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Gastroesophagal implants: a medical device causes serious adverse effects

The regulations governing the sale of medical devices are less stringent than those for medicines.

Enteryx°, a medical device designed to treat gastroesophagal reflux, has been withdrawn from the French and US markets, following reports of serious adverse effects.

Like all medical devices, Enteryx° was put on the market under less stringent criteria than those governing drugs. This device (polymer + solvent) was designed to be injected into the base of the oesophagus. A few years after it went on sale, serious adverse effects were reported, which prompted the French and US drug regulatory agencies to demand its withdrawal. The adverse effects were caused by the injection of the device outside the oesophagus.

As a result of poor evaluation of medical devices before they come onto the market, patients are exposed to high risks of serious adverse effects that are discovered only after the device is made commercially available.

©Prescrire Jannuary 2006

Source: "Implants œsophagiens Enteryx° : décès" Rev Prescrire 2006 ; 26 (268) : 25.

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