Over half a million Americans have received metal-on-metal hip replacement implants;
while these implants were marketed as being much more durable than earlier generation
implants made from ceramic or polyethylene, many recipients of all-metal implants
have experienced premature failure. Many recipients of metal-on-metal hip implants
have been dismayed to find their particular implant the subject of a hip recall.
Injured patients who have suffered a hip recall have been forced to undergo painful,
risky and expensive operations known as revision surgeries in order to remove the
faulty metal hip recall device.
When Hip Implant Failure Leads to Hip Implant Recall
When a hip recall is issued, it is generally because the specific implant has been
found to wear significantly more than it should, generating high volumes of metallic
debris which is then absorbed into the patient’s body. A hip implant recall could
stem from inflammatory reactions among patients leading to groin pain or even tissue
degradation and death or loss of surrounding bone. This tissue and bone loss could
lead to constant pain, a limp or change in walking ability. A hip implant recall
could also be tied to metal toxicity or metal poisoning which can occur when microscopic
metal ions enter the bloodstream, causing a myriad of serious health problems.
Manufacturers Responsibility Regarding Hip Replacement Recall
Several metal-on-metal hip implants have been subject to hip recall just in the
past several years, leaving thousands of patients seeking compensation for their
pain, suffering and other physical injuries. Whether instigated by the FDA or the
manufacturer, a hip recall can strike fear among those patients who have the recalled
hip implanted in their body. Unfortunately, by the time a hip recall is initiated,
many patients have suffered serious injury. Of course hip implant manufacturers
are well aware of their legal duty to properly design, manufacture and test their
products. These manufacturers must also warn the public if a device fails or is
found to have serious side effects. Despite this duty, it seems that time after
time yet another hip recall is in the news. Manufacturers are slow to respond to
consumer complaints, assuring more injuries will occur before a hip recall is issued.
Who is Responsible for a Hip Implant Recall?
The FDA must ensure medical devices are adequately tested prior to marketing, yet
it is more and more common to hear of a hip recall. This is likely due—at least
in part—to an FDA approval process known as the 510(k) which allows manufacturers
to have a device approved based on its similarity to a device which has already
been approved. The hip recall flurry demonstrates this process is not the best way
to handle medical devices and drugs which have the potential to harm or severely
injure patients. Critics of the system maintain that such lax regulation provides
little incentive for manufacturers to ensure their devices are safe for the public.
In some instances it is not until devices are studied by independent medical researchers
that the problems which eventually prompt a hip recall are brought to light.
When a Hip Replacement Recall Becomes Necessary
One all-metal hip device which was marketed as a “cutting-edge” design with improved
durability and mobility underwent a hip recall when data from the U.K. joint registry
revealed metal devices are not only no more durable than their ceramic and polyethylene
counterparts, but were subject to considerably more problems among recipients. The
National Joint Registry of England and Wales published a report that one hip device
which was subject to a hip recall was replaced or removed 29% of the time after
less than six year. When compared to an overall 9.5% failure rate for all-metal
hip implants, this particular hip recall appeared especially necessary.
When a Hip Implant Recall Leads to Lawsuits
Every time a hip recall is issued, the expected lawsuits follow. After all, the
manufacturer of the device has obviously failed to properly test the device or inform
the public of the potential risks before it is too late and a hip recall is issued.
A jury in one 2013 trial against the manufacturer of an all-metal hip device saw
evidence pointing to the fact that the manufacturer was fully aware that within
five years over 40% of the recalled hip devices would fail. Another manufacturer
designed a hip implant which offered surgeons a wide variety of component lengths
and sizes in order to allow surgeons more options, thus a better fit for patients.
When a hip recall was issued for this particular device, the manufacturer stated
it was prone to corrosion and fretting which could release metal debris into the
body, damaging surrounding bone and tissue.
Could You Benefit From Consulting a Hip Recall Attorney?
Those who have suffered harm from a metal-on-metal hip implant could benefit from
speaking to a Sullo & Sullo hip recall attorney. Once a hip recall has been issued,
the statute of limitations begin to run, making it important that you speak with
an experienced hip recall lawyer who can thoroughly assess your individual circumstances
and present you with your options. A hip recall can be a very frightening thing
for those who have the device implanted in their body. Whether you have yet to experience
negative health issues following a hip recall of your particular device, speaking
to a knowledgeable attorney regarding your hip replacement recall may put your mind