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.
Do you have any questions about this post?
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@example.com. You may also reach him at 202-822-1899.