SURGICAL MESH COMPLICATIONS | INJURED BY SURGICAL MESH, TAKE ACTION!
TRUTH IN MEDICINE TESTIFIES AT IOM MEETING JUNE 14, 2010
SHOWN ABOVE ARE TRUTH IN MEDICINE MEMBERS, DAVID SCHMIDT, DENISE JACOBS, AND LANA KEETON , FOUNDER & PRESIDENT.
Institute of Medicine Public Health Effectiveness of the FDA 510 (k) Clearance Process Monaco Hotel, Washington, D.C. Date June 14, 2010
Agenda: The Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process held a public workshop on June 14-15, 2010 in Washington, DC. The purpose of the workshop was for the committee to gather information related to the statement of task. Virtually all Synthetic Surgical Meshes are cleared through the FDA’s 510 (k) Premarket Notification process. Medical device manufacturers are not required to show proof of safety or effectiveness (that they work). YOU become the “clinical trial” for medical device makers. You, the patient, take all the risks and the device makers take all the profits. The 510 (k) must change to protect patients by putting the risks on the shoulders of the manufacturers where it belongs. Only Truth in Medicine Members and National Research Center for Women & Families testified as Patient Advocates representing the millions of injured patients in the United States. HOW IS THAT POSSIBLE? Because it is a very closed process including the FDA, CDRH, medical device makers and doctors. Patient Stakeholders are made aware of these hearings on a limited basis. To hear our testimonies, please click the link below. Next click Public Comment Registered Speakers. Then scroll to the timelines listed below to hear Truth in Medicine Members:
Lana Keetonat 11.00 min Marian Goldberg at 22.25 min Denise Jacobs at 27.17 min David Schmidt at 87.45 min Beverley Jane Pennington at 94.34 min Paul Browning at 98.57 min Below is the direct link to the agenda and video (flash-player) to hear Patients Testimonies of the horrific complications of Synthetic Surgical Mesh.