There are 44,020 reasons not to trust transvaginal mesh – that’s the total number of cases filed against seven different manufacturers as of March 13, 2014. C.R. Bard, American Medical Systems, Boston Scientific Corp., Ethicon, Inc., Coloplast Corp., Cook Medical, Inc. and Neomedic lawsuits have all been consolidated to West Virginia as part of multidistrict litigations being heard by U.S. District Judge Joseph R. Goodwin. There have been mixed results for the companies, but a clear pattern has started to emerge: mesh makers are settling lawsuits that accuse them of manufacturing defective and dangerous products. Last month, we reported that Endo has set aside $520 million as it prepares to resolve litigation over its mesh products. Earlier this month news broke from sources close to Coloplast that the company would settle several mesh lawsuits for $16 million. American Medical Systems, meanwhile, has agreed to settle a number of lawsuits to the tune of $54.5 million, and two bellwether trials held last year ended in settlements for the plaintiffs, one for more than $2 million (the other amount was undisclosed).
Injuries including scarring, infection, urinary problems, pain, and organ perforation – the momentum against transvaginal mesh is growing.
As thousands of women continue to seek compensation for injuries they claim were caused by mesh products – injuries including scarring, infection, urinary problems, pain, and organ perforation – the momentum against transvaginal mesh is growing. You might be surprised to hear, then, that mesh continues to be approved for use in the U.S. – and the EU is currently launching an investigation to determine if the risks outweigh the benefits.
The European Union’s executive branch has requested that the 28-member body’s Scientific Committee on Emerging and Newly Identified Health Risks begin a study of metallic and polymeric screens (read, transvaginal mesh). Specifically, the study is a cost-benefit analysis of mesh as a surgical option for stress urinary incontinence and pelvic organ prolapse – the very use that has led to so many lawsuits here in the States.
The EU, in essence, seems to be weighing the cost of using mesh implants against the potential cost of injuries and ensuing litigation. In its defense, few studies exist examining the overall impact of mesh on rates of pelvic prolapse. As the number of more elderly women in Europe grows due to increased life expectancy and medical advances, doctors are looking for ways to improve gynecological care – and mesh, despite the allegations that it can cause injuries, may be the answer. In its request for the scientific opinion, the European Commission concluded that “[c]urrent data suggest that the use of mesh in surgery is associated with both benefits and risks but few randomized controlled trials have been published.”
Still, the request also justifies the need for a suitable medical device:
“Pelvic floor dysfunction is a major health issue for older women, as shown by the 11.4% (women aged 45-85 years) lifetime risk of undergoing a single operation for pelvic organ prolapse and urinary incontinence, as well as the large proportion of reoperations (29.2%) and the time intervals between repeated procedures that decreases with each successive repair.”
So, Europe needs to know if using mesh makes sense in the long run, but the EC is at least wary of approving mesh products with so many complications already being reported. The SCENIHR has been asked, by January 2015, to “assess the risk of meshes used in urogynecological surgery and more generally for other uses,” and to provide the EC with answers to the following:
- Are certain types of mesh more likely to cause injuries? If so, what materials pose a greater risk?
- Do specific surgery techniques increase or decrease complications?
- Does using mesh add more risk compared to non-mesh surgical intervention?
Mesh does not have to be inherently problematic – it just seems that manufacturers have released products with defective designs and what many would see as unacceptably high rates of injuries and complications. If mesh use in the U.S. is any indicator, the EC should be wary of approving the use of transvaginal mesh without first gaining more information and, perhaps, encouraging manufacturers themselves to address issues that have already affected thousands of patients.