The complications of breast implantation are significant. Rates of contracture vary in the literature from less than 10% to over 60%. Capsular contraction or scarring around the implant, leading to firmness and distortion of the breast, can be painful and sometimes requires removal of the implant and capsule. Implant rupture may occur in as many as 5% to 10% of women, and bleeding of gel through the capsule is even more common (201). In 2006, the U.S. Food and Drug Administration approved silicone gel filled implants for use in women 22 years or older for cosmetic purposes and for reconstruction after breast surgery or in women with traumatic or congenital breast defects (202). The agency recommends MRI scanning 3 years after the first implant surgery and then every 2 years for the detection of implant rupture.
The agency advised symptomatic women with ruptured implants to discuss the need for surgical removal with their physicians. When there is no evidence of associated symptoms or rupture, implant removal is generally not indicated because the risks of removal are probably greater than the risk of retention. If screening ultrasonography shows no rupture, the probability of rupture is 2.2% (203). If ultrasonography shows rupture, true rupture is present in 37.8%. In this setting, a large number of women would have normal implants removed. When MRI is used in addition to ultrasonography, the probability of rupture increases to 86%.
The suggested association between silicone gel and autoimmune disease is poorly documented (204,205). Among the multiple meta-analyses conducted thus far, none have identified a significant association between breast implants and connective-tissue disease (206). Subsequent studies demonstrated no clinical data proving an increased incidence of connective tissue disorders in patients with silicone gel breast implants (207–209). The data continue to reaffirm previous observations that there is no evidence of an association between breast implants and connective tissue diseases (210). In a study of Danish women undergoing reduction mammoplasty compared with silicone implant augmentation, there was no increased incidence of antinuclear antibodies or other autoantibodies between the groups (211). The augmentation group experienced capsular contraction and more pain than the group undergoing reduction mammoplasty. Any association between implants and an increased incidence of breast cancer is unlikely (212). Breast cancer may develop in any patient with a silicone gel prosthesis.
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