Summary of Council decision:
Two issues were investigated, both of which were Upheld.
A website for Vivo Clinic, www.vivoclinic.com, a clinic offering non-surgical vaginal tightening procedures, seen on 6 September 2018, featured a page titled “FemiWand - Vaginal Tightening”. Text under the heading stated “… the FemiWand non-surgical vaginal tightening treatment improves the health and vitality of vaginal tissue, using high-intensity focused ultrasound (HIFU) that is highly effective at rebuilding skin elastin while tightening”. The page included a video which showed a scene from the TV show “The Real Housewives of Cheshire”. The video showed a woman in a clinic preparing to have a contraction ball inserted into her vagina. The woman was joined by two of her friends who appeared to be drinking Prosecco. Further down the page, text stated “FemiWand is a 20-mintue procedure that can be performed on your lunch break”. Another sub-heading on the page stated “Why choose FemiWand - Non- surgical vaginal tightening?”. Text underneath stated “Improved muscle strength, tone, and elasticity of vaginal muscles, Increased sensation during intercourse, Improved control over urinary incontinence”. Further text on the page stated “Vaginal tightening with FemiWand is a non-invasive cosmetic procedure that restores the appearance and function of the vaginal area”.
The complainant challenged whether:
1. the efficacy claims listed in the ad were misleading and could be substantiated; and
2. the ad was irresponsible because it trivialised the procedure.
1. Vivo Clinic Bristol Ltd said that the product was a CE marked device. They said that with any non-invasive or cosmetic procedure, there was always contraindications but there was no evidence to suggest the Femiwand procedure was harmful. They said that there was credible evidence from their patients to show that their treatment improved vaginal and mental health.
2. Vivo Clinic Bristol believed that the ad was not irresponsible. They said that the video on the page was filmed by ITV for a show called “The Real Housewives of Cheshire.” They said that the character in the show had received real treatment.
The ASA noted that the ad featured the claims “the FemiWand non-surgical vaginal tightening treatment improves the health and vitality of vaginal tissue” and “improved muscle strength, tone, and elasticity of vaginal muscles, increased sensation during intercourse, improved control over urinary incontinence”. We considered that consumers would interpret the ad to mean that the FemiWand could provide effective treatment for vaginal tightening and the other listed conditions.
The CAP Code required that medicinal or medical claims and indications were made only for a medicinal product that was licensed by the MHRA or under the auspices of the European Medicines Agency (EMA) or for a CE-marked medical device. We had not seen any documentary evidence to demonstrate that the FemiWand was a CE-marked medical device or licensed by the MHRA or under the auspices of EMA. Because of that, no medical claims could be made for the product. In addition, we had not been provided with any documentary evidence to support the claims that the product could be used to provide treatment for the conditions listed in the ad. We therefore concluded that the ad breached the Code.
On that point, the ad breached CAP Code (Edition 12) rules
Marketing communications must not materially mislead or be likely to do so.
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.
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease. (Medicine, medical devices, health-related products and beauty products).
We acknowledged that the FemiWand procedure, which involved the insertion of a probe into the vagina, was non-surgical but was nonetheless not without risks and was not something which should be undertaken lightly.
The ad included a video clip from the TV show “The Real Housewives of Cheshire” which showed a woman preparing for the procedure joined by her two friends. The video featured the woman’s comical reaction to the procedure while her friends were seen drinking Prosecco and laughing. We considered that the casual and humorous style of the video clip coupled with the frivolous message “FemiWand is a 20-mintue procedure that can be performed on your lunch break” trivialised the nature of the procedure. The suggestion being given was that the decision to go ahead with the procedure could be taken lightly, without serious consideration. We therefore concluded that the ad was irresponsible and breached the Code.
On that point, the ad breached CAP Code (Edition 12) rule 1.3 1.3 Marketing communications must be prepared with a sense of responsibility to consumers and to society. (Social responsibility).
The ad must not appear again in its current form. We told Vivo Clinic Bristol Ltd to ensure that they did not make medicinal claims for a product, unless it was a CE-marked medical device and they held evidence to demonstrate that it was effective in treating the various conditions and ailments listed in the ad. We also told them to ensure that their service was advertised in a socially responsible way.