An article published in Bloomberg News on 5th June 2012 reports that Johnson & Johnson’s Ethicon division has told a federal judge in West Virginia that it intends to stop selling four vaginal mesh implants after being sued by over 600 women who claim the products caused them injury.
In a letter filed yesterday with US District Judge Joseph Goodwin, who is overseeing the legislation, the company has requested approval from the Food and Drug Administration to stop ‘commercializing’ the devices. An Ethicon spokesman stated in an email that the unit would stop sales of the devices worldwide by early 2013.
In January, the FDA ordered Johnson & Johnson and 30 other manufacturers of vaginal mesh implants to study health complications attributed to the mesh implants, which are used to treat incontinence and pelvic organ prolapse. An agency report last year found a significant increase in deaths, injuries and complications resulting from vaginal mesh surgery for pelvic organ prolapse. An advisory panel recommended that the FDA reclassify the devices as high-risk products requiring human testing.
Hundreds of women claim that transvaginal mesh implants have caused them harm and have filed lawsuits against various manufacturers including Johnson & Johnson, CR Bard Inc, and Endo Pharmaceuticals Holdings Inc.
Ethicon has requested 120 days to end sales so it can inform its customers and provide hospitals and surgeons with adequate time to select other treatment options for patients.
The company is reportedly discontinuing sales of the products worldwide but is not recalling meshes already sold or implanted. It claims that its decision to withdraw the products is not based on safety concerns but on other considerations such as commercial viability, regulatory environments and the availability of other treatment options for women. They claim to have continued confidence in the safety and efficacy of the products.
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Atlanta Business News: http://www.ajc.com/business/j-j-to-stop-1452665.html