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According to allegations raised in a wrongful death lawsuit filed by a Florida man, his wife died due to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL); a rare form of cancer caused by Allergan textured breast implants.
William Creeden filed the complaint (PDF) in the U.S. District Court for the District of New Jersey on March 25, on behalf of himself and his late wife, Rita Ann Creeden.
The lawsuit indicates Creeden’s wife had Allergan Biocell breast implants when she developed a rash on her right breast in 2016. She was diagnosed with BIA-ALCL and required surgery to remove the breast implants and capsules. However, her breast implant lymphoma was not cured, and she underwent additional cancer treatments that caused nerve damage and had to be stopped.
By January 2019, Creeden developed a large chest wall mass that eroded through her skin, according to the lawsuit. She had that mass excised in March 2019, but two months later, after nine radiation treatments, a scan showed multiple tumors throughout her chest. Due to the intense pain of the radiation treatments she was unable to continue.
Creeden was put into hospice care and died on August 21, 2019, which the lawsuit indicates was a direct result of a defective and unreasonably dangerous design for the textured breast implants received years earlier.
Allergan was forced to issue a worldwide breast implant recall last year, removing all products from the market that featured the macrotextured design, after federal regulators in the United States determine nearly all reported cases of BIA-ALCL were linked to the design.
The breast implant cancer involves a type of non-Hodgkins lymphoma that may develop in the tissue surrounding the implant. As a result of the risk, dozens of women nationwide have filed claims against the manufacturer, alleging that they may have avoided a cancer diagnosis if the manufacturer had not intentionally covered up the problems and misled patients and the medical community.
According to the lawsuit, the manufacturing process led to variable roughness in the texture of the implants, due to a process known as “salt loss.”
“Plaintiff avers that the use of salt crystals, in tandem with the uncontrolled Allergan Biocell manufacturing process with variable scrub brushing by individual workers, created variant products and the potential for non-conforming adulterated implants such as those implanted in Rita Creeden—implants with an excessive amount of foreign, adulterated, sharp solid silicone particles/fragments/contaminants,” the lawsuit states. “The variable final scrubbing whereby the implant shells are manually ‘abraded after curing to remove the salt’ ‘produces a surface that is very complex with randomly-arranged, cubic indentations covered with ruptured silicone domes and torn silicone fragments.’”
In addition to this breast implant wrongful death lawsuit and dozens of other claims involving cancer linked to Allergan textured implants, a growing number of lawsuits are also being pursued by women who did not develop BIA-ALCL, but indicate that they either already had the implants removed or plan to, in order to protect their safety.
In the federal court system, at least 50 complaints over the breast implant cancer problems have been consolidated as part of a multidistrict litigation (MDL) in the District of New Jersey, where U.S. District Judge Brian R. Martinotti is presiding over all pretrial proceedings to reduce duplicative discovery into common issues in the claims, avoid conflicting schedules and orders, and serve the convenience of common witnesses, parties and the judicial system.
As more women undergo procedures to have breast implants removed due to the cancer problems, or receive a diagnosis of BIA-ALCL, the size and scope of the litigation is expected to continue to expand over the coming months.