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Endo Health Solutions To Settle Certain Transvaginal Mesh Claims
Ennis & Ennis reports Endo's American Medical System agrees to settle some of its transvaginal mesh claims.
Data submitted to the FDA disclosed that in 2010 nearly 100,000 women underwent surgery for pelvic organ prolapse using a mesh product and over 200,000 women had surgery for stress urinary incontinence utilizing transvaginal mesh An August 2011 FDA report found vaginal-mesh products should be classified as high risk to patients based upon reports from January 2008 to December 2010 disclosing the severe side effects. Women’s groups are demanding that the devices be recalled. In 2012, the FDA ordered AMS and other transvaginal mesh manufacturers to conduct post-market safety studies and monitor the rate in which adverse events were reported for three years. Endo is one of four companies who face over 29,000 claims by women who were injured by the vaginal implants. Only two transvaginal mesh cases have been tried to date. A California jury found Bard liable for $3.6 million damages for injuries caused by its Avaulta Plus vaginal implant and an Atlantic City jury found Johnson & Johnson and its Ethicon unit liable for more than $11 million in compensatory and punitive damages based on injuries caused by the Gynecare Prolift.
AMS’s settlement resolves only a portion of the pending transvaginal mesh claims filed against it. There has been no universal settlement and the cases continue to be prepared for trial. Ennis & Ennis, P.A. continues to offer free, nationwide, confidential consultations to anyone who was injured by a transvaginal mesh device including, but not limited to Ethicon’s’