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Shining a light on self-test kits


A couple of years ago, I was in Boots the chemist – the high-street store that also offers NHS stop-smoking and sexual health services. It had a prominent advert on the pharmacy counter.

It was big and pink, and it was for ‘Breastlight' – effectively, a red torch that women were being encouraged to shine into their breasts. To use their own description, it's ‘a new health and wellbeing product for women that helps women notice any changes in their breasts over time,' via use of a ‘harmless red light' which will apparently mean you can ‘get to know what's normal for you, spot any changes and hopefully feel more confident that you're looking after your body the way you'd like to'. 

And I was thoroughly annoyed, what with it costing almost £90, and the company's website claiming that its device could ‘help detect cancer early'.

This was and is incorrect. There have been several trials done of the Breastlight device, none of which examined the accuracy of it in asymptomatic women. Its website says that it has been ‘tested on over 1,200 women'. It has indeed been trialled, in women who have breast lumps and other symptoms. In one trial it showed a shadow in 12 out of 18 cancers proven by biopsy, meaning a third were missed. Just after I complained to the Advertising Standards Authority about them, the company that marketed Breastlight – PWB Health – went into liquidation. But Breastlight is now back on high-street shelves under new owners. The phrase ‘helps detect cancer early' does not appear on the new company's website, but it persists in saying ‘for earlier detection'. Of what? Why?

Breastlight says that women with larger breasts ‘reported that Breastlight gave them more confidence' – but what's the point of more confidence if it's misplaced? The Breastlight website says that the light used in the torch is ‘harmless', but this rather misses the point. What about false positives and false negatives? What about the further harms of, for example, a young woman who finds what seem to be changes or abnormalities in her breasts – what then?

Fears are played upon – and we already know women overestimate their risks of getting breast cancer and underestimate their chances of being successfully treated for it. The NHS is left to sort out the guddle, and so is the taxpayer – the original company got £1.1m from the Scottish Enterprise Co-Investment Fund in 2007, which I understand was lost in the subsequent liquidation. How can it have been right to invest money in a product that had no proven benefit in the population it was being marketed at?

But the real issue is about how we can protect people against potentially harmful and unhelpful health products, and the lack of effective regulation surrounding devices like Breastlight. The ASA acts in these circumstances in retrospect, and can take weeks or months to make a decision. Trading Standards usually passes medical devices to the MHRA, which tells me it is still investigating. And women are offered the idea that technology might offer better odds than what we know can modify risks for breast cancer – attention to weight and alcohol, probably exercise, and breastfeeding. We need better ways to get better healthcare information about evidence to the public.

Dr Margaret McCartney is a GP in Glasgow


Breastlight's reply

PWB Health UK, the new company which markets Breastlight, released the following statement to Pulse: ‘The Breastlight is sold as an aid to breast awareness/self-examination. Women are encouraged to use the Breastlight as an additional part of their regular breast awareness routine where women should regularly look for changes in the appearance and texture of their breasts. If they see or feel any changes, women are encouraged to report the changes to their GP.'