subject: Some Concerns About Fda's 510(k) Regulation Process [print this page] For the woman who lost faith in hip replacement prosthetics and a doctor who declared her surgery a failure, the U.S. Food and Drug Administration (FDA) can be part of the culprit on who to blame about the faulty medical device implant because of the reason that it did not live up to its promise. The FDA not being able to protect her and the US public from companies whose sole business motivation was profit was the thoughts of Katie Kargaokar, a patient who went through a hip replacement surgery. The 41 year-old Denver, Colorado native was still recovering from a painful operation to remove her hip replacement device when she appeared before the U.S. Senate Special Committee on Aging in April 2011 and testified how her prosthetic hip implant became a great letdown for her. Kargaokar is now mouthing off a different tune from being one of the thousands of Americans who underwent surgery to have her hip bone replaced by a metal-to-metal hip replacement system and who ended up in pain. By now she was a living example of one of the most common, successful and sometimes challenging surgical inventions of the 20th century. Now, Kargaokar is facing a number of complications because of this. On a related note, we might be thankful of the discovered robotic system reducing hip replacement complications.
Kargaokar underwent total hip replacement operation that was pain-free at first. Then, by 2007, she was confimed to had Perthes which is a congenital condition that prematurely caused the deterioration of her hip bone. Due to the use of a top-of-the-line, metal-to-metal hip contraption, her surgeon promised her to have a 20 years of life-changing, free movement. Then, a second surgery was needed four years later to remove the implant that had raised cobalt level and chromium in her bloodstream. The levels of metal-bound toxicity increasing around the device are now noticed by doctors.
As per report of the Archive of National Medicine last February 2011, certain medical devices that were recalled from the market for serious hazards were previously given clearance by the FDA through the so-called 510(k) review process, which considered them low-risk items that they were eventually exempt from safety review.
According to a doctor and a co-author of the study and chairman of cardiovascular medicine at the Cleveland Clinic, Mr. Steven Nissen, "In my view, the regulatory system is failing.". During the last four years, Nissen and his research fellows found out that most of the medical service recalls has had taken the regulatory pathway on 510(k) and were given pre-market certifications. Nissen later declared Kargaokar's first implant operation a failure.
Around 80 devices were cleared and eight were given exemptions from the regulation from the 113 recalls of devices sanctioned by the FDA could cause health-related problems or probably death. Most of the devices have not been tested on humans yet and none of those that were recalled were tried clinically in people. A large percentage of the recalls required removal surgery.
Precipitation into calls for realignments in FDA regulations governing medical devices was then made possible by the US Senate hearings. Hosted by the Institute of Medicine (IOM) in Washington, D.C., the The desired changes in the FDA review process had been discussed in public workshops in recent months. Since March 2011, a summary report about potential amendments including the presentations by medical and industry authorities has been long expected. The FDA 510(k) review process remains a key regulatory pathway for new products entering the market. Medical device developers have been allowed in this regulation to introduce new products based on data and technical information from already existing, so-called predicate devices, which have been approved based on the presumption of safety and effectiveness.
As a subsidiary of Johnson & Johnson, DePuy Orthopaedics manufactures the ASR and the Pinnacle hip replacement that the FDA approved. Federal court and multidistrict litigations have been filed against DePuy's ASR Acetabular hip replacement system. Actually, this ASR hip replacement device has already been recalled. Now, although a recall for Pinnacle hip replacement systems have not yet happened, people have already been filing for a Pinnacle lawsuit.
