Sep 15
What does the FDA Safety warning mean for those already with vaginal mesh implants?
There are a growing number of women who have had operations to repair sudden urinary incontinence (SUI) or pelvic organ prolapse (POP). Surgery in these cases is by no means an operation to be undertaken without all other options being explored first. Any incision into the pelvic floor is fraught with danger and only well trained surgeons will undertake it. There are many sensitive organs own there which have started to come out of their normal position if one needs the treatment.
In roughly a quarter of these cases done in recent times has an implant known as a sling, a hammock or vaginal- or transvaginal mesh been used. To a non medical person it sounds horrific but in fact the doctors and surgeons who perform these operations reckon that it is a great boon. The reason for the surgery is that the muscles that hold everything in their allocated places have become stretched and loose, probably through childbirth. Some of the organs then start slipping downwards and forwards and pressing on the vaginal passage. This may be aggravated if a hysterectomy has already been performed as there is now a cavity where the uterus used to be. With most cases this can be corrected with the performance of exercise for those muscles and or a pessary.
But in some cases, especially where a patient is past childbearing and is in great discomfort or has other problems (like incontinence) or inability to have sex without pain is and operation indicated. And in roughly a quarter of these cases will the surgeon wish to use vaginal mesh. They claim that it gives a firm base for the support of the organs, has reduced the percentage of POP or SUI recurrence and greatly reduces the recuperation period.
These latter claims are cast into doubt by the FDA safety warning of 13 July 2011 which is an update of a pervious safety warning in October 2008. In the 2008 warning the FDA stated that there had been some adverse reactions to the implantation of transvaginal mesh, but these were “rare” and there was insufficient evidence of what was untoward.
The 13 July 2011 FDA safety bulletin was far more to the point. They now no longer regard the instances as rare as they had received over 2,400 reports of problems linked to Vaginal Mesh Injury in the 2 years subsequent to the 2008 warning and now regarded the risk as being of “serious concern”.
There are currently 500 cases of women who are suffering from this problem who have now filed a Vaginal Mesh Lawsuit against the manufacturers. This mass tort action is a claim that they have been injured by the mesh and the manufacturer is liable as this should not happen.
All women who have had vaginal mesh implants in the last 10 years are actively encouraged to consult the doctor who did the operation to ensure all is well. A small minority who may be suffering from the mesh failing are encouraged to seek counsel.