Posted by: Salvatore J. Zambri, founding member and senior trial attorney.
Hip replacement is one of the most common surgical procedures in the United States. It is estimated that 250,000 replacements are performed each year. Since the beginning of 2011, the Food and Drug Administration (FDA) has received over 5,000 complaints about metal-on-metal hips, more than the previous four years combined. Some experts believe that this rise in complaints is an indication of the “biggest and most costly medical implant since Medtronic recalled a widely used heart device component in 2007.” In May, the FDA ordered producers of metal hips to submit proposals to the FDA with plans for studying how frequently the devices were failing and to examine the threat to patients. The agency is expected to determine the adequacy of those plans by November, 2011. Even the chief scientist at the FDA who oversees medical devices acknowledges that finding answers to the complaints could take several years.
As more problems are uncovered, some surgeons have abandoned installing all-metal hips, and they are looking for safer alternatives, usually those which combine metal and plastic components. Many surgeons are also dealing with questions related to replacing the all-metal hips in their patients who don’t seem to to have obvious problems. For some patients, crippling injuries have resulted from the tiny particles of cobalt and chromium that shed into the patient’s body. Debris-caused tissue damage is very extensive in those cases. Some researchers believe that many all-metal hip implants have an inherent flaw. Numerous unanswered questions remain about their safety, whether from the the device itself, or its interactions with human tissue.
According to the FDA, “Many all-metal devices were sold without testing in patients or without a requirement that producers track their performance.” According to a recent report in the New York Times, the FDA is now intervening and ordering producers to study how frequently the devices were failing and to examine the threat to patients. There are currently “no standard protocols for a uniform procedure to measure metallic ions in a patient’s blood or how to calibrate diagnostic equipment to best detect tissue damage.”
To date, almost 75% of the hip implant device complaints received by the FDA have been regarding the Articular Surface Replacement (A.S.R.), which was recalled by the DePuy Division of Johnson & Johnson in 2010. Another Johnson and Johnson product receiving complaints was the Pinnacle. Still another model receiving complaints is the Durom Cup, manufactured by Zimmer Holdings. Along with DePuy and Zimmer, other companies submitting study proposals to the FDA include Wright Medical and Biomet.
If you have received a hip replacement, please consult with your surgeon to determine whether the model you received is subject to recall. As the safety of hip replacement devices is further investigated, other models and brands of all-metal implants may be recalled in the future.
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About the author:
Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the ” 2011 Trial Lawyer of the Year“. He has also been acknowledged by Washingtonian magazine as a “Big Gun” and among the “top 1%” of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as “one of Washington’s best–most honest and effective lawyers” who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the “Best Lawyers in America” by Best Lawyers, and has also been repeatedly named a “Super Lawyer” by Law and Politics magazine (2011)–a national publication that honors the top lawyers in the country.
Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.
If you have any questions about your legal rights, please email Mr. Zambri at [email protected]. You may also reach him at 202-822-1899.