Silicone Breast Implants: Are They Safe?
En Español (Spanish Version)


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.

History
The controversy over silicone breast implants began in the 1980s, when unscientific 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 not enough 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 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.

Factors to Consider Before Getting Implants
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:

  • 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
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:

  • 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, 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.



RESOURCES:
Food and Drug Administration

National Cancer Institute

CANADIAN RESOURCES:
The Canadian Society for Aesthetic Plastic Surgery

The Canadian Society of Plastic Surgeons

References:
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.

FDA update on the safety of silicone gel-filled breast implants. US Food and Drug Administration website. Available at: http://www.fda.gov/downloads/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/UCM260090.pdf. Published June 2011. Accessed May 1, 2014.

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 http://www.ebscohost.com/dynamed: 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 May 2014



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