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Board Of Directors
Charles S. Zwerling, M.D.~Chairman
Melissa Grimes; Vice~Chairman
Sadie M. Futrell; Secretary~Treasurer
America Academy of Micropigmentation
FDA Petition Questionnaire
Injectable Iron Oxide Pigments
June 1994
The America Academy of Micropigmentation is a
voluntary, scientific and educational institution organized to improve
the care of the micropigmentation patient, by maintaining an association
of physicians, nurses, and dermatechnicians to foster the exchange
and dissemination of important information, new technology, and
clinical trials in the field of micropigmentation. To this end the
Academy will strive to advance the science of micropigmentation
as well as the ethical and competent practice of its art.
The media has recently reported cases of supposed
allergic reactions to the use of injectable iron oxide pigment.
The Academy has petitioned the FDA in cooperation with leading pigment
and instrument manufacturers to formally investigate the use of
injectable inorganic iron oxide pigments in order to establish the
safety and efficacy of this substance. If successful, the FDA will
grant pre market approval for these pigments. As part of the petition
process, the FDA has stated that they would accept documented clinical
use of iron oxide pigment by the various practitioners.
A previous questionnaire was developed by the
American Society of Micropigmentation in 1985 in response to adverse
publicity concerning eyelash loss resulting from micropigmentation.
The results of the questionnaire provided factual evidence as to
the safety of the procedure. In a similar approach, the American
Academy of Micropigmentation, which has no proprietary interest
in the manufacture of instrumentation or pigments, has prepared
this questionnaire to determine the clinical experience of the micropigmentation
practitioner's use of injectable iron oxide pigment. The Academy
feels that continued, unbiased research and conscientious patient
follow-up is necessary to accurately assess this procedure.
Charles S. Zwerling, M.D. FACS
Chairman of the Board, American Academy of Micropigmentation
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