Allergan Natrelle BIOCELL implants cause rare cancer, but the company won’t replace them.
Allergan, the maker of breast implants, recently had a case filed against it by two female clients in Florida after their textured implants were recalled due to an increased risk of a rare form of cancer. The lawsuit has been filed in federal court in the Middle District of Florida and the women are asking for million in damages. The case is seeking class action status.
Kelli Russell, an Orange County woman, had a double mastectomy after a cancer diagnosis in 2016 and decided to have reconstructive breast surgery. After this ordeal, she opted for one of Allergan’s textured silicone breast implants. The second woman, Amy Ferrera of Hillsborough County, had breast augmentation in December 2009. Her doctor called her to inform her about the recall this year. Both women have health insurance, but their out-of-pocket costs for the procedure would range from $3,000 to $9,000, according to their filing.
Allergan is not offering to cover the costs of removing and replacing this particular type of implant. This leaves women with a “horrible choice: remove the Implant and pay surgical and associated costs out of their own pocket or live in fear knowing that their Implants have increased their risk of developing cancer,” according to the lawsuit.
The lawsuit alleges further that “Allergan breached its implied contract by selling a product that posed a risk to patients, has unjustly profited at the expense of the affected women, and has violated Florida’s Deceptive and Unfair Trade Practices Act.” This is only one case of many filed against Allergan in recent months, and a similar filing was made earlier this year, in August, which sought to cover the costs associated with replacing the breast implants. In yet another filed immediately after this one, two women alleged that they developed the rare cancer.
The federal Food and Drug Administration (FDA) recalled Allergan Natrelle BIOCELL textured breast implants in July because of the increased risk of anaplastic large cell lymphoma (also known as BIA-ALC), which is a form of non-Hodgkin’s lymphoma. Clients have opted to get textured implants because they adhered more readily to surrounding tissue and are, thus, more likely to stay in place without shifting over time, like some others. Although several companies manufacture this type of implant, Allergan’s BIOCELL textured implants were associated with close to six times the risk of developing the cancer than those produced by competitors, according to the recall.
Following the recall, Allergan released a statement indicating “women with textured breast implants who chose to replace their implants” should contact the company and it “would provide smooth implants of similar size for free,” according to the lawsuit. It also offered to “reimburse up to $1,000 in diagnostic fees and up to $7,500 in surgical fees associated with diagnosis and treatment of the BIA-ALCL cancer,” according to the filing. However, it will not pay for the removal and replacement or the cost of implants from a different company.
“The offer is hollow as Allergan refuses to pay the majority of the costs associated with the needed removal of the implants,” according to the lawsuit.
Of the 573 reported total cases of BIA-ALC around the world, the FDA found 481 patients had Allergan breast implants at the time of diagnosis. It is important to note that health officials are not recommending replacement of textured implants if patients have no symptoms such as sudden swelling or enlargement of the breast.