FDA Update Shows 457 Cases of ALCL Linked to Breast Implants

FDA Update Shows 457 Cases of ALCL Linked to Breast Implants

The number of reported cases of anaplastic large cell lymphoma associated with breast implants (BIA-ALCL) has risen to 457, according to a 2018 update from the U.S. Food and Drug Administration (FDA). Nine women have died from this type of non-Hodgkin’s lymphoma, a number that has remained unchanged since 2016.

The increase in known cases may be because of increased awareness since the FDA first reported a possible link between breast implants and ALCL in 2011. Since then, the agency has been working to collect information on this rare type of lymphoma and determine which factors increase the risk for ALCL.

In its update, the agency also reported 246 more BIA-ALCL reports — called medical device reports, or MDRs — than last year, for a total of 660 reports since 2010 and up to September 2018.

Binita Ashar, MD, of the FDA’s Center for Devices and Radiological Health, said the lower number of BIA-ALCL cases compared to that of reports could be linked to the possibility of patients, providers, and manufacturers filing independent reports, potentially leading to duplicates.

BIA-ALCL is not breast cancer, but a rare type of non-Hodgkin’s lymphoma, a cancer of the immune system. This type of cancer is characterized by abnormal growth of T cells and strong expression of a protein, the cytokine receptor CD30.

In most cases, cancer cells are found in the scar tissue and fluid near the implant, but in some cases, they can spread throughout the body.

BIA-ALCL usually develops as a delayed swelling of the breast, which may show fluid collecting around the implant or marked breast asymmetry. It also can be seen as a lump in the breast or armpit, according to the American Society for Aesthetic Plastic Surgery.

Diagnosis usually happens a median of eight years after implantation, but there have been reports as early as two years or as late as 28 years after implantation.

Having detailed information, such as breast implant texture and implant fill, or the patient’s age and time from implantation to diagnosis, “helps us understand how and why this lymphoma may be occurring,” said Ashar, a general surgeon.

Despite the “evolving understanding of BIA-ALCL” that these updates enable, lack of thorough information complicates knowing whether a specific implant characteristic is associated with BIA-ALCL or if an increase in MDRs is associated with a given manufacturer. A breakdown of available data is available on the FDA’s website.

Given the limitations of reports, the FDA also reviews other sources, including the PROFILE registry, compiled by professionals in plastic surgery. The agency’s participation, said Ashar, reflects its commitment to the Medical Device Safety Action Plan to address device safety issues and make the FDA’s responses “more timely and effective.”

The FDA encourages women to read device labeling information for any product they may consider implanting.

“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 products,” Ashar said.

Regulatory agencies in other countries may be reporting different information about breast implant safety, Ashar cautioned. This is because of different devices approved in each country, the extent of adverse event reporting, and availability of data regarding the total number of implants sold. Overall, this makes it difficult to determine risk on a global scale, she said.

The FDA also issued a Letter to Health Care Providers to encourage professionals to learn about BIA-ALCL in women with breast implants, including diagnosis and treatment.

“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 read.

Ashar said, “By providing information to health care providers, we believe more providers will be empowered with information to assist patients who may have BIA-ALCL.”

“We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL,” Ashar said. “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.”

The FDA’s General and Plastic Surgery Devices Panel will have a public meeting March 25-26 at the agency’s headquarters in Silver Spring, Maryland. BIA-ALCL and others topics to be discussed “highlight the importance of continuing to monitor, assess and advance our understanding of breast implant safety,” Ashar said.

2 comments

  1. Gael Bittenbender says:

    What type of beast implants are linked to this? I have “PIP” Implants and am concerned that this is the kind that can cause this health issue.

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