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FDA: More Than 126,349 Reports of transvaginal mesh Adverse Effects

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Transvaginal mesh, also called vaginal mesh or pelvic mesh or bladder sling, tape, or sling has been used in the medical field since the 1950s. It is a medical device that is used to provide additional support when repairing weakened or damaged tissue. Transvaginal surgical mesh was intended to permanently repair stress urinary incontinence (SUI) and pelvic organ prolapse (POP) and were approved specifically for SI use in 1996. But due to the design defects and the manufacturer’s negligence the device has contributed to serious events and complications such as organ perforation and tissue erosion. 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. Commonly reported problems include severe pelvic pain, pain during intercourse, infection, internal bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.

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. In a recent report there were 126,349 adverse events reported to FDA of the device is linked to serious health complications. According to the FDA more than 23,641 adverse effects of the TVM are reported by Physicians. Attorneys are also reporting Transvaginal Mesh adverse events to FDA. The adverse events reported by Attorneys were not less than 25,000. In addition more than 1,000 hospitals and clinics sent negative reports of TVMs to the Food and Drug Administration (FDA). Beside this 49 recalls for the various medical device manufacturers are reported. The manufacturers of transvaginal mesh devices involved in the recall included Boston Scientific, Bard, Medventure Technology and Johnson & Johnson. Johnson & Johnson alone had 42,890 complaints.

In January 2016, the FDA announced the reclassification of transvaginal mesh. The agency re-labeled the products high risk instead of moderate and announced new federal scrutiny for the company. 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. The Women throughout the United States suffering from numbers of life-threatening complications of Transvaginal mesh Include pain during intercourse, Mesh erosion into the vagina, Perforated bladder, perforated bowel or perforated blood vessels, Organ injuries, Multiple occurrences of pelvic organ prolapse and Urinary tract problems. 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.

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. More than 70,000 mesh lawsuits pending in the U.S. District Court for the Southern District of West Virginia. Additional lawsuits are pending in state courts. 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 Cook filter 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.

 

 

 

 

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