Allergan, a global medical device manufacturer, launched a worldwide recall of its textured breast implants in 2019 due to the risk that patients could develop a related form of cancer. The move opened the way for lawsuits on behalf of patients experiencing adverse reactions.
The recall came at the request of the Food & Drug Administration (FDA). The announcement drew attention from patients experiencing a wide variety of otherwise unexplained symptoms they say occurred months and, in some cases, years after the surgical implantation of the Allergan products.
In addition, studies link the Allergan breast implant products to the increased risk of a rare cancer of the immune system.
If you have concerns about your breast implants, the Greensboro product liability firm of Ward Black Law has the legal knowledge and resources to review your situation and pursue the settlement you deserve. We can analyze your medical condition and work to demonstrate how you were injured by these defective implant products. Take comfort knowing your initial consultation by phone, text, or video with us is free and absolutely confidential. Our firm has more than 20 years of experience representing North Carolina women with defective breast implants and has successfully settled claims for more than 1200 women with defective breast implants.
The FDA’s concern has centered primarily on a condition known as breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL for short. A rare cancer of the immune system, it is not a form of breast cancer.
BIA-ALCL is a type of non-Hodgkin’s lymphoma (NHL), which is a cancer of the blood. It is typically treatable if found early enough. It comprises just 1% of NHL cases and just 16% of all T-cell lymphomas, according to the Lymphoma Research Foundation.
In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body and become fatal.
BIA-ALCL is poorly understood and often misdiagnosed. “BIA is a cluster of symptoms that don’t fit into any other classic disease diagnosis,” said Diana Zuckerman, Ph.D., president of the National Center for Health Research and a researcher who studies breast implant safety issues. “Getting it recognized as a bona fide medical condition will take time,” she said.
The United States was slow to address women’s claims that they have been harmed by Allergan’s implants. The action by FDA and Allergan comes after 38 other countries already recalled the implant.
The recall was prompted by the FDA detecting a spike in BIA-ALCL cases. The agency has been monitoring Allergan’s breast implant products since 2011.
The occurrence of BIA-ALCL worldwide is relatively low. However, according to the FDA, the cancer can be fatal if not diagnosed and treated early, such as with surgery to remove the implant and the surrounding scar tissue or with radiation and chemotherapy.
The FDA has updated its tabulation of BIA-ALCL claims. The agency updated the table on its BIA-ALCL webpage to include a total of 733 unique cases and 36 patient deaths globally. This reflects an increase of 160 new cases and 3 deaths since the July 2019 update.
Of 733 total cases of BIA-ALCL reported to the FDA, 620 cases involved Allergan products. The data showed that 496 cases were reported to have textured implants; 209 cases did not specify the implant surface.
Nearly three dozen specific products are on the recall list. They are branded by the company as BIOCELL® textured breast implants and tissue expanders. FDA data show that BIA-ALCL arises more frequently in women whose implants have a textured surface than those with a smooth surface.
The cause is being studied, especially since the cancer appears to be linked with a certain bacterial infection.
Some of the implants were filled with gel, and others with saline.
Women report experiencing a wide variety of symptoms leading to a diagnosis of BIA-ALCL, including:
Some patients may require radiation therapy and/or chemotherapy, depending on the stage of the disease.
A class-action lawsuit has emerged on behalf of patients with adverse experiences with Allergan’s products. The action alleges that the company is misleading patients and asking them to sign away their rights in return for an offer of up to $7,500 to remove the implants.
Recent Allergan lawsuits on behalf of individual women are also winding their way through courts throughout the United States. Some allege the company failed to warn them of the risk the implants posed. Others reported that Allergan sought to make light of the dangers of its BIOCELL brand after learning it was linked to breast implant cancer.
Some women have had surgery to remove their implants, and others are planning to do so. The procedure can be expensive and can lead to pain and disfigurement, according to court filings.
Compensation for victims may cover:
Cases involving medical product liability in Greensboro, the Triad, or elsewhere in North Carolina can be daunting. They require significant research, complex factual evidence, and strategic legal arguments. With Ward Black Law, you can expect this and more.
In fact, with a knowledgeable, experienced attorney on your side, you have the best chance at securing maximum financial recovery. Ask our growing number of satisfied clients. Over the past 10 years, we’ve recovered damages of over $100 million for deserving people.
In addition, you’ll experience the satisfaction of striking a blow against a company whose actions have been harming women and their breasts for years.
Don’t suffer in silence. Contact our breast implant cancer lawyers at Ward Black Law now for a free consultation safely and confidentially at your convenience. We can’t wait to hear your story and explain how we may be able to help you. You can call or text us at 800-531-9191 or visit our contact page.