Surgical mesh tied to complications in women
Last Updated: Wednesday, October 22, 2008 | 5:34 PM ET
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A surgical mesh used to treat incontinence, prolapsed uterus and other health problems in women can cause rare but serious complications, the U.S. Food and Drug Administration warned.
The FDA said it has received more than 1,000 reports of complications in the past three years linked to surgical mesh from various manufacturers.
The mesh is used to repair pelvic organ prolapse — dropping of the bladder, uterus, bowel or rectum from its normal position — and so-called stress urinary incontinence, or leakage of urine when laughing or coughing.
The mesh is inserted through the vagina using minimally invasive surgical techniques.
Complications include:
- Erosion through vaginal tissue.
- Infection.
- Pain.
- Urinary problems.
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 loss of quality of life, including pain during sexual intercourse.
The department said it was investigating the cause of the complications. The overall health of the patient, size and shape of the mesh, and surgical technique used may be contributing factors.
The FDA recommended that physicians:
- Obtain specialized training for each mesh placement technique, and be aware of its risks.
- Be vigilant about looking for potential problems, such as infection and erosion of tissue.
- Watch for complications from surgical instruments.
- Fully inform patients about possible complications.
The problems have been found in mesh from nine different manufacturers.
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