On August 16, 2019 a nationwide class action lawsuit was filed in the U.S. District Court for the District of New Jersey against the medical device manufacturer Allergan to protect women with Allergan’s textured breast implants from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which has now been associated with Allergan’s BIOCELL textured breast implants. The case is Jane Doe I, et al. v. Allergan, Inc., et al., No. 2:19-cv-16784 (D.N.J.).
In July, The United States Food and Drug Administration (FDA) requested that Allergan issue a recall of its BIOCELL textured breast implants and tissue expanders, and Allergan agreed and is removing these products from the global market.
The FDA requested that Allergan recall all of its BIOCELL textured breast implants and tissue expanders based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these implants. The FDA’s “analysis was attributed to a new worldwide reported total of 573 unique BIA-ALCL cases including 33 patient deaths. Of the 573 cases of BIA-ALCL, 481 are reported to have Allergan breast implants at the time of diagnosis. In addition, 12 of 13 deaths occurring in patients with BIA-ALCL where the manufacturer was known occurred in patients implanted with an Allergan breast implant at the time of their BIA-ALCL diagnosis. The manufacturer and/or texture is unknown for the remaining 20 reported deaths from BIA-ALCL.”
In addition, the FDA “analysis demonstrates 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 and potentially death from BIA-ALCL.”
The women involved in the lawsuit are seeking monetary damages for themselves and other women with the implants because they “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.”
A full copy of the complaint is available here. Jane Doe v. Allergan
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