FDA Warns of Risk of Rare Lymphoma With Breast Implants

FDA Warns of Risk of Rare Lymphoma With Breast Implants

Some women with breast implants may be at risk for developing a rare type of lymphoma, according to an FDA advisory. The action follows on a 2011 FDA statement suggesting 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.

The FDA followed suit and issued the following statement: “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.”

BIA-ALCL is a rare condition; when it 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.

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

The FDA reported that 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. 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 (collection of fluid under the skin) 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 (NCCN) when choosing your treatment approach.”

For those considering implants, the FDA urges them to 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.