Numerous reports from surgical mesh manufacturers describe adverse events associated with their devices.
On 20 October 2008, the United States Food and Drug Administration released two public health notifications about serious complications associated with transvaginal placement of surgical mesh in the repair of pelvic organ prolapse and stress urinary incontinence. One notification was directed to health care professionals, the other to consumers. In the release to health care professionals, the FDA noted that over the previous 3 years they had received more than 1000 reports from nine surgical mesh manufacturers of complications associated with these devices used to repair pelvic organ prolapse and urinary stress incontinence. Various complications were discussed, including erosion, infection, and pain; bowel, bladder, or blood vessel perforation; and failure of the procedure. Also discussed was vaginal scarring, which leads to decrease in quality of life due to pelvic discomfort, chronic pain, and dyspareunia.
Based on these results, the FDA recommended that physicians should attain specialized training for the various mesh procedures, should watch for complications, and, most important, should inform patients of the possible complications and explain that the implantation of surgical mesh is permanent and some of the complications may require additional surgery, which may or may not resolve the problem.
The release to consumers was similar, and included a recommendation to interview the surgeon in advance and find out about the pros and cons of using surgical mesh, and the experience of the surgeon with the surgery. Consumers were also encouraged to ask about possible complications and the likelihood of being able to remove the mesh if there are complications, and if the surgical repair could be successfully performed without using mesh.
In November 2007, my colleagues and I published an article in the BC Medical Journal about the various complications noted by the FDA that we had observed. We also made a number of recommendations, including the proper training of surgeons performing the procedure, the use of cystoscopy during the procedure to be certain there is no perforation, and the avoidance of surgery in certain patients, including those with urethral syndrome, interstitial cystitis, chronic pain, or obstructive uropathy. We also recommended that patients be advised of the success rates and complications of the various surgical procedures available to treat incontinence and prolapse.
We expressed our belief that the success rates are quite similar for the various procedures now available to surgeons to treat prolapse and incontinence. However, we were concerned about the serious complications noted with the use of mesh and the difficulty of treating them. The release of two notifications by the FDA confirms our opinion.
Physicians in British Columbia should be aware of the FDA recommendations, including the need to fully inform patients of the nature of these procedures and the potential complications. Patients should be advised that there are alternate non-mesh procedures available with similar success rates.
The absolute numbers of incontinence and prolapse procedures performed is not monitored, and therefore we cannot calculate the rate of complications. There have been a number of reports over the last 10 years that describe these complications, but they are described as uncommon.[2-7] As a surgeon who is seeing increasing numbers of the complications, my personal experience and the experience recounted by fellow health care professionals suggest to me that these complications are more common than have been reported. In addition, these complications, especially pelvic pain and discomfort, can be very difficult to treat successfully.
The FDA notifications can be reviewed online at www.fda.gov/cdrh/ safety/102008-surgicalmesh.html.
Dr Fenster is a professor in the Department of Urological Sciences at the University of British Columbia.
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