1What is transvaginal mesh?
Transvaginal mesh was first approved in the 1990s by the U.S. Food and Drug Administration (FDA) for the repair of pelvic organ prolapse and stress urinary incontinence in women. It is a mesh-like medical device that is made of polypropylene or biological material, most commonly plastic-coated with biologocal materials. It is used to treat feminine urinary incontinence and pelvic organ prolapse by providing stability and support to pelvic organs, including the vagina, uterus, bladder, urethra, small bowel, or rectum. Transvaginal mesh was intended to be an improvement on previous procedures such as retropubic urethroplexy, pelvic reconstruction, or colpocleisis. The mesh implant is often shaped like a sling or hammock. The ends of the implant are secured to the pelvic bones, like the ends of a hammock are attached to a tree. The middle section of the device is made of synthetic mesh material, which fits like a hammock around the involved pelvic organ. The device is surgically implanted through the vagina, giving it the name "transvaginal". Materials used to construct the mesh vary between manufacturers.
2Why is the use of transvaginal mesh dangerous?
Thousands of patients filed injury reports to the FDA from 2005 to 2010. The FDA estimates that failure rates for vaginal mesh devices could be as high as 10 percent. Serious complications from device failure can include mesh erosion through the vaginal epithelium, pain during sexual intercourse, vaginal scarring, inflammation and urinary problems. In some cases, the damage cannot be repaired and is permanent. Nerve damage can cause recurring pain and/or loss of sensation. Any organ close to the location of the transvaginal mesh implant may be subject to damage from the mesh due to perforation.
3Why did the FDA approve a product with such a high rate of side effects?
In 1996, the first transvaginal mesh device was approved under FDA code 510(k) - a clearance process that does not require thorough testing of the product by the manufacturer so it could gain approval through a "fast-track". In 1999, the ProtoGen mesh device produced by Boston Scientific was the first to be recalled after only three years, due to overwhelming numbers of injury reports. Since the devices were not required to pass stringent testing requirements that are normally needed for approval, a number of medical device manufacturers were able to receive clearance for products similar to the recalled mesh.
4What makes a manufacturer liable?
Under product liability law, all that needs to be proven to constitute liability is that a product is defective, or “unreasonably dangerous” for its intended use, and that the product caused injury. Whether the manufacturer bears any fault for the defect is not relevant, as the focus is solely on the product itself. This is referred to as “strict liability,” and it makes product liability law unique among other personal injury theories of recovery.
5What are the typical symptoms?
Usually the overwhelming complaint for vaginal mesh failure is vaginal or severe pelvic or groin pain. Often times, the pain may be felt during sexual intercourse. Other symptoms to look for include urinary incontinence, recurrence of POP, irregular vaginal discharge and infections, abdominal pressure and perforation of pelvic organs, bowels and blood vessels.
6What should an individual do who feels they may have a case?
Since the statute of limitations varies from state to state, time is of the essence for filing a claim. The individual should contact an attorney that is knowledgeable and has experience in the area of transvaginal mesh. Through consultation, the patient will be advised about the strengths and weaknesses of a possible case, and will establish a strategy to pursue monetary compensation if the claim is warranted. Presently, several mesh manufacturers are facing lawsuits from women that have been harmed as a result of complications from a transvaginal mesh device.
7How long will it take?
This is a difficult question to answer. Each case is unique and there are many variables. Generally, large lawsuits are more complex and are subject to a wider range of problems. In many product liability cases, it can take an average of two years before a case is fully resolved. Although many cases are settled out of court, that is not always the case and does not typically occur unless both the patient and the defendant have prepared for a trial.
8Class Action vs. Private Lawsuits
One of the first steps for those who want to file a transvaginal mesh lawsuit is to decide whether to join a class action suit or file a private lawsuit. Both types of lawsuits have their advantages and disadvantages.
A class action suit is when a group of claimants having similar complaints join to bring a lawsuit to a defendant. One of the advantages of class action suit is that plaintiffs generally aren't required to be present at the court proceedings. That may be favorable to claimants who are still recuperating, working or who wish to remain out of the public eye. With multiple victims involved, class action suits can also have a greater impact on society by alerting the public to possible dangers.
Private lawsuits are persued by a single injured person. Claimants usually have a better chance at receiving a more substantial jury award or settlement through a private suit rather than a class action. In a class action suit, any settlement or award is split amomng all members of the class, as well as their attorneys. That can include hundreds or even thousands of individuals. In addition, in a private transvaginal mesh lawsuit, the case will be decided on the specific circumstances of the plaintiff's injury rather than on the overall grievances of a class.