Breast Implants May be Associated With Rare Lymphoma, FDA Says

Some women with breast implants may be at risk for developing a rare type of lymphoma, according to a recent statement released by the Food and Drug Administration (FDA).

In 2011, the FDA stated that there may be a correlation between breast implants and anaplastic large cell lymphoma. It has been researched and studied since, and in 2016, the World Health Organization (WHO) recognized the correlation.

In a statement on March 23, 2017 the FDA agreed with WHO, saying, “Since 2011, we have strengthened our understanding of this condition and concur with the World Health Organization’s designation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma can develop following breast implants.”

According to the American Society of Plastic Surgeons and the Plastic Surgery Foundation, there are an estimated 10-11 million women worldwide with breast implants. The exact number of these women with BIA-ALCL is difficult to determine.

As per February 2017, the FDA says that there have been 359 medical device reports (MDRs) of BIA-ALCL, which included nine deaths from the disease. While not all MDRs stated the surface type of the implants, most of the 231 that did, reported them to have a texturized surface. Further, 312 of the cases provided information on the fill type. Of those cases, 186 of the implants were silicone, while the other 126 were saline.

There are currently no known risk factors, and further investigation is warranted.

“Additional research is critical to identify patients at risk of developing this disease, characterize the early signs and symptoms, and determine best practices for treatment,” the American Society of Plastic Surgeons and the Plastic Surgery Foundation said in a release, noting that common symptoms include spontaneous seroma (collection of fluid under the skin) or effusion after about a year of implantation.

The FDA urged consumers considering breast implants to talk to their health care provider about the risks and benefits of textured-surface versus smooth-surface implants. Further, they noted that individuals who already have breast implants do not need to drastically change their health care or follow-up routines. They should just continue to monitor the implants as per their doctors’ orders and, if their implants are silicone-filled, have frequent MRIs, as instructed by their providers.

More information will be made available by the FDA as significant findings occur.