Tag Archives: cobalt

U.K. Grandmothers Detail Biomet Metal-on-Metal Hip Implant Misery

Two grandmothers in the U.K. recently detailed their problems with metal-on-metal hip implants made by Biomet, Inc. Both women say they began experiencing excruciating pain within a few years of receiving their Biomet metal-on-metal hip implants, and have had to undergo surgeries to correct complications.

Scilla Barret of Cwmdu, Wales received two all-metal Biomet hip implants in 2007, prior to undergoing surgery to correct a curved spine, according to the Carmarthen Journal. The 56-year-old grandmother says the hip replacements “never felt right,” and by January of last year, she was “in such severe pain I was unable to walk at all.”

Tests at the Royal National Orthopaedic Hospital in London revealed high levels of cobalt and chromium in her blood. in November 2011 and January 2012, she underwent surgeries to have both Biomet metal-on-metal hip implants replaced, as well as her left thigh bone.

“The surgeon described the top of my thigh bone as resembling crumbling cheese,” Barret told the Carmarthen Journal. “it was due to the poisoning by the metals coming off the new hip.”

Barret is now considering legal action against Biomet, and is warning other metal-on-metal hip implant recipients to have their blood tested for elevated levels of metal ions.

Regina Farmer, a 51-year-old grandmother from Basinstoke, England, received her Biomet metal-on-metal hip implant in 2006.

“Although the operation itself was a success, very soon after I was suffering with really bad pains in my hip and I wasn’t able to walk as I expected,” Farmer told This is Hampshire.

In 2010, and it was found she had an infection around the Biomet metal-on-metal hip replacement, forcing Farmer to undergo a surgery to have part of the device removed. Plastic was inserted in an effort to stop the metal rubbing together and prevent future problems. despite her surgery, however, Farmer is still suffering painful side-effects and finds it hard to walk or even sit down when the pain is at its worst. she has already filed suit against Biomet.

Farmer and Barret are just two of potentially hundreds of thousands of people throughout the world whose health has been damaged or endangered by metal-on-metal hip implants made by Biomet and other medical device companies. Concerns about the devices started to mount in 2010, when DePuy Orthopaedics issued a recall of its ASR hip implants, following findings that they were failing in about 12 percent of patients within five years.

Last May, the U.S. Food & Drug Administration (FDA) directed 21 companies that market all-metal hip replacements, including Biomet, to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients in the U.K., the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that blood tests should be conducted yearly to check cobalt and chromium blood levels in some all-metal hip implant recipients, those with bearings of 36 mm or above, as well as MRIs for any patient who does exhibit high metal ion levels.

Late last month, the British Medical Journal revealed that metal-on-metal hip implant manufacturers were aware of mounting evidence linking metal-on-metal hip replacement devices to serious, long-term health consequences, but for years failed to warn the public about these dangers. Earlier this month, The Lancet published a study conducted by University of Bristol researchers who found that people with metal-on-metal hip implants were twice as likely to experience early failure of their device compared to those fitted with other types of implants. The authors of the study asserted the devices should no longer be used.

The British Hip Society has gone so far as to recommend that metal-on-metal hip implants with larger bearings no longer be used in total hip replacements until they can be studied further.

Since the DePuy ASR hip implant recall, DePuy and other manufacturers have been named in lawsuits over their metal-on-metal hip replacement devices. Thousands of DePuy ASR hip implant lawsuits have been consolidated in federal court in Ohio. February, a multidistrict litigation was established in the U.S. District Court for the Northern District of Georgia for lawsuits involving the all-metal Wright Conserve Hip Replacement system. Claims involving a metal-on-metal version of DePuy’s Pinnacle hip implant have been consolidated in a multidistrict litigation in Texas. several lawsuits are also pending in the U.S. over Biomet metal-on-metal hip implants.

U.K. Grandmothers Detail Biomet Metal-on-Metal Hip Implant Misery

Study urges ban on controversial metal-on-metal hip implants

Experts are calling for controversial metal-on-metal hip implants to be banned after they found “unequivocal evidence” of high failure rates.

New data on more than 400,000 hip replacements found metal-on-metal implants needed revising more often than other types and that failure rates were higher in women.

It comes two weeks after the Medicines and Healthcare products Regulatory Agency (MHRA) issued new guidance on the implants, saying almost 50,000 patients in the UK will need annual blood or MRI checks.

Tiny metal ions made up of cobalt and chromium are thought to break off from the implants and leak into the blood, with fears this causes muscle and bone damage and neurological issues.

The MHRA says there is a “small risk” the implants can cause complications in patients.

The research, published in The Lancet medical journal and based on the National Joint Registry of England and Wales, found metal-on-metal implants failed much more quickly than other types of implant, with a five-year revision rate of 6.2%.

This compared with 2.3% for ceramic-on-ceramic implants and 1.7% for metal-on-plastic types.

Failure was related to the head size of the implant, with larger heads failing more quickly.

This was equivalent to a 2% increase in the risk of failure for each 1mm increase in head size.

The analysis included more than 31,000 metal-on-metal implants. It looked at patients given implants between 2003 and 2011 and tracked for up to seven years after surgery.

The results showed stark differences between the implants depending on type and head size, and confirm previous findings on failure rates.

In women, failure rates for metal-on-metal were up to four-times higher than for other types, and were also higher compared with men even with the same head size.

At seven years after surgery, some revision rates were as high as 10%, such as for 55-year-old women with a 46mm head implant. for women with a 36mm head, the revision rate was 8.4%.

At five years after surgery, revision rates were 6.1% for women with a 46mm diameter metal-on-metal implant, compared with just 1.6% for those with a 28mm metal-on-plastic implant.

In men aged 60 with metal-on-metal implants, revision rates were 3.2% for a 28mm head, jumping to 5::1% for a larger 52mm head.

The experts concluded: “Metal-on-metal stemmed articulations give poor implant survival compared with other options and should not be implanted.

“all patients with these bearings should be carefully monitored, particularly young women implanted with large diameter heads.”

The authors said they agreed with current MHRA advice but surgeons should seek to use other implants.

Alison Smith, a statistician in orthopaedic surgery at the University of Bristol, added: “we think there are better alternatives so we don’t see a reason to use stemmed metal-on-metal implants any longer.”

Around 65,000 people in the UK have received metal on metal hip implants since 2003, of which 49,000 are affected by the MHRA’s guidance because the joint head is 36mm or greater.

Hip replacements are mostly used for patients with osteoarthritis, where there is substantial wear and tear on the hip joint.

The use of metal-on-metal implants has declined in Wales and England, but data suggests they are still used extensively in the US.

Welsh hip replacement patient Bernard Jones, 72, recently discovered his artificial joint was leeching metal into his body.

He said:” I don’t worry about it on a day to day basis. I just go on with my life. I know the symptoms, I know if I get the same on my left hip I’ll know what it’s all about.”

Dr Susanne Ludgate, clinical director of the MHRA, said: “we recognise that there is emerging evidence of increased revision rates associated with large head metal-on-metal hip replacements.

“But the clinical evidence is mixed and this does not support their removal from the market.

Metal-on-metal resurfacing hip implants enable young patients to lead pain free, independent lives.

“The percentage of patients implanted with these large head metal-on-metal hip implants dropped to 2% in 2010 and is continuing to decrease.”

She said the MHRA was continuing to closely monitor all evidence about the implants.

Study urges ban on controversial metal-on-metal hip implants

Ban metal-on-metal hip replacements, experts urge

Experts are calling for controversial metal-on-metal hip implants to be banned after they found “unequivocal evidence” of high failure rates.

Data on more than 400,000 hip replacements found metal-on-metal implants needed revising more often than other types and that failure rates were higher in women.

It comes two weeks after the Medicines and Healthcare products Regulatory Agency (MHRA) issued new guidance on the implants, saying almost 50,000 patients in the UK will need annual blood or MRI checks.

Tiny metal ions made up of cobalt and chromium are thought to break off from the implants and leak into the blood, with fears this causes muscle and bone damage as well as neurological issues.

The MHRA says there is a “small risk” the implants can cause complications in patients.

The research, published in the Lancet medical journal and based on the National Joint Registry of England and Wales, found metal-on-metal implants failed much more quickly than other types of implant, with a five-year revision rate of 6.2%.

This compared with 2.3% for ceramic-on-ceramic implants and 1.7% for metal-on-plastic types.

Failure was related to the head size of the implant, with larger heads failing more quickly. this was equivalent to a 2% increase in the risk of failure for each 1mm increase in head size. by contrast, ceramic-on-ceramic types of implants performed better with larger head sizes.

The analysis included more than 31,000 metal-on-metal implants. it looked at patients given implants between 2003 and 2011 and tracked for up to seven years after surgery.

The results showed stark differences between the implants depending on type and head size, and confirm previous findings on failure rates.

In women, failure rates for metal-on-metal were up to four times higher than for other types, and were also higher compared with men even with the same head size.

At seven years after surgery, some revision rates were as high as 10%, such as for 55-year-old women with a 46mm head implant. For women with a 36mm head, the revision rate was 8.4%.

At five years after surgery, revision rates were 6.1% for women with a 46mm diameter metal-on-metal implant, compared with just 1.6% for those with a 28mm metal-on-plastic implant.

In men aged 60 with metal-on-metal implants, revision rates were 3.2% for a 28mm head, jumping to 5.1% for a larger 52mm head.

The experts concluded: “Metal-on-metal stemmed articulations give poor implant survival compared with other options and should not be implanted.

“All patients with these bearings should be carefully monitored, particularly young women implanted with large diameter heads.”

The authors said they agreed with MHRA advice but surgeons should seek to use other implants.

Alison Smith, a statistician in orthopaedic surgery at the University of Bristol, added: “We think there are better alternatives so we don’t see a reason to use stemmed metal-on-metal implants any longer.”

Around 65,000 people in the UK have received metal-on-metal hip implants since 2003, of which 49,000 are affected by the MHRA’s guidance because the joint head is 36mm or greater.

Hip replacements are mostly used for patients with osteoarthritis, where there is substantial wear and tear on the hip joint.

The use of metal-on-metal implants has declined in England and Wales, but data suggests they are still used extensively in the US.

Ban metal-on-metal hip replacements, experts urge