FDA Proposes PMAs For Pelvic Organ Prolapse Mesh Devices
This article was originally published in The Gray Sheet
FDA is proposing class III, PMA status for surgical mesh used to treat pelvic organ prolapse based on evidence of health risks including mesh exposures and extrusions, pelvic pain, infections and repeat surgery for complications.
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FDA issued final orders up-classifying surgical mesh for transvaginal repair of pelvic organ prolapse from class II to class III and calling for PMA standards, including clinical trial, animal studies, and materials testing data from new and existing manufacturers.
Current reprocessing methods for duodenoscopes provide no reasonable assurance of safety and effectiveness, and manual cleaning steps need improvement, an FDA panel said. Most panelists called for upgrading manual cleaning, followed by lengthy sterilization of the products until they can be redesigned.
The company announced April 28 that it has settled 2,970 transvaginal surgical mesh device patient lawsuits, but upwards of 25,000 cases or claims against Boston Scientific are still active.