Devices

Petition Seeks Reclassification of BD Mesh/Scaffolds

Cardiac surgeon Hooman Noorchashm, known to FDA for his opposition to power morcellation, has petitioned the agency asking it to change the classification of Becton Dickinson’s (BD) poly 4-hydroxybutyrate (P4HB)-based Phasix and GalaFlex products from medical devices to biologicals so that they undergo proper clinical safety and efficacy testing.

The petition argues that FDA misclassified the products as devices, which has led to their “potentially unsafe introduction into the oncology space without adequate preclinical and clinical testing to ensure safety.”

Noorchashm characterizes P4HB as a transgenic hydrocarbon, which is exclusively produced in bacteria using a fermentation process. BD has commercialized the scale of P4HB production through recently acquired Tepha Medical Devices, he said. The following characteristics of P4HB, according to Noorchashm, require it to be classified as a biologic and not a medical device:

transgenic production of P4HB in bacteria,
active metabolism of P4HB by mammalian cells
immunological bioactivity of P4HB in polarizing a potentially oncogenic M2 macrophage inflammatory response in vivo

The petition further says the misclassification of P4HB-based bioactive mesh and scaffold material as medical devices is posing a potential threat to public health in the oncology space, specifically their use in breast cancer reconstruction. It says it is unclear whether P4HB-induced inflammation of the mastectomy reconstruction space in women would (1) interfere with radiological surveillance for recurrent cancer, and (2) potentiate cancer recurrence rates. “These metrics are critically important to public health and safety in the breast cancer space anytime a biologically active substance is placed in direct contact with an oncological resection space,” Noorchashm says.

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