FDA: Breast Implants Possibly Linked to Rare Cancer
It felt a little like the early 1990’s today when the news broke of the FDA’s report concerning breast implants and Acute Large Cell Lymphoma (ALCL). Any link between breast implants and disease is sure to get a lot of attention, especially given the history of silicone gel implants and a purported disease link (never proven).
This finding was termed a “possible association” by the FDA, and will be closely followed. The FDA recommendations are presented in italics below:
The FDA is recommending that health care professionals and women pay close attention to breast implants and do the following:
- 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 online1 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.
It is important to realize that ALCL is an extremely rare disease. The review idendified 34 cases worldwide (possibly as many as 60). Considering that between 5 and 10 million women are thought to have received breast implants, the risk is probably quite small. ALCL is reported to have an incidence of 3 in 100 million in women without implants. Again, an extremely low number.
Perhaps the most important message to keep in mind is that ALCL is not breast cancer. As with any announcement of this type, it is best to wait for the science to follow before drawing any conclusions.
The FDA’s complete report can be viewed here.
- FDA: Breast Implants May Be Linked to a Rare Cancer (healthland.time.com)
- Breast Implants May Be Linked to Rare Cancer (online.wsj.com)
- ASPS Collaborates with FDA to Establish Breast Implant Registry (prweb.com)