FDA issues public health watch for transvaginal placement of surgical mesh
Device Regulation Alert: Safety, Compliance and Reimbursement News, October 27, 2008
Nine surgical mesh manufacturers submitted more than 1,000 reports of complications associated with surgical mesh devices used to repair pelvic organ prolapse and stress urinary incontinence in the last three years, according to an FDA public health notification.
The FDA recommended physicians:
- Obtain specialized training for each mesh placement technique and be aware of its risks
- Watch for complications associated with transvaginal placement
- Inform patients about the potential for serious complications associated with the device and their effect on quality of life
- Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer
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