The FDA's regulatory history with transvaginal mesh is a powerful tool for mesh plaintiffs. The 2011 Safety Communication — in which the FDA explicitly stated that 'serious complications associated with surgical mesh for transvaginal repair of POP are not rare' — directly contradicted years of manufacturer marketing portraying mesh as a routine, low-risk procedure. This document is entered into evidence in virtually every mesh trial as proof of manufacturer failure to heed regulatory warnings.

The April 2019 market withdrawal order was unprecedented in scope. The FDA ordered Ethicon and Boston Scientific — the two remaining POP mesh manufacturers — to immediately cease sales and distribution, stating that neither company had demonstrated their products were safe and effective. This order effectively confirmed, at the highest regulatory level, that transvaginal POP mesh should never have been marketed as a standard treatment option.