According to the
Institute of Medicine, over a million Americans are severely injured each year
by medical devices. In 2002 alone, the FDA received more than 111,000 reports
of adverse events involving medical devices.
number has increased since the Charite artificial spinal disc was approved for
use in the US in October 2004. As of July 2006, there have been more than 130
serious adverse events associated with its use reported to the FDA.
of the serious adverse events include: migration of the artificial disc
resulting in either removal of the disc or maintaining the disc, both followed
by fusion; pedicle fractures; subsidence or a settling of the disc into the bone;
and nicking of a vein or artery.
B�ttner-Janz and Professor Kurt Schellnack, considered to be leading spine
specialists, originally developed the Charite disc at the
Charite University Hospital in Berlin, Germany, in the mid-1980s. Further
refinements to the design were later incorporated at Waldemar Link GmbH, a
Europe-based medical device maker.
In 2003, DePuy
Spine, a division of Johnson & Johnson, acquired the Link Spine Group, and
gained exclusive worldwide rights to the Charite.
According to Spine
Health.com, the Charite is approved for patients who have severe lower back
pain and have obtained little or no pain relief after at least six months of
non-surgical treatments, such as pain medications, physical therapy, injections,
or manipulation. "The FDA clearance for disc replacement," the site
says, "is for one level of the lower spine, and it must be done at one of
the two lowest levels of the spine (L4-L5 or L5-S1)."
The device was
approved to relieve pain by replacing the damaged disc with the Chirate disc,
as an alternative to the surgical procedure known as lumbar spinal fusion
surgery works to stop motion at the painful level of the spine. In this
procedure, implants are used to help provide initial fixation, such as metal
screws, rods and cages, and are inserted between the vertebrae. Because the
fusion eliminates the motion in the lumbar segment of the spine, if the surgery
is successful, the pain is reduced or eliminated.
When done correctly
for the right indications, experts say, a fusion has a high success rate in
relieving pain. However, because it limits the range of motion, extra stress
may transfer to the discs above and below the fusion site.
An artificial disc
is supposed to allow continued motion in the spinal segment, and therefore, the
Charite was thought to be a viable alternative to spinal fusion surgery for
patients with the right indications.
However, in the
paper, "Total Disc Replacement for Chronic Low Back Pain: Background and a
Systematic Review of the Literature," by M de Kleuver, F Oner, W Jacobs in
the European Spine Journal Volume 12, Number 2, April 2003, the authors
determined that despite the fact that these devices have been implanted for
almost 15 years, on the basis of this literature survey there are currently
insufficient data to assess the performance of total disc replacement
There is no
evidence, the paper said, that disc replacement reliably, reproducibly, and
over longer periods of time fulfills the three primary aims of clinical
efficacy, continued motion, and few adjacent segment degenerative problems.
replacement, they said, seems to be associated with a high rate of repeated operations,
and the potential problems that may occur with longer follow-up have not been
authors advised, total disc replacements should be considered experimental
procedures and should only be used in strict clinical trials.
J&J beat out
competitors Stryker and Medtronic by securing approval of the Charite, but many
surgeons have criticized the FDA for approving the device and ignoring over 17
years of evidence related to its use in Europe, including a study showing that
more than half of recipients had fair or poor results.
The FDA approved the
Chirate based on the results of a single two-year clinical trial, that was
designed to merely establish that the Charite disc worked at least as well as
the Bagby and Kuslich cages (BAK) used in spinal fusions.
The trial was
conducted at the Texas Back Institute in Plano, Texas, on 304 patients, and was
led by a team of surgeons that included Dr Scott Blumenthal, Dr Barton Sachs,
and Dr Stephen Hochschuler, who are considered to be among the best spine
surgeons in the field. Dr Blumenthal presented the results of the trial at a
hearing before an FDA advisory panel.
A transcript of the
June 2, 2004, hearing, reveals the agency�s own reviewer found the study to be
biased in favor of Charite, and that important data about patients had been
excluded. A voting member of the panel, Brent Blumenstein, complained about
omitted patients during the hearing, but went on to vote for approval anyways.
In a nutshell, the
study basically showed no significant differences in complications between the
Charite group and the spinal fusion group.
According to Sergio
del Castillo, a biochemical engineer, and the FDA's lead reviewer of the
Charite approval application, the "purpose of the study was to evaluate
the safety and effectiveness of the Charite and compare it to the BAK Interbody
The study was to
show that the Charite would be at least as good as the BAK within a
non-inferiority margin of 15 percent, Mr del Castillo explained, and was not
designed to demonstrate superiority of one group over the other.
The first five
subjects at each investigational site were treated with the Charite as part of
the training of the surgeons and they were not included in the final assessment
of effectiveness of the devices.
The success rates
for the Charite and the BAK groups were 64 percent and 58 percent,
respectively. Considering the overall success rate is within a non-inferiority
margin of 10 percent of the BAK success rate, "it appears the study has
demonstrated the non-inferiority of the Charite compared to the BAK," Mr
del Castillo told the panel.
Adverse events in
the study, he explained, were categorized as typical or unusual, severe or life
threatening, device related or not device related, severe and device related
occurring within two days of surgery and by date of onset.
The percentage of
Charite and BAK subjects experiencing at least one adverse event, he said, was
essentially equal. However, Mr del Castillo said some adverse events were
reported in a higher percentage of Charite subjects compared to the BAK group,
and included infection, abdominal events, device related events and severe life
He noted that 7.3
percent of Charite subjects experienced adverse events compared to 4 percent of
BAK subjects. A greater percentage of Charite patients experienced: (1)
back or lower extremity pain; (2) neurological events, such as numbness, motor
deficit or nerve root injury; and (3) additional surgery at the index level.
It should be noted,
he advised, that the rate of adverse events was higher in the training group
compared to the randomized subjects in the study and pointed out that training
subjects were not included in the assessment of safety.
effectiveness in the study were evaluated in terms of the complications that
arose during implantation and post-operatively including infection, thrombosis,
migration and subsidence, re-operation, the incidence of adverse events, the
level of the subject's disability and assessment of the subject's neurological
The primary endpoint
for effectiveness consisted of four components: (1) pain in function as
measured by the ODI; (2) any device failures requiring revision, re-operation
or removal; (3) any major complications; and (4) neurological status.
A surgery was
determined to be a success if the subjects: (1) ODI score increased by at least
25 percent at 24 months compared to the subject's baseline score; (2)
experienced no device failures requiring revision, re-operation or removal; (3)
did not experience any major complications defined as major blood vessel
injury, neurological damage or nerve root injury; and (4) the subject's
neurological status was maintained or improved at 24 months with no new
permanent neurological deficits compared to baseline.
subject was considered a success only if he or she was a success in all four
components, Mr del Castillo advised the panel.
The study was
defined as a success if the success rate of the Charite group was found to be
non-inferior to the overall success rate of the BAK group, and safety was assessed
by comparing the rate of incidence of all adverse events observed in the two
effectiveness endpoints, according to Mr del Castillo, consisted of all the
primary endpoint components, listed previously, which are pain in function as
measured by ODI, device failures requiring a revision, re-operation or removal,
any major complications and neurological status.
A Danish surgeon, Dr
Andre van Ooij, also testified at the hearing, and advised the panel about the
known complications associated with the Charite, and provided the members with
visual slides showing the adverse events that occurred in a number of patients.
Dr van Ooij tracked
hundreds of surgeries in Europe and in eight years, he treated 49 Charite
patients, 28 women and 28 men, with some their surgeries performed as early as
1989. All of these patients, he noted, suffered terrible leg and back pain
after the device was implanted and many were unable to undergo a surgical
revision of the disc due to the dangers involved in spinal surgery.
Dr van Ooij also
advised that some men implanted with the device suffered retrograde ejaculation
and erectile dysfunction, and others patients suffered leg complications and
"One big issue
that was not spoken about today," he pointed out, "is breakage of the
"If you look
good at the x-rays," he advised the panel while showing a slide, "you
can see the breakage and the flattening of the polyethylene core and probably
also some wear debris."
Overall, more than
half of the patients in Europe ended up with fair or poor results after the
disc was implanted.
Orthopedic and spine
surgeon, John Peloza, also testified at the hearing and told the panel that
first and foremost, the Charite disc had to last the lifetime of the patient
and that the average age of a person that would be a candidate for the
procedure is about the mid-40s.
"I think it is
critical that these implants last for the life of the patients," he said,
"because revision surgery to remove the implant particular from an
anterior approach will be potentially life threatening in every case."
present," he advised, "there is no consistently successful strategy
to deal with a failed implant."
"I don't think
the polyethylene as they have in this implant will last anywhere near 40 years
or the lifetime of the patient," he advised.
In addition, he said
the fixation of the disc to the bone was compromised.
"The metal base
is secured with a press fit with little spikes," he
explained. "This is not adequate and will predictably fail," he
There are published
studies, he told the panel, that show significant re-operation rates between 5
and 20 percent with complication rates reported greater than 10 percent.
As for results in
regard to pain relief, the clinical studies in Europe and Australia, he said,
essentially report results equivalent to fusion in regard to pain relief.
After listening to
all the testimony about the dangers of the Charite disc, in the end, the FDA
advisory panel's vote for approval of Charite was unanimous.
Seven months later,
on May 13, 2005, the Street.com, reported that Dr Charles Rosen, an associate
clinical professor of spine surgery at the University of California at Irvine,
was calling for an immediate recall of the Charite, pointing out fundamental
flaws in J&J�s study design.
He told the Street
that J&J compared the Charite to BAK cages in spinal fusions, a failed
procedure that had not been performed in years. According to Dr Rosen, the
comparison is �the worst possible operation to compare these things to.�
J&J responded by
saying the BAK was the standard treatment for degenerative disc disease at the
time of the study.
According to the
Street, Dr Rosen said J&J ignored the first patients who underwent the
surgery, and that exclusion of such a significant portion of the sample size
can seriously compromise the quality of statistical data.
Dr Rosen, who is
also the founder of the UCI Spine Center, told the Orange County Register on
April 12, 2006, that the Charite can cause more pain than it cures.
Forty-five year old,
Dane Titsworth, from a hospital bed at UCI Medical Center, recovering from his
fourth back surgery, told the Register, that the pain he experienced with the
Charite he had implanted in May 2005, was like driving a big rig over your
After the Charite
surgery, Mr Titsworth said the pain became unbearable and cost him his job with
State Farm Insurance, and nearly his marriage.
Dr Rosen fused the
part of his spine where another surgeon had implanted the disc.
The Charite does not
absorb shock like a healthy disc or mimic natural motion, Dr Rosen told USA
Today on July 25, 2006, and a dislocation or fracture of the disc can also
cause problems, he said.
In March 2006, Dr
Rosen says, eight more patients like Mr Titsworth contacted him, who have more
pain in their back with the Charite than without it.
In May 2006,
Medicare decided to stop paying for the device in patients over 60, noting that
the $30,000 to $50,000 surgery had not been sufficiently tested for long-term
Blue Cross and Blue
Shield also determined that more research was needed over a longer period of
time, although insurance plans in each state determine coverage decisions
individually, according to USA Today.
On October 20, 2005,
the Bagolie Friedman law firm announced the formation of the �International
Charite Artificial Disc Practice Group,� based on a belief that numerous people
in the US and abroad, "suffer Charite artificial disc failure," and
that "Johnson and Johnson is responsible for manufacturing a medical
device they knew or should have known was unreasonably dangerous in an attempt
to capture some of the lucrative multi billion dollar back surgery
"We will be
reviewing potential cases from the United States, Australia and Europe,"
said Mr Bagolie.
On June 5, 2006, the
Street.com reported that Chicago-based attorney, Pete Flowers, has more than
200 clients who have complications from the Charite and who are seeking
reparations from DePuy Spine.
lawsuits have been filed, Mr Flowers told the Street, and he expects an
additional 40 to 50 more to be filed this month. Dane
Titsworth is a client of the firm.
Mr Flowers� clients
claim the Charite is defective and that J&J improperly marketed the device
and did not adequately warn of the disc's dangers.
"Most of these
people are between 25 and 45 years old," he told the Street.com. "A
lot of them have lost their jobs, their spouses, their families, their houses
Since the disc was
approved in the US, more than 5,000 people have received the implant, says
DePuy Spine's Bill Christianson, vice president of regulatory affairs,
according to USA Today on July 25, 2006.
More information for
injured parties can be found at Lawyers
Evelyn Pringle is a columnist for OpEd News and an
investigative journalist focused on exposing corruption
in government and corporate America.