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Cryolipolysis

A Question of Scientific and Photographic Integrity

Swanson, Eric M.D.

Plastic and Reconstructive Surgery: December 2015 - Volume 136 - Issue 6 - p 862e–864e
doi: 10.1097/PRS.0000000000001786
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Swanson Center, 11413 Ash Street, Leawood, Kan. 66211, eswanson@swansoncenter.com

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Sir:

Conflict of interest is a hot topic in plastic surgery and deservedly so. A close and mutually dependent financial relationship may exist between an investigator and a manufacturer. Although this issue may be a sensitive one to those affected, conflict of interest is simply a reality that is now well-documented in our specialty.1,2

Cryolipolysis serves as a case in point. In a recent publication,3 the authors demonstrate the effect of cryolipolysis on the outer thigh. Measurements (Fig. 1) reveal an increase in width of the treated right saddlebag, from 19.9 cm to 20.2 cm in a patient who gained 1 lb after treatment (a 34-cm hip width was used for calibration based on measurements in a large group of women presenting for liposuction4). The authors also depict a woman who gained 5 lb in the 8 weeks after her treatment.3 Surprisingly, the width of the saddlebag and hip appears to be unchanged on the control side. Remarkably, the untreated left hip is reduced 0.4 cm despite her substantial weight gain (Fig. 2). These findings contrast with the increased dimensions recorded after only a 1-lb weight gain in another patient (Fig. 1). The image overlap shows a 0.9-cm change in the thickness of the treated left saddlebag. Although the left medial thigh border and gluteal fold match almost perfectly, the skin lesions show variable differences in their position before and after treatment (Fig. 2). It is not clear from the photographic overlay which image is the before image and which is the after image. Some panty fold patterns do not appear to match up well (Fig. 1), but it is difficult to be certain because of the (unexplained) darkening of the control side.

Fig. 1

Fig. 1

Fig. 2

Fig. 2

The photographic treatments create questions. Why use a black background? A sky blue background is recommended.5 Why shade the control side (a practice that does not belong in a scientific publication)? Why is there a black margin running down the middle of the illustrations? Should the photographs not be continuous? Why not simply present two standardized photographs side-by-side that are not digitally edited? Photographs featured on an investigator’s Web site6 that also appear on the manufacturer’s Web site7 reveal that the background has been changed from blue to black. The funding statement3 discloses that the manufacturer provided photographic services. Such outsourcing is highly unusual in scientific studies and invites photographic manipulations, both known (e.g., background color change) and unknown. A company that has invested heavily on research and development of its product, including fees paid to investigators,8 should not be entrusted with photographs, which are of essential importance in treatment evaluation.

In addition to photographs, the manufacturer also provided ultrasound services.3 The reported standard error, 0.39 mm, is much lower than the error in photographic measurements,4,9 and contrasts with another study using ultrasound documenting highly variable changes in fat thickness.10 A p value of “7.86E-8”3 is confusing; p values are expected to lie between 0.0 and 1.0. A 2.6-mm mean reduction in fat thickness is similar to the calculated 3-mm reduction8 based on a 39.6-cc decrease in volume of a treatment area,9 and is likely to be within the range of measurement error that is inevitable when making measurements on sonograms, which are sensitive to transducer pressure,10 site selection,10 and the effect of subtracting any change on the control side,10 as was done in this study.3

The manufacturer, Zeltiq Aesthetics (Pleasanton, Calif.), provided equipment and consumables, and compensated both patients and the study site for treatment and follow-up visits.3 Unfortunately, once investigators accept reimbursement, whether directly or indirectly, objectivity is lost.1,2,8 It is becoming increasingly clear that plastic surgeons may function as highly-paid consultants or objective researchers, but not both.1,2 The reader looks to our professional journals for unbiased scientific articles on which to base important decisions regarding treatment recommendations and expensive equipment acquisitions. We need to be diligent to protect the integrity of the scientific process and ensure that our journal publications do not become simply marketing tools.2 It is not clear that the cost-to-benefit ratio favors a method that reduces the fat thickness 1/10 inch in 16 weeks. Patients and surgeons need to be properly informed. Photographic integrity is vital to this process.

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DISCLOSURE

The author has no conflicts of interest to disclose. There was no outside funding for this study.

Eric Swanson, M.D.

Swanson Center

11413 Ash Street

Leawood, Kan. 66211

eswanson@swansoncenter.com

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REFERENCES

1. Lopez J, Prifogle E, Nyame TT, Milton J, May JW Jr.. The impact of conflicts of interest in plastic surgery: An analysis of acellular dermal matrix, implant-based breast reconstruction. Plast Reconstr Surg. 2014;133:1328–1334
2. Luce EA.. Financial conflicts of interest in plastic surgery: Background, potential for bias, disclosure, and transparency. Plast Reconstr Surg. 2015;135:1149–1155
3. Stevens WG, Bachelor EP.. Cryolipolysis conformable-surface applicator for nonsurgical fat reduction in lateral thighs. Aesthet Surg J. 2015;35:66–71
4. Swanson E.. Photographic measurements in 301 cases of liposuction and abdominoplasty reveal fat reduction without redistribution. Plast Reconstr Surg. 2012;130:311e–322e discussion 323e–324e
5. DiBernardo BE, Adams RL, Krause J, Fiorillo MA, Gheradini G.. Photographic standards in plastic surgery. Plast Reconstr Surg. 1998;102:559–568
6. . The Stevens Institute (Web site). Freeze the fat. Available at: http://www.freezethefat.com/before-after-photos-los-angeles/coolsculpting/3006/. Accessed April 25, 2015
7. Zeltiq Aesthetics, Inc. . Coolsculpting (Web site). Available at: http://www.coolsculpting.com/for-physicians/results/. Accessed April 25, 2015
8. Swanson E.. Cryolipolysis: The importance of scientific evaluation of a new technique. Aesthet Surg J. 2015;35:NP116–NP119
9. Garibyan L, Sipprell WH III, Jalian HR, Sakamoto FH, Avram M, Anderson RR.. Three-dimensional volumetric quantification of fat loss following cryolipolysis. Lasers Surg Med. 2014;46:75–80
10. Coleman SR, Sachdeva K, Egbert BM, Preciado J, Allison J.. Clinical efficacy of noninvasive cryolipolysis and its effects on peripheral nerves. Aesthetic Plast Surg. 2009;33:482–488
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