Fears over artificial breasts

Potential dangers of medical devices such as breast implants, hip replacements and pacemakers could go undetected because safety controls are too lax, campaigners warned today.

The system for regulating such products is weak and "swathed in secrecy", according to a report by the Consumers' Association magazine Health Which? published today. The safety of a range of items, which also include contact lenses and CT scanners, is the responsibility of the Government's Medical Devices Agency (MDA) - but the body refuses to publish details about action taken against companies for manufacturing dangerous products.

The 19,000 devices used in the UK have to carry a CE mark, similar to a kite mark, under European law. However, campaigners warned today that the CE mark guarantees neither the safety nor the effectiveness of products - some sold directly to the public.

An investigation found that manufacturers can "shop around" among independent laboratories which can award the CE mark, and the MDA has concerns that the system can be abused by firms seeking the least stringent examiners. Products classified as "low risk", such as latex gloves, are not even assessed under the system.

The Consumers' Association has particular concerns about the safety of replacement joints used by the NHS. Around 70,000 hip replacements are carried out in the UK every year.

Last year more than 2,000 replacement hip joints were recalled following safety fears. Another type, produced by 3M Healthcare, was used on almost 5,000 NHS patients in the Nineties. A possible design fault was identified in 1995, but it was not until 1998 that the MDA advised all patients should be re-examined. Last year, a report by the Royal College of Surgeons revealed more than 600 patients needed corrective surgery.

Professor Christopher Bulstrode, a surgeon at the John Radcliffe Hospital in Oxford, said: "There must be at least 20 hip models being used in Britain today that are, frankly, dangerous."

Professor Paul Gregg, a Royal College of Surgeons investigator, said: "To make sure only the best hips are used a national hip registry is needed. This would help reveal which hips have a high failure rate and which don't."

The Department of Health plans to establish a registry soon - but reporting of problems will not be mandatory.

Sue Freeman, managing editor of Health Which?, said: "Hundreds of thousands of people rely on medical devices. These products should be backed up by comprehensive evidence of their safety."