March 29, 2018
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Breast implant-associated lymphoma more common than originally predicted

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The FDA provided updated information regarding risk for breast-implant associated anaplastic large cell lymphoma.

In 2011, the FDA identified a possible association between breast implants and anaplastic large cell lymphoma (BIA-ALCL); however, the exact number of cases remains difficult to determine.

“The FDA has been closely tracking the relationship between breast implants and a rare type of non-Hodgkin lymphoma since we first identified this possible association. 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 FDA’s Center for Devices and Radiological Health, said in a press release. “As part of that effort, we are working to update and enhance the information we have on this association, including updating the total number of known cases of BIA-ALCL and the lifetime risk [for] developing BIA-ALCL as reported in medical literature.”

As of September 2017, the FDA had received 414 medical device reports of BIA-ALCL. Of those, 272 had information about surface texture of the implant. A majority (n = 242) of the reports related to textured implants. Individuals with textured implants may be associated with a higher risk for BIA-ALCL, according to the report.

Literature reported BIA-ALCL may develop in between one in 3,817 to one in 30,000 individuals with textured breast implants. Additionally, diagnoses occurred within 7 to 8 years following breast implant in half of the reported cases.

The FDA recommended clinicians consider the possibility of BIA-ALCL if a patient has late onset, persistent peri-implant seroma. BIA-ALCL can be identified through pathology tests of seroma fluid and representative portions of the capsule.

Additionally, the FDA recommended all cases of BIA-ALCL be reported to MedWatch and the PROFILE registry, which is collecting information about this condition to better understand causes and treatments.

Roberto N. Miranda

“We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk [for] 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 in the release.

HemOnc Today spoke with Roberto N. Miranda, MD, professor in the department of hematopathology at The University of Texas MD Anderson Cancer Center, about the FDA’s report, diagnosing BIA-ALCL and treatment outcomes.

 

Question: What are your thoughts about the FDA’s report on BIA-ALCL ?

Answer: The FDA’s statement refers to an increase in the number of reported cases and an increase in the estimated lifetime risk for developing BIA-ALCL. The initial report emphasized the disease was extremely rare — with a lifetime risk of approximately one in 300,000 women with breast implants — whereas the update provided a new estimate of one in 3,817 to one in 30,000. The statement appears to refer to those women who have received textured, and not smooth, breast implants. This new statement is significant in that it removes initial statements that the disease is extremely rare, which previously suggested that any clinician may not see a case in their practices. The new statement with the new ranges reveals that, although unusual, BIA-ALCL is a disease that we may see in our practices.

 

Q: What should clinicians know about the association between textured implants and BIA-ALCL, and how should they counsel patients?

A: There is a rationale in the use of textured implants instead of smooth implants, based on the surgeon and the patient decision and expectations. A retrospective analysis by Doren and collaborators demonstrated that almost all patients who developed BIA-ALCL had a textured implant; only one of the cases analyzed appeared not to have received textured implant. The decision to receive a textured, and not a smooth, implant should be discussed between the clinician and the patient in the light of the revised estimated risk for developing BIA-ALCL.

 

Q: How can clinicians identify BIA-ALCL early?

A: The most common manifestation of BIA-ALCL is an effusion that patients feel as swollen breast that usually appears an average of 9 years after the implant was placed. Effusions that appear within the first 1 or 2 years after implantation are probably related to known surgical procedures such as hemorrhage or infection and are not likely to be BIA-ALCL. Clinicians should pay attention to the so-called late “seromas.” Less commonly, patients note an induration or a mass on the sides of the implant, with or without effusion. Thus, clinicians should suspect that these manifestations raise the concern of BIA-ALCL and properly sample the effusion or the mass. The most appropriate screening testing is fine needle aspiration of the effusion or the mass, with examination by a pathologist or cytopathologist. Imaging studies also are necessary to define the nature of the lesion and confirm the presence of effusion with ultrasound or investigate the nature of the mass with PET scan.

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Q: What do treatment and long-term outcomes look like for these patients?

A: We have advocated that removal of the implant and resection of any suspicious lesion is the best approach that leads to cure of the disease with a very low rate of recurrence. If the disease is underdiagnosed or neglected, we believe that the disease does not go away spontaneously and may progress to a more locally aggressive disease and, more rarely, disseminate to distant organs.

 

Q: What research is being done in this area?

A: I am involved with clinical research trying to define the diagnostic criteria, the most appropriate way of sampling and handling suspicious lesions and to determine prognostic factors after pathologic evaluation. Other researchers are more involved with the underlying immune and molecular mechanisms that trigger the disease.

 

Q: Is there anything else you would like to mention?

A: Awareness among clinicians, pathologists, radiologists and patients is the most important step, so disease is detected when it can be cured by removal of implants and any evidence of disease. More advanced disease is more difficult to treat and may require adjuvant therapy. – by Cassie Homer

 

Disclosure: Miranda reports no relevant financial disclosures.