FDA says more data needed before banning implants associated with rare cancer
The U.S. Food and Drug Administration this week stopped short of joining several countries globally that have banned textured breast implants linked to a rare and aggressive type of cancer.
Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), is not breast cancer but a type of non-Hodgkin’s lymphoma that affects cells in the immune system found around the breast implant. According to earlier FDA reports, 457 American women have been diagnosed with BIA-ALCL and nine have died.
While rare, Moffitt Cancer Center medical oncologist Dr. Frederick Locke has treated patients with this condition. “There may be something about the texture of the implant inducing some inflammation causing the cancer, but currently it’s not well understood why it happens,” says Locke.
The FDA issued its statement this week following a two-day public hearing on breast implant safety in March. It said more data is needed to meet the agency’s standard for an outright ban. The majority of women who develop BIA-ALCL have had textured implants, but the statement points out that there are known cases in women with smooth-surface breast implants as well.
As for other countries that have banned or restricted use of textured implants, the statement says many of those particular implants are not marketed in the U.S. The use of textured implants in foreign markets is much higher than in America, where less than 10% of breast implants sold are textured.
Moffitt surgeons do use implants for breast reconstruction. However, the cancer center does not use permanent textured implants. Our treatment team also thoroughly discusses any possible complications that can result from reconstruction surgery and provides extensive follow up afterward.
These informed discussions of risks and benefits are exactly what the FDA recommends for surgeons and their patients considering breast reconstruction.
In the meantime, the FDA is considering plans to update warning labels on textured implants. It also will work to require manufacturers to submit more transparent reports about adverse-events with breast implants.
“We are still investigating the cause of the (BIA-ALCL) association and we will continue to monitor, assess and report our findings as we continue to strengthen our evidence collected so that women and providers can be better informed about BIA-ALCL as they consider breast implants,” the statement reads. “We believe these efforts to improve communication and focus on evidence generation will contribute significantly to improving the safety of breast implants.”