In order to understand bladder injuries, it is important to understand why pelvic mesh is a misguided and faulty idea and a defective device in the first place.The device is so dangerous that over 100,000 women sued the manufacturers and many won millions of dollars. The collective financial hit to the manufacturers is in the billions. Many have had their lives substantially changed for the worse, losing health, jobs, marriages, etc.—yet the makers continue to sell the device and gynecologists and urologists continue to situate pelvic mesh inside the most vulnerable area of a woman’s body–at a rate of 300,000 a year.
Pelvic mesh is really a plastic woven or knitted hammock that holds up sagging organs in the pelvis; the bladder, uterus, and large bowel or is placed to control a leaky bladder.
In order to insert a sling, special surgical tools were invented: a trocar that looks like a giant sewing needle that was caught in the blender, or staples, screws, and large non absorbable sutures. With transobturator tapes (TOT’s), the trocars puncture through sensitive areas in the lower pelvis, grab hold of one end of the sling or tape and pull it under the bladder where it meets another trocar from the other side. The procedure is done “blind,” meaning the surgeon can’t see what he/she is doing but try to “feel” the resistance to the trocar in order to mentally identify pelvic structures ias they go. If the guess is wrong, the trocar can go right through the delicate bladder structures (as well as nerves, blood vessels, and the bowel).
The most common complication during mesh implantation is perforation of the bladder. If this is not discovered and fixed during the original operation, it can lead to frequent urinary tract infections, pain while urinating, persistent leakage, hematuria (blood in the urine), chronic pain and voiding difficulties and cause the development of a hole between the vagina and the bladder known as a vesicovaginal fistula.
Sometimes normal movement after surgery turns the “hammock” into a hacksaw cutting its way into the bladder. This process eventually perforates the bladder and is know as erosion.
Diagnosing erosion should be done by a careful interview with the patient, listening to complaints of worsening pain as the bladder fills with an easing after emptying, a feeling like a razor blade is cutting them or that they are sitting on knives. Most MRI’s and CT scans cannot identify the placement of mesh. A specialized ultrasound known as a translabial ultrasound can but few radiologists know how to perform them or read them. A cystoscopic exam (a narrow tube with a camera on the end that is inserted inside the bladder) can only identify mesh after mesh enters the inside surface of the bladder but mesh can be embedded on the outside, cause great pain and yet not be seen. Most urologists seem not to know that cystoscopy cannot be used to rule out erosion by itself. Many women have been told the problem they are experiencing is not due to the mesh only to discover during removal surgery that the mesh had become embedded inside their bladders, vaginas, blood vessels, muscles or rectum.
Interestingly, women complain that their pain is worse on one side or the other. Studies mention the experience of the surgeon , whether he is right-handed or left-handed, or whether the patient was vulnerable to injury yet there has been no focus on the design of the instrumentation or studies that measure the subjective feelings of patients with injuries as to whether the risk for injury outweighed the problem that took them to the doctor in the first place. With studies showing wildly different estimates of the numbers of complications between ten and 75%, and many injuries that go unreported to the FDA, the real risk remains uncertain. It is clear the use of pelvic mesh has not risen to the level of “Gold Standard,” yet patients continue to report to each other that they are hearing that comment from their physicians.
On October 8, 2008 the FDA issued this warning about the mesh and trocars to all surgeons:
- 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
- Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations
- Inform patients that implantation of surgical mesh is permanent, and that some complications
- associated with the implanted mesh may require additional surgery that may or may not correct the complication
- Inform patients about the potential for serious complications and their effect on quality of life
- including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair)
- Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available
Despite the warning, patients receive pelvic mesh implants in unprecedented numbers and many come to support groups saying they were never warned and do not have a written copy of the patient label.
The newer mini-tapes are still polypropylene based and mesh affected women continue to report higher than normal rates of foreign body reactions and autoimmune disorders.
Peggy Day is working on a book to combine all these stories. This is an excerpt from Pelvis in Flames: Your Pelvic Mesh Owner’s Guide. Your input is welcome to help make Pelvis in Flames the book you need to read.
If you’d like to join an online support group and learn about erosion, partial removals, surgeons, or just find out that you are not alone, join my group, Surgical Mesh or check the list of support groups here.
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