A California woman who developed a rare form of lymphoma after receiving Allergan, Inc.’s Biocell textured breast implants has filed a new lawsuit alleging the company’s manufacturing process was responsible for her cancer.
According to a complaint filed in the U.S. District, District of New Jersey, on April 23rd, Michelle Forney received Biocell textured breast implants in 1999. In 2015, she began to experience a ‘horrible, aching pain” in her right breast and other unusual symptoms. Although she took her complaints to six medical providers, she was repeatedly misdiagnosed with capsular contracture, mastitis, herpes, shingles, and various infections.
In 2017, Forney underwent an ultrasound that revealed a build-up of fluid around her right breast implant. The fluid was aspirated in 2018, but quickly accumulated. On January 18, 2018, she underwent bilateral explant and capsulectomy, at which time dozens of tumors were found on the capsule. The subsequent pathology confirmed a diagnosis of breast implant anaplastic large cell lymphoma (BIA-ALCL)
BIA-ALCL is rare and slow-growing form of lymphoma that develops in the scar capsule surrounding breast implants. Symptoms typically include:
While removal of the breast implants and surrounding scar tissue typically cures BIA-ALCL in the early stages, more advanced cases may require radiation and other interventions. When breast implant lymphoma has proven fatal, it’s usually because diagnosis and treatment were significantly delayed.
The U.S. Food & Drug Administration (FDA) began investigating reports of breast implant lymphoma in 2011, noting at the time that the majority of cases involved devices with a textured surface. Last summer, the agency warned that Allergan Biocell textured breast implants had been implicated in 80% of BIA-ALCL reports, as well as 12 of the 13 fatalities in which a manufacturer was identified.
The FDA ultimately asked Allergan to recall all Biocell textured breast implants and tissue expanders from the worldwide market. While Allergan complied, the company has not announced any plans to compensate recipients for medical monitoring and other costs related to the increased risk of BIA-ALCL or its treatment.
Forney’s breast implant lawsuit claims Allergan’s manufacturing process led to variable roughness in the texture of Biocell devices, due to a process known as “salt loss.” As a result, the Biocell textured surface contained silicone particles, shredded silicone fragments, encapsulated sharp salt crystals or other compounds or chemicals that were toxic to the human body. She further asserts that the company and its predecessor were aware of this problem as early as the 1990s, but failed to issue required reports and warnings to the FDA.
“Had the FDA been notified of BIA-ALCL cases and reports as required by Defendants’ post PMA reporting requirements, the medical community would have been made aware of the existence of the true frequency, severity and significance of BIA-ALCL caused by Allergan’s Biocell textured Breast Implants, the complaint charges. “Medical professionals and providers, including those who advised and served Mrs. Forney, would not have advised patients, including Mrs. Forney, to proceed with implantation of the Biocell textured implants.”