The FDA has published a new letter to providers in radiology, pathology, emergency medicine and several other specialties with updated information related to breast implant associated-anaplastic large cell lymphoma (BIA-ALCL).
Patients are at “an increased risk” of developing BIA-ALCL “within the scar capsule adjacent to the implant,” according to the document, which is signed by William Maisel, MD, MPH, CMO of the FDA’s Center for Devices and Radiological Health.
“We want all healthcare providers to be aware of BIA-ALCL, particularly in patients with new swelling, lumps, or pain around breast implants, to expedite diagnosis of this malignancy,” the FDA letter’s read. “We are also asking health care providers to report to the FDA cases of BIA-ALCL in patients with breast implants. This includes reporting individual cases as well as rates you may have experienced during your practice.”
The FDA noted that it has received a total of 660 medical device reports (MDRs) of BIA-ALCL. After closer review, the final tally is 457 MDRs for the disease. Nine patient deaths “may be attributable” to BIA-ALCL.
In the letter, the agency recommends that providers provide all manufacturer labeling to patients before implantation, explaining both the benefits and risks of different types of implants. In addition, when treating patients with “late onset, peri-implant seroma,” BIA-ALCL should be considered a possible cause.
“In some cases, patients presented with a mass or masses adjacent to the breast implant,” the document read. “If you have a patient with suspected BIA-ALCL, refer the individual's case to a multidisciplinary team for evaluation.”
The FDA also recommends that providers develop a plan for treating this disease, drawing from applicable clinical guidelines as necessary.
All confirmed cases of BIA-ALCL should be reported through the FDA’s website.