More women are getting breast implants than ever before. In 2008, more than 300,000 women and teenagers underwent breast implant surgery for augmentation and almost 80,000 women underwent breast implant surgery for reconstruction after mastectomy.1 The number of breast augmentations of women and teenagers has more than tripled since 1997, when there were just over 101,000 of these procedures.1
The dramatic increase in breast implant surgery does not necessarily reflect a similarly dramatic increase in the number of women with breast implants, however. Many women who undergo surgery are replacing old implants that have broken or caused problems; some women report as many as ten or more surgeries as their implants are replaced over the years. There are no available statistics on how many women undergo their first breast implant surgery every year.
A breast implant is a flexible silicone envelope filled with salt water (saline) or silicone gel. Because of safety concerns, silicone implants were banned for use in cosmetic surgery in 1992. However the FDA recently reapproved their use, and beginning in 2007 silicone implants can be used for breast augmentation.
How risky are breast implants? This is a controversial question, but implant manufacturers have done research showing that local complications, including pain, rupture, and the need for additional surgery, are very common within the first three years. The need for additional surgery is especially high for mastectomy patients who underwent reconstruction. Within 10-12 years, most women will have at least one broken implant, although women with silicone gel implants don’t always realize it. Research by scientists at the National Cancer Institute found that women with breast implants for at least seven years are more likely to die from brain cancer, lung cancer, or suicide, compared to other plastic surgery patients of the same age. There are also concerns that breast implants may be associated with other health risks such as autoimmune diseases; unfortunately little research on long-term risks has been done. In addition, breast implants can interfere with cancer detection, as implants can obscure the mammography image of a tumor. Mammogram machinery can also rupture an implant.
Debate swirls over the risks of breast implants, and women considering implants are justifiably confused by the conflicting information available. We’ve posted several articles, including a History of the FDA and Breast Implants, Silicone Breast Implants: No Safety Data Mean No Real Choices, the testimony of the American College of Women’s Health Physicians at the 2005 FDA hearings on silicone implants, and a letter to the FDA from several women's groups about recent research findings that increase concerns about the safety of silicone implants.
Breast cancer patients often face difficult decisions about breast reconstruction without the information they need to be fully informed. A 2006 report, Decisions in the Dark: The FDA, Breast Cancer Survivors, and Silicone Implants (.pdf), summarizes research by implant makers, government scientists, and university faculty to determine what is known about short-term and long-term risks for breast cancer survivors and for women who may get breast cancer in the future.
We've also posted several articles that examine the politics of breast implants being marketed in the U.S. Breast Implant Safety: Will We Ever Know?, examines the potential conflicts-of-interests that occur when implant manufacturors finance the research examining the safety of breast implants. Independent Justice: How Our Civil Justice System Protects Consumers and Patients in Ways the Regulatory System Does Not (.pdf) looks at the role breast implant civil suits have played in holding manufacturers accountable for their actions. A final report, FDA Advisory Committees: Does Approval Mean Safety?, examines the FDA approval process and finds that FDA advisory panels almost always recommend approval for medical devices. Although the report does not focus on breast implants, Appendix E is a summary of how the FDA's willingness to approve breast implants is entirely consistent with their tendency to approve medical devices that are not proven safe.
To find up-to-date information on research, risks, and controversy over breast implants, see The Implant Information Project, a website created by the National Research Center for Women & Families. Also see Implants Still Not Safe, a Feb 2007 op ed by plastic surgeon Edward Melmed and OBOS director Judy Norsigian on the FDA's recent re-approval of silicone implants.
Written by Diana Zuckerman, PhD, Elizabeth Nagelin-Anderson, MA, and Elizabeth Santoro, RN, MPH. Adapted with permission from material from the Implant Information Project. Last revised January 2010.
1 The National Resource Center for Women & Families. What You Need to Know About Breast Implants. Accessed online at http://www.breastimplantinfo.org/augment/implantfacts.html on 7/6/11.
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