Silicone Breast Implants: Are They Safe?
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.
In 1995, Dr. Jorge Sanchez-Guerrero and colleagues examined the relation between silicone breast implants and connective tissue diseases. The researchers analyzed 14 years worth of data from the Nurses’ Health Study. When the researchers measured the risk among women with implants compared to those without, they found no association between silicone breast implants and connective tissue diseases.
In a study published in the Journal of Women’s Health and Gender-based Medicine, researchers examined the prevalence of revision surgery (surgery that removes or replaces an implant) among silicone implant recipients. Researchers interviewed and collected data from 907 such women in Birmingham, Alabama. One third of the women were found to have undergone additional surgery, and of this group, half reported that their implants were ruptured when removed. There was an average time lapse of 11.5 years between implantation and revision surgery. The most common reason for the revision was implant problems that affected the breast. In the study conclusions, the researchers note that women considering silicone breast surgery should be informed of the risk of rupture and additional surgeries at a later time.
A study from Denmark examined local complications after cosmetic breast surgery. The study evaluated 754 women through self-administered questionnaires for complications following cosmetic breast implants. Women were 32 years old on average when they received their implants. A total of 77.8% of implantations had no complications, 17.8% of implantations experienced one complication, 3.6% had two complications, and 0.8% had three or more complications. Of the complications, the most common was capsular contracture—a tightening and squeezing of the implant by scar tissue—occurring in 11.4% of implantations. This complication was also the most frequent reason for additional surgery and hospitalization. However, the researchers note that most complications were minor and required no further hospitalization.
Food and Drug Administration
National Cancer Institute
The Canadian Society for Aesthetic Plastic Surgery
The Canadian Society of Plastic Surgeons
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/cdrh/meetings/041105-summary.html. Accessed May 4, 2005.
FDA advisory panel recommends conditional approval of Mentor gel-filled silicone breast implants: patient advocates hail decision as victory for women considering breast augmentation or reconstruction. Mentor Corporation website. Available at: ]]>http//www.mentorcorp.com]]>. Accessed May 7, 2005.
FDA advisory panel votes that Inamed’s gel-filled breast implants PMA is not approvable. Inamed Corporation website. Available at http://www.inamed.com. Accessed May 7, 2005.
FDA Breast Implant Consumer Handbook . Food and Drug Administration website. Available at: http://www.fda.gov/cdrh/breastimplants/handbook2004. Accessed May 10, 2005.
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 (2000). Institute of Medicine website. Available at: http://www.iom.edu/.
Kjoller K, Holmich LR, Jacobsen PH, Friss S, FRyzek J, McLaughlin JK, et al. Epidemiological investigation of local complications after cosmetic breast implant surgery in Denmark. Ann Plast Surg. 2002;48:229-37.
Safety of silicone breast implants ( June 1, 1999). Institute of Medicine website. Available at: http://www.iom.edu/.
Sanchez-Guerrero J, Colditz GA, Karlson EW, Hunter DJ, Speizer FE, Liang MH. Silicone breast implants and the risk of connective tissue diseases and symptoms. NEJM. 1995:332:1666-1670.
Last reviewed June 2010 by ]]>Brian P. Randall, MD]]>
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