Epidemiology of silicone-gel breast implants.
Silicone breast implants have been marketed in the United States since 1963. Questions remain unanswered on the safety of these medical devices despite their popularity and availability. In 1992, the Food and Drug Administration restricted the availability of silicone-gel breast implants to women requiring them for reconstruction after breast cancer or for other medical indications. Inflatable saline breast implants have remained available for either reconstruction or for cosmetic augmentation while manufacturers completed studies addressing issues of safety and effectiveness. The Food and Drug Administration (FDA) has less concern today regarding a putative association between breast implants and autoimmune disease because of epidemiologic studies that have indicated that there is not a large increase in risk for connective tissue disease in women with breast implants. These studies have not ruled out a small increase in risk of connective tissue disease to these women nor have they addressed the issue of an atypical syndrome related to silicone. The FDA has continuing concerns over local complications that are related to breast implants. The current review provides a brief discussion of the regulatory history of silicone implants and of FDA concerns over breast implants, implant prevalence, studies of systemic and local complications related to breast implants, and a brief description of the FDA study of silicone-gel breast implant rupture.
Brown
S Lori
SL
Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850, USA. syb@cdrh.fda.gov
D001327:Autoimmune Diseases / Q000453:epidemiology; D018427:Breast Implants / Q000009:adverse effects; D001943:Breast Neoplasms / Q000453:epidemiology; D016021:Epidemiologic Studies; D005260:Female; D006801:Humans; D011475:Prosthesis Failure; D012307:Risk Factors; D012449:Safety; D020034:Silicone Gels / Q000009:adverse effects; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration
D020034:Silicone Gels