A wrongful death lawsuit has been filed on behalf of a Missouri woman, Lizabeth Parr, who died in August 2019 from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) allegedly caused by Allergan’s recalled Natrelle Biocell breast implants. Allergan’s textured breast implants were recalled last year after federal regulators found that nearly every reported case of BIA-ALCL in consumers was linked to implants that featured Allergan’s textured Biocell design, which was a successor to the previous McGhan Style breast implants. If you or someone you love has been diagnosed with lymphoma and you believe the cancer to be linked to textured breast implants manufactured by Allergan or another company, contact an experienced product liability lawyer today to find out if you are eligible for compensation through a BIA-ALCL lawsuit.
The first possible link between breast implants and ALCL was reported in 2011, when the FDA issued a “white paper” describing the risk of ALCL in women with breast implants. At that time, federal regulators had identified at most 60 cases of the rare lymphoma in women with breast implants from 1997 to 2010. In the years that followed, additional research was conducted to analyze the potential connection between breast implants and ALCL, and it was discovered that the risk of cancer was higher with implants that featured a textured design, which was meant to help the implants hold their position better and reduce the risk of scarring. Allergan’s Natrelle Biocell breast implants, which have been directly linked to injuries and deaths from BIA-ALCL, feature a textured surface that is unique to those implants and used only by Allergan.
In a study published in the journal Plastic and Reconstructive Surgery in October 2017, researchers concluded that textured breast implants may be associated with a 10- to 14-times increased risk of anaplastic large cell lymphoma compared to smooth breast implants. In January 2018, a Dutch study estimated the risk of BIA-ALCL in women with breast implants to be: one in 35,000 for women at age 50, one in 12,000 for women at age 70 and one in 7,000 for women at age 75. By the time Allergan announced a global recall of its Biocell textured breast implants in July 2019, just one month before Lizabeth Parr’s death in August 2019, the FDA had received reports of at least 573 cases of BIA-ALCL worldwide, including 33 deaths. Of those cases, 481 were linked to Biocell breast implants, and of the 13 deaths where the manufacturer of the breast implant was known, Allergan’s implants were implicated in 12.
In a news release issued in July 2019, when the FDA requested that Allergan recall its textured breast implants due to the risk of BIA-ALCL, FDA Principal Deputy Commissioner, Amy Abernethy, stated, “Although the overall incidence of ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health.”
In its Biocell textured breast implant recall announcement, the FDA indicated that “Based on the currently available information, the FDA’s analysis demonstrated that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. and continued distribution of Allergan’s BIOCELL textured breast implants would likely cause serious, adverse health consequences, including death, from BIA-ALCL.”
Allergan faces dozens of product liability lawsuits and wrongful death claims filed on behalf of women who received Biocell textured breast implants and subsequently developed BIA-ALCL. This latest wrongful death lawsuit was filed last month by Calvin Parr in the U.S. District Court for the Eastern District of Missouri, on behalf of himself and his late wife, Lizabeth Parr. According to the lawsuit, Parr was originally implanted with McGhan Style 168 textured saline breast implants in 2002. In 2010, she had them replaced with Allergan Natrelle 120 silicone gel Biocell textured implants, which were included in the list of Allergan products recalled by the FDA.
“Because Ms. Parr had two sets of Biocell implants – in 2002 and in 2010 – she was twice exposed to the dangerous and defective Biocell textured implant surface in the peri-implant capsule space and particles/toxins from the implants that directly caused her fatal case of BIA-ALCL,” the wrongful death lawsuit states. The lawsuit also notes that “in the explantation surgery in 2010, no capsulectomy was performed.” A capsulectomy is a procedure in which the scar tissue (capsule) that naturally forms around the prosthetic implant after implantation is removed. Most cases of BIA-ALCL can be successfully treated by removing the breast implants and the surrounding scar tissue. Unfortunately, in Lizabeth Parr’s case, the cancer had metastasized, or spread to other sites in her body, which contributed to her death.
Despite the potential risk of BIA-ALCL in women with textured breast implants, the FDA is not recommending that women have the implants removed if they are not experiencing any symptoms of the cancer, which may include pain or swelling near the implant site. Women with breast implants who are diagnosed with BIA-ALCL are advised to undergo surgery to have the implants and surrounding scar tissue capsule removed. In the meantime, attorneys across the country are currently investigating claims involving women with textured breast implants who have been diagnosed with the rare form of implant-associated lymphoma. And as more and more women learn that their breast implants may have caused their cancer diagnosis, the number of lawsuits filed against Allergan and other breast implant manufacturers is expected to grow.