Last March Which? reported Breastlight, a breast-screening device, to the Medicines and Healthcare Products Regulatory Agency (MHRA) because we’re concerned it doesn’t meet legally required conditions for sale.
But the MHRA has made no decision and the product remains on sale in stores, including major high street retailer Boots. By contrast, the health regulator in Canada has requested an immediate end to sales.
Not a priority
A spokeswoman for the MHRA told us: ‘Our investigation has involved an extensive review of the product. As we have received no adverse reports or user complaints and there are no known safety issues, it has not been classified as a high priority and higher-risk devices have taken precedence. Cases are handled according to priority in the interests of public health.’
In contrast to the MHRA’s indecision, the health regulator in Canada has requested an immediate end to Breastlight sales, saying there’s no evidence that it detects early breast cancer and it could pose a health risk to women who rely on it for that purpose.
Women may miss diagnosis
UK-based consultant radiologist Dr Steven Allen told us: ‘Many women may be using this unproven technology because it’s on sale through such a large retailer. Reliance on an ‘all-clear’ result – rather than a mammogram – could have potentially devastating consequences for a few.
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