Background: On April 7, 2009, the International Committee for Quality Assurance, Medical Technologies and Devices in Plastic Surgery (IQUAM) issued its 8th Position Statement. IQUAM is a professional medical and scientific organization committed to the surveillance of existing and new technologies and devices in plastic surgery. IQUAM periodically reviews and evaluates updated international literature and studies and scientific data, and recommends standards of treatment for plastic surgery devices and technologies. IQUAM proscribes potentially deleterious use of products, devices, and technologies, or their unintended application or application for unsuitable indications.
Methods: Presentations of an international panel of experts made during the Transatlantic Innovations Symposia in Paris, in April of 2009, were reviewed by an advisory board that prepared the position statement for distribution to plastic surgeons and regulatory bodies. The advisory panel was international in nature and included plastic surgeons with expertise in the specific areas evaluated.
Results: Three clinical areas of greatest concern to plastic surgeons were evaluated for efficacy and safety: silicone breast implants, tissue engineering, and injectable therapies.
Conclusion: Specific recommendations designed to increase clinical safety and patient education for informed consent were made in each area.
Munich and Regensburg, Germany; Bratislava, Slovakia; Los Angeles, Calif.; and Minneapolis, Minn.
Received for publication April 3, 2010; accepted July 19, 2010.
Disclosure: The authors have no commercial associations or financial disclosures that might pose or create a conflict of interest with information presented in this article.
Constance Neuhann-Lorenz, M.D., Theatinerstrasse 1, 80333 München, Germany, firstname.lastname@example.org