As discussed in part one of
this article, many recipients of the Stryker Rejuvenate and ABG II hip implant
devices have found their lives turned upside down from adverse health symptoms
relating directly to the recalled implants. Although makers of medical devices
have a duty to ensure the safety of their products many patients who received
all-metal or partial-metal hip implants have found that duty was not upheld.
DePuy and Johnson & Johnson are currently embroiled in thousands of
lawsuits over their own recalled hip implant and following the July, 2012
recall of the Rejuvenate and ABG II Stryker is beginning to see the lawsuits
against their own company mount.
Less than five years elapsed
between the time Stryker began marketing these two implants and the time of the
recall. Many believe that greed is a factor related to the time which passes
between the first adverse reports from patients about an implant and the
eventual recall. Over 53,000 Stryker ABG II and Rejuvenates were sold, and it
is thought that most of those were likely implanted although the United States
does not maintain a hip implant database.
While all revision surgeries
are considered riskier and more complex than the original hip implant surgery,
there are particular risks associated with the Rejuvenate and ABG II. The stem
of these devices is implanted deeply into the femur, therefore when it must be
removed the process is fraught with potential problems. The surgical procedure
itself takes from 4-5 hours which increases the likelihood of excess bleeding,
damage to the nerves, infection and patient mortality. In fact, the mortality
risk for a Rejuvenate or ABG II revision surgery is as high as 2.5% compared to
less than 1% mortality risk for the original surgery.
In many cases the stem of the
Rejuvenate and ABG II must literally be pried loose and dug out of the femur
which can result in shattering of the femoral bone. Should this occur, the
patient must be sent home in a wheelchair in the hopes that the bone will
re-grow and a new implant can be placed in the hip. Some patients end up in a
wheelchair for an extended period of time—or even for the rest of their life
following a revision surgery for these recalled Stryker hip implant devices.
The recovery time following a
Rejuvenate or ABG II revision surgery is significantly longer than the original
recovery time—as long as six weeks. Dislocation is an issue which causes
physical therapy to be much slower. Lost wages and medical expenses can be overwhelming
for the patient and everyday tasks may become impossible. The FDA is in the
process of looking at the current application process for artificial hips
following the huge number of medical problems suffered by those with these
devices. While the present system requires only that the device be
substantially similar to another device on the market, new requirements would
make clinical trials mandatory and patient safety would move to the forefront
above financial gain for the hip manufacturers.
The FDA has also mandated that
surgeons should carefully weigh the risks vs. benefits before recommending a
metal hip implant to their patients. The patients should be given all
information regarding the implant and should understand the risks involved.
Patients who have a Stryker Rejuvenate or ABG II implant should make an
appointment with their physician in order to undergo testing for metal levels
as well as x-rays and an MRI. Even those patients who have suffered no ill
effects from their hip implant should see a doctor to determine their risk for
future issues. It can be wise to seek legal help as well; if you have already
suffered from a recalled implant you are entitled to compensation for your
medical expenses and lost wages. Because of the statute of limitations involved
in product liability cases, if you have not yet experienced medical problems
due to your implant it can still be a good idea to consult an attorney.
