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Allergan faces a growing number of class action lawsuits over its Biocell line of breast implants, which were recalled last summer due to an unacceptable risk that women may develop 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 late last month in the U.S. District Court for the Central District of Illinois, plaintiff Lana Tauben presents a claim for damages on behalf of herself and other women who Allergan’s Biocell textured breast implants, even if they have not developed cancer.
According to the lawsuit, women with Allergan Biocell implants face a risk of developing BIA-ALCL in the future, indicating that the manufacturer should be forced to pay for future medical monitoring, as well as procedures to remove and replace the defective implants.
Tauben indicates that she has received the recalled Allergan implants twice. The first time was in November 2016, but after the surgery she began suffering pain and swelling. That set of Allergan Biocell implants were removed in July 2017, and replaced with another set.
“These implants were later recalled by the FDA on July 24, 2019,” the lawsuit states. “Plaintiff would not have had the recalled Biocell product implanted had she known prior to her surgery that the Biolcell textured implants increased her risk of contracting BIA-ALCL, in addition to the costs associated with surgical removal of the implants.”
The FDA has reported that there are at least 573 known cases of BIA-ALCL diagnosed worldwide, including at least 33 deaths. Of those, 481 have been linked to Allergan breast implants, which have also been linked to at least 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.
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.
Tauben’s complaint presents allegations similar to those presented in a number of Allergan breast implant ALCL lawsuits, which 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. Plaintiffs allege that the manufacturer knew or should have known about the Allergan Biocell ALCL risk, yet continued to sell the dangerous implant without warning women or the medical community.