Survey 9704 Index
THE U.S. SPINE MARKET:
THE SURGEON'S PERSPECTIVE
SEGMENT 1 of 5 - OVERVIEW OF THE U.S. SPINE MARKET.
SECTION 1-1. AN HISTORICAL PERSPECTIVE.
The last five years in the U.S. spine market have been
anything but calm. Manufacturers of spinal implants and
instrumentation and the surgeons implanting their products
have weathered many a storm.
In August 1993, the U.S. Food and Drug Administration
(FDA) ordered U.S. manufacturers of spinal implants and
instrumentation to cease and desist any promotional
activities that related to the use of bone screws in the
pedicle of the spine. The ABC news program, 20/20, which
aired in December 1993, alleged that spinal fusion patients
were nothing more than "guinea pigs," as their surgeries
included the implantation of screws that had not received
FDA marketing clearance for use in the spine. The program
"exposed" manufacturers and surgeons, particularly AcroMed
and its surgeon founder, for illegally promoting pedicle
screws and using them experimentally in unknowing patients.
This negative publicity brought with it numerous
lawsuits, spurred by lawyers advertising from Tacoma to
Tampa for patients who may have been "maimed" or "injured"
as a result of the use of pedicle screw fixation in their
spinal fusion surgery. Thousands of lawsuits threatened
U.S. manufacturers, despite clinical results indicating
that pedicle screws represented not a cure-all, but
treatment that
"...definitely decreased the number of returns to the
OR to repair failed fusions."
(Bruce E. Dall, M.D., as cited in Orthopedics Today,
November 1993)
As the legal banter continued, surgeons and manufacturers
throughout the United States pressured FDA to consider the
downclassification of pedicle screws, such that the
technology would be more readily available for uses that
surgeons insisted had been proven safe and efficacious.
"Without this technique...we'd be going back to the Dark
Ages.
It would be like taking away penicillin."
(R. Geoffrey Wilber, M.D., as cited in The Plain Dealer,
December 17, 1993)
In 1994, the Orthopaedic and Rehabilitative Devices
Advisory Panel of the FDA recommended that pedicle screws
be downclassified and in early 1995, many companies
received clearance from FDA for marketing of pedicle screws
in limited spinal applications.
By 1996, a Federal court had dismissed many state law
product liability claims, resulting in dismissal of some
lawsuits brought against companies, societies, surgeons,
etc. for various alleged violations of FDA regulations and,
at the end of the year, AcroMed Corporation agreed to a
limited fund settlement by proposing to pay up to $100
million to plaintiffs who had brought suit against the
company. No other company has joined AcroMed in proposing
settlement on such a wide scale and Sofamor Danek has
publicly indicated that it will not do so.
While the dust appeared to have settled, a U.S. district
court in mid-1997 did not dismiss specialty societies from
lawsuits, leaving FDA to potentially determine what
products surgeons could or could not use. As for
downclassification, FDA has still not disposed on it,
although a determination could come by the end of 1997.
Spine surgeons have been routinely implanting bone screws
into the pedicles of the spine since the 1980s. Results
have been positive, with fusion achieved in more than 70
percent of patients with degenerative disc disorders.
"Information available from those who have experience in
the use of pedicle screws
for spinal fixation supports the conclusion that this
treatment is superior to
alternative procedures for properly selected patients. In
fact
there is substantial literature documenting both the
safety and efficacy of spinal fusion."
"...more than 300,000 patients have been treated with
pedicle screw implants. To date,
2,100 have participated in the related litigation and the
number of actual
failures of the device, at most, is substantially less than
1 percent."
(The AAOS Bulletin, April 1996)
Due to the historical challenges facing pedicle screw
manufacturers, many companies bowed out of the market
altogether. Others began to develop technologies that
could potentially either obviate the need for pedicle
screws or make their implantation more "foolproof."
In late 1996, interbody fusion cages obtained clearance
from FDA for certain indications (painful degenerative disc
disease) in the lumbar spine and by mid-1997, the
resurgence that began in the U.S. market for spinal
implants and instrumentation was further propelled by the
first "new" technology to enter the marketplace in years.
Fusion cages have been readily adopted and may prove
beneficial for both the patient and the cost-conscious
healthcare system.
Minimally-invasive surgery (MIS) holds promise for speeding
surgery, speeding recovery and reducing overall costs from
admission to discharge. Driven largely from a patient
population that has little time for long stays in the
hospital and long periods away from work or family, MIS
technologies have found application in some types of spine
surgery, i.e. discectomy.
However, as one spinal surgeon indicated,
"Minimally-invasive [is] still unsuitable for my practice."
(Surgeon respondent to the Knowledge Enterprises, Inc.
survey)
Bone substitutes, too, have entered the spinal arena, as
most spinal fusion procedures require the use of some sort
of bone graft material. Although autograft is considered
the gold standard of bone graft materials, its use is not
without problems, the most pressing of which is pain
associated with opening a second site for procurement of
the bone. Numerous companies are developing bone
substitutes or bone growth products for use as adjunctive
materials to enhance bony fusion in the spine.
Other technologies like bone proteins, cement grouts,
viscoelastics, fibrin glues, artificial discs, etc. also
have substantial potential for use in spine surgery.
Proteins could enhance bone growth in fusion. Grouts could
supplement bone lost to osteoporosis or tumors.
Viscoelastics could replace disc fluid or prevent
postsurgical scar formation. Glues could repair soft
tissue tears. The list of potential applications goes on;
however, technologically, the U.S. spinal implants and
instrumentation market remains in its infancy.
Opportunities abound for improvements, however incremental,
in the approach that surgeons take, in the instruments they
use and in the products that they implant in their
patients. For the U.S. manufacturer, the spinal market
represents one of the most demographically perfect segments
of the orthopaedic marketplace. Back problems escape few
people and, until man returns to life as a four-legged
animal, millions of Americans will seek out relief for pain
and disability that mark the very nature of their existence
as two-legged creatures.
End
