Silicone Breast Implants: Science, Safety, and Choice
Article by Michael C. Edwards, MD, FACS
Las Vegas Plastic Surgeon
The release of silicone gel implants by the FDA on Friday, the 17th of November signifies a decision based on science, safety and choice. Silicone is used safely in the body in many medical devices and products, including pacemakers, heart valves, artificial joints and baby pacifiers. In fact, silicone gel-filled breast implants are arguably the most studied medical devices and decades of research have evaluated their safety and effectiveness. This decision is not only important for the woman who desires a breast augmentation with silicone implants but as important for the breast reconstruction patient as well as the woman with saline implants who desires a change to silicone. Although there are many women who are very satisfied with their saline implants, there are some who would benefit from the change.
Today's silicone implants represent a new generation when compared to the implants that the FDA imposed a moratorium on back in 1992. Those older implants had a thinner shell covering a more liquid silicone filler. These implants were more prone to leak over time into the scar tissue that formed around the implant referred to as the capsule. In spite of reports that women were harmed by these older implants, there has yet to be any solid medical evidence to the fact. Current, so called third generation silicone implants are filled with a more cohesive silicone covered by a thicker shell which is less likely to leak, although they should not be considered a lifetime device. The benefits of silicone implants over saline implants relates to a more natural feel of the breast.
Some common questions that have been asked about the silicone implants:
1. What did the FDA base its decision upon?
The FDA’s approval of Silicone-Filled Breast Implants follows the Agency’s review of extensive pre-clinical device testing of the company’s silicone gel-filled breast implants, as well as four-year data from 715 women involved in the company’s Core Clinical Study, which is an on-going, 10-year prospective, multi-center safety study of women who have undergone breast augmentation, reconstruction or revision surgery.
In addition, the FDA reviewed a large amount of scientific data available on silicone gel-filled breast implants, including the Institute of Medicine (IOM, 1999) 400-page landmark report, entitled “Safety of Silicone Breast Implants,” which concluded that “a review of the toxicology studies of silicones and other substances known to be in breast implants does not provide a basis for health concerns.”
2. Are silicone implants more likely to leak than saline implants?
No, both saline and silicone implants are not lifetime devices. It is possible that at some point in a patient’s lifetime that the implant(s) will need to be removed and replaced.
3. Who can have silicone implants now?
Any woman who is 22 or older may have silicone implants used for primary breast augmentation. Silicone implants may be used for reconstruction in any patient, 18 years or older.
4. Do I still need to follow-up with my plastic surgeon?
Yes, you will still need to follow-up with you plastic surgeon as you would normally on at least an annual basis after your initial healing has completed.
5. What if I have saline implants now and I would like to change to silicone?
In many cases the silicone implants may improve the look and the feel in the case of a woman who has thin tissue over her implants. You may need other revisional surgery which can be determined at your consultation.
6. Is there a guarantee from the implant manufacturers?
Yes, each of the two implant manufacturers, Allergan and Mentor, provide a lifetime replacement on their implants if they are found to deflate. If this deflation occurs in the first 10 years after the surgery, there is a monetary stipend which helps to offset some of the cost of the replacement surgery.
7. Do I still need to have mammograms?
Yes, without question you still need to perform monthly self breast exams and have mammograms in accordance with the recommendations of the American Cancer Society.
8. Can the silicone in the implant get into a mother’s breast milk?
No, the 1999 Institute of Medicine Report concluded that there is no evidence of elevated silicone in breast milk or any other substance found in women with silicone gel-filled breast implants that would be harmful to her infant.
There are undoubtedly many other questions about silicone breast implants and you are encouraged to seek consultation with a board-certified plastic surgeon to review these. Many women have had breast surgery with saline-filled breast implants and are very satisfied with their results. Silicone implants are not for everyone and this decision should be made only after careful consideration of the options and what will help you obtain your goals.