March 2017 FDA Report Provides Update On Emerging Safety Issue: Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
In March 2017 the FDA updated its "Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)" information page (accessed 3/31/17).
The most notable new facts are found in the Medical Device Reports part of this FDA breast implants - lymphoma page, specifically the most-current figures on the number of BIA-ALCL cases:
As of February 1, 2017, the FDA has received a total of 359 medical device reports (MDRs) of BIA-ALCL, including nine deaths. There are 231 reports that included information on the implant surface. Of these, 203 were reported to be textured implants and 28 reported to be smooth implants. Most of the reports contained no information about the surface textures of any previous implants. In addition, 312 of the 359 reports included information on implant fill types. Of these, 186 reported implants filled with silicone gel and 126 reported implants filled with saline.
From this March 21, 2017 article, "9 Deaths Are Linked to Rare Cancer From Breast Implants", published by The New York Times (NYT), we get some background information and observations regarding this still-emerging health problem:
About 290,000 women in the United States had implants for breast enlargement in 2016, and 109,000 received them for reconstruction after breast cancer, according to the American Society of Plastic Surgeons.
In many cases when the lymphoma occurs, just removing the implant and the tissue around it eliminates the disease. But some women may need chemotherapy and radiation.
Why there is a difference in risk related to the surfaces is not known, but the body’s reaction to textured implants is different from its reaction to smooth ones, according to Dr. Alex K. Wong, a plastic surgeon and researcher at the University of Southern California’s Keck School of Medicine. Tissue grows into microscopic grooves in the textured implants....
“We’re still trying to find out why the surface matters,” he said, adding that in some cases the cancer seems also to be associated with a certain bacterial infection.
Surgeons use textured implants if they want the implant to stick in place and not move, which is important for newer, anatomically shaped implants that would look bad if they were to shift or turn upside down.
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One may wonder about the timing of this March 2017 FDA update report about a little-known and rare type of lymphoma, or blood cancer, developing in some women who have had breast implant procedures done for augmentation or reconstruction purposes. The same NYT news story provides some contextual information which seems to help understand that issue:
A spokeswoman for the F.D.A., Stephanie Caccomo, said Tuesday’s announcement was made because “in 2016, there were several advances in the description of the disease and treatment recommendations, including recognition of the disease by the World Health Organization and publication of diagnosis and treatment guidelines by the Plastic Surgery Foundation and National Comprehensive Cancer Network.”
Together with other law firms, we are currently investigating breast implant - lymphoma cases as possible products liability lawsuits against the responsible medical device companies.
Of course we will continue to monitor the medical literature and regulatory realm for further developments concerning breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).