Transvaginal mesh also known as a pelvic mesh or bladder sling 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. The device is implanted through the vagina to support weakened, sagging pelvic muscles. The mesh is produced by seven manufacturers and has been used in tens of thousands of surgical procedures in the United States despite the device is linked to serious health complications. In thousands of cases, defectively designed and manufactured meshes have caused irreparable pain and injuries often require painful and invasive revision surgeries to correct. 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.
In January 2016, the FDA announced the reclassification of transvaginal mesh. The decision by the FDA to reclassify the transvaginal mesh products as “high risk products” is a confirmation of the inherent danger of these products. In Its announcement FDA states that the manufacturers are informed that to submit proof of their devices are safe and effective as proven by clinical trials within 30 months to the agency. Thousand women have suffered from pain during intercourse, pelvic pain and several surgeries to remove the mesh and filed lawsuits against the manufacturers of concealing known risks, failing to warn about side effects, and continuing to market the mesh as safe and effective device. The plaintiffs accuse the company for manufacturing a defective medical device.
There have been thousands of adverse events reported to FDA associated with Transvaginal Mesh including infections, pain, urinary tract problems and painful intercourse as well as a recurrence of prolapse and incontinence. Though there are many manufacturers of transvaginal mesh devices, thus far companies named in current lawsuits include such notables as: American Medical Systems (AMS), a subsidiary of Endo, C.R. Bard, Cook Medical Inc., Boston Scientific, Coloplast Corp and Neomedic. Women suffered with several injuries, financial distress and complications affecting families as a result of the use of transvaginal mesh (TVM) products filed lawsuits against the manufacturers of concealing known risks, failing to warn about side effects, and continuing to market the mesh as safe and effective device. Women accuse the company for manufacturing a defective medical device. Poor testing and inadequate research on the device put thousands of women life in danger.
The FDA has the authority to ban such defective medical device on the basis of all available data and information and physicians should discontinue its use in treatments. If you had a trans vaginal mesh (TVM) implant, also known as a pelvic mesh implant or bladder sling, and are suffering from painful, serious transvaginal mesh side effects after one or more revision surgeries. You may be entitled to compensation. 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.