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Medical Devices for Aesthetic Medicine: The Four Stages Model for the Search for the “Holy Grail”

Ad El, Dean D. M.D.

Plastic and Reconstructive Surgery: October 2012 - Volume 130 - Issue 4 - p 636e–637e
doi: 10.1097/PRS.0b013e318262f713
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Department of Plastic Surgery & Burns, Rabin Medical Center, Petah Tikva, Israel, Tel Aviv University School of Medicine, Clafit Aesthetics, Clalit Health Services, Tel Aviv, Israel

Correspondence to Dr. Ad El, Department of Plastic Surgery and Burns, Rabin Medical Center, Beilinson Campus, Petah Tikva 49100, Israel deana@clalit.org.il; deanadel@yahoo.com

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Sir:

The world of aesthetic medicine has changed in the past two decades: most of the aesthetic procedures are being performed by nonsurgeons, and morbidity and downtime have become major issues. The relevant history started with the carbon dioxide laser.1,2 In the ensuing decades, pigment-based lasers and intense pulsed light3 were developed for treating birthmarks and tattoos and for performing hair removal. The indications widened and devices were planned to cope with leg veins and facial rejuvenation. Since then, devices have been developed using radiofrequency4 and ultrasound, advanced lasers,2 and their combinations.

Why have we not found the “Holy Grail?” It is important to define what we are looking for: a device that will produce facial rejuvenation or body contouring with less downtime and morbidity than is associated with surgery. Market analysis and current statistics5 show constant growth in the field of medical aesthetic devices, with an average of 7.3 percent every year over the past 5 years. Are we surgeons feeling comfortable with our techniques and/or could not stand inferior results being achieved after numerous sessions (as our dermatology colleagues), or is there a problem with those devices?

The answer to the former question is yes and yes: Medical device type of practice should be built for numerous treatment sessions at a low cost. The other truth is that the current status of medical devices is far from reaching clinical results comparable to surgery. For a device to be successful, it has to “pass” a certain barrier on its way to satisfactory aesthetic results. I divide the barrier into four distinct checkpoints:

  1. Physical stage: Most devices are based on sound physical principles.
  2. Biology: Energy delivered in the tissues can spread and not reach its target. The biological system is complex and includes many unknown and personal variables.
  3. Clinics: A higher barrier in the way of patient satisfaction is true clinical evidence. Many of the published data of the commercial devices show impressive photographs but ignore true statistics, patient selection factors, and other factors.
  4. Patient satisfaction: True evidence of any aesthetic intervention is the final “product”—patient satisfaction. It is highly dependent on the clinical results, but not only. Expectations are not less important. Social factors and marketing and pricing of the procedure are also important. Patients are willing to accept inferior results for less morbidity and downtime, but those results should also be seen by the patients and society.

In the past, Food and Drug Administration and European Conformity approval of medical devices was given only after safety was proven. However, today, true efficacy is required. Sound studies have to be performed after institutional review board approval.

In summary, I believe that aesthetic surgery will be replaced in many cases by comparable noninvasive and minimally invasive devices. Currently, we are not there yet because of certain facts: (1) most devices are planned by nonclinicians; and (2) the companies’ interest is finance, so new devices usually appear before the technology is truly tested in the true clinical and aesthetic environment.

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DISCLOSURE

The author has no financial interest to declare in relation to the content of this article.

Dean D. Ad El, M.D.

Department of Plastic Surgery & Burns

Rabin Medical Center

Petah Tikva, Israel

Tel Aviv University School of Medicine

Clafit Aesthetics

Clalit Health Services

Tel Aviv, Israel

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REFERENCES

1. Kaplan I, Ger R, Sharon V. The carbon dioxide laser in plastic surgery. Br J Plast Surg.. 1973;26:359–362
2. Tajirian AL, Goldberg DJ. Fractional ablative laser skin resurfacing: A review. J Cosmet Laser Ther.. 2011;13:262–264
3. Babilas P, Schreml S, Szeimies RM, Landthaler M. Intense pulsed light (IPL): A review. Lasers Surg Med.. 2010;42:93–104
4. Burns JA. Thermage: Monopolar radiofrequency. Aesthet Surg J.. 2005;25:638–642
5. American Society of Plastic Surgeons.. 2011 Plastic surgery procedural statistics. Available at: http://www.plasticsurgery.org/News-and-Resources/2011-Statistics-.html
©2012American Society of Plastic Surgeons