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Silicone Breast Implants: Are They Safe?
Factors to Consider Before Getting Implants
- Implants will not last a lifetime. At some future point, you will most likely need surgery to correct or remove the implant. If you decide to have your implants removed in the future, you may need a breast lift or other surgery to return your breasts to the way they looked before.
- Implant rupture is a common concern. If your silicone implant ruptures, you may not notice right away. A ruptured implant may eventually cause the shape of your breast to change, and you may have some breast pain. You will need surgery to remove the implant. A replacement implant can be inserted in the same procedure.
- If you have silicone implants, the FDA recommends that you have an MRI every two years, beginning three years after the implant is initially placed. An MRI can help you doctor identify ruptures.
- Breast implants might interfere with breast cancer screening tests, such as mammograms. You might need a different test that gives special views of your breasts, and images might be more difficult for your doctor to interpret.
Information for Women with Silicone Implants
- Follow up regularly with your doctor, including having routine MRIs that can detect implant rupture.
- Know that silicone implants are not lifetime devices. As many as one out of five women will need to have the implant removed within 10 years. The longer you have implants, the more likely you are to have complications. Some women will have breast pain, wrinkling, asymmetry (unevenness), scaring, and infection.
- Pay attention to any changes in your breasts or unusual symptoms. Serious side effects should be reported to the implant manufacturer and to the FDA's safety information and adverse event reporting program, Medwatch.
- If you are part of a study put on by an implant manufacturer, you should continue to participate. Studies are the best way to collect information about the long-term effects of implants and the rates of complications.
Breast Implants Food and Drug Administration http://www.fda.gov/
National Cancer Institute http://www.cancer.gov/
The Canadian Society for Aesthetic Plastic Surgery http://www.csaps.ca/
The Canadian Society of Plastic Surgeons http://www.plasticsurgery.ca/
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.
- Reviewer: Brian P. Randall, MD
- Review Date: 06/2012
- Update Date: 06/29/2012