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According to allegations raised in a recently filed class action lawsuit brought by women who received Allergan Biocell breast implants, which were recalled worldwide last month due to a risk of cancer linked to the textured design, the manufacturer should be forced to provide funding to allow women to have the breast implants removed and replaced, as well as medical monitoring to detect cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) that may develop in the future.
The complaint (PDF) was filed by two women identified only as “Jane Doe 1” and “Jane Doe 2” on August 16, in the U.S. District Court for the District of New Jersey. The lawsuit names Allergan Inc, as well as its former incarnations, Inamed Corporation and McGhan Medical Corporation, as defendants.
The women are from Arizona and Illinois, and each indicates that they were implanted with Allergan Biocell breast implants, which features a micro-textured design that has been linked to reports of a rare lymphoma that may develop in the tissue surrounding the implants.
Although neither of the plaintiffs indicate that they have developed BIA-ALCL from the Allergan Biocell implants, they indicate that they now live in perpetual fear of developing the cancer, and claim that Allergan should have to pay for all women who received the implants to have them removed and replaced and should pay for medical monitoring for the women for life.
To date, Allergan has only offered to pay for the replacement breast implants themselves, not the surgery to remove and replace its current implants, nor medical monitoring for cancer.
The Allergan Biocell class action lawsuit comes several weeks after the FDA announced that the manufacturer had agreed to issue a worldwide breast implant recall for all of products featuring the microtextured design.
“Allergan received a substantial benefit from selling thousands of the recalled Biocell products from 2006 through July 14, 2019 at the expense of Plaintiffs and the Class who are exposed to the risk of developing BIA-ALCL, a serious and deadly disease,” the lawsuit states. “Plaintiffs and the Class will be forced to expend substantial sums for the removal of the recalled implants, surgical and diagnostic fees, and/or medical monitoring and invasive diagnostic procedure required as a result of their exposure to the risk of contracting BIA-ALCL.”
The plaintiffs present claims of failure to warn, negligence, unjust enrichment, medical monitoring, and violation of the Illinois Consumer Fraud Act, and the case joins a growing number of both individual and class action breast implant cancer lawsuits filed against Allergan by women throughout the United States.
Biocell Breast Implant Concerns
The FDA indicates that there are at least 573 known cases of BIA-ALCL worldwide, including 33 deaths. Of those, 481 have been linked to Allergan breast implants. Allergan implants were also linked to 12 of the 13 deaths where the manufacturer of the breast implant was known.
In June 2017, a study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants.
Another study, published in October 2017, warned that many breast implant cancer cases worldwide have likely not been reported, and noted that doctors and patients may not be aware of BIA-ALCL.
The FDA is not recommending women have the breast implants removed if they are showing no symptoms. Instead, the regulators recommend recipients of these implants become familiar with the symptoms of BIA-ALCL, including persistent swelling or pain near the implant, and talk to their health care provider for further information. Those with BIA-ALCL should undergo breast implant removal and removal of the surrounding scar capsule.
The agency also recommends those who receive breast implants keep a record of the device manufacturer, unique device identifier and implant model name, which may have been provided on a patient device card from the surgeon.
Those with questions regarding the safety communication can email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or by calling 800-638-2041 or 301-796-7100.
Cases of BIA-ALCL or other complications should be reported to the FDA MedWatch Adverse Event Reporting Program.