The FDA has ordered thirty-three manufacturers to study the rates of infection, painful sex and other complications linked to vaginal mesh products. The agency wrote the manufacturers, which include Johnson and Johnson, C.R. Bard and Boston Scientific, instructing them to conduct three years of trials to evaluate the safety and effectiveness of the devices amid concerns from patients and doctors who claim that the mesh implants have harmed women. The FDA made the decision following a September FDA advisory panel recommendation that such studies be required. To learn more about the vaginal mesh complications which have prompted this action, visit
http://www.classaction.org/transvaginal-mesh.html today.
To date, complications associated with these devices have reportedly spurred more than 650
vaginal mesh lawsuits against the products’ makers, as well as concerns regarding the FDA program which introduced the meshes into the marketplace without human testing. The FDA’s 510(k) system was used to approve the meshes, allowing them to be cleared for sale based on the agency’s decision that they were similar to devices already on the market. The clearance system aims to allow manufacturers to continue updating existing products without having to conduct lengthy testing with each change.
The manufacturers contacted by the FDA have 30 days to respond to the letters requiring post-market studies of the vaginal mesh implants. While the FDA isn’t likely to grant some patient advocates’ request for a vaginal mesh recall, according to reports, it is still considering whether to reclassify transvaginal mesh implants used in the repair of pelvic organ prolapse as “high-risk” devices which require human testing, a recommendation made by an advisory panel in September. Amid growing concerns of
vaginal mesh problems, Class Action.org is currently offering a free case review to all women implanted with a vaginal mesh product, either in the treatment of pelvic organ prolapse or stress urinary incontinence, to help determine if they have legal recourse to seek compensation for medical bills, pain and suffering and other damages. To receive your free case evaluation, visit ClassAction.org today.
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Class Action.org is dedicated to protecting consumers and investors in class actions and complex litigation throughout the United States. Class Action.org keeps consumers informed about product alerts, recalls, and emerging litigation and helps them take action against the manufacturers of defective products, drugs, and medical devices. Information about consumer fraud issues and environmental hazards is also available on the site. Visit http://www.classaction.org today for a no cost, no obligation case evaluation and information about your consumer rights.
