Problems In Transvaginal Mesh Complications. Despite the fact that Canada has a much lower population than the United States, Canadian women are having as many problems as women in the U.S. with transvaginal mesh complications. There are tens of thousands of women who have undergone TVT (tension-free vaginal tape) sling and transvaginal mesh procedures. Hundreds of these women have filed lawsuits claiming serious problems stemming from these devices.
The U.S. Food and Drug Administration (FDA) has received thousands of adverse event reports concerning transvaginal mesh (TVM) complications over a three-year period ending in December 2010. The agency has since increased the risk classification for TVM. A while ago the FDA announced it was mandatory for all manufacturers of transvaginal mesh to conduct post-market studies with the purpose of assessing the safety and efficacy, or not, of transvaginal and TVT mesh.
FDA and Safety Issues of Mesh Products
The FDA approved TVM mesh as an appropriate solution to pelvic organ prolapse (POP) as compared to more traditional methods that involve more invasive surgery. Pelvic mesh is approved to treat POP and stress urinary incontinence (SUI), the involuntary release of urine during every day activities. The mesh devices are made to give additional strength to the pelvic walls and muscles by way of supporting sagging organs.
Safety questions have emerged in the past few years after complaints from women of injuries including mesh erosion. This is where the mesh goes through the vaginal wall and becomes embedded in organ tissues to the point where they are impossible to be safely removed. Allegations have been made of sharp edges of mesh protruding through the vaginal wall after having traveled from the original insertion location.
With women revealing the presence of pain and suffering that may become unbearable, increasing degrees of caution have been added to the conversation concerning the controversial devices, without actually banning them.
Plaintiffs in lawsuits as well as patient advocates noted that transvaginal mesh products were approved by the FDA through 510(k). This is a fast-track process where the medical devices are not subject to stringent testing before they are approved. To facilitate this streamlined process, device manufacturers must show that the device is “substantially equivalent” to a device that has previously been approved.
At the beginning of 2016, the FDA announced that transvaginal mesh implants were to be reclassified from the former status of moderate-risk (Class II) to high-risk (Class III). This ensures that pelvic mesh devices may no longer pass through 510(k), but must undergo exacting testing for safety and efficacy.
Allegations of synthetic mesh material degradation causing inflammation to surrounding tissue, have been made. A study at the 36th Annual Meeting of the American Urogynecologic Society in Seattle, Washington in October 2015 and published in the American Journal of Obstetrics & Gynecology in August 2016 told of women reporting TVT side effects and transvaginal mesh complications. The allegations included mesh promoting inflammation that persisted for possibly years following implantation.
Lawsuits Resulting from Mesh Product Complications
Tens of thousands of women have sued device manufacturers over painful and on occasion irreversible injuries and complications they have suffered after implantation of mesh products. An estimated 100,000 lawsuits filed in state and federal courts against mesh device makers allege that substandard materials, poor design, and inadequate testing led to the women’s injuries and complications. A number of cases were organized into multidistrict litigations (MDLs). MDLs are a way of making pre-trial proceedings more efficient and cost effective by centralizing similar lawsuits before one judge.
Parker Waichman LLP has successfully represented individuals who have suffered from injuries allegedly associated with transvaginal mesh products.
A 51-year-old woman in Delaware was awarded $25 million in compensatory damages and $75 million in punitive damages in a case involving Boston Scientific’s transvaginal mesh product. The plaintiff alleged she was injured due to the implantation of their device. The woman was implanted with Boston Scientific’s Pinnacle and Advantage Fit mesh products in 2009, to treat pelvic organ prolapse and stress urinary incontinence, according to her 2011 lawsuit. The plaintiff alleged the products led to serious complications, and that some of the mesh is still in her body and continues to cause pain. Jurors found that Boston Scientific had been negligent in designing and producing the devices, and the company had neglected to alert patients and doctors about potential risks, according to Reuters.