There are currently three main areas of concern regarding the safety of silicone gel implants: implant failure; a potential link to autoimmune connective tissue disease; and a possible link to breast cancer. All silicone gel implants ‘bleed’ small levels of silicone. In addition, silicone gel implants appear to fail (leak or rupture) with time. Most implants in place for less than seven years appear to be intact. It appears that many silicone gel implants implanted for over seven years are probably ruptured or leaking. Implant failure may occur simply from deterioration. Implants can also rupture following closed capsulotomy. Mammography and ultrasound studies are generally not helpful in predicting implant failure. Magnetic resonance imaging (MRI) studies appear to be useful, but the ‘breast coil’ necessary to perform these studies is not currently available in most MRI units in Canada. The significance of implant failure is not known. There is a growing (but unproven) concern that immunological sensitization to silicone could develop in women with silicone gel implants. An extensive review of all clinical and immunological studies in the current literature has failed to demonstrate any conclusive link between silicone gel implants (whether intact or nonintact) and the development of autoimmune connective tissue disease or other disease process. However, large scale epidemiological studies remain to be done. Several large studies have proven that there is no relationship between silicone gel implants and the development of breast cancer.
