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The Growing Problem With Failed Hip Replacements
All-metal hip implants were once thought to be safe, but as complaints filed with the Food and Drug Administration (FDA) continue to grow, the federal government has decided to take a closer look at the dangers of metal-on-metal hip replacements.
September 21, 2011 /Surgery PR News/ -- Hip replacement is one of the most common procedures in the United States -- with approximately a quarter of a million routine procedures occurring each year. Of those 250,000 annual hip replacements, it is believed that about one-third of patients receive metal-on-metal implants -- implants where the artificial ball and cup are both made of metal. According to the New York Times, it is estimated that more than 500,000 patients have received all-metal hip replacements.
All-metal implants were once thought to be safe, but as complaints filed with the Food and Drug Administration (FDA) continue to grow, the federal government has decided to take a closer look at the dangers of metal-on-metal hip replacements.
Trouble for medical hip device manufacturers first began brewing last summer. In August 2010, Johnson & Johnson recalled its DePuy ASR (Articular Surface Replacement) hip implant. In the year since the DePuy hip implant recall, the FDA has seen a surge of reports about failed metal-on-metal hip replacements. Since January 2011, more than 5,000 complaints about DePuy replacement hips have been filed -- more complaints in a six-month span than in the previous four years combined. The FDA has also received a number of complaints about Zimmer Holdings' Durom cup.
This surge in complaints appears to be leading up to the FDA's largest defective medical device since 2007, when Medtronic recalled the Spring Fidelis lead wire, which was used in thousands of defibrillators implanted in heart patients around the world.
According to the New York Times, most of these complaints are from people who have already had their all-metal hips removed or are scheduled to do so in the next few months. One pattern remains the same: Many of these artificial hip devices, like the DePuy ASR hip implant, failed after only a few years of use -- despite the fact that hip replacements are expected to last at least 15 years.
What Impact Do Failed Hip Replacements Have on Patients?
For most patients who have received a defective hip implant such as the DePuy ASR hip, the problems are not life-threatening, but do cause a lot of pain. For others, serious permanent injury has occurred due to tiny metal particles digging into their tissue as parts of the metal-on-metal hip devices rub together.
In May, the FDA ordered all manufacturers of metal-on-metal replacement hips to study how often the devices were failing and to examine the dangers the medical devices posed to patients who had received them. Manufacturers such as DePuy (a division of Johnson & Johnson), Simmer Holdings, Wright Medical and Biomet are trying to comply, but their researchers are faced with the challenge of tracking down patients to be used in the studies because there is no centralized patient registry for hip implants.
Additionally, many researchers are finding difficulties in determining exactly what kind of tissue damage is occurring because some patients have significant pain from metallic debris while others have none.
As a result, it may take years for many manufacturers to gather all of the information the FDA has requested. And years may be too long for many patients, as noted by the New York Times. While replacing the defective all-metal hips can resolve pain for many patients, others have already suffered irreparable tissue damage. In many of these cases, patients have already filed lawsuits against producers of DePuy hip implants. It is expected that this number will grow as the FDA continues to investigate the dangers of defective hip implants.
The FDA is currently reviewing study proposals provided by each of the metal-on-metal hip manufacturers. It will likely be months before standards are established for these studies, such as how metallic ions in a patient's blood are measured. It also may be another year before standard protocols are developed that would facilitate future studies involving defective medical devices.
Article provided by Trolman, Glaser & Lichtman, P.C.
New York Medical Malpractice Attorneys
Visit us at www.tgllaw.com
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