The Food and Drug Administration released a statement on Jan. 26, 2011, that women with silicone or saline breast implants may be at an increased risk of developing anaplastic large cell lymphoma (ALCL). Though the FDA currently believes the risk to be small, the agency is currently undertaking studies to determine the incidence of ALCL in breast implant patients.
Right now the link between breast augmentation and ALCL is based on a group of only 34 patients, with an estimated number of 60 breast augmentation patients worldwide who have developed ALCL. According to the FDA, the ALCL developed in the scar tissue that forms around each implant (the “capsule”) years after these women’s initial breast augmentation surgeries.
The FDA has asked for more reports from doctors and implant manufacturers, as well as other scientific authorities, on women with implants who have developed ALCL, but at this time is not recommending that women who have already undergone breast implant surgery have the implants removed. Instead, the FDA recommends that women with breast implants keep undergoing regular breast screenings and seek a doctor if they notice hardening, pain, or other changes in the breast.
The FDA estimates that between 5 and 10 million women have breast implants, and reiterates that the risk of ALCL, even if it is proved to exist, is very small-for women without breast implants, ALCL is found in the breast tissue in only 3 out of 100 million women.
The ALCL was found both in women with silicone implants and women with saline implants, and the FDA’s reports so far find no greater risk of ALCL for one implant fill material over the other.
This is the first implant-related scare since 1992, when the FDA pulled silicone implants off the shelf because of a possible connection between silicone implants and auto-immune diseases such as rheumatoid arthritis. While silicone implants were still available to women undergoing breast reconstruction surgery after mastectomies, it was not until 2006 that the FDA concluded that there was no link between silicone implants and auto-immune diseases and once again made silicone breast implants available for cosmetic as well as reconstructive breast surgery.
Despite the FDA’s approval of silicone breast implants and doctors’ conclusions that the implant surgery merely enhanced the tendency for auto-immune diseases to emerge, rather than actually resulted in the disease, many women still claim that silicone breast implants took their health and even, in some cases, their lives.
The FDA will release more information as it becomes available, but if you have breast implants and have developed ALCL, contact the FDA at the Center for Devices and Radiological Health, or call 1-800-638-2041.
This possible link may result in an increased interest in a new breast augmentation technology: stem cell breast augmentation, which uses a woman’s own fat to increase her bust size.
Sources: FDA, “FDA review indicates possible connection between breast implants and a rare cancer,” FDA News Release
FDA, “FDA Consumer Update: FDA Advises Women with Implants.”