What exactly is Transvaginal Mesh?
Have you or someone you loved been injured from the transvaginal mesh implant? Don’t feel left out. Women across the United States have experienced life-altering side effects as a result of the defective vaginal mesh products.
If you have been injured as a result of any of the transvaginal mesh products, you should contact our firm, SettleOurTVM to learn more about your rights. Our firm has been helping women and their families for many years now. We understand your pain and our concerned attorneys sensitive are available to discuss the nature of your injury. Your initial consultation is free and confidential.
Get in touch with our network of attorneys and surgeons at 1-888-994-2165.
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SettleOurTVM Transvaginal Mesh Lawyers
Did you undergo pelvic organ prolapse (POP) repair surgery and have transvaginal mesh implanted? Have you suffered from the undue complications like eroded mesh, chronic infection, pain, or perforations of the bladder, bowel, or blood vessels? If yes, you may be eligible for financial compensation.
Lawsuits are being filed across the nation by transvaginal mesh lawyers alleging that the manufacturers of TVM or bladder slings failed to warn both doctors and patients of the increased risk of complications associated with the material.
Latest from the FDA
On January 4, 2016, the Food and Drug Administration (FDA) made the move to reclassify transvaginal mesh medical products from Class II to Class III. Class III devices are considered “the highest risk devices" and are therefore subject to the top-most level of regulatory control. This regulation meant manufacturers such as C.R. Bard, Inc., Ethicon, Johnson & Johnson, American Medical Systems, Boston Scientific, and other companies should submit premarket approval (PMA) applications “to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.”
Between 2011 and 2015, more than 20,000 complaints were submitted to the FDA. The agency issued warnings, and in May 2014 proposed to change the risk classification to Class III and to require pre-market approval, which is followed by the current orders.
More recently, the FDA has urged Coloplast and Boston Scientific to stop selling surgical mesh for some, but not all, procedures related to pelvic floor disorders. The recall is applicable to the mesh used in transvaginal repair of POP. However, the FDA has not recalled the mesh which is inserted through an abdominal incision (laparoscopic, open, or robotic) for POP repair, or the mesh used in the treatment of stress urinary incontinence (SUI).
Timeline for FDA updates
2008: In October, the FDA announced a Public Health Notification to inform health providers and patients of the adverse events related to surgical mesh.
2011: The FDA again warned about the adverse event reports associated with the surgical mesh. The department published a report highlighting the 2,874 Medical Device Reports they received from 2008 – 2010. The reports included cases of device malfunctions, injury, and even death.
2012: The FDA mandated manufacturers of transvaginal mesh to carry out post market surveillance research on the devices to evaluate its effectiveness and safety.
2014: Two separate orders for the surgical meshes were carried out in May. The first was to reclassify the surgical mesh for POP into Class III instead of the existing Class II. This labeled the surgical mesh as being a high-risk rather than a moderate-risk device. The second order required manufacturers to put forward a premarket approval application highlighting the safety concerns.
What should you do?
Make sure to proceed with great caution before moving further with transvaginal mesh surgery. If you are currently suffering from pelvic organ prolapse, or any other condition which has the scope to be treated with transvaginal mesh, make sure to have an elaborate discussion with a trusted doctor about all other options and the possible complications.
But, if transvaginal mesh has already been implanted in your body, and you are now suffering from adverse health issues, call 1-888-994-2165 to reach the extensive team of SettleOurTVM. Meet the transvaginal mesh lawyers and surgeons who are here to support you, and you won’t pay a thing unless your case is settled.
Contact SettleMyTVM today for your FREE legal consultation.
The FDA recently issued a warning that Transvaginal Mesh can cause serious side effects and complications. If you’re suffering from a Mesh Implant or bladder sling you may be entitled to significant compensation and even surgical help to potentially correct your complications. If you or a loved one are suffering as a result of a Transvaginal mesh, call us right now.
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So far, there have been verdicts totaling MILLIONS of dollars for victims like you, but there are strict deadlines to file your claim.
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Whether you deserve financial compensation, or NEED SURGICAL RELIEF we can help. Our network of attorneys and surgeons are here to support you, and you won’t pay a thing unless your case is settled.