This week, the U.S. Food and Drug Administration released information describing “a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma.”
The FDA reviewed literature and related information from 1997-2010 and identified 34 unique cases of ALCL in women with either saline or silicone breast implants. This is a relatively small number, and the agency indicates that read data is needed to better understand any possible link between implants and the disease. As a result, the agency is asking healthcare providers asking to report all confirmed cases of ALCL in women with breast implants through the MedWatch Program.
A consumer update has been provided by the FDA – women with breast implants and no unusual symptoms are advised to continue monitoring their implants and to notify their physicians if any changes are noticed. They also advise that “women considering breast implants should be aware of the very small, but increased risk of developing ALCL and discuss it with a physician.”
Additional FDA Resources:
- Questions and Answers about Anaplastic Large Cell Lymphoma (ALCL)
- Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses
- FDA Medical Device Safety Communication: Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants
- Breast Implants – general consumer and safety information