The general destruction of normal uterine tissue as a result of UAE
has not been given significant status in the evaluation of this procedure. I believe
this stems directly from the culturalization that the uterus is an organ which we can
eliminate with surgical easy (hysterectomy). And the value of the uterus is not held other
than for childbearing in the majority belief system.
If you suspend your socialized
concepts about the uterus and hold a position that the uterus has intrinsic physiological
functions including but not limited to:
sexual response
creation of hormones
and other substances
(inhibin, relaxin, prostacyclins etal,) and
is an organ of
placement for the pelvis
This concept of the human
female uterus significantly impacts on the evaluation of said organ and its role in female
anatomy and physiology.
I was and continue to be
maliciously attacked by the American College of Obstetrics an Gynecology (ACOG), the CMB
and by an appointed Judge for stating the uterus was a "sexual organ". The
manner in which my own career has been affected by stating my beliefs reflects the need of
such institutions’ to protect their existing belief systems.
How you view this organ imports
on who you treat it.
Also how you view women is
impacted on how you treat them. To often entrepreneurial medicine focuses on the
fears of women and begins its sales campaign based on fear and ignorance. Ignorance
then is then feed with quick fixes and so called noninvasive treatments offering safe and
effortless cures.
In the case of uterine fibroids
I am able to say after more than 15 years of surgical experience that there are many
approaches that are successful that are advanced over traditional myomectomy that remove
uterine fibroids. The standard surgical approach in general has not advanced in the
world of gynecological surgery. Rather than focus on learning new ways to remove
uterine fibroids the gynecological community has elected to support
entrepreneurial medicine such as UAE. This is a political social reality that needs
to be exposed.
POINT OF VIEW
Perhaps some analogy needs to
be imposed within this discussion to try and demonstrate the absurdity of the approach
that we are discussing here today.
A simple neoplasia ( non
cancerous tumor ) of the testes can be treated with this UAE approach. Why are you not
discussing here the occlusion of the vessels to the testes? Cutting of the blood supply to
the neoplasia will cause it to shrink , to necrosis. Why is this not a topic here today?
These are all social issues in
which we need to reevaluate our value system.
I find it appalling that the
medical community has accepted the belief system that we can shut of the blood supply to
uterus. We can shrink fibroids but leave them in the uterus enlarged, scarred and
inflamed and call this a cure. It is my opinion that we are doing more harm when we
destroy the anatomy and make surgical intervention more difficult in the future which is
what occurs with all UAE cases.
The resulting necrosis of
lieomyomata causes the capsule of the fibroid to bind and adhere to the normal myometrial
tissue. In normal conditions the hard fibroid is distinctive from myometrial tissue and
separated my a dense capsule.
The very thing that allows a
surgeon to detect and remove uterine fibroid from the uterus ...is eliminated through the
UAE process. UAE by the ischemia reaction causes significant loss of normal anatomical
distinction. The myomertrial tissue is severely affected by UAE. The normal myometrial
tissue becomes inflamed and damaged.
We are not dealing with an AV
malformation in the cerebrum that is not accessible for surgery. We are dealing with
benign tumors that can be easily extracted from the uterus. However the giant cell
reaction, fibrosis, myometrial necrosis, histiocytic clumping, micro abscess formation
within the normal myometrium make the surgical detection and removal of uterine fibroids
extremely difficult even for the most skilled surgeon .
LACK OF SURGICAL
EXPERTISE
The lack of training in the
removal of uterine fibroids is an issue with in this nation. Many surgeons will be forced
to perform hysterectomies on post UAE patients because of the anatomical changes that take
place throughout the uterus.
Separation between the necrotic
degenerating fibroids and the myometrium which has become inflamed and reactive to the
necrosis is not easily delineated. The capsules of the fibroids become like super glue to
the normal myometrial tissue.
I wonder how many women with a
single fibroid tumor that was not symptomatic have undergone UAE. These women are
excellent surgical candidates for tumor removal. The reality with new surgical approaches
the number of tumors or size of tumors are not issues with reconstructive processes.
Women are not being fully
informed that the likely hood of complete necrosis of their tumors in many cases is not
possible. They are then further not told that they are at higher risk for a hysterectomy
or a very difficult myomectomy. Many of the small seed fibroids will not be detected at
surgery and re-growth is likely.
FAST
I asked Acheing Wamabo to
describe her UAE in one word. She looked up at me and said "FAST". She was given
no time to ask questions. She was not given adequate consent which seems to be a
consistent complaint with this procedure.
Women are not been adequately
informed of the negative affects . I have reviewed this case and it is present as a
typical UAE. This patient was given Lupron to shrink her tumors before the UAE. She had a
pulmonary emboli shower from the Lupron. This negative out come with Lupron was never
reported. Many woman with negative Lupron experiences have no idea this can be reported.
Worse, their physicians are not reporting these events.
I will be attacked for
reporting this case and issue. No good deed goes unpunished has been the hallmark of my
career. The physicians involved in Ms. Wambos case are leaders in the UAE movement (
Roxborgouh Hospital Penn.).
Her PE was in 1998. It is not
referred to in any of her UAE records. The radiologist denied being told about it. The
Achieng states she discussed this repeatedly because she nearly died. She has two official
UAE operative reports in her file. One that states both right and left arteries where
blocked . One that states on the left side was blocked. She had no follow up at all. No
one performed a follow up ultrasound. No one dealt with the fact that she was still
walking around with a massive size uterus with severe pressure and reoccurring right sided
pains. She was living in fear of having any surgery told it could not be done because of
her prior pulmonary emboli. The lack of evaluation and follow up in this patient needs to
be seen as the trend in the FAST MILL sales development of UAE that has become the
standard of care.
There was also an attempt to
have Achieng seen by a surgeon who would remove her uterus and not report any of these
findings. The physician involved with her LUPRON PE refused this woman her own
records.This physician refused her records to myself. The records showed that there was no
ultrasound follow up for two years. Trying to care for this woman was difficult to say the
least. Her referring gyn had no files and no memory of her. She will be filing a FDA
Device report and a report on Lupron.
I have had more than ten women
this year tell me similar stories about their UAE. None of them had the negative outcomes
reported. None of them knew about reporting. The data being report is very none
representative . follow up has vanished . I see this as another abusive technology .
IS THIS ANOTHER OVA
BLOC ...silence
What happened to the thousands
of women injected under FDA studies with silicone in their fallopian tubes with the OVA
BLOC fiasco. A conspiracy of silence develops around these issues.
CONCERNS:
RADIATION EXPOSURE
Radiation exposure to the
female for a non life threatening condition I feel is to great. I am concerned about the
long term affects of radiation on the ovaries.
I am aware that we have
technology to avoid this today. Visualization does not require radiation.
TOXIN EXPOSURE
The Polyvinyl family is linked
with toxic exposure and complications. These agents are linked with hormonal changes that
may be related to development of female cancer.
LACK of FULL DISCLOSURE
The surrent documents and oral
discussions with potential patents do not fully explain the unknowns of UAE and the known
complications that have been witnessed. This area is lacking in adequate disclosure
FOLLOW UP
The rush to get these women
into UAE is part of the extensive marketing program that’s taken place. However, the
follow up care is lacking .
Vikki Hufnagel MD
323 650 6182 update - current number is now 323-874-5530 |
