Posts Tagged ‘GA’

GA March 23, 2012 Mesh News: Prolift Pelvic Mesh Product Sold For Over 3 Years Without Necessary FDA Clearance

Sunday, March 25th, 2012

Read more: //www.timesunion.com/business/press-releases/article/FDA-Confirms-Johnson-Johnson-Prolift-Pelvic-3426909.php#ixzz1q5Io0Rjv

The FDA confirmed in a March 16, 2012 communication released to Bloomberg News that the vaginally pl

aced pelvic mesh product known as the Prolift, sold by Johnson & Johnson subsidiary Ethicon, Inc. since March, 2005, was initially marketed without any clearance or approval from the FDA. Ethicon attempted to justify this decision, claiming the Prolift, a vaginal mesh medical device for treatment of pelvic organ prolapse, was legally marketed pursuant to the 510K for a significantly different product.In the March 16, 2012 communication, FDA spokesperson Morgan Liscinsky stated that the: “FDA disagreed with this assertion.” The FDA statement unequivocally rejects Ethicon’s contention that the Prolift was legally marketed under the 2002 clearance provided to the other device known as Gynemesh PS.

If you or anyone you know has been hurt by any pelvic mesh, call us at: 877 882 0095

Read more: //www.timesunion.com/business/press-releases/article/FDA-Confirms-Johnson-Johnson-Prolift-Pelvic-3426909.php#ixzz1q5J7lsqi

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