New Congressional Bill Could Block Transvaginal Mesh
Seeking to limit the rate of patient complaints over implants, including transvaginal mesh, House democrats introduced a bill this month that would block devices from FDA approval when they are similar to products such as transvaginal mesh that have already been recalled. Many patients with such devices have already been instructed to consult with their doctor and a transvaginal mesh lawyer following complications with pain and internal injuries.
The FDA issued an alert last year when patients with transvaginal mesh implants began complaining of difficulties. However, transvaginal mesh had been approved by the FDA without any human testing because they are similar to products already tested by the Food and Drug Administration. Legislators want to close this loophole.
As Representative Edward Markey of Massachusetts noted, “If an automobile is recalled for a major safety problem, we wouldn’t allow future models to repeat this same flaw, and the same should be true for the medical devices used in our bodies.” The proposed legislation would ensure that mistakes that exist in one product do not continue to receive automatic approval.
The FDA was giving blanket approval to transvaginal mesh produced by Johnson & Johnson because it was similar to another device that had been given approval. The problem, as Markey explains it, is that the device had also been taken off of the market because of safety concerns.
Among the devices targeted by the bill is transvaginal mesh. The mesh had been implanted in approximately 300,000 women per year to help strengthen muscles in the pelvic and to help with bladder control. However, following numerous complications, the Food and Drug Administration has ordered more safety studies, arguing that transvaginal mesh implants may pose more risk than benefit in relation to other surgical options.
Among the problems that can be caused by transvaginal mesh are erosion through the vaginal tissue, infection, bleeding, pain, urinary difficulties, and pain during intercourse. Though the mesh often corrects the problem of incontinence and weakened muscle tissue, it is questionable as to whether or not it is more effective in doing so than non-mesh surgery.
If you or a loved one has had transvaginal mesh implanted, it is important that you consult with a doctor as soon as possible to determine if you are experiencing any complications due to the mesh. Following a consult with the doctor, you will want to meet with a specialized transvaginal mesh lawyer who can explain whether you have a case so that you can be compensated for medical expenses, pain and suffering, and any lost wages.
About the Author
| Mary Wiglue Transvaginal Mesh Lawyer - As Florida personal injury attorneys, Robert J. Fenstersheib and Associates deal exclusively in personal injury, accidents, defective medical products, prescription drug liability, and wrongful death claims throughout Florida, including complications associated with transvaginal mesh. A personal injury lawyer who specializes in such cases is critical, so call 1-855-TELLROBERT or visit us on the web @ http://www.tellrobert.com/ today to discuss your specific circumstances with a highly qualified professional attorney, and let us help you get the compensation you deserve. |