In 2011, the FDA identified an association of ALCL (anaplastic large cell lymphoma), a type of non-Hodgkin’s lymphoma and a cancer of the immune system, with breast implants. This cancer is known formally as BIA-ALCL and in the majority of cases, has been found in the scar tissue surrounding breast implants or the fluid nearby. The risk of this cancer is very low at approximately 1:30,000 of breast implant placements, although research is ongoing. It is generally assumed to be associated with only textured implants. (However, recently the FDA stated that there have been known cases in women with smooth breast implants.) There have been cases reported with other types of implants as well including those used in orthopedic knee replacement. Generally speaking, current research suggests that some kind of irritation due to the surface of the implant and possible bacterial contamination are contributing factors.
The FDA recently conducted a review of textured breast implants in March 2019. In May 2019 after performing a thorough review of existing scientific data, the agency concluded that the risk of this cancer involving textured breast implants did not meet the standard to ban them as medical devices. While a few other countries internationally have initiated a ban on textured breast implants, these markets typically use a much larger proportion of textured implants than the United States – up to 80% market share versus the United States at 10%. These countries also allow a kind of textured breast implant not approved for use in the United States. In addition, the FDA has announced further measures to help track cases of the BIA-ALCL and to educate the public on the risks associated. The agency will partner with patient registries, such as
PROFILE, to collect accurate BIA-ALCL data on patient outcomes. Manufacturers will also be required to file individual adverse event reports, which will be made available to the public. Previously, these companies were permitted to submit summary reports of such events. The FDA is also taking steps to make other women’s healthcare professionals outside of the plastic surgery community such as gynecologists, dermatologists, and internists aware of this rare cancer and to work with pathologists about testing.
While plastic surgery research in this area is ongoing, Dr. Zuckerman feels that all patients should be fully informed about the risks of BIA-ALCL before undergoing
breast augmentation surgery with breast implants. He discusses this issue with all prospective breast augmentation patients but encourages patients to weigh the relative risk of this disease given its rarity.
