Breast Implant Surface Texturing Process Causes Lymphoma, Lawsuit Alleges

According to allegations raised in a product liability lawsuit filed recently against Allergan, the texturing process used to manufacture its now-recalled Biocell breast implants increased the risk of women developing a rare type of cancer, now commonly known as breast implant anaplastic large cell lymphoma (BIA-ALCL).

Michelle Forney and her husband, John, filed a complaint (PDF) in the U.S. District Court for the District of New Jersey on April 23, claiming that Allergan failed to warn consumers about the known risks and problems linked to the Biocell line of breast implants.

The lawsuit also accuses the manufacturer of recklessly and continually failing to meet the FDA’s Premarket Approval Application requirements with the implants, blaming the surface texturing process for creating the unique cancer risk associated with the breast implants.

Forney, of California, received McGhan Biocell saline-filled breast implants in 1999. McGhan was later acquired by Allergan, Inc.

“In 2015, Mrs. Forney started to develop strange symptoms including horrible itching and pain in her right breast,” the lawsuit states. “She went to 6 medical providers to try to determine the problem and received multiple mis-diagnoses, including capsular contracture, mastitis, herpes, shingles, and various infections.”

Her condition was not properly diagnosed until 2018, when she got her right breast implant removed. Surgeons found “dozens of tumors” on the capsule around the implant, and pathology results tested positive for BIA-ALCL.

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.”

This lawsuit, and other recently filed complaints, have pointed to the use of salt crystals and scrub brushing of the implants, in a process meant to abrade the implant shells after curing with salt and remove any remaining salt, as a potential cause for increased breast implant cancer risks. Forney’s lawsuit suggests that the manual scrubbing results in variable results which can leave behind randomly-arranged cubic indentations, ruptured silicone domes and torn silicone fragments.

Forney’s complaint joins dozens of other breast implant ALCL lawsuits, as well as a growing number of claims presented by women who did not develop the cancer, but indicate that they either had the implants removed or plan to do so, 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.