07/01/2013 // Concord, CA, USA // Vaginal Mesh Website // Greg Vigna, M.D., J.D. // (press release)
An unfortunate consequence of the transvaginal mesh procedure is intractable pain in the form of vulvar allodynia that reduces a women’s tolerance to sitting, produces discomfort with everyday activities and interferes with sexual function. Allodynia is pain that is produced by sensations that normally would not be noticed or if noticed, it would involve minimal non-painful sensations. Vulvar allodynia takes the normal sensation of friction from tight fitting pants to a miserable sensation of pain. Allodynia may be part of the complex system that is the clinical diagnosis of Reflex Sympathetic Dystrophy (RSD), which is now called Complex Regional Pain Syndrome (CRPS). CRPS is subdivided into Type I, which is related to a soft tissue injury, or Type 2, which is related to a nerve injury.
In the case of the transvaginal mesh patient, CRPS Type I may be related to direct irritation from the mesh device itself on the soft tissues or injury to the soft tissues during the procedure itself. CRPS Type 2 is related to injury to the pelvic nerves that may occur directly by the mesh device or by the procedure itself. Myofascial pain can be ‘Primary Myofascial Pain’ that is muscle pain and spasms associated with soft tissue dysfunction or ‘Secondary Myofascial Pain’ which is muscle pain and spasms caused by nerve injury. Most patients with myofascial pain will not have CRPS, while most patients with CRPS will have a component of myofascial pain. Transvaginal mesh patients, who have significant vulvar allodynia and who do not respond to traditional medical interventions such as physical therapy, oral and local medications, Botox, nerve blocks, and decompressive procedures to the nerves of the pelvis, may have CRPS Type I or Type 2. This may require ketamine.
The mechanism that causes CRPS is largely unknown but it is believed to be related to a concept of “central sensitization” which heightens the excitability of pain carrying nerve cells of both the peripheral nervous system and the central nervous system (spinal cord and brain). Central sensitization causes a spread of the pain in distributions outside the area of injury with increase in sensitivity to activation of the pain carrying nerve cells both in the peripheral and central nervous system. It appears that the stimulation of the NMDA receptor is key to this mechanism of increase in sensitivity. Ketamine acts by blocking the NMDA receptor from the stimulation.
Studies have shown that a low-dose ketamine intravenous infusion was effective at decreasing pain in patients with CRPS. The effect of ketamine was not related to the length of the disease and worked best on the burning type of allodynia and dynamic allodynia that occurs with normal activity. Other pain such as myofascial pain, overall pain, joint pain, and quality of life indicators had findings consistent with improvement following the use of ketamine. Side effects related to ketamine include headache, nausea, and fatigue. Hallucinations and delusions may occur but appear to be decreased by the addition to midazolam, which is a Valium like drug. Some studies indicate there might be deficits in short-term memory but this not confirmed in all studies. Ketamine infusion for pain syndromes is a relatively new therapeutic option being use in the United States since early 2002. There may be a benefit to utilizing ketamine in conjunction with other interventions such as physical therapy and regional nerve blocks. The use of ketamine is an evolving study on ‘human subjects’ that generally involves desperate patients with severe intractable pain. Patients will be required to make a fairly broad informed consent prior to receiving intravenous ketamine.
Life Care Planning Perspective:
A life care planner considering the life-long treatments required in a transvaginal mesh patient must start with the premise that pain often worsens as a patient ages. A life care plan for a transvaginal mesh patient with intractable pain may include the following: routine evaluations by physician, routine medications including Botox, routine evaluations by a pelvic physical therapist, and routine pelvic physical therapy. All reasonable and medically necessary care must be considered. In the unfortunate patient with severe pain and functional loss a life care plan providing for ketamine infusion may be necessary. A life care planner should recommend a referral to a center of excellence for pelvic pain with all of the state of the art treatments for mesh related complications. By collaborating with the physicians at a center of excellence, the life care planner will be best able to plan all of the future needs of the patient.
A competent serious injury attorney must prove to the jury all past and future medical costs that are directly related to the transvaginal mesh procedure. Future management of chronic pain related to the transvaginal mesh procedure over the projected lifetime of the injured patient is typically a significant amount. An injured client will need an outcome that will fairly compensate him for his future medical needs, and often times, the biggest challenge is finding enough insurance coverage or deep pockets that can adequately satisfy a significant damages award. In mesh cases, there are deep pockets depending on which pharmaceutical companies placed unreasonably dangerous meshes in the marketplace. All future treatments must be included in the life care plan, testified to by a life care planner, and supported by testimony and the records of the treating physician. Future damages must be medically necessary and appropriate in the future. Independent to future medical cost, lost wages, loss of earnings capacity, pain and suffering is an additional award under general damages and would be a large component of an award. Future planned treatment of a patient’s pain, as well as testimony by the patient, family members, friends and loved ones are the types of evidence that a jury would consider when awarding a significant pain and suffering award.
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