Stress urinary incontinence occurs in ~17% of women 40-years+. If surgery is done, complications may cause skeletal pain, nerve damage, pain during sex, & more.
SANTA BARBARA, CALIFORNIA, UNITED STATES, November 27, 2018 /EINPresswire.com/ — Stress urinary incontinence (SUI) occurs in approximately 17% of women 40-years of age or older. When conservative treatments such as Kegel exercises or pessaries fail to control incontinence to an acceptable degree surgical options are considered which include procedures that utilize polypropylene (plastic) mesh and those that do not use the petroleum-based plastic.
Polypropylene transvaginal devices used in the treatment of SUI include two basic designs: 1) the retropubic sling that is anchored to the pubic bone in front of the bladder and 2) the transobturator sling that penetrate the obturator membrane that separates the groin from the pelvis. Both of these designs have been the subject of the largest Multidistrict Litigation (MDL) in the history of the United States involving over 100,000 injured women. Claims were made against the manufacturers for complications of the devices including erosions into adjacent structures, failure of device, musculoskeletal pain, nerve damage, and pain interfering with sex (dyspareunia). The claims were based on alleged defective design and failure to warn women.
Despite massive payouts to injured women by manufacturers of the device, the retropubic sling and transobturator sling continue to be implanted into women despite little change in the design of the device and in many circumstances, no change to the design. Manufacturers are simply utilizing alterations in their warnings to dodge liability by expanding their list of complications that these devices are known to cause.
Unfortunately, to date the warnings provided to unknowing women and doctors have failed to differentiate the important differences in complications when comparing retropubic slings to transobturator slings. The literature supports similar efficacy for treatment of SUI when comparing retropubic slings to transobturator slings. The literature also supports the association of catastrophic pain syndromes of pudendal neuralgia and obturator neuralgia with transobturator slings while at the same time these diagnoses are rarely mentioned (if ever) in association with retropubic slings. The anatomical reason for this is that the arms of the retropubic sling are implanted nowhere near the obturator and pudendal nerves while the arms of the transobturator sling are designed to implant in close proximity to these nerves that may directly damage the nerve or overtime cause inflammation that damages the nerve by way of traction or scar tissue.
Women must be warned that transobturator slings may cause ‘life altering pain and disability’ that prevents functional mobility, sitting, sexual function, and bowel and bladder function. The warnings for transobturator slings must include a specific warning of the occurrence of obturator neuralgia that causes intractable groin pain and pudendal neuralgia which causes intractable pain to the perineum.
Pudendal neuralgia, obturator neuralgia, Complex Regional Pain Syndrome Type 2 are all diagnoses caused by transobturator slings that turns the normal friction from wearing underwear or jeans into an intolerable burning sensation or intense irritation. Simply obturator and pudendal neuralgia results in ‘Women Can’t Wear Tight Pants’. These diagnoses are rarely (if ever) seen in association with retropubic slings,
Women must be warned in a consistent fashion in a written and explained informed consent before being implanted with a transobturator sling that they consent to the unique pain syndromes and that there are other options without these complications for the treatment of SUI including the retropubic polypropylene transvaginal mesh devices or non-mesh surgical procedures.
For resources related to pudendal and obturator neuralgia visit: http://pudendalportal.lifecare123.com/.
For a free eBook on Pudendal Neuralgia visit: http://tvm.lifecare123.com/page/e-book.html.
For Video Related to Obturator Neuralgia visit: http://hibner.phaktory.net/video/65674772.
Dr. Greg Vigna is a practicing physician, medical expert in Life Care Planning, and a national pharmaceutical injury attorney.
References: National Institute of Neurological Disorders and Stroke, Diagnostic Criteria for Pudendal Neuralgia by Pudendal Nerve Entrapment (Nantes Criteria), Neurourology and Urodynamics 27:306–310 (2008), European Journal of Clinical Nutrition: Nov. 2018
Greg Vigna, M.D., J.D.
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