For several decades, silicone-gel breast implants were available to plastic surgeons in the United States and throughout the world. In 1992, however, the FDA removed silicone-gel implants from the US market while it reviewed data related to their safety and efficacy. From 1992 to 2006, silicone-gel implants could be used in the United States only for the following indications:
- to replace existing implants;
- for use in breast reconstruction after surgery for breast cancer;
- for reconstruction of ptotic breasts when combined with a mastopexy; or
- for primary augmentation mammoplasty in patients for whom saline implants would be unacceptable.
Patients were enrolled in studies to monitor their clinical course after having received silicone-gel implants. During this time, most women in the United States who desired aesthetic breast augmentation were limited to receiving only saline-filled implants.
Although saline-filled implants were an acceptable choice for women who underwent primary breast augmentation, many observed that these implants did not feel as natural as they would have liked. Whereas plastic surgeons continued to believe that silicone-gel implants were safe and effective, the FDA reviewed data obtained over the ensuing 14 years before it allowed these implants to be made available for general use in primary augmentation mammoplasty.
Many surgeons believed that the negative position taken by the media caused more distress and disease than the implants did. Many women reacted to the negative press with a strong desire to have their silicone-gel implants removed and replaced with saline implants—a choice that was not evidence-based.
On November 17, 2006, the FDA approved the use of silicone-gel implants manufactured by Allergan Inc of Irvine, Calif, and Mentor Inc of Santa Barbara, Calif. Women older than 22 years could now choose silicone-gel implants for primary augmentation mammoplasty or breast reconstruction.
The FDA relied upon scientific information such as that obtained by the Institute of Medicine (IOM), which, in 1999, concluded that silicone-gel implants do not cause major health problems such as lupus erythematosis and rheumatoid arthritis. IOM found that although complications such as capsular contracture and implant rupture can occur, most women were pleased overall with the result obtained with silicone implants. Already approved in 60 countries worldwide, silicone implants were now available again in the United States.
In tandem with the FDA’s decision, the major organizations of board-certified plastic surgeons—the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS)—developed continuing medical-education courses for plastic surgeons on the selection and technical aspects of using these devices.
The FDA’s approval of silicone-gel-filled breast implants came with several conditions, including requiring each company to “conduct a large postapproval study; continue its core study through 10 years; conduct a focus-group study of the patient labeling; continue laboratory studies to further characterize types of device failure; and track each implant in the event, for example, that health professionals and patients need to be notified of updated product information.”1
Patients had to be properly informed of the risks, both minor and major, associated with the implantation of these devices. This is accomplished in the implant packaging and patient labeling. In addition, women were advised to have serial MRI examinations of the breasts to determine whether the implant was leaking or ruptured—in which case, removal and replacement were recommended. The first MRI should be performed 3 years after breast augmentation and then repeated every 2 years for the life of the implant.
Certainly, the cost of these studies may exceed the cost of the initial surgical procedure and may not be covered by health insurance. Patients should also check with their health insurance carriers because some carriers will not write an individual health-insurance policy for women with silicone breast implants.
As an integral part of the FDA’s approval of silicone breast implants for primary augmentation mammoplasty, 40,000 women will be followed for 10 years. The FDA will be looking at minor and major complications as well as the possible relationship between silicone-gel implants and autoimmune diseases, effects on offspring, lactation, neurologic disease, suicide, and other adverse outcomes.
A major public-education endeavor by ASPS and ASAPS has been the development of a Web site that provides a wealth of information for physicians and patients on the topic of breast implants. The site, www.breastimplantsafety.org, also has links to the FDA Web pages that deal in depth with this topic, providing the data that led to the approval of these devices.
|See also “The Educator” by Rich Smith in the October 2006 issue of PSP.
Women now have the choice of saline-filled or silicone gel-filled breast implants. Guiding them in their choices are the informed physician, their own information-gathering, and accessing the Web-based information cited above.
Malcolm D. Paul, MD, FACS, is in private practice in Newport Beach, Calif, and a clinical professor of surgery at the Aesthetic and Plastic Surgery Institute of the University of California, Irvine. He can be reached at .
- Silicone gel-filled breast implants approved. FDA Consumer Magazine. Jan-Feb 2007. Available at: http://www.fda.gov/fdac/features/2007/107_silicone.html. Accessed March 19, 2007.