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 a 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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