TVM slings used for treatment of stress urinary incontinence continue to be implanted in thousands of women despite risk of catastrophic pain syndromes.
SANTA BARBARA, CA, USA, January 8, 2019 /EINPresswire.com/ — Transvaginal mesh manufacturers have settled thousands of claims that were ‘moved’ to the Multidistrict Litigation (MDL) in West Virginia for several billion dollars. Despite this, TVM slings used for treatment of stress urinary incontinence (SUI) continue to be implanted in thousands of women, unknowing of the non-mesh surgical options available, and not knowing of the risk of catastrophic pain syndromes associated with both the retropubic sling and transobturator (TOT) sling. To date there have no meaningful change to the design of both the retropubic sling and the TOT slings that addresses the occurrence of life altering catastrophic pain syndromes.
The design of the retropubic sling has remained unchanged. Manufacturers apparent position on the safety of retropubic sling is that the benefits of the device outweighs the risk of the device and those risks are adequately warned by the manufacturer as listed in the Instructions of Use (IFU) that is enclosed in the packaging for the product. Unfortunately, to the detriment of hundreds of women, that is not the case.
The retropubic slings are composed of polypropylene (plastic) and that has not changed despite billions of dollars in settlements and this material causes chronic inflammation identified in pathology specimens of explanted mesh. The result of this chronic inflammation is the rare occurrence of Reflex Sympathetic Dystrophy (RSD), also known as Complex Regional Pain Syndrome Type I (CRPS-1). Chronic inflammation and chronic hypoxia that occurs adjacent to the mesh, is the cause of RSD.
Allodynia is the hallmark of RSD which is characterized by pain that occurs from non-painful stimuli. Gentle rubbing onto the skin in the region of RSD is interpreted by the brain as burning. RSD involving the perineum may spread to adjacent areas, that causes profound impairments in mobility, vocational loss and disability, and painful sexual intercourse (dyspareunia). Women with allodynia from RSD caused by the retropubic slings ‘Can’t Wear Tight Pants’ or tight undergarments. Symptoms may begin years after implantation as the device hardens and contracts.
Proper diagnosis is necessary as women with RSD require ongoing treatment for the rest of their lives. Treatments might include pelvic floor physical therapy, vaginal suppositories with Baclofen and/or Valium, medication management, psychological support, neuromodulation (stimulators), and sometimes Ketamine.
As women suffer from new injuries from the vaginal mesh the proper diagnosis to receive proper treatment and the diagnosis must be for the purpose of litigation because ‘pain is just pain’ if not diagnosed. Subjective pain is difficult to explain and quantify for the jury but with RSD it isn’t. RSD is a diagnosis that is accepted in the determination of receiving Social Security Disability as it is a generally accepted diagnosis. In litigation RSD is easy to explain as the ongoing inflammation from the mesh is the cause of RSD and makes this diagnosis biologically plausible and allows for ‘specific causation’.
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Greg Vigna, M.D., J.D.
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