Ministry checking UK probe of 'toxic hip implants'

Pinnacle implant has not been recalled anywhere in the world, despite reports it leaks toxic metal to bloodstream.

By
March 2, 2012 02:57
2 minute read.
hip implant X-Ray

hip implant X-Ray [illustrative]_390. (photo credit: Thinkstock/Imagebank)

 
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The Health Ministry is looking into reports from abroad about hundreds of thousands of hip implants carried out around the world – including some in Israel – that the BMJ (British Medical Journal ) and the BBC said were defective and leaked toxic metal into the bloodstream.

The ministry learned of the then-embargoed article this week from The Jerusalem Post and started questioning its officials in charge of approving medical technologies, as well as the Israel Orthopedic Society. Called “metal-onmetal” implants, hip replacements by Johnson & Johnson of the ASR type were not allowed to be marketed over a year ago in Israel due to suspected complications.

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Now, following an intensive investigation, the BMJ and BBC have implicated a different type, called Pinnacle and manufactured by Depuy for Johnson & Johnson, in leaching toxic metal into patients’ blood.

The Pinnacle implant has not yet been recalled anywhere in the world.

The ministry initially stated that it did not believe many of the models in question were in use in Israel, but it did not have figures. It contracted the Israel Orthopedic Society to look into the matter and find out how widely these implants were used here, and whether their conclusions matched the British researchers’. It also asked the Israeli agent for Johnson & Johnson to provide more information.

The ministry said it was in contact with experts abroad to find out the reactions in other countries and whether the concerns were significant for Israelis.

The British investigative journalists, who also wrote a BMJ editorial on the subject this week, said the hip implants may affect more people than the recent affair of PIP-tainted breast implants. Hip implants, like breast implants, do not have to pass any clinical trials before they are put into patients, they said.

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The investigation reported how cobalt and chromium ions can seep into the tissues of patients with metal-onmetal implants, causing local reactions that may destroy muscle and bone and leaving some patients with long-term disability.

“Studies have also shown that metal ions can leach into the bloodstream, spreading to the lymph nodes, spleen, liver and kidneys, before leaving the body as urine. There are also concerns about damage to chromosomes, leading to genetic changes,” the investigators stated.

Michael Carome, deputy director of the UK public Citizen’s Health Research Group, called the situation “one very large uncontrolled experiment exposing millions of patients to an unknown risk.

We will only find out about the safety of these devices after large numbers of people have already been exposed.”

BMJ editor Dr. Fiona Godlee wrote that “hip replacements are one of the great successes of modern medicine. But a combination of inadequate regulation and untrammelled commercialism has caused actual and potential harm for large numbers of patients around the world. They should have known about the risks, as the manufacturers and regulators did, but they were not told.”

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