The U.S. Food and Drug Administration (FDA) announced an association between a rare type of blood cancer and breast implants Tuesday, saying at least nine women have died as a result of the disease.

As of Feb. 1, the agency had received 359 reports of breast implant associated-anaplastic large cell lymphoma, sometimes known as ALCL. This is a rare type of non-Hodgkins lymphoma that attacks cells in the immune system. The cancer is not considered a form of breast cancer, but it can develop in the scar tissue capsule that forms around a breast implant

“Since 2011, we have strengthened our understanding of this condition and concur with the World Health Organization designation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants,” the FDA said.

 

Textured Surfaces May Increase Risk of ALCL

 

The disease is much more likely to occur with textured breast implants than with smooth implants. Of the 231 reports to the FDA that included the type of implant surface, 203 involved textured implants and 28 involved smooth implants.

The contents of the implant did not seem to have any significance, however. Of the 312 reports that included information on implant fill types, 186 used silicone gel and 126 used saline.

Information from the Australian Therapeutic Goods Administration, the medical regulatory agency of the country, revealed similar findings. It found 46 confirmed cases of the cancer, including nine deaths, since 2007. None of the cases involved smooth implants.

It is unknown whether the textured implants are the cause of the development of the disease or simply associated with a higher incidence,

According to Dhivya Srinivasa, a plastic surgery resident at the University of Michigan who recently looked at a review of data on the cancer worldwide, textured implants are supposed to allow tissue to grow around the implant. This helps minimize the occurrence of a complication called capsular contracture, which is when scar tissue around the implant becomes painful.

However, she said that textured implant surfaces can vary wildly.

“There’s many kinds of texturing, and different companies do it differently,” Srinivasa told NPR. This makes it difficult to find which textures are more associated with the cancer.

Dr. Alex K. Wong, a plastic surgeon and researcher at the University of Southern California’s Keck School of Medicine, told the New York Times that the body tends to have a different reaction to smooth and textured implants. Textured implants have tissue that grows in the grooves.

“When we take these out, you can hear a peeling sound,” Dr. Wong said to the New York Times. “Whereas with a smooth implant, it’s like Jell-O. You can spin it around. It moves really easily.”

Textured implants are also used to secure more anatomically shaped implants that might look unnatural if shifted.

The FDA is warning patients considering implants to talk about the benefits and risks of different implant surfaces with doctors.

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

Rise of Information and Studies Since 2011

 

The March 21 update from the FDA was a long time coming. The federal agency began investigating a possible association between breast implants and anaplastic large cell lymphoma since January 2011.

“Although ALCL is extremely rare, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant,” the FDA said in a safety communication in 2011.

Part of what prompted the recent update was an increase in studies and information about the topic. Last year was particularly significant in research about BIA-ALCL.

In 2016, the World Health Organization recognized the cancer developed after breast implants to be a separate diagnosis based on data. Around the same time, the Plastic Surgery Foundation and the National Comprehensive Cancer Network published guidelines for physicians to better understand and detect the cancer.

Along with the Australian Therapeutic Goods Administration estimating the risk of developing the breast implant-associated cancer to be between 1-in-1000 and 1-in-10,000 women with breast implants, the French National Agency for Medicines and Health Products Safety asked textured breast implant manufacturers to perform biocompatibility testing.

 

FDA Encourages Continuation of Routine Care

 

In its announcement, the FDA issued recommendations for health care providers and patients.

The agency warned providers that the cancer is rare but is often identified in patients undergoing implant revision operations for late onset, persistent seroma.

“Because it has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended,” the FDA said.

The FDA also emphasized that patients with breast implants do not need to change their routine medical care and follow-up because of the rarity of the cancer. However, routine mammography screening and periodic resonance imaging (MRI) for silicone-filled implants are encouraged.