Health
US Approved Device for Battlefield Injuries Despite Serious Risks, Former FDA Reviewer Says
The FDA says the device, designed to repair broken blood vessels to stem bleeding, showed a “clinically meaningful benefit.”
The US government approved a medical device that was highly sought after by military officials to stem battlefield bleeding and save limbs, despite internal warnings among regulators that the product poses serious risks that could lead to death, a former US Food and Drug Administration reviewer said.
Robert Lee, who spent 10 years at the FDA, said agency reviewers were pressured to approve Humacyte Inc.’s Symvess even after he says he repeatedly raised concerns with senior FDA leadership and asked them to hold a public advisory panel meeting of outside experts to discuss the risks and benefits of the product.