Women are increasingly deciding that their transvaginal mesh implant is causing more complications than it cured and are opting to have it removed, but a new report says the removal procedure may cause a host of injuries to the uterus.
Researchers from the Mayo Clinic and Spectrum Health Medical Group in Michigan have published their findings this week in the American Journal of Obstetrics and Gynecology.
This is unusual in it is one of the few findings that attributes some injuries to the material most synthetic mesh is made from, petroleum-based polypropylene. Researchers found the synthetic mesh kits using polypropylene mesh promote fibrosis or scar tissue, which may necessitate removal.
Vaginal mesh is inserted through the vagina to hold up prolapsed pelvic organs. A mesh sling may be used to support a sagging urethra and bladder to treat stress urinary incontinence. Mesh complications include shrinkage, erosion into nearby organs, nerve and muscle pain, hardening, balling up, and causing infections, among other complications.
Hundreds of thousands of women are still having these mesh implants every year.
The plastic mesh utilizes anchors, usually metal, somewhere near the uterus to hold up the mesh. During a mesh removal, surgeons frequently must leave behind the metal anchors.
In two cases profiled in this report, removal surgeries for the mesh and fibrosis damaged the uterus which was cut during removal surgery. One woman having an Ethicon (J&J) Prolift mesh removed had her uterus transected and needed additional surgery and use of a catheter to assist with urination. Another patient had an American Medical Systems Apogee and Perigee mesh removed because it had eroded into her vagina and she was left with pain and incontinence.
“The literature suggests that 4.4% to 14.5% of patients have significant morbidity after mesh kit procedures, including mesh erosion, infection, pain, incontinence and recurrence of prolapse,” researchers noted. “The significant inflammation from host incorporation, relatively blind placement, and the proximity of urinary structures to supporting anchors predisposes the ureter to injury during mesh placement and removal.”
Bottom line: Women need to be better counseled so they know the risks of not just the mesh but the removal procedure should that be necessary.
However that in itself poses a question. Because the U.S. Food and Drug Administration does not conduct post approval monitoring of mesh complications, the actual complication rate is unknown, making it difficult for a medical professional to counsel a patient. Industry still claims a 1% rate for some meshes, which is demonstrably untrue.
Between 2008 and 2010, the FDA reported at least 2,874 mesh complication complaints into its database which reflects a fraction of the actual injuries since the database requires extensive information about your mesh implant, something most women do not think to retrieve following their surgery. A patient suffering a complication then must know where the database is located and what information to enter in public health jargon.
Searcy Denney encourages all of our vaginal mesh clients to enter their complication report into the FDA MAUDE database so the agency can get some idea what’s happening to thousands of women who made the mistake of trusting the mesh makers and their promises.