Food and Drug Administration Affirms Safety of Breast Implants

Last month, the Food and Drug Administration (FDA) met to evaluate current information regarding the safety of silicone gel filled breast implants. William Maisel, MD MPH, chief scientist for the FDA center for devices stated that silicone gel implants were safe. In Nov, 2006, after 15 years of scientific study, the FDA approved silicone gel filled implants for use in this country. This was followed by a recommendation (not a requirement) that women undergo MRI exams three years after surgery and every two years thereafter to evaluate their breasts for silent rupture of the implants. MRI exams used for this purpose are expensive and it is believed by many that these MRI studies probably will not be paid for by most insurance carriers. It was not clear what scientific basis was used to create this recommendation. Many plastic surgeon, myself included, believed that this was excessive, expensive and not justified. Please see my previous blog: Silicone Breast Implants – Are routine MRI’s really necessary? (February 21, 2011). During the recent meeting, the FDA removed this recommendation. Current scientific evidence clearly supports the safety of silicone gel filled breast implants.
Certainly, if a woman has undergone breast augmentation with silicone gel implants and has a problem with their breasts such as breast pain, change in shape, appearance or feel of their breasts, or develops a mass in their breasts. They should see their physician. In these cases, an MRI may be necessary to evaluate the health of the breast. The current FDA withdrawal of the recommendation for routine breast surveillance with MRI’s applies to women with asymptomatic breasts.
The conclusion of multiple epidemiologic studies is that there is no connection between silicone gel breast implants and connective tissue diseases (i.e. rheumatoid arthritis, scleroderma, lupus) nor is there a connection between silicone gel implants and breast cancer.