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.

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Women may face a risk of Anaplastic Large Cell Lymphoma (ALCL) from certain breast implants.

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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.

1 Comments

  • MaxJanuary 6, 2023 at 5:02 pm

    But... this study looked ONLY at 56,000 women who underwent cancer-directed mastectomy Did it not occur to anyone that women who already had breast cancer before getting implants were much more likely to develop further problems after the mastectomy? How could they possibly factor out that their entire sample set were women who were already predisposed to cancer? "five cases of breast ALCL[Show More]But... this study looked ONLY at 56,000 women who underwent cancer-directed mastectomy Did it not occur to anyone that women who already had breast cancer before getting implants were much more likely to develop further problems after the mastectomy? How could they possibly factor out that their entire sample set were women who were already predisposed to cancer? "five cases of breast ALCL were diagnosed over 421,223 person years" What is the average study span per person? Let's assume it's something like looking at women from age 20 to age 75, so 55 years. Does that mean we would be looking at 421,223/55 = 7658 women, and there were only 5 cases of this lymphoma, or .065%? And it jumps to 40x worse with implants (in prior cancer patients!) or 2.6% or prior cancer patients who get implants get this lymphoma. -- -- Look, I'm not saying there couldn't be a contributing factor here, but they are not giving enough information in this article to make any kind of informed decision, and the study itself seems very myopic to only study women with a previous breast cancer so serious that it required a mastectomy.

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