AAM Petitions FDA to Investigate Injectible Inorganic Iron Oxide Pigments
FDA Petition
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
