A local press ad for the Contour Clinic was headed "i-lipo". Further text stated "i-Lipo - The intelligent alternative to liposuction", "Results can often be seen immediately after treatment. Typically a 2-4cm loss in abdomen circumference can be achieved with every treatment. A course of 8 treatments is recommended over 4 weeks with 2 treatments per week", "Improve the appearance of cellulite", "Fat reduction, cellulite improvement, body contouring and skin tightening - all with one non-invasive system" and "i-Lipo Ultra- Improve the appearance of cellulite. The i-Lipo Ultra system uses low-level lasers for smoothing cellulite, fat reduction and body shaping treatments". Further text also stated "It is essential after having the treatment to increase your heart rate by participating in cardiovascular activity to speed up this process".
The complainant challenged whether the claims "i-lipo" could reduce fat and improve the appearance of cellulite could be substantiated.
The Contour Clinic said i-lipo was designed and used for fat reduction and cellulite treatment and they had previously provided studies to us supporting this as part of a case that was resolved informally. They said they made sure the ad stated that post-treatment exercise was required to see results. They provided three short articles from the manufacturer's website: one referred to Food and Drug Administration (FDA) clearance; the second to the publication of a supplement on the subject of i-lipo by a guide to aesthetics techniques; and the third was the abstract of a study of the use of i-lipo to reduce fat. They also provided a number of further studies to support the claims as well as copies of the i-lipo's FDA approval letters and details of client results from the Contour Clinic.
The ad included the claim that i-lipo treatment could lead to "Typically a 2-4cm loss in abdomen circumference can be achieved with every treatment. A course of 8 treatments is recommended over 4 weeks with 2 treatments per week". The CAP Code stated that advertisers must not claim that people could lose a precise amount of weight within a stated period, or that weight or fat could be lost from specific parts of the body, except through invasive procedures. The ASA therefore concluded this claim breached the Code.
We considered the general claims that i-lipo could reduce fat and improve the appearance of cellulite were new 'breakthrough' claims and that a high level of robust evidence was required to substantiate them. We understood that, as per the information given in the ad, the manufacturer's instructions included doing exercise after each treatment session. Because exercise could reduce fat by itself, and therefore improve the appearance of cellulite, we considered we needed to see robust evidence that i-lipo could have an additional effect beyond exercise alone. We assessed the various studies provided by the advertiser.
The first study provided related to the use of i-lipo to reduce fat in the abdomen area and 20 subjects were treated with a four-week course of i-lipo with two sessions each week. The authors concluded that a circumferential reduction could typically be expected immediately after treatment, and could be maintained with exercise, but any reduction was likely to be lost if exercise was not carried out. The study did not specify whether the 20 subjects were given advice on diet or exercise and we considered that this was an important factor in determining the cause of any weight loss. The paper also included a case study on a patient who carried out 30 to 45 minutes of cardiovascular on the day of the treatment, after it had taken place. We were concerned at the small number of subjects in the study and that it was not randomised, double blinded or controlled. It had also not been published or peer reviewed. We therefore considered the study was not sufficiently robust to support claims relating to fat reduction.
Three studies from a French dermatology and cosmetology research group were provided, along with two sets of results photos. None of the studies had been published or peer reviewed. The first study's objective was to evaluate the anti-cellulite effect of i-lipo; 15 subjects were treated with a four-week course of i-lipo with two sessions each week. Measurements were taken of the circumference of the treated area, fat level in the treated area, weight and overall body fat. The study concluded the results showed a statistically significant reduction of thigh and abdominal fat. However, the subjects were also given diet advice and were told to carry out exercise immediately after the treatment, which we considered could have contributed to any fat loss. We were also concerned at the small number of subjects in the study and that it was not randomised, double blinded or controlled. We therefore considered the study was not sufficiently robust to support claims relating to fat reduction. The study did not refer to any measurements in relation to the appearance of cellulite, and we therefore considered it did not support the claims made in the ad. The second study was a follow up of 13 of the 15 subjects in the original study with the aim of evaluating the long-term efficacy of i-lipo three to four months after the last treatment session using the same measurements as previously. They found that the subjects reverted back to their weight at the start of the original study, but that a reduction in circumference and fat tissue thickness remained. However, due to the deficiencies in the original study we did not consider the follow-up sufficient to support the claims in the ad, and noted that the study specifically stated that any weight loss was not maintained. The third study evaluated the i-lipo device for the reduction of cellulite using an experimental model of human skin implants. The authors concluded that an anti-cellulite effect was observed. However, we did not consider that an ex-vivo study was in itself sufficient to support the claims, and we considered that robust evidence from trials conducted on humans was required.
A further study of 15 subjects was provided, which again had not been published or peer reviewed. Measurements were taken of the circumference of the abdomen, flanks and back and the authors concluded the treatment reduced these measurements. However, the study was not randomised, double blinded or controlled and subjects took part in a 40-minute aerobic workout after each treatment session which could have contributed to any fat loss. We did not consider the study was sufficiently robust to support the claims.
The advertiser also provided treatment results for patients at the Contour Clinic. However, patients were instructed to exercise after each treatment and we did not consider that patient results were a sufficiently robust form of evidence to support the claims.
A retrospective review of treatment outcomes recorded in low-level laser diode treatments for fat reduction and body reshaping was provided. However, the paper only looked at the results of people who had had the treatment, which included an instruction to exercise immediately after each session. It was also authored by the Clinical Manager of the company who manufactured i-lipo and had not been published or peer reviewed.
A double blind, randomised and controlled study of 34 subjects was provided. Patients were randomly allocated to receive low-level laser treatments or sham irradiation from devices identical in appearance. Both groups maintained similar dietary patterns and completed identical exercise sessions immediately post treatment. Three circumference measurements were taken from the waist area and the person collecting the measurements was blind to the participant group allocations: 79% of the active treatment group saw a mean circumference reduction of 4 cm, while less than 7% of the placebo group saw such a reduction. The mean difference in circumference reduction between the two groups was found to be statistically significant. The authors concluded that i-lipo could reduce circumference measurements of treated areas to a greater extent than diet and exercise alone. We acknowledged that the study had been double blinded, randomised and placebo controlled, and was therefore of a higher quality than the other studies provided, and the results appeared to be statistically significant. However, we noted that it had been authored by the Clinical Manager of the company who manufactured i-lipo along with the Medical Director of the dermatology clinic where the study was carried out, which we understood offered i-lipo, and therefore considered this introduced the possibility of some bias. We also considered that the study gave insufficient information about the amount of exercise that each treatment group did overall during the study period, which we considered was important in determining the cause of any fat loss. The study had also not been published or subject to peer review. We did not consider that the study was in itself sufficiently scientifically robust to support the claim that i-lipo could reduce fat.
Two FDA approval letters had been provided. These gave the indications for use for the i-lipo 'lower level laser system' as treatment for the temporary reduction in circumference of the waist and for the 'ultra vacuum massage system' as treatment for the temporary reduction in the appearance of cellulite. However, the FDA was a regulatory agency based on the USA and we did not consider that their approval of a product, or their stated indications for use, was sufficient to support the claims.
The article that referred to FDA clearance being given to market the i-lipo for "circumference reduction" and referred to the study of 34 participants, which had been provided. The second article referred to the publication of a supplement on the subject of i-lipo by a guide to aesthetics techniques, which we did not consider relevant to substantiating the claims made in the ad. The third was the abstract of a study relating to the use of i-lipo to reduce fat, which appeared to be the same study of 20 subjects previously provided.
Overall, we did not consider that the evidence provided by the Contour Clinic formed a sufficiently robust body of evidence to support any claims that i-lipo could reduce fat or improve the appearance of cellulite. We therefore concluded the claims had not been substantiated.
The ad breached CAP Code (Edition 12) rules 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. (Misleading advertising), 3.7 3.7 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation. (Substantiation), 12.1 (Medicines, medical devices, health-related products and beauty products) and 13.1 13.1 A weight-reduction regime in which the intake of energy is lower than its output is the most common self-treatment for achieving weight reduction. Any claim made for the effectiveness or action of a weight-reduction method or product must be backed, if applicable, by rigorous trials on people; testimonials that are not supported by trials do not constitute substantiation. 13.9 13.9 Marketing communications must not contain claims that people can lose precise amounts of weight within a stated period or, except for marketing communications for surgical clinics, establishments and the like that comply with rule 12.3, that weight or fat can be lost from specific parts of the body. and 13.9.1 13.9.1 Marketing communications for surgical clinics, establishments and the like that comply with rule 12.3 must not refer to the amount of weight that can be lost. (Weight control and slimming).
The ad must not appear again in its current form. We told the Contour Clinic not to claim or imply that i-lipo could reduce fat or improve the appearance of cellulite unless they held new and robust evidence that this was the case.