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