A federal judge in West Virginia denied Boston Scientific Corp. summary judgment in two separate cases this month, both regarding transvaginal mesh products. While the factual issues at stake were slightly different for each product, they both reflect a growing concern about transvaginal mesh’s overall safety.
Have you had serious complications after receiving Pelvic Mesh? Act Now. you may be entitled to financial compensation.
Summary Judgment Denied in West Virginia Courts
Judge Joseph Goodwin is a judge for the U.S. District Court for the Southern District of West Virginia, where several cases have been consolidated in the wake of mounting transvaginal mesh lawsuits. Two of Boston Scientific’s TVM products, Advantage and Pinnacle, sought summary judgment but were denied. It’s up for debate whether Boston Scientific failed to provide implanting surgeons with enough warning about the dangers of their Advantage transvaginal mesh. With their Pinnacle TVM product, however, the judge found another question of fact exists: potential intentional misconduct or gross negligence.
According to Harris Martin Publishing, Boston Scientific had been warned not to implant the material polypropylene into the human body – a material found in several of its products. Essentially, a jury could find that the company actually knew of a defect at the time the device was marketed, and that its lack of clinical testing could indicate a lack of care for consumer safety, says Product Liability Law Daily.
An Accidental Approval and Its Repercussions
Several different drug makers have been slammed with lawsuits in recent years, thanks to consistent injuries across the board. Transvaginal mesh is a relatively similar product, regardless of who manufactured it, and it’s one that many doctors and patients now say should never have been cleared for use.
So how did a product that causes so many problems end up on the market? Through a type of loophole in the FDA approval process. When a new device is similar enough to an older one, it can automatically pass through the clinical testing stages and rigorous approval process the FDA usually employs. In this case, current TVM products were similar to an older TVM brand – one that was recalled due to safety issues. This points to an obviously faulty process, as it doesn’t take into account how safe or effective the previous product was when evaluating the new one.
Even the older TVM device was approved based on an older abdominal mesh. While this product has not historically caused the same problems as TVM does today, it was used in an entirely different place of the body. Researchers and drug makers did not anticipate that it could cause different reactions when it was implanted into new areas of the body, but they also ran little to no clinical testing to confirm this.
When doctors began implanting the product into women with organ prolapse or vaginal vault prolapse, it began to erode through many women’s vaginal walls. Vaginal scarring, shortening and intense pelvic pain were common side effects, and countless women sought to have the device removed entirely—a procedure that, once the device has begun to erode, is nearly impossible. After initially posting a warning about the dangers associated with the device, the FDA posted an additional statement on TVM, saying that injuries were not uncommon and that doctors should take caution.
Speak With a Professional
If you or someone you know has been implanted with transvaginal mesh, you may be eligible to file a lawsuit. Before you get started, it’s a good idea to have an attorney who is familiar with mass torts of this nature, as he or she can help you be more successful moving forward.
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.