Silicone breast implants are allowed in cosmetic surgery in the United States again, after having been banned for over a decade. In November 2006, the US Food and Drug Administration (FDA) approved the marketing of silicone gel-filled breast implants after determining that they are safe and effective. They are approved for breast reconstruction in women of any age and for breast augmentation in women 18 years or older. Here is a summary of the controversy behind silicone breast implants.
The controversy over silicone breast implants began in the 1980s, when anecdotal accounts linking connective tissue disease to silicone implants started to surface. Around this same time, a multimillion dollar lawsuit was filed alleging a connection between silicone implants and systemic disease.
In 1992, the FDA determined that there was inadequate safety data to support continued approval of silicone implants. Up until 2006, silicone implants had only been allowed in certain cases. Specifically, only women undergoing reconstructive surgery (eg, after mastectomy) or revision surgery (implant removal or replacement) and those enrolled in a clinical trial could receive silicone implants. Women seeking breast augmentation for cosmetic purposes were only allowed to receive saline implants.
In 1997, the US House of Representatives asked the Department of Health and Human Services to carefully study the safety of silicone breast implants. The Institute of Medicine (IOM) took up the effort and wrote a comprehensive report published in 1999. Among the findings was evidence that silicone implants do not cause major disease, including breast cancer and autoimmune diseases like lupus, Raynaud’s phenomenon, rheumatoid arthritis, and scleroderma. The IOM report also stated that silicone implants do not harm developing fetuses or breastfed infants.
It is important to be well-informed before making a decision that can impact the rest of your life. You should discuss your options carefully with your doctor and be sure you know all the benefits and risks. Especially consider these factors:
A recent FDA safety report points out that there is currently no conclusive evidence showing that silicone breast implants cause conditions like breast cancer, reproductive problems, or rheumatoid arthritis.
If you decide to have silicone implants, you should follow these safety tips from the FDA:
Food and Drug Administration
National Cancer Institute
The Canadian Society for Aesthetic Plastic Surgery
The Canadian Society of Plastic Surgeons
Breast implants: saline vs. silicone. Mayo Clinic website. Available at: http://www.mayoclinic.com/health/breast-implants/WO00052. Updated January 16, 2010. Accessed June 29, 2012.
Brown SL, Pennello G. Replacement surgery and silicone gel breast implant rupture: self-report by women after mammoplasty. Journal of Women’s Health & Gender-based Medicine. 2002;11:255-64.
Center for Devices and Radiological Health. General and Plastic Surgery Devices Panel – April 11-13, 2005. Food and Drug Administration website. Available at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/ucm125146.htm. Accessed June 29, 2012.
FDA Breast Implant Consumer Handbook . Food and Drug Administration website. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm064242.htm. Accessed June 27, 2012.
Gladfelter J. The return of silicone gel-filled breast implants: will you be ready? Plastic Surgical Nursing. 2005;25:44-46.
Information for women about the safety of silicone breast implants. Institute of Medicine website. Available at: http://www.iom.edu/Reports/2000/Information-for-Women-about-the-Safety-of-Silicone-Breast-Implants.aspx. Accessed June 27, 2012.
Safety of silicone breast implants. Institute of Medicine website. Available at: http://www.iom.edu/Reports/1999/Safety-of-Silicone-Breast-Implants.aspx. Accessed June 27, 2012.
FDA provides updated safety data on silicone gel-filled breast implants. US Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm260235.htm. Published June 22, 2011. Accessed June 27, 2012.
7/1/2011 DynaMed's Systematic Literature Surveillance DynaMed's Systematic Literature Surveillance: FDA provides updated safety data on silicone gel-filled breast implants. US Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm260235.htm. Published June 22, 2011. Accessed July 1, 2011.
Last reviewed June 2012 by Brian P. Randall, MD
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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