Is the failure of a vaginal mesh implant actionable?
This is what will be argued when a Vaginal Mesh Lawsuit comes to trial. On the face of it the manufacturers have been producing and selling this device for insertion beneath the vaginal wall in surgeries to repair two women’s problems; those of Sudden urinary Incontinence (SUI) and the more serious Pelvic Organ Prolapse (POP)
Both of these problems are not routine. POP is frequent in women who have had children and are getting on in years. The muscles that supported the various organs around the uterus stretched and weakened while carrying a child and these are prone to allow the organs to shift and subside onto the front of the vagina causing distress. There are other causes but that is the chief one.
As many as 50% of all women will experience some form of POP but usually it is very mild and can be addressed with a set of exercises or/and with an insert able and removable prosthesis known as a pessary. Usually the problem will go away or at least be manageable. In a small number of cases the problem becomes severe. When it does surgery becomes necessary.
This surgery is extremely difficult as there are many organs that inhabit that part of the body and they have started to move around. The surgeons who perform these operations are always concerned as the stitches they put in could easily perforate something unintended. Thus when the mesh became available it was seen as a great help. For POP repairs lately mesh has only been implanted in about 25% of cases. The Health givers have claimed that is give great assistance in strengthening the vaginal passage and gives support to the organs that are lodged in that region. Recovery was also seen to be a lot quicker, and recurrence of prolapse was greatly reduced, it was claimed.
However some complications were noted and a safety warning was published by the FDA in October 2008 reporting some rare instances of adverse reactions attributed to the implantation of Vaginal Mesh. They continued to monitor the situation and in July 2011 they updated the warning changing the rating to no longer rare and was now of serious concern. There had been a fivefold increase of reports relating to problems stemming from vaginal mesh implants in 2009 and 2010!
As this blog is being written the manufacturers have met the FDA and have submitted and agreed to some measures. These include repackaging the device to include a health warning and to further clinical trials. As at the moment the device is rated as a “moderate risk” by the FDA.
In the meantime there are a number of law suits pending. This will be a mass tort action in that the medical device should not have been sold if it was possible that it would cause the user harm. The harm it causes is great discomfort and pain, bleeding, infection and other urinary and bowel problems. Removal of the device is extremely difficult and unlikely to repair the damage it has caused.
Anyone who is suffering from a Vaginal Mesh Injury should contact an attorney who will advise and represent them in the mass tort lawsuit.