Vaginal Mesh Implants Pulled From Market Due to Safety Concerns

Sharp Increase in Lawsuits Force Manufacturer to Discontinue Ethicon Products
 
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June 13, 2012 - PRLog -- Ethicon, a subsidiary of one of the world’s largest healthcare products manufacturers, Johnson & Johnson, has informed a federal judge in West Virginia that it will discontinue sales of its vaginal mesh implant line. Marketed by Ethicon, the decision covers the Prolift, Prolift+M, TVT Secur, and Prosima systems. Ethicon has requested permission from the Food & Drug Administration (FDA) to continue selling a related product, the Gynecare Gynemesh.

Hundreds of women have sued vaginal mesh implant manufacturers due to pain, internal injuries, and other symptoms that develop as the implants shrink or erode over time. Originally hailed as innovative, the products have been used to treat severe overactive bladder, incontinence, and to shore up weakened pelvic muscles following childbirth, menopause, or hysterectomy. The lawsuits claim that these products are now the cause of infection, internal damage, and other severe health complications.

According to the FDA (www.fda.gov), approximately 75,000 women received vaginal mesh implants for pelvic organ prolapse in 2010.

The Ethicon vaginal mesh implant has a shaky history. The FDA claims the company marketed and sold one version of this product for three years without FDA approval. J&J claims that FDA approval was unnecessary because this product was similar to another the FDA had previously approved. Despite these difficulties, the matter was settled, and the product was eventually approved in 2008.

However, a 2011 FDA report indicated a sharp increase in deaths, injuries, or malfunctions due to vaginal mesh implants. In addition, an FDA advisory panel suggested the products should be reclassified as “high-risk”. This classification requires manufacturers to conduct costly clinical trials. In fact, the FDA asked vaginal mesh makers for further safety studies in early 2012.

If you have a vaginal mesh implant and are experiencing health issues, we encourage you to contact the personal injury lawyers at Goldberg & Osborne today. It is important to stay informed about your rights to compensation. Simply call 1-800-THE-EAGLE (1-800-843-3245) or fill out our online case form for your free, no obligation evaluation.

Visit http://1800theeagle.com/practice-areas/defective-medical-... for more information.

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