FDA Cautions Breast Augmentation May Be Linked to ALCL

The FDA is looking into 359 reports linking silicone and saline breast implants with development of anaplastic large cell lymphoma (ALCL), a rare type of NHL.

“All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL, compared with women who do not have breast implants,” the FDA said in a statement.

The FDA started looking into the association in 2011. ALCL can take approximately 10 years, on average, to develop after the implant is first inserted. The lymphoma usually develops in the area near the implant, although it can spread, according to researchers from the World Health Organization who published an article reporting their findings in Blood.

As of February 1, 2017, the FDA had received a total of 359 medical device reports (MDRs) of ALCL, including nine deaths. There are 231 reports that include information on the implant surface. Of those, 203 were textured implants and 28 smooth implants. Most of the reports contained no information about the surface textures of any previous implants.

“Although it is rare, breast implant-associated ALCL appears to develop more frequently in women with textured implants than in women with smooth-surfaced implants,” the agency’s report said. “Before getting breast implants, make sure to talk to your health-care provider about the benefits and risks of textured-surface versus smooth-surfaced implants.”

Details on breast implant surface and fill type are limited. Although the MDR system is a valuable source of information, it may contain incomplete, inaccurate, untimely, unverified, or biased data, the FDA noted. In addition, the incidence or prevalence of an event cannot be determined from the MDR system because of potential underreporting, duplicate reporting of events, and lack of information about the total number of breast implants.

Sources: U.S. Food and Drug Administration news release, March 23, 2017; Chalasani P, Go RS, Parsons B, Al-Hamadani M. Anaplastic large cell lymphoma of the breast: incidence, patterns of care, and outcome in the US population. Blood. 2015;126:5035.

SHARE