Toys from China and Medical Devices Share Scrutiny in EU

Many in the United Kingdom assume that an implanted medical device is reviewed for safety before it is permanently placed inside a patient. They would be wrong. The Guardian reports (here) that the European quality standard – the CE mark - represents an assurance that is the same whether the product is a breast implant or a Chinese-made yo-yo.Assurance of Quality Medical Devices?

Europe offers consumers many of the same products as the U.S. and the move in recent years has been to reduce the cost of manufacturing. That’s why Allergan’s breast implants, which were made in Ireland, are now manufactured in Costa Rica which can give a CE mark. The defective breast implants made by PIP (Poly Implant Prothese) did not receive a CE mark in France but rather in Germany, a location chosen by the manufacturer. The Guardian reports that PIP was alerted 10 days before inspectors would come to the plant.

Regardless, the inspectors never found the owner of PIP, Jean Claude Mas, was buying a cheaper agricultural and industrial-grade silicone to fill the implants.

And just like in the U.S., it is up to the manufacturer to decide whether to report a serious problem to health authorities. The Guardian reports among employees of PIP, a ruptured breast implant was not considered serious enough to be reported to authorities, in that case the Medicines and Healthcare Products Regulatory Authority (MHRA). The MHRA licenses drugs but does not approve medical devices and it can’t stop those that have a CE approval from being marketed. It is supposed to send out letters to doctors about risks and benefits.

Reviews for medical devices are carried out by about 70 for-profit companies not regulators. In the U.S., the FDA’s Center for Devices and Radiological Health handles reviews, though most medical devices are put on the market with a 510(k) application claiming equivalence to a device already marketed.

Europe has taken a tougher stand than the U.S. issuing an ethical code in 2008 that prevents doctors from receiving lavish trips from major manufacturer. But the UK did approve a Covidien lung sealant and an elbow fracture treatment that were never approved in the U.S.

Thousands of UK patients have also received the metal-on-metal artificial hip implant made by Johnson & Johnson’s DePuy which is now under recall since last September.

Many believe the UK system of device regulation is tougher than the U.S. which is ironic then that many U.S. manufacturers threaten to take their products overseas for approval unless the FDA lessens the regulation of U.S. medical devices. Members of Minnesota’s congressional delegation wrote a letter to the FDA last October urging a speedier approval process for medical devices or else jobs and industry innovation would go overseas. See the letter here.

The PIP founder was arrested Thursday, January 26 at his villa in the south of France. The French government has advised 30,000 women to have their defective breast implants removed.