• Vena Cava IVC Filter Lawyers- IVC Filter Helpline:   Bard and Cook IVC Filter Lawyers Lawsuits are being filed  because the IVC (Inferior Vena Cava) Filters have been linked to migration and perforation of various organs in the body. An IVC (In...

  • Omni Life Hip Apex Arc Replacement Lawyers: Omni Life Apex ARC Hip Replacement Lawyers OMNI Life Science’s ARC hip Replacement has a  chromium and cobalt ball connecting to a titanium stem, is a metal-on-metal design. This hip replacement is l...

Posts Tagged ‘DePuy Hip recall lawyer’

DePuy Hip Replacement Helpline, New Updates on Metal on Metal Hip Failures

Written by lisaspitzer on . Posted in Depuy Hip Replacement News

DePuy Hip Replacement Helpline, New Updates on Metal on Metal Hip Failures

Reuters) – New research confirmed that all-metal artificial hips fail more often than other types, fuelling concerns about the devices and prompting a call from researchers on Tuesday for a ban.

The analysis in The Lancet medical journal came two weeks after Britain's medical regulator said nearly 50,000 Britons with metal-on-metal hips needed annual check-ups to monitor for problems, including exposure to toxic metals.

The finding will likely fuel criticism about the regulation of medical devices in the wake of a scandal over French-made breast implants and past problems with other implantable devices, including faulty leads on some heart defibrillators.

Metal-on-metal hips were developed to be more durable than traditional implants, which combine a ceramic or metal ball with a plastic socket.

But recent experience suggests they may actually do worse, prompting the recall of one device made by Johnson & Johnson that critics argue should never have been allowed on the market.

Results from the most comprehensive study to date now show that there is a 6.2 percent chance patients with all-metal hips will need a replacement within five years – some three times greater than the revision rate seen with older implants.

The rate was particularly high with larger-head implants and those used in women, in whom failure rates were up to four times higher, the researchers said.

The team from the University of Bristol analyzed data from the National Joint Registry of England and Wales covering more than 400,000 hips replacements, including 31,171 all-metal ones, that were undertaken between 2003 and 2011.

The results, they said, were unequivocal: "Metal-on-metal stemmed articulations give poor implant survival compared with other options and should not be implanted."

Their analysis did not cover resurfacing systems, which avoid the use of a stem sticking into the bone, such as Smith & Nephew's Birmingham Hip Resurfacing joints.

TIGHTER REGULATION

In recent years, the use of metal-on-metal implants has declined in Britain, but they are still used extensively around the world, including in the United States.

Art Sedrakyan of Cornell University said the problem highlighted weaknesses in the regulatory systems on both sides of the Atlantic due to "outdated and low-threshold regulatory pathways".

In a strongly worded Lancet commentary accompanying the latest research, he called for better studies before implants reach the market.

"We are left with more than 500,000 patients with metal-on-metal prostheses in the USA and more than 40,000 in the UK who are at elevated risk of device failure, which will inevitably result in the burden of further surgical treatment as well as billions of dollars in costs to taxpayers," he said.

Ashley Blom of the University of Bristol said that total hip replacement surgery remained a very successful operation for the vast majority of people but regulators should learn lessons as they seek to balance safety against innovation.

"In this case, with the benefit of hindsight, I think that tighter regulation may have prevented this," he told Reuters.

Under the new guidelines from Britain's Medicines and Healthcare Products Regulatory Agency (MHRA), doctors are being advised to consider removing and replacing implants if patients have abnormal MRI scans or if metal ion levels in the blood reach worrying levels.

With the exception of J&J's DePuy ASR system, which was pulled from the market in 2010, the MHRA decided in its recent ruling against a ban on use, arguing that stemmed metal-on-metal implants could still be good news for some patients.

Other companies that make metal-on-metal hip implants include Zimmer, Stryker, Corin and Biomet

 

Metal on Metal Hip Replacement Toxicity, Hip Recall Lawyers Accepting Clients

Written by lisaspitzer on . Posted in Depuy Hip Replacement News

Fears of faulty 'toxic' hip replacement implant

Mon, 30 Jan 2012 12:33:00 EST

Today many newspapers and TV stations have reported that medical regulators have launched an investigation into a type of hip replacement called a “metal-on-metal” (MoM) device (DePuy ASR hip replacement implant). The concern is that as the hip replacements wear down, metal particles can be released from the artificial hip, react with the soft tissue (such as muscle and ligaments) surrounding the joint and enter the bloodstream. In 2010, the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a product recall for DePuy ASR, a brand of MoM artificial hip. This meant that surgeons were told not to implant DePuy ASR hip replacements and return any unused implants to the manufacturer.

The MHRA has urged surgeons to tell all patients that had received these DePuy ASR hip replacements about the recall, and to schedule them for annual follow-up visits. If the person who had a DePuy ASR hip replacement implant experiences pain, the surgeons should consider measuring the level of metals in their blood measured and should examine the soft tissue to see if reactions have occurred. If necessary, removal and replacement of the implant should be considered.

The Sunday Telegraph has brought this story to the public attention again because of what it says are subsequent developments. The Telegraph claims that the risk from the devices is greater than previously thought, with greater failure rates. The Telegraph says that the MHRA is drawing up a new alert for anyone with any type of metal-on-metal hip replacement. Channel 4 News reported that around 30,000 people in Britain have received MoM hip replacements, and that the MHRA has said that, on the evidence currently available, “the majority of people with metal on metal hip replacements are at low risk of developing any serious problems”. A spokesman for the MHRA is quoted as saying: “We are continuing to closely monitor all evidence. This needs more analysis before any conclusions can be drawn and further advice given”.

Medical devices, like medicines are regulated but are coming under more scrutiny, from both the regulators and the media following widespread concerns over the emergence of faults with illegally made PIP breast implants. Find out the latest NHS information on PIP breast implants.

What types of hip replacements are there?

In the UK, approximately 70,000 hip replacements are performed each year. In a total hip replacement operation an artificial ball is attached to the top of the leg bone and an artificial socket is attached to the hip bone. The socket can be made out of plastic or ceramic, while the ball is metal. The ball is attached to a shaft, which is placed in the hollow of the leg bone (femur). Some people do not need a total hip replacement, but have a hip resurfacing operation. This has the advantage of removing less of the person’s own bone. The joint surfaces are replaced with metal inserts that cover the surfaces of the hip but do not extend down the inside or hollow of the leg bone. The metal mixtures used in hip replacements contain the metals chromium and cobalt.

What are the risks of problems following a metal-on-metal hip replacement?

When hip resurfacing was initially introduced, metal-on-metal (MoM) replacements were popular, especially with younger, active patients. An article by two orthopaedic surgeons working in Britain and published in the British Medical Journal in 2011 said that they were used in 10% of hip operations between 2006 and 2009, and 50% of all hip replacements in people younger than 50 years. However, problems with the metal resurfacing included raised chromium and cobalt in the blood, loosening of the joint, hip fracture and soft tissue reactions around the hip. It reported that problems with metal on metal hip replacements could include reactions to metal debris and associated pain, swelling, loss of movement and limping.

In March 2011, delegates at the British Hip Society annual conference discussed MoM hip replacements. Units in Belfast, Southampton, Cardiff and Stockton-on-Tees that had researched the outcomes for people who had these devices fitted over the short- to mid-term, said that a high proportion of MoM devices from other manufacturers may also be showing similar results to the withdrawn DePuy device. They found that, overall, the MoM devices showed a higher than anticipated early failure rate (most hip replacements last about 20-30 years). They found that 49% of people who had been fitted with the DePuy device needed it to be replaced by six years and between 12 and 15% who had other metal-on-metal hip replacements needed these to be replaced by five years. They said that the patients whose replacements failed tended to come to the doctors when they experienced pain. X-rays showed some patients had loosening of the joint, and some patients had raised levels of cobalt and chromium in their blood.

The inclusion of the word “poisoned” in some newspapers is likely to be wrong. Metal from the hip replacements can enter the bloodstream, but the levels of cobalt and chromium found give an indication of the wear to the hip replacement. No evidence for damage other than local tissue damage was presented. The MHRA’s advice is to monitor the level of chromium and cobalt to see if a patient requires further follow-up.

What is the advice for people who have had a MoM hip replacement?

The MHRA has not issued new guidance as yet. However, the report from the British Hip Society annual conference says that they believe that the existing advice from the MHRA still applies. This means that people who have been treated with a MoM hip replacement should be followed up regularly for five years and probably for the life of the implant. People with the withdrawn MoM hip replacements who experience pain should have this thoroughly investigated. Following the withdrawal of the DePuy device, and the MHRA guidance, the British Hip Society and the British Orthopaedic Association said:

    Everyone with a hip replacement that has been withdrawn should be informed and told that they will be under close clinical follow-up.
    Some form of follow-up should be carried out at least annually and patients should be given contact information so that they can be reviewed quickly if they have pain or lose function in their hip.
    Patients should be followed for the life of the implant until more data are available.
    If someone with a withdrawn MoM hip replacement experiences no pain or loss of function, no further investigations are required apart from standard follow-up.
    If a person with a withdrawn MoM hip replacement reports that they are in pain, the cause of the pain should be further investigated. Blood cobalt and chromium levels should be measured to indicate how much the device has worn, but there is no evidence that the implant must be replaced above a certain metal concentration.
    Treatment decisions should be confirmed with a second experienced “revision” surgeon.

People who have had a hip replacement, who are concerned, should contact their orthopaedic surgeon or GP. They should be given records of the type of hip replacement they had and receive the follow-up, if any, that is required.

If You have been diagnosed with chromium or cobalt metal toxicity from a metal on metal hip replacement call the DePuy Hip replacement Helpline and speak to amedical social worker today.