In recent years, Allergan, the Ireland-based medical device manufacturer, has found itself at the center of thousands of lawsuits involving its textured breast implants, which have been linked to a rare and serious type of blood cancer. These implants, known as Biocell, have been associated with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a form of cancer that primarily affects women who have undergone breast augmentation procedures. The issue has caught the attention of both the medical community and class action lawyers, with many patients filing claims for compensation due to the risks and harm caused by the implants.

Breast implants come in two general types: smooth and textured. Both types serve the same primary purpose of enhancing breast shape, size, or reconstruction following mastectomy. Textured implants, including those made by Allergan, are often preferred due to their lower risk of implant migration, which can reduce complications like capsular contracture, a painful condition that leads to the hardening of the tissue around the implant.

However, studies have shown that textured implants, including Allergan’s Biocell implants, pose a significant health risk. The textured surface of these implants is believed to trigger the formation of scar tissue around the implant. This tissue can create an environment where cancerous cells develop, leading to a rare type of blood cancer. Although it occurs in the breast area, BIA-ALCL is classified as a form of non-Hodgkin lymphoma, a cancer that affects the lymphatic system.

BIA-ALCL was first identified in 1997, but it wasn’t until years later that medical experts began to establish a connection between the disease and textured breast implants. While BIA-ALCL is exceedingly rare, it is notably more prevalent in women with textured implants, especially those who have received Allergan’s Biocell models. According to an analysis by the U.S. Food and Drug Administration (FDA), 84% of the reported BIA-ALCL cases involved Biocell implants.

Alarmingly, women with Allergan Biocell implants were found to be six times more likely to develop BIA-ALCL than those with other textured implants. Given that Allergan is one of the leading manufacturers of textured breast implants, this translates to hundreds of thousands of women around the world who could be at risk of developing the condition, making the situation particularly troubling.

Despite increasing awareness of the risks associated with Biocell implants, it was not until 2019 that the FDA issued a full recall of Allergan’s textured implants. The recall followed mounting evidence of the connection between these implants and BIA-ALCL.

By the time the recall was issued, however, many women had already received the implants. Allergan began selling its Biocell textured implants in 2006, and over the years, they became widely used in both cosmetic and reconstructive breast surgeries. The implants were particularly popular due to their design, which was thought to reduce the likelihood of complications. However, as the years passed, it became clear that the benefits of the implants came at a high cost, with a growing number of women experiencing serious health problems linked to their use.

For women who had Allergan’s Biocell breast implants before the recall, the risk of developing BIA-ALCL remains a significant concern. Though the FDA did not recommend that women immediately remove their implants, medical professionals have emphasized the importance of regular monitoring for signs of the disease. This is crucial, as early detection of BIA-ALCL can greatly improve treatment outcomes and reduce the risk of the cancer spreading.

Symptoms of BIA-ALCL may not appear immediately after the implantation of the breast implants. In fact, the onset of symptoms can take several years. When BIA-ALCL is detected early, treatment typically involves the removal of the implant and surrounding tissue. In more advanced cases, chemotherapy or radiation therapy may be required. This process can be emotionally and physically taxing, particularly for those who already faced a difficult recovery from breast cancer or surgery.

The issue of BIA-ALCL and Allergan’s breast implants began to gain attention several years before the FDA issued the recall. In fact, as early as 2011, the FDA had raised concerns about the potential risks associated with textured breast implants. However, it wasn’t until 2018 that the first lawsuits were filed in the United States by individual victims, alleging that Allergan should have warned them about the risks of BIA-ALCL.

The early lawsuits were limited in number, and plaintiffs faced significant challenges in proving that Allergan had known or should have known about the dangers associated with its implants. However, once the FDA issued the recall in 2019, the number of lawsuits increased exponentially. Victims began to come forward, seeking compensation for the harm caused by Allergan’s implants. This led to the creation of multidistrict litigation (MDL) in 2019, which consolidated thousands of individual claims into a single court case.

The core of the legal claims against Allergan centers on product liability, which holds manufacturers responsible for defective products that harm consumers. In the case of Allergan’s textured breast implants, plaintiffs argue that the company is liable for:

Defective Design. The textured surface of Biocell implants is inherently dangerous, as it contributes to the formation of scar tissue and increases the likelihood of BIA-ALCL. Plaintiffs argue that Allergan should have designed the implants in a way that would not cause such complications.

Failure to Warn. Another central claim is that Allergan failed to adequately warn both consumers and healthcare providers about the risks associated with its implants. Evidence is emerging that suggests the company may have been aware of the dangers of Biocell implants but did not take sufficient steps to inform the public.

Proving these claims requires extensive documentation, including evidence that Allergan knew or should have known about the risks and that there were safer alternatives available. If the plaintiffs can demonstrate that Allergan was negligent in its design or failure to warn, they may be entitled to compensation for their medical expenses, pain and suffering, and other damages.