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FDA Public Health Notification
FDA first warns of complication associated with transvaginal mesh -
FDA Public Health Notification
Second FDA warning of complications associated with transvaginal mesh. -
AUGS/ACOG Committee Opinion
AUGS/ACOG publish a document recommending that vaginal mesh repair should be reserved for high-risk patients only where benefits clearly outweigh the risks of the procedure. -
Device Class Change
FDA reclassifies transvaginal mesh from a Class II medical device to Class III medical device. Industry is now required to perform clinical trials before placing a product on the market. This applies to new products only. -
FDA Pulls Mesh off the Market
The FDA mandates that sales and manufacturing of transvaginal mesh stops. Due to failure to prove safety and effectiveness.