Jan. 26, 2011 -- Women with breast implants "may have a very small but increased risk" of a rare form of cancer, the FDA today warned.
The FDA is aware of some 60 reports -- 34 in the medical literature and others from doctors, regulators, and implant makers -- of anaplastic large cell lymphoma (ALCL) in women with breast implants.
ALCL is a very rare disease that almost never starts in the breast. Yet an accumulating number of case reports suggest that ALCL in the breast may be a rare side effect of breast implants. ALCL is not breast cancer. It is a form of lymphoma that affects white blood cells called T cells.
The ALCL tumors linked to breast implants appear in the scar tissue that surrounds the implant, not in the breast itself. Although ALCL can be a deadly disease, case reports suggest that ALCL linked to breast implants is less aggressive -- and more easily treated -- usual ALCL.
Some 5 to 10 million women worldwide have received breast implants, yet only a very few have ALCL. It's not yet clear whether the implants actually cause ALCL. Women without ALCL symptoms do not need to have their breast implants removed.
"Women not showing symptoms or problems do not need to change their health-care routine. ALCL has occurred in a very small number of women compared to the millions who have had breast implants," William Maisel, MD, MPH, chief scientist at the FDA's device center, said at a news teleconference.
Most of the ALCL cases linked to breast implants have been in women who underwent implant revision operations due to a collection of fluid around the implant that would not go away. In the cases described in the medical literature, ALCL developed one to 23 years after implant -- on average, eight years after the initial implant.
It's not at all clear why implants might cause ALCL. One hypothesis is that silicone from the shell of the implant (saline implants also have silicone shells) might cause cancerous changes in T cells. But there is far too little evidence to know whether this is the case, Maisel said.