Transvaginal Mesh Lawsuits
Information published by the Food and Drug Administration over the last several years has revealed that there is a significant occurrence of serious health complications associated with Transvaginal mesh.
Background on Transvaginal Mesh
Typically made from synthetic materials or animal tissue, transvaginal mesh was approved by the FDA in 2002 to repair pelvic organ prolapse and to treat stress urinary incontinence. Both conditions, caused by weakened pelvic muscles, lead to discomfort and most often occur in women following childbirth and as they age.
The purpose of the surgical mesh is to reinforce supportive pelvic tissues and help keep sagging organs in place. Mesh manufacturers – Johnson & Johnson and Bard are the two largest – have touted the product as being a minimally invasive method of treating both pelvic conditions since it could be used without needing to trim the vagina or suture mesh to the vagina.
Soon after the mesh was approved, reports of adverse health effects began to roll in. In 2005, researchers in Germany and Switzerland reported over 15 percent of patients who used transvaginal mesh experienced mesh erosion and exposure.
In 2008, the FDA first warned of potentially serious health effects associated with the mesh, including mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, urinary problems and other complications.
Mesh erosion in particular can require multiple surgeries to repair and can be debilitating for some women. Even multiple surgeries will not resolve the problem for some patients.
Three years later, the FDA went on to announce that the aforementioned health complications caused by transvaginal mesh that was used to treat pelvic organ prolapse were not rare. In fact, from 2008-2010, 2,874 complications associated with the mesh were reported, and mesh erosion was the most common problem.
Mesh contraction, or shrinkage, was also discovered to be a previously unidentified risk of transvaginal pelvic organ prolapse repair.
The condition is associated with vaginal shortening, vaginal tightening and vaginal pain.
Both mesh erosion and mesh contraction can cause severe pelvic pain, painful sexual intercourse and an inability to engage in sexual intercourse.
They can also cause pain to the penis in men during sexual intercourse, according to the FDA.
“Furthermore, it is not clear that transvaginal [pelvic organ prolapse] repair with mesh is more effective than traditional non-mesh repair in all patients with [pelvic organ prolapse] and it may expose patients to greater risk,” the FDA wrote in a July 13, 2011 safety communication.
In an effort to better understand the use of surgical mesh for its intended purposes and evaluate its safety and effectiveness, the FDA reviewed all scientific literature published from 1996-2011. As a result, the FDA found that transvaginal mesh used in pelvic organ prolapse repair introduced risks not present in traditional non-mesh surgery and that mesh placed abdominally for the repair versus transvaginally resulted in lower rates of complications.
It can be argued that the FDA “approval” process that currently exists for many medical devices, including mesh, is partly to blame for the widespread use of the faulty product since it is a less rigorous process than what is required for drug approval. Devices must only be “cleared” through what’s called the 510(k) process, which simply requires that the new device, or mesh in this case, is shown to be “substantially equivalent” to a comparable device already on the market.
This means that the FDA required little to no safety and efficacy testing for the approval and marketing of transvaginal mesh.
As a result of inadequate testing, the FDA in April 2014 proposed to reclassify surgical mesh for transvaginal pelvic organ prolapse from a moderate-risk device to a high-risk device and require manufacturers to submit a premarket approval application for the agency to evaluate safety and effectiveness.