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Uterine artery embolism (UAE), AKA uterine fibriod
embolization (UFE) is a new medical treatment/device being promoted and done by obgyn's
along with the assistance of radiologists/x-ray for the treatment of uterine
fibroids. Currently only positive reports are on the web covering this technology.
This site has general information, and shows UAE/UFE in a totally different perspective
from the web sites, doctors, and organizations who sell and promote uterine artery/fibroid
embolization. Bringing a medical device to market
and gaining FDA approval is very costly. The FDA (in 2001) is just now allowing clinical
trials to begin for uterine artery embolization/uterine fibroid embolization. Trials
are a requirement in order to gain FDA approval and can last a few months or a few
decades. Clinical trials are usually hosted, funded, done, and reported by
those who have a vested interest in seeing the treatment come to full market.
Doctors in the private sector often provide data for these trials. Manufacturers of mecial
devices, as a matter of business, hire public relations (PR) firms to promote their
product to the medical community and to the FDA. When things go wrong these hired
guns work as crisis management to protect the image of the company they work for and the
products/services they promote.
Myth #1:
Truth #1:
UAE is not experimental
UAE is highly experimental
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| On 5-22-2001 Dr. Hufnagel testified
in front of the FDA and notice
was given to HALT ALL UAE until the 15,000 women who have received the
device/treatment has been contacted, properly evaluated, and followed up. To date she is
the only physician to have done so. Today uterine artery embolization is routinely offered
to women and is presented as being a safe alternative to hysterectomy. Adverse
outcomes such as death, hysterectomy, ovarian failure, and radiation burns, are not being
investigated or reported on. |
REPORTING ADVERSE
EFFECTS OF
UTERINE ARTERY EMBOLIZATION (UAE):
NOTICE:
No one is going to report your adverse effects of UAE to the FDA or to your State
Medical Board except for YOU.
Reporting to
your doctor bad side effects, or to those who are conducting a clinical trial or study
does NOT mean that the FDA is being notified of your negative outcome. The
fact is when UAE clinical trials and studies are done and negative outcomes manifest
(hysterectomy, ovarian failure, etc...) those conducting the study are allowed to exclude
certian numbers and term that attempt as "Treatment Failed".
Your numbers are NOT being counted!
Outcomes such as death, hysterectomy, ovarian failure, radiation burns,
are not being investigated or reported on.
To report an adverse
outcome to your state medical board or to the FDA begin by submitting a Primary Complaint Intake Form.
Each state has a governmental regulatory board that serves
to protect citizens form unethical doctors or dangerous medical practices. Their duties
include licensing doctors, overseeing the activities of the physicians who offer services
in their state, investigating when a complaint is made, and disciplining doctors when
their actions merit so. Disciplinary actions can range from ordering further education and
training to revoking the physicians medical license. Filing a complaint with your state
medical board is not a lawsuit.
As a consumer of medical services you have a right and a duty to wage a complaint if
you believe you were uninformed, mislead, treated unfairly, or injured by a physician or
treatment while in any medical setting. If your physician did not properly inform
you before your uterine artery embloization, if your current doctor is not offering you
help or treatment, or if any doctor or medical professional in any field of practice has
ever acted unethically or inappropriately, your state board needs to be notified.
As the PCV pellets/foam used in UAE and the
arteriogram/fluoroscopy (x-ray) are medical devices governed by the FDA,
adverse outcomes after UAE needs to be reported to the FDA. Directions for reporting
to the FDA are provided upon filing your Primary Complaint Intake Form.
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