The meetings continue today but, the FDA panel already appears to be heavily in support of an FDA plan to reclassify all vaginal mesh as Class III devices.If this is done, Medical device makers who fast-track approval of the devices will have to do detailed clinical trials before being allowed to put them on the market. Existing products will be allowed to remain on the market.
The pelvic organ prolapse surgical mesh products, which are implanted through the vagina, are currently considered a Class II medical device. This means that manufacturers can apply for approval through the FDA’s 510(k) approval process. That process requires that a manufacturer show that the device is substantially equivalent to an existing device on the market, without requiring increased clinical testing.
The various vaginal mesh products have been in the news the past few weeks due to the current FDA meetings with clinicians and manufacturers.
Because of the many Horror Stories ,Injury Lawyer Network now has an online support group for women to share their stories and get support from other women. According to Lisa Spitzer MSW, Injury lawyer Network" The vaginal surgical mesh complications have taken their toll on women not just physically but, psychologically." Spitzer says"These side effects have added stress to marriages and changed the quality of life of women effected." "I have listened to so many horror stories"says Spitzer. "Women need a support group to share their feelings and experiences." "They should not be left to feel helpless and alone"." The approval the FDA gave these companies was inadequate", continues Spitzer. "These women have suffered severely." One woman who called today said "This is effecting entire families. When mommy does not feel good the entire family suffers". Spitzer continues "women call in tears, lives completely turned around.They are in constant pain.""Many have lost faith in their doctors and do not know where to turn or what doctor to trust". "Men are being effected as well when the mesh erodes thru the vaginal wall."" The stories are endless.""The pain, suffering and tears is a daily occurrence on the helpline."
An FDA advisory panel considering the use of trans vaginal mesh leans toward reclassifying the products as high-risk without issuing a recall. "It is Important that women involved be updated," says Spitzer MSW and spokes person for Injury Lawyer Network. Over 3000 Vaginal mesh patch, Vaginal Mesh lawsuits have been filed Nationwide. Over 300,000 women have been treated for uterine prolapse. According to Spitzer"this is a worldwide problem.""We have had calls from Canada and the UK."
Injury Lawyer Network is not just lawyers interested in cases. They offer support and help to women going thru this traumatic experience. The helpline is not only a means of connecting with an experienced physician, but also support and information. Women are encouraged to leave their stories on line for other women to read and know they are not alone. According to Spitzer,spokes person for Injury Lawyer Network "women should see a physician immediately to know where they stand and make available all avenues for financial compensation." Spitzer continues," For the stories I hear ,there is no compensation large enough that will justify this kind of pain and suffering" Injury Lawyers Networks' Surgical mesh legal team is accepting claims against the various manufacturers for the women who are victims. Spitzer says," the FDA must hear these suffering voices and act"
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