Trans vaginal mesh. Part 1: Deadly devices (Carl Heneghan and Tom Jefferson, 21 April 2023)

Summary

In this blog, Carl Heneghan, Professor of Evidence-based Medicine at the University of Oxford and Clinical Epidemiologist Tom Jefferson look at the long-term consequences of inadequate regulation and approval of pelvic mesh devices. They argue that regulators and health systems around the world failed to heed the early warnings, which lead to thousands of women being irreversibly harmed.

They highlight that as early as 1999, a study of 34 women who had ProteGen mesh implants showed that 50% of mesh devices had eroded through the vaginal wall. Boston Scientific voluntarily recalled 20,000 devices as a result. In spite of this, the FDA continued to approve vaginal mesh devices, citing ProteGen as their predicate device.