[Sent – 8
July 2018 to the 170+ surgeons et al of our Surgical
Ethics (Education) Consortium]
Greetings.
For the ‘Surgical Ethics Education Resources’ #3 communication, I am sharing
with you a professional integrity challenge/warning one of our consortium
members issued a few weeks ago to our department in his graduating chief
resident presentation. The subject – surgical innovation. He used
as his reference point a very disturbing revelation my colleague Lewis Wall,
MD/DPhil (at the time a senior uro-gynecologic surgeon in the WashU Ob/Gyn
Department) and I published in 2010 re a vaginal mesh practice bulletin.
I have inserted below the key PowerPoint slide in the presentation. You
need some background information in order to fully appreciate the serious
ethical implications.
By 2007 Dr. Wall
and his fellow urogynecologic surgeons in academic medical centers around the
country had treated an alarming number of patients for vaginal mesh surgical
complications. The reason – various vaginal mesh kits had been marketed
aggressively since the late 1990s based only on FDA 510(k) clearance.
ACOG released in February 2007 Practice Bulletin #79 that described vaginal
mesh procedures as ‘experimental’. ACOG then in September 2007 abruptly
replaced Practice Bulletin #79 with Practice Bulletin #85. Practice
bulletins are never updated/replaced in such a short time unless some dramatic
breakthrough has occurred. But no such breakthrough had been
announced. So Dr. Wall and I decided to compare #79 and #85 line by
line. We discovered that only one sentence had been changed (see the
wording in the slide below). The word ‘experimental’ had been
deleted. The new wording shifted responsibility for bad outcomes to the
patients.
Dr. Wall and I
submitted a manuscript for publication to ‘the green journal’ (the American Journal of Obstetrics and
Gynecology) that had two parts – (1) a review of the step-by-step process
for the development of surgical innovations that every medical school
teaches/expects and (2) a detailed comparison/assessment of Practice Bulletin
#79 and Practice Bulletin #85. The journal offered to publish the first
part but refused to consider the second part. We then contacted the International Urogynecology Journal and
explained the situation. IUGJ
decided to publish the second part of the manuscript. So we divided our
manuscript and had the two parts published in separate journals. ACOG’s
Vice-President of Practice Activities wrote a letter to the IUGJ editor, arguing our questions/concerns were unfounded. We responded in a letter to the IUGJ editor that the ACOG representative had presented no new or
additional information relevant to our questions/concerns. At that point, the Practice Bulletin chair at the time #79
was circulated and then abruptly withdrawn (after which she resigned from the
committee) sent – courageously, in our opinion – a clarifying letter to the IUGJ editor. Here is her letter to
the IUGJ editor:
As the author
responsible for the controversial wording of the ACOG Practice Bulletin on
pelvic organ prolapse, I would like to thank Drs. Wall and Brown for bringing
this matter to the attention of clinicians, and Dr. Karram and the
International Urogynecology Journal for their willingness to publish this.
The explanation
that I was given at the time that ACOG decided to change the wording (over my
strenuous objections) was that the meaning of the word “experimental” was
ambiguous. This is disingenuous at best. In fact, the ACOG staff member at the
meeting of the Committee on Practice Bulletins-Gynecology described the real
reason for concern: “…that the current wording would possibly deny payment for
some physicians.” Most of the clinicians who objected to the use of the word
“experimental” understood only too well exactly what meaning was intended –
that these procedures lacked sufficient evidence of risk versus benefit to
adequately counsel patients as to expected outcomes. Such clinicians were
concerned that insurance companies would not cover procedures labeled
experimental, and they were concerned about their medicolegal risk should a
complication arise in the course of procedures labeled experimental. Exactly
the kinds of concerns that a professional organization that truly promoted best
medical practices would see as a red flag – that clinicians’ concerns were not
focused on what was best for the patient, but on what protected their income.
That ACOG chose to align itself with these few Fellows at the expense of
patients’ outcome and safety is of grave concern.
If ACOG had
actually decided that the meaning of the word “experimental” was ambiguous, it
could have decided to clarify the meaning of the term in the document itself.
As an alternative, ACOG could adopt an official definition of the term, as
other professional organizations (such as the American Society of Reproductive
Medicine) have done. That ACOG made neither of these choices underscores the
real motivation behind deleting the “experimental” term from the Practice
Bulletin.
I agree with Drs.
Wall and Brown that ACOG can, and should, do better. Particularly given the
heightened concern about complications with the mesh kits that prompted the
FDA’s public health advisory, as noted in the article by Drs. Wall and Brown,
the appropriate action of the part of ACOG at this time is to restore the
wording of the original Practice Bulletin, to emphasize the truly experimental
nature of these procedures and to stand behind its promise to women, in its own
Bylaws, by “serving as a strong advocate for quality health care for women, and
maintaining the highest standards of clinical practice”.
[key PowerPoint slide from the graduating chief resident presentation]
I welcome your
questions and observations. You are free to use the above materials as
you think might be helpful in your surgical ethics education efforts.
Doug
