Breast Implant ALCL Risk Evaluated in New Study

Allergan faces more than 1,000 breast implant ALCL lawsuits, as researchers continue to work to better understand the risk women face from certain designs

Amid continuing concerns over the safety of several newer breast implant designs, a new study has been published that attempts to quantify the risks of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which is a rare a form of cancer that has been found to develop in the tissue surrounding certain breast implants.

Anaplastic large cell lymphoma is a serious type of non-Hodgkin lymphoma, which is often aggressive and may spread quickly if not diagnosed promptly. However, researchers found that women who with breast implants were 40 times more likely to develop the cancer, compared to women without implants, according to findings published recently in the JAMA Network Open.

After concerns about the problems emerged several years ago, the FDA began requiring manufacturers of breast implants to provide a black box warnings designed to alert patients, and a number of manufacturers have faced breast implant cancer lawsuits brought by women who allege they may have avoided a diagnosis if proper warnings had been provided to users and the medical community about the ALCL risk.

In this latest study, researchers looked to evaluate the breast implant ALCL risk, reviewing data on more than 56,000 women who underwent cancer-directed mastectomy with implant reconstruction for any tumor within the breast from 2000 to 2018, using records from the Surveillance, Epidemiology and End Results (SEER) 17 database.

According to their findings, between 3.6% and 4.9% of women in the U.S. have breast implants, and there are typically only five cases of breast ALCL were diagnosed over 421,223 person years. However, that results in an observed incidence rate more than 40 times higher among women with breast implants than women who did not receive breast implants.

While researchers noted that the absolute risks remain low, they also noted the breast implant ALCL risk was not readily diagnosed until 2008, and the incidence rate appears to be rapidly rising in the U.S.

“Patients with breast cancer who are eligible for mastectomy should be counseled on the risks of breast ALCL after implant reconstruction. However, based on these results, we do not believe that women should be dissuaded from pursuing implant-based reconstruction due solely to the risk of ALCL,” the researchers concluded. “Specific brands of macrotextured implants with high-surface-area have been associated with higher rates of ALCL and may be avoided based on regulatory guidelines and clinical discretion.”

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.