SURGICAL MESH COMPLICATIONS | INJURED BY SURGICAL MESH, CONTACT US!
FDA USES FLAWED DATA: DEADLY MEDICAL DEVICES REMAIN ON THE MARKET, PATIENT BEWARE!
Dateline Miami Florida March 17, 2011 FOR IMMEDIATE RELEASE
While the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (FDA/CDRH) clears medical devices for sale through the FDA’s 510(k), not requiring proof of safety or efficacy, it’s not the same for getting deadly devices off the market.
Created by the Medical Device Amendment Act of 1976 and signed into law by President Gerald Ford, the 510(k) is the ultimate slacker provision for government and industry. In a speech before the Institute of Medicine Committee currently reviewing the 510 (k) on June 14, 2010, Peter Barton Hutt, who headed the group who actually wrote the law, stated 510(k) leaves tremendous discretionary power to individual employees of the FDA/CDRH on purpose. He cited the FDA and Industry’s inability to perform in a timely manner. In December of 2007, Linda O’s 76 year old father died when synthetic surgical mesh, implanted 7 years before for an inguinal hernia, broke up and strangled his bowels. He went to the emergency room with severe abdominal pain. Exploratory surgery showed the cause of the pain but it was too late. Linda’s father died an unnecessary, extremely painful slow death six weeks later. He was never released from intensive care following the exploratory surgery. Despite a Synthetic Surgical Mesh investigation team created in 2007 in response to the thousands of mesh adverse events reported on its MAUDE database and a Public Health Notification (PHN) issued in October 2008 warning of the Significant Risks and Complications from trans-vaginal placement of, no PHN warning of synthetic mesh used for hernia repair has been issued to the public and virtually all synthetic meshes remain on the market. Every day, thousands of men and women worldwide, like Linda’s father, have mesh hernia repair and are unknowingly living in danger of the same deadly complications. Why is this? In a February 2009 conference call with Truth in Medicine patient advocates, Ann Ferriter, Network Leader for the Mesh Team, cited information on the Center for Disease Control (CDC) website as the denominator for the number of “successful” hernia repairs with mesh and the reasoning for not issuing a Public Health Notification. Ms. Ferriter was referring to the National Hospital Discharge Survey (NHDS), a survey of the hospital records of discharged inpatients. Success or failure of the procedures is not part of the survey. This in no way provides a denominator of “successful” mesh hernia repairs. Yet the FDA’s Mesh Team bases its decision making process on this inadequate, flawed data. The point is: they have no real data to make life and death decisions for patients. There ARE no honest denominators for mesh hernia repair. Yet the FDA errs on the side of the industry, the medical device maker. It has not warned patients of the significant risks and complications from the use of mesh for all types of hernia repair. In August 2010, attorneys in a multi district litigation lawsuit against Davol Bard Inc won a $1.5 million verdict for Christopher Thorpe and his wife, Laure, for its recalled Kugel Hernia Mesh Patch. The weld holding the plastic ring to the mesh patch is the reason the product was recalled. The other culprit is the mesh itself. But who’s talking about that? Not the attorneys and Certainly not the FDA. Once attorneys filed suit against Davol Bard for the Kugel Mesh Patch, Bard then applied for, and received, a Remedial Action Exemption (RAE) from the FDA. No matter how many more adverse event reports there are, no matter how many more people are harmed, you will not find this info on the MAUDE database. Adverse event reports are no longer required for this particular product because of the RAE. The public will never know the truth about the extent or the number of patients harmed by this one 510 (k) cleared medical device, the Kugel Hernia Mesh Patch. At the same time, the FDA gave a new 510 (k) clearance for the same design of Kugel Mesh Hernia Patch, for manufacture and distribution by Davol Bard, with one change: stronger welds to hold the plastic ring in place. It’s a pretty neat package for the medical device maker: Quick and easy clearance of a medical device through the FDA’s 510(k) process. Make sure you have enough money on your financial statement to cover the cost of defense attorneys and potential negative verdicts. File for a Remedial Action Exemption (RAE) when the lawsuits are filed. No one ever knows the extent of the damage caused by your bad medical device because of your RAE. Re-apply for clearance of the same product, re-named or modified slightly, through the 510 (k) process. Injure more patients. Start the same process all over again. The FDA’s Mesh Team continues today. The cycle continues. Synthetic surgical mesh continues to harm patients no matter the diagnosis, by which doctor or where in the body it is implanted. The FDA continues making bad decisions based on flawed data and allowing deadly medical devices to stay on the market. The FDA is not protecting you. Patient Beware! Lana Keeton President and Founder Truth in Medicine Incorporated 1521 Alton Road, #198 Miami Beach, FL 33139 phone:305-671-9332 Ext #1 e-mail:lanakeeton@truthinmedicine.us.com website:www.truthinmedicine.us.com