Serious Complications with Surgical Mesh for
FDA Patient Safety News: Show
#83, February 2009
The FDA is alerting healthcare professionals about rare but serious
complications associated with the surgical mesh used to treat pelvic
prolapse and stress urinary incontinence. The mesh is usually placed
transvaginally using minimally invasive techniques.
Over the past three
years, FDA has received over a thousand reports of complications. The
frequent included erosion of the mesh through the vaginal epithelium,
pain, urinary problems, and recurrence of the prolapse or the
There were also reports of bowel, bladder, and blood vessel perforation
insertion. In some cases, vaginal scarring and mesh erosion led to a
decrease in quality of life due to discomfort and pain, including
Treatment of the complications included IV therapy, blood transfusions,
drainage of hematomas or abscesses, and additional surgical procedures,
cases to remove the mesh.
Clinicians using mesh for treatment of pelvic
organ prolapse and stress urinary incontinence should:
specialized training for each mesh placement technique, and be aware of
• Be vigilant for potential adverse events from the mesh,
especially erosion and infection, and also from the tools used in
placement, especially bowel, bladder and blood vessel perforations.
Inform patients about the potential for serious complications and their
on quality of life, including scarring and pain during sexual
Patients should also be informed that implantation of surgical mesh is
permanent, and that some complications associated with the mesh may
additional surgery that may or may not correct the problem.
patients with a written copy of the patient labeling from the surgical
manufacturer, if it is available.