The number of complications related to transvaginal mesh, also referred to as a bladder sling, is staggering. There could be tens of thousands of injuries and hundreds of deaths according to reports made to the FDA. Official reports of complications, made in the form of Adverse Event Reports (AERs), currently number in the thousands with at least 10 deaths being reported.
These reports are voluntarily made by physicians or patients who become aware of the complications by various means. Recent studies estimate that the actual rate of injury may be 1,000 times what is reported in the AER database. This rate of injury would not be surprising considering that more than 100,000 of these types of procedures are performed annually.
AERs are an important and helpful tool for the FDA. The FDA will use this in their post-approval surveillance. But it is important to remember that the FDA is a regulatory body, and a severely underfunded one at that. The manufacturers of these types of products are in the best position to know what is happening with their product. They have representatives that are in doctors offices daily and actually assist with surgery. It may surprise some to learn that these company representatives actually “scrub in” for surgery to help doctors with the placement of the mesh. It defies logic to think that these representatives, and in turn the manufacturer of the transvaginal mesh, did not know that so many women were getting hurt.
I was intrigued by what Rebecca G. Rogers, MD had to say in 2008 about this trend in medical device surgery, and its practical implications:
In the past, surgery was learned from mentors, typically senior surgeons, who either taught us directly as residents and fellows or indirectly as colleagues when discussing or observing cases. Surgical innovation was driven by expert opinion. Innovations are still introduced by surgeons, but are now marketed by companies whose primary allegiance is to their stockholders, not to our patients.
Sadly, Dr. Roger’s insightful words appear to be even more relevant than ever, considering the amount of injuries being reported from transvaginal mesh, and the amount of money that was being made by this product. Individuals injured by these products need to summon the courage to hold these manufacturers responsible for their misconduct.