Women across the nation are filing lawsuits against Allergan Inc. claiming they have contracted a rare form of lymphatic cancer caused by Allergan’s BIOCELL textured breast implants. Plaintiffs are alleging that Allergan failed to warn doctors and patients of the increased risk of cancer and concealed known risks from regulators and the public.
Allergan uses a unique manufacturing process known as “close salt-loss texturing” in the production of its BIOCELL implants. Plaintiff’s attorneys claim the technique is flawed and creates defective implants with extreme texturing which can shred apart and leave silicone debris inside the body. When the body reacts to the silicone particles it causes chronic inflammation leading to a rare form of cancer known as Breast Implant Associated Anaplastic Large Cell Lymphoma or BIA-ALCL. In addition to cancer, many women have complained of fatigue, brain fog and other problems that are collectively known as “breast implant illness.”
Many women choose textured breast implants because they provide a firmer feel than a smooth round implant. Texturing helps the implant adhere to the breast tissue which prevents rotation of the implant within the implant pocket.
Worldwide Recall of Allergan BIOCELL Textured Breast Implants
On July 24, 2019, Allergan announced a worldwide recall of their popular BIOCELL textured breast implants after the U.S. FDA determined that the medical grade implants may be linked to an increased risk of cancer. According to the American Society of Plastic Surgeons (ASPS), every confirmed case of BIA-ALCL has involved textured implants with the overwhelming majority being produced by Allergan. According to the FDA, out of the reported cases of BIA-ALCL, 84% were attributable to implants manufactured by Allergan Inc. While many BIA-ALCL cancer victims are diagnosed early and successfully treated, some women have died from the cancer.
In the recall letter sent to patients, Allergan offered to replace the textured implants with non-textured ones at no cost to the patient. However, to accept Allergan’s offer a patient must sign a release of liability and agree not to pursue legal action against the company. A tactic some critics say is deceitful and underhanded and designed to avoid a costly legal claim against Allergan.
FDA Response: Too Little Too Late Critics Say
After being criticized for years for not taking a more aggressive stance, in October 2019 the U.S. Food and Drug Administration proposed breast implant manufacturers use a boxed warning to spell out risks more clearly to patients and plastic surgeons. The FDA guidance suggested disclosing that implants are not lifetime devices and the chances of complications increase over time. The proposed warning also lists that implants are linked to a rare form of lymphatic cancer and that some patients report fatigue, muscle aches and joint pain.
In a statement, FDA executives said “we have heard from many women that they are not fully informed of the risks when considering breast implants” The new recommendations are “designed to help inform conversations between patients and health care professionals when breast implants are being considered. The FDA also proposed that patients be provided a checklist to guide conversation with their doctors about the risks and benefits of implants before women decide to undergo surgery. Prior to announcing the new recommendations, the FDA received numerous complaints from patients who said they were not adequately informed about risks and potential complications from breast implant surgery.
You may have a claim for damages against Allergan Inc.
If you are suffering from BIA-ALCL cancer caused by Allergan textured breast implants, you may qualify to join a mass action lawsuit that has been filed against Allergan Inc. Case Works is not a law firm, but we work with some of the best attorneys in the nation and can help you get connected with one of them to evaluate your case. Click the button below to get in touch with us.