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A North Carolina woman has filed a product liability lawsuit against Allergan, Inc., alleging that the textured design of her McGhan breast implants caused the development of a rare type of cancer, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
The complaint (PDF) was filed by Karon Howe in the U.S. District Court for the Western District of North Carolina on March 19, indicating that Allergan sold a defective and unreasonably dangerous breast implant design, which has been linked to a risk of cancer around the breast implant.
Howe first received her McGhan saline textured breast implants in 1996, when they were made by the McGhan Medical Corporation. However, Allergan acquired the company in 2006, and continued the line of textured breast implants under the Biocell brand name.
In June 2019, Howe was diagnosed with BIA-ALCL after she began experiencing pain in her right breast. In July 2019 she had both the implants surgically removed.
That same month, Allergan was forced to issue a worldwide breast implant recall, 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.
Howe has since had to undergo additional treatments, including radiation therapy, and must undergo regular medical monitoring for the rest of her life, the lawsuit indicates.
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.
“At the time the implants were placed into Ms. Howe’s body, she was not advised, nor did she have any independent knowledge, that the breast implants were anything other than safe, life-long products. Nor was she advised that the product was associated with and/or known to cause BIA-ALCL and that she would require future surgery and treatments,” the lawsuit states. “If Ms. Howe had been advised that implantation was associated with even the slightest risk of developing ALCL and/or BIA-ALCL she would not have proceeded with implantation.”
A growing number of lawsuits are also being 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. At least six women filed claims last week in New Jersey state court indicating that Allergan should be required to pay for medical procedures, and breast implant replacements.
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.