Surgical mesh is used to treat multiple conditions in which the body’s organs need added support. Transvaginal mesh has two uses:
- Treating pelvic organ prolapse, which occurs when a woman’s pelvic organs descend and protrude through the vagina.
- Treating stress urinary incontinence, which is a condition that causes a woman to experience involuntary urine leakage.
Transvaginal mesh is primarily constructed from a synthetic plastic type of material, but there are also versions made from stainless steel and biological materials. Mesh is usually sewn in place through a surgical procedure and is intended to be a permanent solution to the medical issues it treats.
Because mesh had been so successful for treating hernias, doctors began using it to treat pelvic organ prolapse, but instead of placing it abdominally, they inserted it through the vagina. This has proven to be a risky procedure, as some women have experienced organ perforation during insertion.
Perforation is not the only complication associated with transvaginal mesh. Some women have also experienced erosion or disintegration of the mesh, and several have required follow-up surgery to repair the problems. Unfortunately, these follow-up procedures are often unsuccessful.
FDA Takes Action on Transvaginal Mesh
The FDA was so concerned about the complications related to transvaginal mesh, it issued a notification in 2008 regarding the more than 4000 adverse event reports it had received over the course of five years.
Almost two years in later in July of 2011, the FDA updated its report to patients and surgeons who use the transvaginal to treat the pelvic organ prolapse. The new report advised that complications for transvaginal mesh users treating pelvic organ prolapse and stress urinary incontinence are “not rare.” The report also made clear there was limited evidence as to whether transvaginal mesh for treating pelvic organ prolapse was any more effective than non-mesh treatments. It questioned whether there might actually be greater risk for these patients.
Approximately six months after that update, the FDA issued another report stating it was considering reclassifying transvaginal mesh as a high-risk device. In April 2014, the FDA did just that. Tens of thousands of lawsuits in America were filed by woman who experienced transvaginal mesh complications following that reclassification.
Transvaginal Mesh Lawsuits
With more than 70,000 lawsuits filed against manufacturers of transvaginal mesh in federal court, many of the claims are similar. Women believe the makers of transvaginal mesh misled the medical community and consumers by concealing information about the risks associated with mesh. These companies are also accused of failing to warn of the risks related to placing mesh. Many plaintiffs also believe the products were rushed to market without appropriate testing or evaluation by the FDA.
One of the major concerns related to transvaginal mesh and mentioned in many of the lawsuits is that once mesh is placed it cannot be removed. This means once mesh is placed, if complications arise, women are forced to live with the pain and misery they experience.
Women who have been injured as a result of using transvaginal mesh might have the right to take legal action against the manufacturers of this material. So far, a high rate of women have been successful with their legal claims against transvaginal mesh maker. Many have received sizeable awards in court and because of that trend, many manufacturers are now tending to offer settlements to avoid lengthy and highly publicized trials.
In 2012, Bard was ruled liable for $3.6 million regarding its transvaginal mesh product. The following year the company settled out of court on the first day of the bellwether trial. Endo Pharmaceuticals paid $54 million in a transvaginal mesh settlement in 2013. Perhaps one of the most noteworthy rulings came in 2014 when Bard was ordered to pay $73 million over its mesh devices.
Our goal is to make sure women understand the risks associated with transvaginal mesh, especially when it is used to repair pelvic organ prolapse. We also want them to know there are alternatives, which the FDA believes might even be more effective, and to discuss those alternatives with their healthcare provider. And if you or a loved one has received a transvaginal mesh implant and suffered health complications as a result, we want to make sure you know compensation might be available.