A Louisiana woman who survived breast cancer only to be diagnosed with a rare form of lymphoma linked to breast implants following a mastectomy is suing the implant manufacturer for failing to disclose problems to federal regulators.

In 2019, Christine D. was diagnosed with breast implant-associated anaplastic large cell lymphoma. or BIA-ALCL. In her Aug. 3 lawsuit, filed in U.S. District Court for the Western District of Louisiana, she says the implant manufacturer did not comply with U.S. Food and Drug Administration (FDA) requirements by failing to report “adverse events” that occurred with its implants, reporting Christine claims may have prevented her from ever getting the implants and developing cancer.

Allegations

According to Christine’s lawsuit, breast implant-maker McGhan, which was later purchased by another company before being sold to Allergan, the FDA in May 2000 granted pre-market approval for the implants Christine received.

As part of that approval, McGhan was required to conduct follow up studies of patients with the implants to further assess the long-term safety – to watch for possible links between the breast implants and cancer, among other things – and report the findings to the FDA.

Christine’s lawsuit says the company did not report “adverse events” from the post-market approval studies, which would have indicated the implants posed a risk of contributing to serious problems.

“(The company) knew of the manufacturing failures, and multiple risks associated with (the) implants design, and consciously responded by terminating the studies required … in favor of self-serving research that it could control,” the lawsuit claims. And “misrepresented the risks to the users, physicians, and regulatory agencies.”

Background

In 2000, Christine was diagnosed with bilateral breast cancer. She underwent a mastectomy and breast reconstruction, the civil complaint says. She and her doctor chose McGhan’s saline implants for the reconstruction.

She says she began having pain in her left breast in late 2011 and after consulting with her doctor and a surgeon, had the implants removed in 2012.

Seven years later, Christine went to the doctor after noticing one of her breasts was enlarged. In October 2019, testing revealed she had breast implant-associated anaplastic large cell lymphoma.

Breast Implant-Associated Anaplastic Large Cell Lymphoma

Breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, is a cancer of the immune system, not breast cancer. It is very rare. Although an estimated 10 to 11 million women worldwide have gotten breast implants, fewer than 10 patients a year are diagnosed with the disease, according to the FDA.

Most cases of BIA-ALCL occur in those with textured implants, which are thought to cause more inflammation of the surrounding tissue than smooth implants, Cleveland Clinic says. Whether they are filled with saline or silicone does not seem to make a difference, studies have shown.

Allergies, reactions to implant materials, reactions to bacteria that grow on the surface of the implant, and genetics are contributing factors to breast implant-associated anaplastic large cell lymphoma, the hospital says.

The standard treatment is surgical removal of the breast implants and surrounding scar tissue.

Breast Implants and Cancer

In her lawsuit against Allergan, Christine accuses the manufacturer of misleading regulators and the public about the possible links between breast implants and cancer by omitting important information from its reports to the FDA.

Had she been aware of the risks, the plaintiff says she would not have chosen to get the implants and thus would have avoided getting BIA-ALCL.

The Allergan Breast Implants and Cancer Lawsuit is Christine Downey, et al., v. Allergan Inc., et al., Case No. 5:20-cv-00985, in the U.S. District Court for the Western District of Louisiana, Shreveport Division.

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