Thousands of women around the country have filed transvaginal mesh lawsuits against manufacturers of these devices after experiencing serious complications that have lead to the need for surgical removal of the mesh. Doctors use TVM to treat conditions such as stress urinary incontinence and pelvic organ prolapse. But in many cases, women suffer from chronic pain, perforation, organ damage and other major issues because of this device. Injured patients say repairing these issues with TVM leaves them severely or permanently damaged as a result. Recently, two Dallas women sought justice and compensation in court.
Dallas Jury Awards Plaintiff $1.2 Million in Damages
Dallas District Court Judge Ken Molberg presided over two transvaginal mesh trials. According to the Dallas Observer, the first case ruled in favor of the plaintiff, Linda Batiste. That verdict ordered mesh maker Johnson & Johnson to pay Batiste $1.2 million in damages. The second trial is currently underway against Boston Scientific.
The second plaintiff, Martha Salazar, sued due to injuries from her Obtryx mesh sling. Salazar’s attorney showed jurors an internal Boston Scientific employee email. In it, employees discussed a research paper that brought to light some negative mesh side effects. However, the employees decided against sharing this research with any healthcare customers.
TVM Manufacturers Respond to Allegations
“I don’t feel that this paper would useful to the sales force, in terms of helping defend business or selling more slings,” a Boston Scientific employee wrote to a coworker in sales, according to the Dallas Observer. “It actually is a fairly negative outcome in terms of our Obtryx sling.”
Boston Scientific’s lawyers wanted to tell the jury that the mesh sling received U.S. Food and Drug Administration approval. However, Judge Molberg did not allow it. He noted the device was grandfathered in, but not cleared. In other words, this particular mesh never gained FDA approval. The judge was referring to the organization’s 510(k) program, which fast-tracks new devices. This program “clears” devices for market without undergoing any initial safety testing. Instead, manufacturers find a similar product that’s already on the market and argue that the device is “substantially equivalent.”
The Consumers Union noted this fast-tracking process clears 78% of high-risk medical devices for market. The union then argued this percentage is much too high for devices like TVM.
What You Can Do
If you have required surgery to remove a mesh device after suffering serious consequences, you might be eligible to file your own transvaginal mesh lawsuit. You may want to consider speaking with an attorney if you choose to pursue this course of action as he or she will have the expertise you need to have your best chance of winning.
Lori Polemenakos is Director of Consumer Content and SEO strategist for LeadingResponse, a legal marketing company. An award-winning journalist, writer and editor based in Dallas, Texas, she's produced articles for major brands such as Match.com, Yahoo!, MSN, AOL, Xfinity, Mail.com, and edited several published books. Since 2016, she's published hundreds of articles about Social Security disability, workers' compensation, veterans' benefits, personal injury, mass tort, auto accident claims, bankruptcy, employment law and other related legal issues.