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The US Food and Drug Administration (FDA) has provided an update on breast implant–associated anaplastic large cell lymphoma.

In January 2011, the agency identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL).

Since then, "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 in a statement March 21.

Over 350 Cases, 9 Deaths

The FDA notes that most data suggest that BIA-ALCL occurs more often after implantation of breast implants with textured surfaces rather than those with smooth surfaces.

As of February 1, 2017, the FDA has received a total of 359 medical device reports (MDRs) of BIA-ALCL, including 9 deaths. Of the 231 reports that included information on the implant surface, 203 concerned textured implants and 28, smooth implants.

Of the 312 reports that included information on implant fill types, 186 described implants filled with silicone gel and 126, implants filled with saline.

"It is important to note that details on breast implant surface and fill type are limited. While the MDR system is a valuable source of information, it may contain incomplete, inaccurate, untimely, unverified, or biased data," the FDA says. 

During the last 6 years, a "significant body" of literature has been published on BIA-ALCL, including additional case histories and comprehensive reviews of the natural history and long-term outcomes of the disease, the agency notes.  "All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants."

Most cases of BIA-ALCL are treated by removal of the implant and the capsule surrounding the implant, and some cases have been treated by chemotherapy and radiation. However, because BIA-ALCL 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 exact number of cases of BIA-ALCL worldwide is unknown.

The FDA is continuing to collect and evaluate information about BIA-ALCL. For now, the agency recommends that clinicians who have patients with breast implants take the following action: 

  • Be aware that most confirmed cases of BIA-ALCL have occurred in women with textured breast implants. Provide the manufacturer's labeling as well as any other educational materials to your patients before surgery and discuss with them the benefits and risks of the different types of implants.

  • Consider the possibility of BIA-ALCL in a patient with late-onset, persistent peri-implant seroma. In some cases, patients presented with capsular contracture or masses adjacent to the breast implant. A patient with suspected BIA-ALCL should be referred to an appropriate specialist for evaluation. When testing for BIA-ALCL, collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out BIA-ALCL. Diagnostic evaluation should include cytologic evaluation of seroma fluid with Wright-Giemsa–stained smears and cell block immunohistochemistry testing for a cluster of differentiation and anaplastic lymphoma kinase markers.

  • Develop an individualized treatment plan in coordination with the patient's multidisciplinary care team. 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.

  • Report all confirmed cases of ALCL in women with breast implants to the FDA's MedWatch system.

  • Submit case reports of BIA-ALCL to the PROFILE Registry to contribute to a better understanding of the causes and treatments of BIA-ALCL.



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