(New York Times) – The agency OK’d an artificial vessel to restore blood flow in patients, even though its own scientists flagged questionable study results and potentially fatal ruptures of the product.

When the biotech company Humacyte designed a study to see if its lab-grown blood vessel worked, it decided to measure whether blood was flowing freely through the high-tech tube 30 days after it was implanted in a person.

As those days passed, some of the 54 patients in the study ran into trouble. Doctors lost track of one. Four died. Four more had a limb amputated, including one who developed a clot and infection in the artificial vessel, Food and Drug Administration records show. (Read More)