The U.S. Food and Drug Administration (FDA) has informed all physicians about the serious complications associated with the transvaginal placement of surgical mesh in the repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the FDA website reports.
This surgical mesh is used in women to cure of pelvic prolapse, bladder prolapse, and similar problems. It is rooted in the vagina, aiding as a pelvic or bladder sling and reinforcing the vaginal wall.
Over the past three years, FDA has received over 1,000 reports against nine surgical mesh manufacturers documenting complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are regularly located transvaginally make use of utensils for nominally hostile post.
The most common problems comprised erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse or incontinence. There were correspondingly reports of bowel, bladder, and blood vessel tear during insertion. The vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia, in some cases according to the FDA.
The treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), intravenous therapy, blood transfusions, and drainage of hematomas or abscesses, says the FDA website.
Specific characteristics of patients at increased risk for complications have not been determined, according to research findings. Those contributing causes may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.
To avoid complications, physician should obtain specialized training for each mesh placement technique and be are aware of its risks, according to FDA recommendations. Doctors are advised to be vigilant over potential adverse events from the mesh, especially erosion and infection. They are also asked to watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
Primarily, specialists were to tell patients that implantation of surgical mesh is enduring, and that some problems related with the implanted mesh may require additional surgery that may or may not alter the complication, the FDA reported.
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fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotifications/ucm061976.htm
