05/14/2013 // Concord, CA, USA // Vaginal Mesh Website // Greg Vigna, M.D., J.D. // (press release)
Women across the world are suffering with pain from transvaginal mesh implants, which was both inadequately studied and aggressively marketed by the manufacturers. What should a women do from a medical standpoint for a solution to their pain if they have undergone the transvaginal mesh procedure for either prolapse or stress incontinence? I offer my opinion for an approach that I believe is both rational and practical for patients with pelvic pain caused by the transvaginal mesh implants. This approach is extrapolated from many years of clinical practice in the management of spinal disorders as well as my individual research and my conversations with the medical authorities in the field of chronic pelvic pain. This approach is focused on a determination of both the primary pain generator and secondary pain generators of pelvic pain understanding that often complete pain relief can not be achieved. I believe that by differentiating the pain generators and treating them a patient may have improvements in their pain syndrome and become more functional with less psychosocial stress on the patient’s life. This approach is made with an understanding that the pelvis is an incredibly complex part of the body with multiple functions.
Clinicians taking care of patients with chronic pelvic pain have been slow to adopt this approach of determining the primary and secondary pain generators of pelvic pain because historically there has been a focused on the idea that pelvic floor pain is primarily caused by myofascial pain. That is pain arising from the muscles of the pelvis itself. Until recent there has been little focus from the medical community regarding a potential pain generator in the pelvis, the pudendal nerve. There is a well described malady that was once rare, but well described, called the pudendal neuralgia that has destroyed the lives of many. By recognizing the neurologic origins of pain that may cause chronic pelvic pain in addition to the more common myofascial pelvic pain, a clinician will have greater success in the management of the transvaginal mesh patient with chronic pelvic pain.
The transvaginal mesh kits may cause pudendal neuralgia. That is a fact beyond dispute. This has been proven by clinical experience, intraoperative findings, and cadaver studies. The arms of the transvaginal mesh kits are blindly placed up in the pelvis that may cause direct damage to the nerves of the pelvis or cause damage by way of traction or inflammation upon the nerves. Pudendal neuralgia is a clinical diagnosis determined by symptoms of the patient that directly relate to the anatomy of the nerve and proven by both diagnostic and therapeutic injections. The pudendal nerve has three branches, the clitoral, perineal, and the inferior rectal branch. Symptoms include pain that interferes with sitting, numbness of the clitoris, anorectal pain, perineal pain (pain where sit if you were on a saddle), and incontinence. Other symptoms include sharp lancing pain in the buttock, coccyx pain, and pain with sexual intercourse. It must also be recognized that pudendal neuralgia may also cause myofascial pain which I call secondary myofascial pain (myofascial pain secondary or caused by the pudendal neuralgia) that can cause further tightening of the muscles of the pelvis which may indeed contribute to further compression on the nerve. It is therefore, important to address the myofascial component of pain in a patient suspected of having pudendal neuralgia.
Primary myofascial related pelvic pain, also referred to a myofascial pelvic pain syndrome (MPPS), is pain that is believe to arise from the muscles themselves. Primary myofascial pain have similar symptoms to that of a pudendal neuralgia patient in that there is also pain with sitting, coccyx pain, incontinence, rectal pain, and pain with sexual intercourse. The mesh may cause adhesions between structures, generalized inflammation of the pelvis, or direct pressure on the muscles, vagina, uterus, and rectum that causes myofascial pain.
Understanding that both primary and secondary myofascial pain can coexist is necessary for the clinician who is providing care for a patient with transvaginal mesh related pain. By understanding the both primary and secondary myofasical pain a physician will understand that it is necessary to formulate a treatment plan that may achieve improvement in pain for both conditions while not making subsequent treatments more difficult.
The following is a rational treatment for mesh related pelvic pain in a patient prior to mesh removal:
Patients who have pelvic pain related to the mesh will need an extensive history and physical. Important points will include the reason why the mesh was placed. The most important question for the astute clinician is what type of mesh was used. Prolift, Elevate, Apogee, Pergee and several others. Each one of them is placed slightly differently and has potential of injuring different structures. Also how many meshes were implanted? Were the all implanted at the same time? Were all or some of them or parts of them removed? Was the onset of pain immediate or some time after placement, because immediate pain is more consistent with direct nerve injury? Did the patient have any pain or discomfort with intercourse prior to surgery? Was it for an anterior or posterior prolapse issue? Was it for stress incontinence? Was there a prior history of pelvic pain prior to the mesh placement? When did the pain develop? Did the pain improve or worsen over time? What activities make the pain better? What activities make the pain worse? Is there incontinence? Is there a sensation of an object in the vagina or rectum? Is there shooting/lancing pain in the buttock or anus? Is there coccyx discomfort? Is the leg numbness? Is there pain with sexual intercourse? Is there pain with a full bladder? Is there numbness of the clitoris? What medications have been tried? What medications have been effective? Does the patient suffer from depressive symptoms since the mesh? Are there marital issues since the mesh has been placed?
Physical exam will involve evaluation for vaginal erosions, muscle spasms will be evaluated by palpation both via vaginal and rectal exam, and the elasticity of the rectal and vaginal walls will be evaluated on exam.
2) Physical Therapy:
All patients will be referred to a pelvic floor physical therapist to deal with the myofascial pain. The goal of therapy is to decrease muscle spasm and will include trigger point desensitization, stretching, exercises, intravaginal and intrarectal mobilization and massage, and biofeedback.
If myofascial pain persist despite therapy efforts then local agents may be added such as vaginal and rectal baclofen and/or valium suppositories. These medications are to decrease muscle spasm and to aid therapy interventions. Botulinum toxin A (Botox) injections may also be tried. They have been proven in the literature to be effective in pelvic muscle spasm related ailments. Oral medications such as antidepressants that are effective in pain and Gabapentin (Neurontin) or Pregabaline (Lyrica) may be tried.
If pain persist the patient will undergo a pudendal nerve block to determine if there is a neuropathic component to the pain. This is done both for therapeutic and diagnostic purposes. Three shots may be attempted every six weeks. Patients potentially can be “cured” with these injections despite keeping the mesh in place. If there is relief for a period of time the patient will have the diagnosis of pudendal neuralgia. Any patient that has continued pain at this stage of the process with or without temporary improvement following the pudendal nerve block will undergo complete mesh removal. That will require both a vaginal and lower abdominal incision to get both the sling and the arms of the mesh. A patient who has symptoms consistent with obturator neuralgia should undergo decompression of the nerve during mesh removal.
5) Following removal of the mesh the clinician will determine if ongoing physical therapy is indicated, if medications are necessary, and if further procedures are necessary. For example, in the group that had transient relief to the pudendal nerve block but remains symptomatic with pain six months following mesh removal may undergo nerve decompression via transgluteal approach. In a patient who preoperatively had no relief with a pudendal nerve block who continues to have pain six months following mesh removal, these patients may require further therapeutic and diagnostic blocks to either the main branch of the pudendal nerve or individual blocks to the terminal branches as determined by the symptoms the patient has. If there is a positive response to the injection in that the pain is improved the patient may be considered a candidate for decompression of either the main branch of the pudendal nerve or decompression of the individual branches as determined by which nerve is responsible for the symptoms.
I urge the women suffering from side effect of mesh implants with sufficient resources to go to a center of excellence that handles both mesh removal and decompression to do so. The clinical history, the determination regarding the response to attempted therapies and procedures, and the overall satisfaction of the patient will be improved with the continuity of care with one provider who manages the problem from start to finish.
My recommendation for the women without the resources to go to a center of excellence is the following: 1) If you have symptoms of obturator neuralgia and are planning to undergo mesh removal, you need to go to a center of excellence because the obturator nerve can be decompressed at the same time the mesh is removed, 2) If there are no symptoms of obturator neuralgia insist that the entire mesh must be removed and that requires both transvaginal and lower abdominal incisions, 3) If pain persist 3-6 months following mesh removal you will need to go to a center of excellence for therapeutic and diagnostic injections to the nerves, 4) Finally, never undergo a diagnostic or therapeutic injection to a pelvic nerve with a physician who is not trained in decompression, because likely the surgeon who is trained in decompression will insist on repeating the injections for his own piece of mind that surgery is indicated.
Finally, I would like to add that if patients and physicians disagree with the above, I have achieved my goal of stimulating a discussion in the medical community. This discussion is essential to establish best practices, which will ultimately improve the care and lives of those suffering from mesh related complications.
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