More Than 1,300 Breast Implant ALCL Cases Diagnosed Worldwide, Including 35 Deaths: Report

Researchers found breast implant ALCL cases worldwide appeared to be exclusively linked to textured implants

Plastic surgeons worldwide have identified more than 1,333 cases of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), including 35 deaths linked to the rare form of cancer that develops in the tissue surrounding certain types of implants.

Anaplastic large cell lymphoma (ALCL) is a serious type of non-Hodgkin lymphoma, which is often aggressive and may spread quickly if not diagnosed promptly. However, researchers have found that women with breast implants are 40 times more likely to develop the cancer, compared to women without implants.

After concerns about the problems emerged several years ago, the FDA required manufacturers of breast implants to provide a black box warning on their products and a number of breast implant cancer lawsuits have been brought by women throughout the U.S., alleging that they may have avoided a diagnosis if proper information about the risks had been disclosed to users and the medical community.

According to new data presented earlier this month at the Miami Breast Cancer Conference, the American Society of Plastic Surgeons now indicates the worldwide number of reported cases of BIA-ALCL was 1,333 as of late 2022. They also found 35 deaths associated with the condition since it was first detected in 1997.

In the United States alone, at least 402 BIA-ALCL cases have been identified, including eight deaths, according to data presented by Dr. Kelly K. Hunt, of the University of Texas MD Anderson Cancer Center.

The new data also appears to confirm BIA-ALCL is exclusively a problem associated with textured breast implants. However, why this is the case is not yet completely understood.

Breast Implants Lymphoma and Squamous Cell Carcinoma Risks

The data comes shortly after the FDA issued a new breast implant warning in September 2022, indicating that it has received reports of squamous cell carcinoma (SCC) and other lymphomas occurring in breast tissue capsules around implants through postmarketing reports.

The agency reported that, as of September 1, 2022, it had received 22 reports of various lymphomas tied to breast implants, including 10 reports of squamous cell carcinoma; a form of skin cancer. However, these breast implant cancers were different from the BIA-ALCL cases, which have resulted in prior warnings.

In an update issued earlier this month, the FDA indicated it had found 19 cases of squamous cell carcinoma linked to breast implants in published literature. It is unclear how many of those cases overlap.

Squamous cell carcinoma is the second most common form of skin cancer, which causes abnormal squamous cell growth. It often appears as red, scaly patches, sores, and thickened wart-like skin which can bleed, itch, crack and crust over. It can often be easily treated if caught early, but can be disfiguring and deadly if diagnosis and treatment are delayed. An estimated 1.8 million SCC cases are diagnosed each year, and the incidence rate has doubled over the last 30 years, health experts warn.

In its latest update, the FDA urged health care providers and those considering breast implants to be aware of the risks of SCC and various lymphomas in the capsule around the breast implant. The FDA asks health care providers and those with breast implants to continue reporting cases of any cancers involving the implants to be reported to the agency.

BioCell Breast Implant Associated ALCL Recall Lawsuits

In response to concerns about the ALCL risk associated with certain Allergan Biocell implants featuring a textured surface design, a massive breast implant recall was issued in 2019, after the FDA determined the design was linked to nearly all known cases of BIA-ALCL.

In mid-2020, the FDA reported it was aware of at least 733 breast implant-associated ALCL cases, leading to the rapid adoption of the term BIA-ALCL to describe the diagnosis. Since then, the number of diagnosed cases has risen rapidely

There are currently more than 1,000 Allergan breast implant ALCL lawsuits pending in the federal court system, each raising similar allegations that the textured design was unreasonably dangerous and defective.