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 especially for the woman who lost faith in hip replacement prosthetics and a doctor who declared her surgery a failure. Katie Kargaokar, a patient who went through a hip replacement surgery says the FDA was not able to protect her and the US public from companies whose sole business motivation was profit. When the 41 year-old Denver, Colorado native 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, she was still recovering from a painful operation to remove her hip replacement device. 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, Kargaokar now is mouthing off a different tune. Right now, she can be taken as a living example of one of the most common, successful and sometimes challenging surgical inventions of the 20th century. And a number of complications is now being faced by Kargaokar because of this. In relation, we need to be thankful about the this robotic system said to lessen 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. Her surgeon told her that her top-of-the-line, metal-to-metal hip contraption would bring her 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.
Last February 2011, the Archive of Mational Medicine reported that 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. Kargaokar’s first implant operation a failure was later declared by Nissen.
Up to 113 recalls of devices sanctioned by the FDA could cause health-related problems or probably death, up to 80 were eventually cleared and eight were given exemptions from the regulation. Most of the devices have not been tested on humans yet and none of those that were recalled were tried clinically in people. From these recalls, a large percentage required removal surgery.
The US Senate hearings precipitated into calls for realignments in FDA regulations governing medical devices. 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. This regulation allows medical device developers 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.
The ASR and the Pinnacle hip replacement that the FDA approved were manufactured by DePuy Orthopaedics, a subsidiary of Johnson & Johnson. Federal court and multidistrict litigations have been filed against DePuy’s ASR Acetabular hip replacement system. In fact, a recall has already been made for this ASR hip replacement device. On the other hand, people have already been filing a DePuy Pinnacle hip replacement lawsuit although a recall has not yet happened.
References:
abcnews.go.com/Health/Wellness/medical-devices-senate-committee-aging-examine-fdas-safety/story?id=13364031
naplesnews.com/news/2011/oct/03/help-hips-robotic-skill-makes-surgery-less-invasiv/?partner=RSS