Many manufacturers of devices used to treat stress urinary incontinence and pelvic organ prolapse are facing transvaginal mesh lawsuits from women who were seriously injured after being treated with these products.
TVM Manufacturer American Medical Systems Warned by FDA
American Medical Systems, which manufactures transvaginal mesh devices, received a warning letter from the U.S. Food and Drug Administration (FDA) regarding issues the organization found at a facility run by the company. These included risk analysis and process validation procedures.