Thousands of women have been injured due to transvaginal mesh (TVM) devices used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) – conditions that typically occur after pregnancy and childbirth.
So many TVM lawsuits have been filed that they have been consolidated into five vaginal mesh multidistrict litigations (MDLs) against manufacturers American Medical Systems (AMS), Ethicon, Boston Scientific, Coloplast and C.R. Bard. Three of those MDLs – AMS, Ethicon, and Boston Scientific – will begin Bellwether trials starting in 2013. Here’s what it all means…
TVM MDLs / Bellwether Trials
The process of consolidating cases allows lawsuits associated with a particular product – in this case, similar transvaginal mesh products manufactured by different companies – to be coordinated under one judge for pretrial litigation. This allows each lawsuit to retain its own identity while avoiding duplication in the discovery process. However, unlike a class action lawsuit, if the MDL does not resolve the cases by settlement, they are transferred back to where they were originally filed.
Some cases within the MDL go to trial to discover what types of issues will arise and to determine how a jury (and other juries in future cases) may react to the evidence presented. It’s these initial cases that are known as Bellwether trials.
What’s The Expected Outcome?
Clearly that’s the question everyone wants to know. What’s generally known is that TVM manufacturers allegedly failed to adequately warn women about the serious transvaginal mesh side effects they might face, neglected to conduct meaningful clinical trials on the products and may have knowingly rushed them through an FDA process known as the 510(k) simply to get them on the market as soon as possible.
Last July, the FDA issued a warning that complications associated with transvaginal mesh injuries were much more common than originally thought and asked over 30 TVM manufacturers to conduct post-market safety studies to assess the risk of the devices on organ damage and other health issues relating to mesh use. Ironically, the FDA also stated that there is no substantial evidence to show that using transvaginal mesh offers any significant benefits over using traditional methods of treating POP or SUI.
Transvaginal Mesh Lawsuits
Correcting transvaginal mesh injuries can often require undergoing painful revision surgeries to either fix the problem (if even possible) and to remove the mesh altogether – both options that result in losing more time from work, enduring additional pain and suffering and paying even more medical bills. If you’ve been injured or are considering whether you might have a transvaginal mesh lawsuit, please contact the Driscoll Firm. We can explain how the current litigation might affect your lawsuit and discuss the types of compensation to which you might be entitled.