NEW YORK (Reuters Health) – The US Food and Drug Administration has issued an alert about complications related to transvaginal placement of surgical mesh devices used to repair pelvic organ prolapse and stress urinary incontinence.
The agency has received more than 1000 adverse event reports over the past 3 years from nine surgical mesh manufacturers. In a “Dear Healthcare Practitioner Letter” dated October 20, the FDA advises physicians to “obtain specialized training for each mesh placement technique, and be aware of its risks.”
The most frequent complications have been erosion through the vaginal epithelium, infection, pain, urinary problems, and recurrence of the condition being treated.
Physicians are also warned about complications associated with the placement procedure, especially perforations of the bowel, bladder, and blood vessels. In some cases, additional surgery has been required, including removal of the mesh, as well as intravenous therapy, blood transfusions, and drainage of hematomas and abscesses.
The FDA requests that patients be told that surgical mesh implantation is permanent and informed about the potential for serious complications possibly resulting in pain during sexual intercourse, scarring, and narrowing of the vaginal wall. If available, a copy of the patient labeling from the surgical mesh manufacturer should be given to the patient.
Adverse events related to surgical mesh should be reported directly to MedWatch at www.fda.gov/MedWatch/report.htm or by calling 1-800-FDA-1088. For more information, visit: