Feds want more input on materials with ‘high-profile safety concerns’

The FDA today asked the public to submit comments on how devices that contain certain materials should be labeled.

The materials are ones to which patients have long-term exposure — contact time exceeding 30 days — and that have presented “high-profile safety concerns,” according to the agency. They include female sterilization devices, metal-on-metal hips and breast implants.

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Allergan must face breast implant class action

A federal judge in New Jersey on Friday shut down part of Allergan’s request to dismiss a multi-district lawsuit over its Biocell textured breast implants, but kept most other parts of the litigation.

Judge Brian Martinotti ruled that some of the plaintiffs’ claims against Allergan (now part of AbbVie) were preempted by federal law while most others could stand — including one alleging that Allergan failed to report adverse events related to Biocell implants to the FDA.

Textured breast implants have been linked to BIA-ALCL, a type of non-Hodgkin’s lymphoma. The FDA asked Allergan to recall its Biocell textured implants in July 2019, saying that “the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers.”

The recall covered 246,831 Biocell implants in the U.S., according to the judge’s order. Allergan refuses to pay the implants’ users for …

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