This week the US Food & Drug Administration issued updated information on a very rare form of cancer called BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma). As of February 1, 2017, the FDA identified more than 350 possible cases, and 9 deaths attributable to BIA-ALCL. This was widely reported in the news media, and many are concerned. I first wrote about this in 2010, at which time 25 cases had been identified. At that time, there was very little known about the condition. One thing we did know was that although it is classified as a lymphoma (immune cell cancer) based on its appearance microscopically, its behavior is much more benign. Nevertheless, it became the focus of intensive research and monitoring, with unprecedented cooperation between plastic surgeons and the FDA. This latest update is the result of those efforts.
Here is what we know now:
- BIA-ALCL is “incredibly rare” according to expert Dr. Mark Clemens of MD Anderson Cancer Center.
- BIA-ALCL is not breast cancer, but a tumor of the scar capsule that forms around implants.
- It can occur with saline or silicone implants, but is especially associated with textured implants. There have been no confirmed reports of a woman with ONLY smooth implants (no history of previous textured implants) developing BIA-ALCL.
- It is curable in most cases by removing the entire scar capsule (capsulectomy.) It seems likely that the deaths from BIA-ALCL were related to delayed diagnosis because of the rarity of the disease, or initial under-treatment because there were no evidence-based treatment guidelines until recently.
- The FDA has NOT recommended that women with textured implants have them removed.
- BIA-ALCL presents at an average of 8-12 years after implantation, typically with sudden onset of swelling due to fluid around the implant called a seroma. If you have implants and develop sudden swelling on one side you should have it evaluated immediately. Keep in mind that most cases of a late seroma will not be ALCL.
- The true incidence is unknown, because the FDA tally is based on Medical Device Reports, which almost certainly contain duplicate reports of the same patient from different sources, unconfirmed cases, or cases where data is incomplete.
I hope this information is reassuring to women with breast implants. While any case is one too many, it is important to put things in perspective; for example, more people are injured or killed by lightning strikes every year in the U.S. than the total number of BIA-ALCL cases identified worldwide in the past 20 years. Nevertheless, plastic surgeons have invested substantial resources through our professional organizations to better understand BIA-ALCL. I will keep you updated here as new information becomes available.