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2 Florida women file $5 million lawsuit over recalled Allergan breast implants

Orlando Sentinel logoOrlando Sentinel 10/28/2019 By Naseem S. Miller, Orlando Sentinel

Two women in Florida have filed a lawsuit against Allergan, the maker of textured breast implants that have been recalled because of their association with increased risk of a rare cancer.

The lawsuit, filed in federal court in the Middle District of Florida on Oct. 22, is demanding $5 million in damages. It is seeking class action status.

At the crux of the lawsuit is the surgical costs associated with removing and replacing the textured breast implants, which Allergan is not offering to cover.

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," the lawsuit says.

The lawsuit alleges 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.

The case is one of several lawsuits filed against Allergan in recent months. A similar lawsuit filed in August sought to cover the costs associated with replacing the breast implants. In another lawsuit, filed in September, two women alleged that they developed cancer because of Allergan’s textured implants.

Compared with implants that have a smooth outer surface, textured implants provide more friction with the surrounding tissue and thereby are more likely to stay in place. Several companies, including Allergan, make textured implants.

But the Food and Drug Administration recalled Allergan BIOCELL textured breast implants in July because of the increased risk of anaplastic large cell lymphoma, or BIA-ALCL, a type of non-Hodgkin’s lymphoma.

FDA officials said that the risk of developing the cancer with Allergan’s BIOCELL textured implants was nearly 6 times the risk of developing the cancer from textured implants manufactured by other companies.

Federal health officials are not recommending replacement of textured implants if patients have no symptoms such as sudden swelling or enlargement of the breast.

Following the recall, Allergan -- an international pharmaceutical company based in Ireland, which is the maker of Botox Cosmetic, Coolsculpting and other drugs and medical devices -- said that if women with textured breast implants chose to replace their implants, the company would provide smooth implants of similar size for free, according to the lawsuit.

The company 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, the lawsuit says.

But Allergan is not offering to pay for all the expenses associated with removing and replacing the recalled implants or for the cost of implants from a different company, according to the lawsuit.

“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.

Kelli Russell, the Orange County woman in the lawsuit, had a double mastectomy after a cancer diagnosis in 2016 and decided to have reconstructive breast surgery, choosing one of Allergan’s textured silicone breast implants, according to the lawsuit. She learned about the recall in a letter from Allergan in August.

The second woman, Amy Ferrera of Hillsborough County, had breast augmentation in December 2009 and found out about the recall after her doctor called her in September and told her that she needed to schedule an appointment to discuss her options, according to the lawsuit.

Both women have health insurance, but their out-of-pocket costs for the procedure would range from $3,000 to $9,000, excluding time off from work, the lawsuit says.

The odds of developing anaplastic large cell lymphoma are still low, but diagnosis is serious and can lead to death if the cancer isn’t diagnosed early.

The FDA recall was based on reports of 573 cases of anaplastic large cell lymphoma worldwide, including 33 deaths. Of all the cases, 481 had Allergan breast implants at the time of diagnosis, according to the FDA.

"The continued distribution of Allergan’s BIOCELL textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL,” the FDA wrote on Aug. 2.

Textured implants make up less than 10% of all breast implants sold in the U.S., and the FDA is still trying to determine if the risk of anaplastic large cell lymphoma is only associated with specific models of textured breast implants or all of them.

Since the recall, Allergan has started removing the breast implants from the market. The agency also advised doctors to stop using the breast implants and return their inventory to the company.

Attorneys for the women did not respond to requests for comment, nor did Allergan.

nmiller@orlandosentinel.com.

If you’re thinking about getting breast implants, check this list for important advice: www.fda.gov/medical-devices/breast-implants/things-consider-getting-breast-implants

If you have questions about the recall, email DICE@FDA.HHS.gov or call 800-638-2041.

To see a list of recalled breast implants, visit www.fda.gov/medical-devices/safety-communications/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan

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©2019 The Orlando Sentinel (Orlando, Fla.)

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