All of the thirty five surgical procedures performed by Drs.
Polly and Kuklo at that time involved the use of biodegradable
polylactide (Hydrosorb™) intervertebral disc prosthetic cages
distributed by Medtronic which were not approved by the U.S.
Food and Drug Administration for use in the human spine. In
addition, these Hydrosorb™ cages were packed with a bone growth
potentiator rhBMP-2 (Infuse™) which was an off-label use of a
biologic substance which had only recently been introduced for
limited and specific spinal use.
Infuse™ was also a Medtronic product.
Under the documented
circumstances it should have been mandatory that such surgery be
reviewed, authorized, and monitored by an Institutional Research
Review Board (or equivalent) and include full pre-operative disclosure to
all patients regarding these most unusual and important circumstances.
Fortunately, in the history of American medicine there have been
only a few examples where physicians have exploited captive
hospital patients in such a manner. The past actions of
Colonel Stafford Warren
has represented such an example.
Drs. Kuklo and Polly were among the first surgeons in the world
to implant the unapproved Hydrosorb™ intervertebral cages.
Previous use of these spinal implants had been associated with
significant concerns. In 2001 spine investigators in Europe
expressed their view that “further in-vivo animal experiments
are essential prior to the clinical application of biodegradable
lumbar interbody fusion cages.” The concerns regarding the
safety and efficacy of the Hydrosorb™ cages included mechanical
failure, premature decay, and extrusion sometimes associated
with neurologic impairment. These respresent concerns which have
does not appear that the U.S. Army or Walter Reed Hospital were
aware of the actual circumstances under which these surgeries
being performed on their hospitalized soldiers or patients by Drs. Kuklo and
Polly at that time.
They were probably also unaware of the patient selection process
and whether or not these spinal fusions were appropriate in the
first place. It is important, in the light of what is now known
about the Hydrosorb™ devices to follow-up on this operated
patient population and determine their surgical outcomes.
is now clear from reviewing the medical literature that Drs.
Kuklo and Polly intended to use the Walter Reed experience as a
means of advancing both the continuing use of Hydrosorb™ as an
intervertebral device as well as promoting the future use of
2009 a prospective, randomized study published in the journal
SPINE indicated that the efficacy of the polylactide cages in
enhancing interbody spinal fusion had yet to be established.
Rosen has asked that the Army look into this serious situation
which appears to Burton Report to be in violation of the
Nuremberg Laws. Given the present concerns regarding
unnecessary spinal surgery in the United States;
most specifically its being performed as a treatment for
low back pain due to disc degeneration (something that 80% of
the population experiences) it will
also be important to identify who these patients were, what were
the indications for their surgery, and how they have fared since
According to an article published by Duff Wilson
in the New York Times on December 27, 2010, the Walter Reed Medical Center had
not yet replied to the concerns initially expressed by Dr. Rosen or to
subsequent inquiries made by Senator Charles Grassley (Iowa).
Further inquiries made by Senator Max Baucus
(Montana), the present head of the Senate Finance Committee,
again supported by Senator Grassley,
to Col. Norvell Coots, commander of the Walter Reed Healthcare
System indicated that Walter Reed planned to take no action
against the surgeons involved although their investigators had
concluded that: "the doctors violated Army rules by failing to
seek or receive permission" to conduct their research on
hospital patients. What exactly constitutes "conduct
unbecoming an officer" has been further clouded by the
events surrounding the case of Capt. Matthew Webb.
As of this time there continues to be no indication that the dearth of ethical behavior
Drs. Kuklo and Polly has even occasioned a reprimand by the
Walter Reed Army Hospital.