UK warning over hip replacements
Source: Agencies |
February 29, 2012, Wednesday
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Print Edition
Print Edition
Most British patients with all-metal artificial hips should be followed up for the life of the implant with annual tests to monitor for problems, including exposure to toxic metals, Britain's medical regulator said yesterday.
Patients with large-head implants should have blood tests to check for metal ions and magnetic resonance imaging scans if they have raised metal levels or show adverse symptoms, the Medicines and Healthcare Products Regulatory Agency said.
It issued the new clinical guidelines to doctors about the artificial hips after reports of swelling and tissue damage in some patients, and high failure rates with certain devices.
The regulator said around 49,000 patients out of 65,000 with all-metal hips were in a high-risk category.
The move will fuel controversy about the regulation of medical devices in Europe in the wake of a scandal over France's Poly Implant Prothese (PIP) breast implants. Critics argue European oversight is too lax to spot substandard products.
The regulator's update came on the same day as an investigation by the British Medical Journal into all-metal artificial hips, which warned that the problem may affect more people than the breast implant scandal.
"Metal-on-metal" hips were developed to be more durable than implants which had a metal or ceramic ball and a plastic socket.
Patients with large-head implants should have blood tests to check for metal ions and magnetic resonance imaging scans if they have raised metal levels or show adverse symptoms, the Medicines and Healthcare Products Regulatory Agency said.
It issued the new clinical guidelines to doctors about the artificial hips after reports of swelling and tissue damage in some patients, and high failure rates with certain devices.
The regulator said around 49,000 patients out of 65,000 with all-metal hips were in a high-risk category.
The move will fuel controversy about the regulation of medical devices in Europe in the wake of a scandal over France's Poly Implant Prothese (PIP) breast implants. Critics argue European oversight is too lax to spot substandard products.
The regulator's update came on the same day as an investigation by the British Medical Journal into all-metal artificial hips, which warned that the problem may affect more people than the breast implant scandal.
"Metal-on-metal" hips were developed to be more durable than implants which had a metal or ceramic ball and a plastic socket.
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