FDA Alerts Consumers Of Risks Of Mesh
Last week the FDA issued a public health notification on the use of surgical mesh for treating uterine prolapse and stress incontinence. Here is the link: http://www.fda.gov/cdrh/safety/102008-surgicalmesh.html.
Some things to know:
- About 380,000 procedures are done annually in the U.S. using surgical mesh.
- Over the past three years, FDA has received over 1,000 reports of complications from the nine surgical mesh manufacturers.
- These complications have included erosion into the bladder, urethra or vagina, pain or even reports of bowel, bladder or blood vessel perforation during insertion of the mesh.
- There are various kinds of mesh - from biologic to synthetic - and different procedures may use differnt amounts of mesh.
The FDA issued guidelines for physicians, but what I wanted to say to you is that if you are having an operation for prolapse or stress incontinence repair, you may want to ask your doctor a few basic questions:
- How much mesh is being used?
- Where is it being placed and how is the incision performed?
- How many of these procedures have you done and where/how did you get trained?
- What types of risks are associated with the procedure and what are the potential complications?
- What warning signs should you look for in the weeks following surgery?
For me, a patient who has had, herself, some complications associated with the gold standard of pelvic surgery involving mesh, I must say that this FDA warning is a good thing. To me, it reiterates the need to talk to your doctor and highlights the importance of you being an aware consumer.
No procedure is without risk, but to minimize the risk of any surgery, you should have confidence that your doctor does these procedures regularly, is well trained in the products he/she is using and, perhaps in the case of mesh, which is a foreign object being placed in your body, uses just what he/she needs in the situation. This is not a case for “bigger is better.”
I have also learned as a patient, that you are your own best advocate, so ask questions and keep asking questions until you are comfortable with the answers.