FDA Review Indicates Possible Association Between Breast Implants and a Rare Cancer
Posted Jan 26 2011 12:03pm
Health care professionals are requested to report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.
Health care professionals should consider the possibility of ALCL if a patient has late onset, persistent fluid around the implant (peri-implant seroma). In cases of implant seroma, send fresh seroma fluid for pathology tests to rule out ALCL.
There is no need for women with breast implants to change their routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants. Although not specific to ALCL, health care providers should follow standard medical recommendations.
Women should monitor their breast implants and contact their doctor if they notice any changes.
Women who are considering breast implant surgery should discuss the risks and benefits with their health care provider.
The FDA published its literature review in a document posted on FDA’s website site today titled “Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: Preliminary FDA Findings and Analyses.”
The FDA also plans to provide an update on its review of silicone gel-filled breast implants in the spring of 2011. This update will include interim findings from ongoing post-approval studies for silicone gel-filled breast implants currently sold in the United States, adverse event reports submitted to the FDA, and a review of the scientific literature on these products.