Breast-checking device to be investigatedWhich? prompts investigation of Breastlight

25 February 2010

Breast light

A breast-screening device on sale in high street stores including Boots is being investigated by the Medicines and Healthcare Products Regulatory Agency (MHRA) after Which? raised concerns that it may not meet legally required conditions for sale.

Breastlight (£85), a hand-held breast examination device, is marketed to help women spot changes which, it claims, ‘can lead to the earlier detection of breast cancer’. The consultant breast radiologists Which? asked to review the device are worried that the required scientific research evidence isn’t robust enough.

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Responsible breast examination

Despite the company behind the device, PWB Health Ltd, stating that women should use Breastlight in addition to normal screening and checks, consultant radiologist Dr Steven Allen raised concerns: ‘Though it’s an interesting technological advance, I believe it’s irresponsible to market it without further scientific evaluation in bigger research trials, so we can tell how well it works.’

A PWB Health Ltd spokeswoman told us: ‘Breastlight fully complies with the EU Medical Device Directive. Clinical evidence shows that it is capable of detecting early-stage tumours with very low incidence
of false negatives or false positives.’

Which? thinks it’s unrealistic to expect that Breastlight won’t falsely reassure some women, potentially leading them to delay investigation of cancer, and falsely alarm others. We’ll let you know the outcome of the MHRA’s investigation.

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