The Food and Drug Administration (FDA) has issued new advice for breast implant recipients: there may be an association between both silicone gel-filled and saline breast implants and anaplastic large cell lymphoma (ALCL), a rare form of cancer. ALCL is lymphoma, a type of cancer involving the cells of the immune system, not to be confused with cancer of the breast tissue. Breast implants are placed in the body behind the breast tissue or under chest muscle. Over time, a scar capsule forms around the implants separating it from the rest of the breast. Breast implant recipients should understand that they may have a small but significant risk of ALCL developing in the scar capsule adjacent to the implant. Of the 34 cases reviewed, the median age of patient was 51, with the youngest 28 and the oldest 87. In the study, 24 silicone and 7 saline implants were involved. Three implants were unspecified. The review looked at the time frame from implant placement until diagnosis of ALCL, which ranged from 1 to 23 years, with 8 years being the median. However, until there is a large, comprehensive study, there is insufficient evidence to suggest that the fill of an implant (saline versus silicone) or the texture of an implant (smooth versus textured) increase a woman’s risk of developing ALCL.
Most cases reviewed by the FDA were diagnosed after patients experienced pain, lumps, swelling or asymmetry that developed after their surgical site around their implants were fully healed. Their symptoms were attributed to a collection of fluid, hardening of the breast area around the implant or masses surrounding the implant. When the fluid and capsule around the breasts of these patients were examined, a diagnosis of ALCL was made.
The physicians and researchers at the FDA advise women with implants to be vigilant in monitoring their breasts for any changes and to continue to receive regular breast screening evaluations. While the FDA is not recommending that women who are having no symptoms remove their implants or seek immediate medical attention, those with silicone gel-filled implants should get periodic MRI’s to detect ruptures.