Pharmaceutical

Prompted by DePuy recall, U.K. to issuer stronger warnings about all-metal hip implants

U.K. doctors and medical regulators have expressed greater concern for recipients of hip implants made from all-metal parts, saying the devices are more dangerous to human health than they previously thought, an investigative report by the Sunday Telegraph has found.

All-metal hip implants consist of a metal ball and metal cup. Friction between these metal parts can release particles of cobalt and chromium into the blood and tissue, sometimes in dangerously high levels. Over time, a buildup of these metals in the body can cause a spectrum of illnesses and injuries related to metal poisoning, including muscle damage and bone fracture and/or decay, and slow, steady poisoning of the central nervous system, heart, and lungs.

DePuy’s ASR hip implants were recalled in 2010, but its other hip device remains on the market despite a growing number of lawsuits filed by patients who claim to be experiencing personal injuries similar to those linked to the recalled devices.

According to British regulatory guidelines, U.K. patients with all-metal hip implants should undergo annual scans and blood tests so that doctors can monitor blood metal levels and look for physical damage. But now advisers to the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), who worry the devices could cause “systemic toxicity” throughout the body, are pushing the agency to develop stronger measures to ensure recipients of DePuy’s ASR hip devices and other all-metal hip implants are monitored for damage.

According to the Sunday Telegraph, “A report from a conference of senior surgeons, held behind closed doors, describes the situation regarding all metal-on-metal hip replacements as ‘frightening’ given the number of patients now suffering tissue reactions amid ‘component failure of catastrophic proportions.’

“There was also concern that increased cobalt and chromium levels in the blood could be toxic to kidneys and, in the case of pregnant women, be passed on to the unborn child,” the Sunday Telegraph reported.

The British Orthopaedic Association (BOA) has contacted orthopedic surgeons by letter, “expressing fears that not all patients who received the DePuy devices have been recalled for checks,” according to the Sunday Telegraph. BOA data indicates that nearly two-thirds of DePuy hip devices implanted in patients have yet to be recalled, suggesting that many patients may be fully unaware of the damage their all-metal hip implants may be inflicting on their bodies.

Britain’s MHRA has not said when the new alert would be issued or what it would say.

Approximately 10,000 patients in the U.K. have received DePuy’s recalled ASR implants. Of those, 1,136 have filed lawsuits against the manufacturer.

Source:

The Sunday Telegraph