the recently released report are summary and analysis of adverse events received over the years by the FDA, and a comprehensive review and analysis of recent scientific publications that discuss the safety and effectiveness of silicone gel-filled breast implants.

Report confirms that silicone gel-filled breast implants are safe and effective when used appropriately. However, women should fully understand the risks prior to considering silicone gel-filled breast implants for breast augmentation or reconstruction. Thus, FDA report said, women should be aware that:

  • Breast implants are not lifetime devices. The longer a woman has silicone gel-filled breast implants, the more likely she is to experience complications. One in 5 patients who received implants for breast augmentation will need them removed within 10 years of implantation. For patients who received implants for breast reconstruction, as many as 1 in 2 will require removal 10 years after implantation.
  • The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation (additional surgeries) and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection.
  • The complications that existed for women receiving breast implants at the time of approval are similar to the complications observed today.
  • Preliminary data do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, studies would need to enrol more women and be longer than those conducted thus far.

FDA's report further recommends the following to health care professionals and women who have silicone gel-filled breast implants:

  • Follow up. Women should continue to routinely follow up with their health care professionals. This includes getting routine MRIs to detect silent rupture.
  • Be aware. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes.
  • Pay attention to changes. Women should notify their health care professionals if they develop any unusual symptoms. All serious side effects should be reported to the breast implant manufacturer and Medwatch, the FDA's safety information and adverse event reporting program.
  • Stay in touch. If a woman has enrolled in a manufacturer-sponsored post-approval study, she should continue to participate. These studies are the best way to collect information about the long-term rates of complications.