Surgical Mesh And Sling Devices Must Undergo Post-Market Studies

09 Jan 2012

FDA sends post-market study orders to 33 manufacturers of urogynecologic surgical mesh used for pelvic organ prolapse and to seven makers of single-incision mini-slings used for stress urinary incontinence.

FDA is ordering manufacturers of transvaginal surgical mesh and mini-slings to conduct post-market studies to assess safety complications with the devices used to repair women’s pelvic problems.

On Jan. 3, FDA sent 88 post-market study orders to 33 manufacturers of urogynecologic surgical mesh used for