Serious Complications with Surgical Mesh for Gynecologic Surgery

The FDA is alerting healthcare professionals about rare but serious complications associated with the surgical mesh used to treat pelvic organ 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 most frequent included erosion of the mesh through the vaginal epithelium, infection, pain, urinary problems, and recurrence of the prolapse or the incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in quality of life due to discomfort and pain, including dyspareunia.

Treatment of the complications included IV therapy, blood transfusions, drainage of hematomas or abscesses, and additional surgical procedures, in some cases to remove the mesh.

Clinicians using mesh for treatment of pelvic organ prolapse and stress urinary incontinence should:

• Obtain specialized training for each mesh placement technique, and be aware of its risks.

• Be vigilant for potential adverse events from the mesh, especially erosion and infection, and also from the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.

• Inform patients about the potential for serious complications and their effect on quality of life, including scarring and pain during sexual intercourse. Patients should also be informed that implantation of surgical mesh is permanent, and that some complications associated with the mesh may require additional surgery that may or may not correct the problem.

• Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if it is available.

FDA Patient Safety News: Jan/Feb 2009

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=83#4

Category:

Education

Tags:

• Mesh
• gynecologic surgery
• incontinence
• mesh
• prolapse
• complication
• FDA
• adverse event

[Adamlikesgoodmusic]

It is a nightmare. I had this mesh for a stage 2 bladder drop and my surgeon told me nothing at all about the warning or complications. I am in only 49 was in great shape. I am having to drive 5 hrs. to a specialist to get this stuff out of me. It is malpractice on the physicians part!!! The FDA should also take it off the market!!

[obgyn1954]

I have been using this mesh for 4 years, approx 200 patients with no significant complications. This mesh has been thrust apon the public by physicians who have gone to a weekend course and come home to try it out without proper training or mentoring. Performed correctly it is exceedingly safe and effective. It is a shame that women and physicians will have to resort to inferior types of traditional surgery with at least a 30% failure rate.

[pamrai01]

This mesh is wrecking peoples lives, I wonder how many people have not been warned about it in the UK. Please ask for full advice about this mesh and what the results can be because they can be horrendous, and extremely painful.

[lorreva]

My adverse report was forwarded to the FDA on serious complications associated with the Ethicon Gynecare Transvaginal Tension Free Medical Device. I had the device implanted October 2005 with ongoing health issues ever since, it is a living nightmare to cope with.