To see the latest updates from the FDA regarding Silicone implants, visit the FDA Website for Silicone Breast Implants.
Is silicone safe? Studies conducted by implant manufacturers
The following studies, which are for informational purposes only, are closed, meaning that no new participants are being accepted. Because silicone gel breast implants are now approved, there is no need to enter into a study to obtain silicone gel prostheses.
Mentor Adjunct Study - During the moratorium on silicone gel breast implants, which lasted from 1992-2006, women receiving silicone gel breast implants were automatically enrolled into the Mentor Adjunct Study. McGhan/Inamed also conducted adjunct studies. Click on the link to read more about the study.
Mentor Core Gel Study - In 2000, Mentor began a small study of 1000 patients, which are to be followed for 10 years. Click the link to read more about the Core Gel Study.
Mentor CPG Study - The Mentor CPG study was another small study of about 950 patients. It's purpose was to evaluate the safety and effectiveness of Mentor's CPG (contour profile gel) breast implant, which is a semi-solid, or "gummy bear", breast implant. Click the link for more information.
McGhan Cohesil 410 Breast Implant Study - Like Mentor's CPG study, this was a study to study the safety and effectiveness of the McGhan 410 Cohesil (gummy bear) silicone gel breast implants. Click the link to read more.
Silicone toxicity: Open health studies
National Science Panel - There is no evidence that silicone breast implants precipitate novel immune responses or induce systemic inflammation. There is no consistent data to suggest systemic inflammation or systemic induction of anti-silicone or auto-reactive responses in women with silicone breast implants. No association between silicone gel-filled implants and any of the definite connective tissue diseases or the other autoimmune/rheumatic conditions.
Institute of Medicine - The Institute of Medicine finds no evidence or links are found between silicone breast implants and autoimmune disorders and breast cancer.
Mayo Clinic Study - This study found no association between breast implants and twelve connective tissue diseases and a variety of signs and symptoms of such diseases. Specifically, women with breast implants were no more likely to develop connective tissue disease than the age-matched controls without breast implants.
National Cancer Institute - Researchers from the National Cancer Institute (NCI) in Bethesda, Md., found that women with silicone breast implants were not at increased risk for most cancers. Although they did find small increases in the risks for respiratory (cancers of the lung and larynx) and brain cancers, the significance of these findings is not clear. Because most of the respiratory cancers were found through death certificates, the role that smoking played in development of the cancers is not clear, since information about lifestyle factors was obtained through a questionnaire administered to living participants. However, among the living participants, there was no significant difference between the smoking rates of implant patients and plastic surgery controls.
Harvard Nurses' Health Study - 87,501 nurses who were free from connective-tissue disease in June 1976 were followed through May 31, 1990, before there was widespread media coverage of the possible association of breast implants and connective-tissue diseases. In this large cohort study , no association was found between silicone breast implants and connective-tissue diseases, defined according to a variety of standardized criteria, or signs and symptoms of these diseases.
Swedish Cohort Study - Cohort study led by Olof Nyr?n included 7433 women with breast implants, as well as 3351 women who had undergone breast reduction mammoplasty. The results concluded that there is no link between breast implants and neurological disease.