FDA warns recalled breast implant manufacturer for failing to comply with regulations

The U.S. Food and Drug Administration sent a warning letter to Allergan, now AbbVie, reprimanding the medical device manufacturer for serious deficiencies in Allergan’s post-approval studies of its recalled breast implants, which have been linked to an increased risk of cancer.

Allergan’s Biocell^® textured breast implants and tissue expanders were recalled in July 2019 due to an increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare form of non-Hodgkin’s lymphoma. The FDA now says the company’s failure to follow FDA regulations prevented adequate evaluation of the “safety, effectiveness, and reliability” of the implants leading to these alleged harms and multiple breast implant related lawsuits.

(Allergan’s) failure to follow federal regulations is “unacceptable,” the FDA stated in a press release, adding that it “will continue to hold manufacturers accountable if they fail to fulfill their obligations.”

 “The FDA has taken steps to protect the public from potentially dangerous breast implants, but it can’t successfully do that without the full cooperation of the manufacturers involved,” said medical device attorney Esther Berezofsky. “This company manufactured medical devices that allegedly cause serious injuries to users, and owes it to its consumers to fully examine the defects, so that they, and the FDA can make informed decisions on how best to mitigate the harm done.”

Motley Rice LLC, a South Carolina Limited Liability Company, is engaged in the New Jersey practice of law through Motley Rice New Jersey LLC. Esther Berezofsky is the attorney responsible for New Jersey practice.