The FDA Expresses Concern over Surgical Mesh

Recently, the FDA ordered manufacturers of surgical mesh to conduct new studies, especially when used to treat pelvic organ prolapse and stress urinary incontinence.  This is the first step toward tighter regulation.  Surgical mesh was originally developed in the 1950s to repair hernias; however, doctors later adapted it for other uses.  The FDA has received hundreds of reports of serious complications involving the product.  Some of the manufacturers are now facing lawsuits.  Complications reported include pain, infection and bleeding.  The manufacturers of surgical mesh include: C.R. Bard Inc, Boston Scientific Corp and Johnson & Johnson.

In July, the FDA suggested other procedures than the vaginal mesh for pelvic organ prolapse as it “poses risks.”  This product was never tried on humans before going to market.  One of the problems is that the FDA device-clearance process does not require preclinical tests in patients.  The FDA has proposed requiring tests in patients before a device is approved but has yet to make a final decision.  The consumer group Public Citizen has called for existing pelvic-organ-prolapse mesh products to be recalled.