Transvaginal mesh, also known as TVM, pelvic mesh, or a bladder sling was intended to permanently repair stress urinary incontinence (SUI) and pelvic organ prolapse (POP). The device has been sold to millions of women for years, and resulted in thousands of lawsuits about severe health issues associated with the device. Thousands of lawsuits have been filed by women and their families against medical device manufacturers of vaginal mesh products. More than 70,000 lawsuits filed by women who were injured by mesh implantation. The vaginal mesh lawsuits are pending in the U.S. District Court for the Southern District of West Virginia. Additional lawsuits are pending in state courts. The Lawsuits have similar allegations that the health care giant Johnson & Johnson have not disclose and mispresented the severe risks associated with transvaginal mesh implant and falsely marketing the device without adequate warning of it adverse effects.
Transvaginal mesh is a medical device that is used to repair tears in the connective tissue of the pelvis, causing the intestines, bladder or bowel to protrude into the vagina. Vaginal mesh, transvaginal tape, and transvaginal slings are used to stitch the connective tissue in the vaginal wall muscle back together. Unfortunately, thousands of women have been seriously injured when their implant eroded into their vagina, perforated organs, caused chronic pain, or required revision surgery. Transvaginal mesh is implanted through the vagina to support weakened, sagging pelvic muscles. The mesh is produced by several manufacturers and has been used in tens of thousands of surgical procedures in the United States. But TVM has been linked to serious health complications that can often require painful and invasive revision surgeries to correct.
The FDA has warned women about the risks of transvaginal mesh and its complications for years. Recently in July of this year two final orders have been issued by the U.S Food and Drug Administration to manufacturers and the public, the first one is to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP. Now, the agency is finally taking direct action to limit the use of this popular but potentially dangerous product and announced new federal scrutiny for the company. According to the FDA, the transvaginal placement of the surgical mesh may put women at a greater risk for POP mesh complications than other surgical options.
As per a report the serious complications associated with the product and the increasing number of lawsuits may have this disputed product off the market by 2019. Despite multiple warnings released by the FDA the manufacturers are continue to sell their defective and dangerous product in the market without considering the life-threatening risk cause by their device. As per the FDA guidelines, Patients should be notify by provider that mesh is permanent, once implanted it may not be possible to remove. The implanted mesh may require additional surgery that may or may not correct the complication and the provider should be careful in most cases, mesh is not required and all complications can be avoided by not using it.
If you or somebody you know was injured or suffered complications or death from Transvaginal mesh, you should contact Drugsclaim.com for a free case consultation. All cases are pursued on a contingency fee basis there are never any out-of-pocket costs to hire our attorneys unless we win your case. The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs Lawsuits.