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After developing symptoms of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a Louisiana woman filed a lawsuit against Allergan, claiming the manufacturer should pay for surgical removal of her Natrelle Biocell implants, which have now been removed from the market.
The complaint (PDF) was filed by Stephanie Grayson Ohler in the U.S. District Court for the Eastern District of Louisiana on September 10, indicating she now shows classic signs of the rare form of lymphoma linked to the textured design of the recalled breast implants.
Ohler received Allergan’s Style 168 Natrelle Biocell rough textured saline-filled breast implants in January 2014. Although the manufacturer issued a worldwide breast implant recall last year for all products featuring the design, the lawsuit notes she did not learn about the problems until last month.
Allergan recalled the Biocell implants after the FDA determined that the design was linked to nearly all cases of BIA-ALCL, which is a form of non-Hodgkins lymphoma. Since then, doctors have determined that removing the implants is the best means of treating BIA-ALCL in most cases, but the manufacturer continues to refuse to pay for women to have the recalled breast implants removed.
Ohler indicates that she first learned about the link between her breast implants and cancer in August 2020, after her mother saw a television show about the problem, which noted that testing for BIA-ALCL was invasive and that breast pain was a clear sign of breast implant lymphoma.
Although Ohler never received a copy of the letter Allergan was supposed to send out to all recipients of its Biocell implants, informing them of the cancer risks and the recall, she has now scheduled with her surgeon to have the implants removed.
According to allegations raised in the lawsuit, Allergan knew about the problem for years, but failed to adequately warn recipients of the implants, like herself, or healthcare professionals and federal regulators.
“Until 2017, Allergan buried evidence of ruptures and other injuries with its implants by reporting these as routine events that did not require any public disclosure,” the lawsuit states. “Additionally, Allergan did not report to the FDA adverse events from its required post-market approval studies. These post-market approval studies indicate that the recalled BIOCELL textured implants have caused or contributed to death and/or serious injury by increasing the risk of BIA-ALCL.”
According to a recent FDA update about the risk of breast implant malignant lymphoma issued last, at least 733 ALCL have been identified worldwide among women who received breast implants, with at least 620 of the cases linked specifically to Allergan implants.
Given similar allegations raised in breast implant lymphoma lawsuits filed throughout the federal court system, cases brought in U.S. District Courts nationwide are all centralized before one judge in the District of New Jersey, for coordinated discovery and pretrial proceedings as part of a federal multidistrict litigation (MDL). However, if settlements or another resolution for the litigation is not reached, each individual claim may later be remanded back to separate federal courts nationwide for separate trial dates.