Breast Implant Cancer Linked to 9 Deaths, FDA Warns Doctors

Published on February 8, 2019 by Laurie Villanueva

The U.S. Food & Drug Administration (FDA) is warning healthcare providers to be on the lookout for anaplastic large cell lymphoma (ALCL), a rare cancer linked to breast implants.

In a February 6th letter, the agency indicated it had received 660 breast implant cancer reports during the past decade. Following a careful review to eliminate duplicate reports and confirm a diagnosis, the FDA identified 457 unique cases of breast implant-associated ALCL.

The confirmed reports included 9 deaths “which may be attributable” to the disease.

Most Breast Implant Cancer Involves Textured Devices

“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 letter states. “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 began investigating ALCL in 2011, and confirmed a link to breast implants in 2017.

While the slow-growing cancer can occur with ether silicone or saline breast implants, the vast majority of cases involve devices with a textured surface.

The estimated incidence rates for breast implant cancer range from a high of 1 per 3,817 patients to a low estimate of 1 in 30,000.

Breast Implant Cancer Symptoms and Treatment

It’s important to note that ALCL is NOT breast cancer. The disease is actually a form of non-Hodgkin’s lymphoma that develops in the scar capsule that forms around breast implants.

Early symptoms generally include:

  • Lumps
  • Swelling in the breast
  • Asymmetry around the breast implant after the surgical site is fully healed
  • Pain around the breast implant

According to the FDA, these symptoms are caused by fluid-filled seromas in the tissue around the implant. Sometimes a mass or masses will also form in the adjacent tissue.

Because ALCL is a slow-growing cancer, most patients will only require surgery to remove the breast implant and surrounding scar tissue.

Patients with more advanced ALCL may require chemotherapy. In rare cases, these patients may also undergo radiation treatment and/or stem cell transplant therapy.

FDA Recommendations for Healthcare Providers

The FDA is now recommending that breast implant surgeons:

  • Ensure all patients are aware of the benefits and risks of the different types of breast implants prior to surgery.
  • Provide breast implant patients with all manufacturer’s labeling (including patient-specific labels) and other relevant educational materials before the procedure.

Surgeons and other providers, including gynecologists, primary care physicians, nurse practitioners, physician assistants, and emergency room doctors, should:

  • Consider breast implant-associated ALCL when treating a patient with late onset, peri-implant seroma.
  • Refer patients with suspected breast implant cancer to a multidisciplinary team for evaluation.

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