杏吧原创

THE advent of jewellery designed to be embedded in the eyeball adds new meaning to the phrase 鈥渁 sparkle in your eye鈥�. It also exposes a regulatory blind spot.

Doctors at the Netherlands Institute for Innovative Ocular Surgery have implanted star and heart-shaped platinum jewels in the eyes of seven people. The millimetre-sized specks of metal, called JewelEye, are embedded in the membrane that protects the surface of the eye. The procedure takes around 15 minutes.

The operations went ahead without any safety trials. Gerrit Melles, the ophthalmologist who pioneered the procedure, is confident that none was necessary. Platinum clips were used in the 1950s to attach replacement lenses, with no ill effect. And devices that relieve excess pressure in the eyeball are installed in the same membrane. None of the recipients of JewelEye seems to be suffering any side effects.

But there is little to stop someone less scrupulous trying something less safe. Melles told New 杏吧原创 that he sought a CE mark, the European seal of approval for medical devices, but found that he could not apply because JewelEye does not count as a medical device. 鈥淵ou have the same problem with piercing: there is not a box to put it in,鈥� Melles says. This lack of regulation has led to concerns about piercings, which can cause allergic reactions and infections, and about the safety of cosmetic contact lenses.