FDA Issues Update on Rare Breast Implant-Associated Lymphoma

Megan Brooks

March 21, 2018

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

The FDA has been closely tracking the relationship between breast implants and ALCL since the agency first identified a possible association in 2011.

"We've been working to gather additional information to better characterize and quantify the risk so that patients and providers can have more informed discussions about breast implants," Binita Ashar, MD, director of the Division of Surgical Devices in the FDA's Center for Devices and Radiological Health, said in a statement.

As of September 30, 2017, the FDA has received a total of 414 medical device reports (MDRs) of BIA-ALCL, including nine deaths, the agency said today. That's up from 359 MDRs of BCL-ALCL reported in the FDA's last public update released in March 2017, as reported by Medscape Medical News.

Of the 414 reports, 272 included information about the surface of the implant at the time of the report. There were 242 reports of implants with textured surfaces, and reports of 30 implants with smooth surfaces. Of the 413 reports that included information on implant fill types, 234 of the reported implants were filled with silicone gel, and 179 were filled with saline.

BIA-ALCL has been identified most often in patients undergoing implant revision operations for late-onset, persistent seroma. Half of the reported cases of BIA-ALCL were diagnosed within 7 to 8 years of implantation.

On the basis of studies in the medical literature, the FDA estimates that the lifetime risk of developing BIA-ALCL for patients with textured breast implants ranges from 1 in 3817 to 1 in 30,000.

"We hope this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL. At the same time, we remain committed to working in partnership with all stakeholders to continue to study, understand, and provide updates about this important public health issue," Ashar said.

Action Points

Today's update does not change the FDA's recommendations regarding breast implants. "Choosing to obtain a breast implant is a very personal decision that patients and their providers should make based on individual needs and with the most complete information about risks and benefits," the FDA says.

The agency 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:

  • Continue to provide routine care and support to patients with breast implants. Because BIA-ALCL has generally only been identified in patients with late onset of symptoms, such as pain, lumps, swelling, or breast asymmetry, prophylactic breast implant removal in patients without signs or symptoms is not recommended.

  • 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 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, 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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