A far more common unrecognized injury of the vaginal mesh debacle is ‘painful bladder syndrome’ previously referred to as interstitial cystitis.
Retropubic slings and transobturator slings used for stress urinary incontinence (SUI) and devices used for pelvic organ prolapse (POP) such as the Prolift, manufactured by Ethicon, Inc. cause life altering pelvic pain from neurological injuries including pudendal neuralgia, obturator neuralgia, and complex regional pain syndrome. A far more common unrecognized injury of the vaginal mesh debacle is ‘painful bladder syndrome’ previously referred to as interstitial cystitis.
In 2002, the International Continence Society defined interstitial cystitis, calling it painful bladder syndrome (PBS) as the following: “Painful bladder syndrome is the complaint of suprapubic pain related to bladder filling, accompanied by other symptoms such as increased daytime and nighttime frequency, in the absence of proven urinary infection or other obvious pathology.”
It is not uncommon for mesh injured women to have the diagnosis of IC for years, only to be diagnosed with pudendal neuralgia well after a settlement against a TVM manufacturer has been accepted. – Dr. Greg Vigna
Unfortunately, the medical community has been slow to recognize the significance of this 2002 change in terminology away from interstitial cystitis (IC) recognized as a distinct disease to that of a ‘syndrome’ which is not specific to only one disease. IC or PBS may be caused by spastic pelvic floor syndrome or pudendal neuralgia both complications of polypropylene TVM devices.
Dr. Greg Vigna, MD, JD, practicing physician, national pharmaceutical injury attorney, and damages expert states, “It is not uncommon for mesh injured women to have the diagnosis of IC for years, only to be diagnosed with pudendal neuralgia well after a settlement against a TVM manufacturer has been accepted.” Dr. Vigna goes on, “To date manufacturers have provided little to no long-term evidence of safety and efficacy of their polypropylene transvaginal mesh devices used for pelvic organ prolapse leading to the April 16th, 2019 FDA ban of these devices. Similarly, there is little long-term evidence that extend out longer than a year to capture complications such a PBS for devices used for SUI and POP. This is despite urodynamic studies which show bladder wall overactivity post-operatively in women receiving prolapse devices which may be consistent with PBS.”
Dr. Vigna explains, “The incidence of painful bladder syndrome has not been studied in the retropubic and transobturator polypropylene sling population and has not been compared to populations receiving autologous slings that are made from a patient’s own tissues. PBS or IC is a complication of polypropylene transvaginal mesh device and are not being recognized as an injury in the Matrix Settlements to date. It is not uncommon for women to have been diagnosed for years with IC only to find out they have Complex Regional Pain Syndrome or Pudendal Neuralgia well after a settlement has been accepted.”
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