Trans Vaginal Mesh, Part 1: Deadly Devices

The long-term consequences of lax approval and the failure to heed the early warnings would lead to hundreds of thousands of women being irreversibly harmed.

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Apr 21, 2023

∙ Paid

In 1996, the US FDA approved the ProtoGen sling, agreeing that the product was "substantially equivalent" to the Mersilene Mesh used to treat hernias. Boston Scientific relied on a 90-day study in rats and its use in cardiovascular implants for approval. At the time, clinical data for its use in the vaginal area wasn’t required for approval.

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Trans Vaginal Mesh, Part 1: Deadly Devices

The long-term consequences of lax approval and the failure to heed the early warnings would lead to hundreds of thousands of women being irreversibly harmed.

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