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Following an Allergan Biocell breast implant recall issued earlier this year, a number of class action lawsuits have been filed on behalf of women who received the textured device and now face a risk of developing a rare type of cancer in the surrounding tissue, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
In a complaint (PDF) filed earlier this month in the U.S. District Court for the Eastern District of New York, a woman identified only as Jane Doe seeks class action status to pursue damages for women implanted with Biocell saline-filled or silicone-filled breast implants or tissue expanders that have been recalled.
The lead plaintiff indicates that after paying $10,000 for Biocell implants, she paid another $6,000 to have the device explanted after the recall, and replaced with another implant that features a smooth surface, which has not been recalled.
“Plaintiff Jane Doe wold not have had the recalled Biocell product implanted had she known prior to the procedure that implantation with Biocell would subject her to the risk of contracting BIA-ALCL, as well as the costs associated with removal, surgical and diagnostic fees, medical monitoring, and invasive diagnostic procedures to detect BIA-ALCL, as well as the cost of the explant and implant replacement procedures,” according to the complaint.
At the time Allergan Biocell implants were recalled, the FDA indicated that nearly all cases of BIA-ALCL have been linked to this one design.
As of July 2019, there were at least 573 known cases of breast implant ALCL diagnosed worldwide, including at least 33 deaths. Of those, 481 have been linked to breast implants sold by Allergan, which have also been linked to at least 12 of the 13 deaths where the manufacturer of the breast implant was known.
“Allergan received a substantial benefit from selling thousands of the recalled BIOCELL products from 2006 through July 24, 2019 at the expense of Plaintiff and the Class who are exposed to the risk of developing BIA-ALCL, a serious and deadly disease,” the lawsuit states. “Plaintiff thus brings this action individually and on behalf of others in the United States who have recalled BIOCELL textured breast implants and tissue expanders to seek relief for damages caused by Defendants’ conduct at their expense. Plaintiff 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 procedures required as a result of their exposure to the risk of contracting BIA-ALCL.”
For women who have the recalled Allergan breast implants, the FDA is not currently recommending removal of the device if they are not showing symptoms of BIA-ALCL, which may include persistent swelling or pain near the implant. Instead of removing the implants, the FDA is recommending that women remain aware of the BIA-ALCL risk, and talk to their health care provider if they have concerns.
In addition to class action claims pursuing damages for the costs associated with removal or medical monitoring, a number of Allergan breast implant ALCL lawsuits have been brought by women diagnosed with the cancer, which typically results in the need for breast implant removal and removal of the surrounding scar capsule.