Manufacturers of transvaginal surgical mesh and mini-slings have been ordered by FDA to conduct Sec. 522 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 pelvic organ prolapse and 11 post-market study orders to seven makers of single-incision mini-slings used for stress urinary incontinence. The Sec. 522 study orders come in response to numerous adverse events. In addition, published literature has shown little clinical benefit from mesh compared to non-mesh repair, and data also suggest little benefit from single-incision mini-slings compared to multi-incision retropubic or transobturator mesh slings, the agency said.
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