A video on www.breastlight.com, seen in August 2016, and a poster seen in July 2016, promoted a self-examination device.
a. The video included on-screen text which stated, “’Something like Breastlight that'll help identify a problem earlier, is just wonderful’ Fawn Leith, Family Nurse; ’Breastlight may increase confidence in women's own breast assessment’ Dr Sarah Burnett, consultant radiologist; … ‘With the Breastlight, you can back-up what you're feeling & looking at - it's extra reassurance’ Becky Wheeldon, Prison Nurse; … ‘It appears that Breastlight is effective in the detection of malignant tumours and in some cases can differentiate between malignant and benign disease’ Mr Obi Iwuchukwu, Consultant Breast Surgeon, Sunderland City Hospital; … ‘It could prove useful for younger women who do not benefit from routine mammogram testing’ Jayant Vaidya, Consultant Breast Surgeon, UCLH”.
b. The poster stated, "Breastlight gives you a clear view inside your breast tissue to observe any abnormalities … Something like Breastlight that will help identify a problem earlier is just wonderful”. It featured a picture of a woman using the device.
A GP and a member of the public challenged whether the ads misleadingly implied the device was effective for use in early detection of breast problems.
PWB Health (UK) Ltd said there was substantial research and continued clinical support for the product from across the globe. They said breast cancer affected one in eight women in the UK, and roughly 1.3 million new cases were discovered each year globally. They said the effectiveness of treatment depended almost solely on early detection. PWB Health said the aim of Breastlight was to assist in early detection as a preliminary screening tool which could be used by clinics in many developing countries and by consumers in the West, where disposable income was more readily spent, and where professional healthcare was more advanced. They said they always marketed the product as an assistant to any regular breast care routine, never as a replacement.
PWB Health said transillumination of soft tissues to observe abnormalities in blood flow was not a new science. Rather, it had been utilised in healthcare across the world since the 1920s. They provided an article written by Max Cutler, MD in 1929, who they said had discovered its effectiveness. They said the article stated transillumination did not provide a diagnosis but was a useful aid, and that on all Breastlight literature including the packaging and their website, they strongly advised women to take advantage of screening programmes and to see their doctor if they had any concerns whatsoever. They also advised that Breastlight was to be used as part of a normal breast screening routine, not as a substitute. They believed that was responsible marketing, because they were fully committed to selling their product as a useful aid, and not a replacement for mammography or professional check-ups by a doctor. They said the article stated the practical uses of transillumination in enabling a more accurate estimate of a tumour than palpation alone. They said palpation could be particularly difficult for women with large or fibrous breasts and Breastlight could help in giving a further analysis into a perceived problem. They said they had never claimed it would diagnose an issue, but merely that it was a useful tool alongside medical examinations, mammography and palpation.
PWB Health provided several studies. In 2009, the Breastlight underwent clinical testing at Sunderland City Hospital by Dr Obi Iwuchukwu. They also provided a study from 1995, which was a preliminary clinical evaluation of a combined optical Doppler ultrasound instrument for the detection of breast cancer, and an earlier trial showing preliminary results using computerised telediaphanography for investigating breast disease.
PWB Health said since they had taken over the current company, there had been several smaller studies carried out globally with the help of their distributors, which they provided. One was carried out in Iran between 2011 and 2013, which they said suggested Breastlight could detect over 50% of what could be detected through mammography. They said palpation alone could not come close to that figure and they therefore believed Breastlight was a useful tool in home screening. Another was conducted in Egypt in 2012 and 2013, and they said it showed very promising results whereby Breastlight had an 88.2% accuracy at diagnosing breast cancer, and the physicians involved agreed it was a valuable tool for women’s personal breast awareness.
PWB Health said studies showed how unreliable palpation was as a way of detecting problems and due to the lack of support for its reliability, most women did not ever check their breasts. They said their product encouraged women to be more aware of their own breast health.
In relation to the claim “Something like Breastlight that’ll help you identify a problem earlier, is just wonderful”, PWB Health pointed to their most recent study, where all palpated lumps were found by Breastlight and 23 masses were found that were not discovered through palpation alone. Furthermore, they said, the study in Iran showed almost 50% of masses 2 cm and above were detected and for 4 cm masses it was up to 85.7%. They said Breastlight, according to that study, could detect all stage 2 breast cancers and there was no evidence to suggest palpation could achieve that result.
In relation to the claim “Breastlight may increase confidence in a woman’s own breast assessment”, they provided two user evaluation studies. In relation to the claim "With the Breastlight, you can back-up what you're feeling & looking at - it's extra reassurance", they said they always marketed the product as such and that their website was full of information stating that women should take advantage of mammograms where possible, and always to use Breastlight as part of a regular breast care routine. Furthermore, they said they knew the product backed up a regular breast care routine by a study they provided stating that it could detect all palpated masses.
They said there were ongoing discussions in medicine regarding the advice given to women concerning their self-awareness routines and that different advice was given in different countries. They said advice was changing as developments were made, and that they had a large and growing amount of user data, anecdotes and results from women who had used the product. For example, in their consumer trial, one participant had used the Breastlight and saw ‘something’, which had led to a referral from her GP, and she was found to have previously undiagnosed breast cancer. They provided a newspaper article which reported on the story. They acknowledged that result was not statistically significant, but believed it demonstrated the product was capable of providing earlier detection both as a result of increased frequency in checking and in the earlier observations of potential abnormalities made by users before clinical detection and diagnosis.
They provided details of a further study carried out in Iraq.
The ASA noted the following claims in ad (a), “Something like Breastlight that'll help identify a problem earlier, is just wonderful" and "It appears that Breastlight is effective in the detection of malignant tumours and in some cases can differentiate between malignant and benign disease". We also noted the ad was directed at consumers rather than health professionals, and considered that consumers were likely to understand from those claims that the product was effective as one that consumers could use at home for the early detection of cancer. Similarly, the claims in ad (b), "Breastlight gives you a clear view inside your breast tissue to observe any abnormalities … Something like Breastlight that will help identify a problem earlier is just wonderful” would be understood in the same way.
We understood that the claim "It could prove useful for younger women who do not benefit from routine mammogram testing” in ad (a) referred to the fact that younger women were not invited for routine mammograms, unlike older women. We considered that it also implied it could provide an effective way to detect breast problems early, again in the context of home use.
The results of the market research indicated that women might use the device as part of, and to increase the frequency of, their normal breast health routine. However, we did not consider such surveys, nor the 1929 article or the Sun article, to be sufficient evidence to support the implication that the device was effective for use in early detection of breast problems.
We noted the clinical trials were carried out within hospitals, and in all but one, the patients were symptomatic. For example, one was conducted in a symptomatic breast clinic where the women had been referred by their GPs. The device was used by healthcare professionals who we considered would have greater expertise examining breasts compared to most consumers. One study noted that the 2003 Cochrane Review found screening by breast self-examination or by clinical exam was not associated with lower death rates. It increased harms, in terms of increased numbers of benign lesions identified and an increased number of biopsies performed. The study carried out in Iraq concluded that the product’s high false positive detection rate and significantly low specificity in excluding malignancy precluded its use as a screening tool for breast cancer in Iraq. Another study, carried out in Ghana, did not include a full methodology and largely concerned the use of a similar, but different, device from the Breastlight. The examinations were, again, in a clinical setting and used alongside clinical examination. We therefore did not consider that evidence to be adequate substantiation for the implied claim that the Breastlight device was effective for use by consumers in early detection of breast problems.
For those reasons, we concluded the ad was likely to mislead.
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. (Medicines, medical devices, health related products and beauty products).
The ads must not appear again in their current form. We told PWB Health (UK) Ltd not to claim that the Breastlight was effective for use in early detection of breast problems in the absence of adequate evidence to substantiate that this was the case.