FDA Warning Links Breast Implants to ALCL

Breast implants may increase an individual’s risk of developing anaplastic large cell lymphoma, a recent FDA advisory warned.

The warning follows on a statement released by the FDA in 2011 suggesting a potential link between breast implants and the rare lymphoma. The issue was subsequently researched and in 2016, the World Health Organization (WHO) recognized the correlation.

“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 that can develop following breast implants,” the FDA reported in a statement.

An estimated 10 to 11 million women worldwide have breast implants, according to the American Society of Plastic Surgeons and the Plastic Surgery Foundation. When BIA-ALCL occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma, the FDA noted. The exact number of cases remains difficult to determine due to significant limitations in worldwide reporting and lack of global implant sales data.

There have been 359 medical device reports (MDRs) of BIA-ALCL, which included 9 deaths. Of the 231 in this group that did provide information on the implant surface, most reported the implants involved were texturized, according to the FDA reported. 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 statement, noting that common symptoms include spontaneous seroma or effusion after about a year of implantation.

The FDA recommends that healthcare practitioners continue to provide their patients with breast implants routine care and support, because BIA-ALCL is very rare: “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.”

When BIA-ALCL does occur, however, it happens most often in patients undergoing implant revisions for seroma; thus, clinicians should be aware of the risk when presented with a patient with late-onset, persistent, peri-implant seroma, and refer her to an appropriate specialist for further evaluation.

The agency further suggests that clinicians develop an individualized treatment plan in coordination with any impacted patient's multidisciplinary care team and “consider current clinical practice guidelines, such as those from the Plastic Surgery Foundation or the National Comprehensive Cancer Network when choosing your treatment approach.”

The FDA recommended that individuals considering implants talk to their healthcare provider about the risks and benefits of textured- versus smooth-surface implants. Individuals who already have breast implants do not need to drastically change their healthcare or follow-up routines, according to the FDA. They should continue to monitor the implants according to their physician’s instructions and, if their implants are silicone-filled, have frequent MRIs, as instructed by their providers.

Practitioners are also asked to report all confirmed cases of ALCL in women with breast implants to the FDA and submit case reports of BIA-ALCL to the Plastic Surgery Foundation’s PROFILE registry.