The FDA is warning physicians and women of a link between breast implants and a rare form of cancer. Anaplastic Large Cell Lymphoma (“ALCL”) is a type of T-cell lymphoma that can be particularly aggressive. Fortunately only about 600 women in the United States contract this cancer each year, but recent studies have shown that women with breast implants contract ALCL at a much higher rate than those who do not have implants.
The FDA first issued preliminary findings in a January 2011 report that announced its intention to collaborate with physicians and breast implant manufacturers to develop a greater body evidence on the possible connection between implants and ALCL. But this week the FDA announced that it now concurs with the World Health Organization designation of breast implant-associated anaplastic large cell lymphoma (“BIA-ALCL”) as “a rare T-cell lymphoma that can develop following breast implants.”
The FDA’s announcement comes hot on the heels of December 2016 findings from the Australian Department of Health that the risk of developing BIA-ALCL likely falls in between 1:1,000 and 1:10,000. While still rare, this risk of lymphoma is vastly higher than the risk posed to women who have not received breast implants. In fact, a 2008 study found the risk of ALCL in breast cancer recipients was 18.2 times higher.
For now, the FDA is not suggesting that women with implants have them prophylactically removed. Rather the agency suggests that women speak with their doctors about the possible risk and continue to monitor their implants as they’ve been instructed.
These developments raise the specter of a new wave of products liability litigation against breast implant manufacturers. The first published report linking breast implants to lymphoma appeared in medical journals in August of 1997. Numerous articles in peer-reviewed medical journals have continued to report the association in the intervening 20 years. Industry experts estimate that approximately 10 million women have breast implants worldwide, with about half of those residing within the United States. If implant manufacturers knew of this risk and failed to warn doctors and their patients, they could be held liable for the damages caused by the resulting lymphoma.
Our law firm is investigating cases involving breast implants and lymphoma throughout the United States. If you would like to speak to a South Carolina personal injury lawyer at Chappell, Smith & Arden about a potential case, please call us at 1 (800) 531-9780 or contact us online.