The glove, which is actually designed like a mitten (see image at right), is made of thin polyurethane material that is hypo-allergenic and lubricated inside by mineral oil, and costs £25. It is a patented device and has a CE Mark, being manufactured in conformity with the Medical Device Directive of the European Union. It apparently works by reducing friction between a woman’s fingers and the skin overlying her breast, thereby magnifying her sense of touch between 3 and 15 times. Suppliers claim that the glove “is designed to detect breast lumps the size of a grain of rice.”
The evidence to back up the claims comes from a single study published three years ago in the Journal of Plastic Dermatology (which has no impact factor). The lead author, Dr Stefano Verardi, is a professor at the University of Tor Vergata in Rome and is best known as a celebrity plastic surgeon. The study included 130 women who were trained in breast self-examination, half using their bare hands and the other half using the glove. After 18 months, only 48% of the barehanded women could detect their lumps, while the gloved women were 100% successful. Despite the anti-mammography rhetoric, there was tacit acknowledgement that digital mammography is still the gold standard for detecting breast tumours.
Since breast self-examination is patient centred, inexpensive and non-invasive, it has a certain logical appeal. However, the evidence does not support it as a screening tool. Two large randomized clinical trials — one conducted in St Petersburg, Russia with 122,471 women and the other with 266,064 women in Shanghai, China — have shown that there is no reduction in breast cancer mortality.
While some charities such as the Cancer Association of South Africa have endorsed the Donna Glove, others like the Breast Cancer Campaign in the UK have urged women not to use the glove as a substitute for mammography, but “to check their breasts regularly, know what is normal for them and discuss any concerns with their GP.”