Breast Implant ALCL Diagnosis Guidelines Issued By Cancer Experts

Researchers with the National Cancer Institute have released new best practices guidelines on how to properly diagnose patients as having breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), a rare form of cancer specifically linked to recalled textured breast implants that were sold in recent years.

The guidelines were published online on February 11 in the Journal of Clinical Oncology by researchers from the institute, which is a part of the National Institute of Health (NIH). The researchers warn that early diagnosis of breast implant ALCL, like with all forms of cancer, can be crucial in preventing the lymphoma from spreading and becoming life threatening.

Over the past few years, there have been concerns about the link between textured breast implants and cancer that may develop in the tissue surrounding certain types of implants. An Allergan Biocell breast implant recall was issued in July 2019, in response to an FDA determination that nearly all cases of BIA-ALCL have been linked to this one type of device.

“To better inform patients and healthcare providers about BIA-ALCL, we convened to review diagnostic procedures used in the evaluation of patients with suspected BIA-ALCL. We focused on the processing of the seroma fluid/effusion surrounding the implant, the handling of capsulectomy specimens following removal of implant(s), and the preoperative evaluation of the patient with suspected BIA-ALCL,” the researchers wrote. “Recommendations were based on the published literature and our experience to optimize procedures to obtain an accurate diagnosis and assess for tumor invasion and the extent of the disease.”

The recommendations note that swelling of the breast due to fluid build-up is the most common sign of BIA-ALCL, and calls for early and accurate evaluation of the effusion fluid surrounding the implant when signs of swelling occur. The recommendations detail the technical aspects of how those diagnoses should be conducted.

The FDA indicates there are at least 573 known cases of BIA-ALCL worldwide, including 33 deaths. Of those, 481 have been linked to Allergan breast implants. Allergan implants were also linked to 12 of the 13 deaths where the manufacturer of the breast implant was known.

In June 2017, a study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants.

Another study, published in October 2017, warned that many breast implant cancer cases worldwide have likely not been reported, and noted that doctors and patients may not be aware of BIA-ALCL.

Despite the recall, the FDA is not recommending women have the breast implants removed if they are showing no symptoms. Instead, the regulators recommend recipients of these implants become familiar with the symptoms of BIA-ALCL, including persistent swelling or pain near the implant, and talk to their health care provider for further information. Those with BIA-ALCL should undergo breast implant removal and removal of the surrounding scar capsule.

The agency also recommends those who receive breast implants keep a record of the device manufacturer, unique device identifier and implant model name, which may have been provided on a patient device card from the surgeon.

A number of women nationwide are now pursuing class action lawsuits to secure compensation for the defective and dangerous implants, and individual breast implant ALCL lawsuits are being filed against the manufacturer by women diagnosed with this rare cancer after receiving one of the recalled devices.