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Ethicon Ignored Warnings About Transvaginal Mesh Dangers
In the first trial against Johnson & Johnson’s Ethicon unit, maker of the Gynecare Prolift vaginal mesh, testimony has revealed that Ethicon ignored warnings, from both internal and outside sources about potential dangers of the mesh.
In the New Jersey Superior Court, Dr. Owens who was Director of Ethicon when the Gynecare Prolift was put on the market, testified she was concerned about the mesh’s susceptibility to erode and retract and of the injuries these complications could cause. Dr. Owen was aware that the Prolift could cause certain nerve damage and injuries including the inability to enjoy sexual relations. It was Dr. Owen’s responsibility to author the Clinical Expert Report. This report should include all adverse events so physicians would fully understand the product prior to use. However, despite her knowledge of the mesh’s adverse affects, the clinical expert report authored by Dr. Owen fails to discuss the Prolift’s potential for retraction or any injuries likely to result from that retraction.
Perhaps even more disturbing it that virtually no thought was given to how to address any of the complications relating to retraction or erosion. Dr. Owens testified there was no study regarding how to remove the mesh causing damage and that Ethicon had not addressed finding a safe and effective way to remove some or all of the Prolift mesh if necessary.
Dr. Klinge, a surgical mesh expert also testified that he delivered a talk in 2005 to Ethicon explaining that in order to be safe for patients, surgical mesh implanted in the pelvis must be very lightweight and have pores measuring at least 1 millimeter in all directions. Despite this directive, Ethicon marketed the Prolift mesh which was larger and heavier than Dr. Klinge indicated would be safe for patients. Although Dr. Klinge was not involved in the development of the Prolift, he stated that Ethicon executives knew of his surgical-mesh-
This is the first of over 1,800 transvaginal mesh lawsuits against Ethicon pending in New Jersey Superior Court to go 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 Boston Scientific’s Pinnacle and Uphold, American Medical Systems’ Elevate, Apogee and Perigee, C.R. Bard’s Avaulta and Pelvilace products, Caldera Medical’s Ascend, Ethicon’s Gynecare products and other products manufactured by Mentor and Tyco Covidien by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form.