According to reports, Ethicon has asked the FDA to allow it 120 days to end sales of these vaginal mesh systems. The company said that this would provide them the opportunity to notify customers and allow hospitals and surgeons adequate time to choose alternative treatments for their patients. Ethicon “will also discontinue or revise, as appropriate, all marketing materials during this time,” the letter states. In an e-mail, a spokesman for the company said that Ethicon is discontinuing sales of the products worldwide, but is not recalling those already sold or implanted, according to reports.
Amid concerns about vaginal mesh compilations, the FDA in January ordered that Johnson and Johnson and 30 other vaginal mesh manufacturers study organ damage and other side effects linked to the products. Two months later, the FDA announced that Johnson and Johnson had sold its Gynecare Prolift system for three years without the appropriate regulatory clearance. Johnson and Johnson maintained that it could market the Prolift, introduced in March 2005, without approval because it was substantially similar to its Gynemesh, which was already approved. The Prolift mesh was cleared in May 2008.
Hundreds of women have alleged that their vaginal mesh implants have eroded and caused other problems, including severe pain, after the products were inserted transvaginally. Johnson and Johnson and number of other manufacturers are facing lawsuits over these systems, and for patients suffering vaginal mesh complications, it’s not too late to make a claim. If you or a loved one is experiencing problems after vaginal mesh surgery for pelvic organ prolapse or stress urinary incontinence, you may be able to participate in a lawsuit seeking compensation for physical pain, medical expenses and other damages resulting from your complications. To receive a free, no obligation evaluation of your claim, 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.
ClassAction.org
Hannah Armstrong
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pressrelease@lawyercentral.com
Source: EmailWire.Com
