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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.

Cobalt Toxcity Found in Hip Replacement Patients, Anchorage Alaska

Written by lisaspitzer on . Posted in Depuy Hip Replacement Blog

Anchorage Fracture and Orthopedic Clinic.)
Cobalt Toxicity in Two Hip Replacement Patients
Introduction
Over the past decade, cobalt-chromium Metal-on-Metal Hip Arthroplasty (MoMHA) has been performed with increasing frequency throughout the United States, particularly in active and younger patients. During a recent review of the Nationwide Inpatient Sample database, 35% of 112,095 primary total hip replacements performed in the United States between October 1, 2005, and December 31, 2006 were MoMHAs.1 Cobalt and chromium ions are commonly detected in the blood and urine of MoMHA patients as a result of wear at the bearing surfaces over time. The accumulation of metal ions in the areas surrounding the prosthetic joint can cause metallosis, indicated by the formation of giant cells and fibrosis in surrounding tissue. Patients with malfunctioning MoMHAs can have Serum Cobalt Levels (SCoLs) that are more than 100-fold that of physiologic levels.2
An essential trace element, cobalt can cause serious adverse health effects at high exposure levels. Serum concentrations >1 mcg/L indicate possible environmental or occupational exposure, and concentrations >5 mcg/L are considered toxic.3
Signs and symptoms of cobalt poisoning can include visual impairment, cardiomyopathy, cognitive impairment, auditory impairment, hypothyroidism, peripheral neuropathy, and rashes.4 Three prior case reports note blindness, deafness, heart failure, peripheral neuropathy, rashes, and hypothyroidism in patients with SCoLs >200 mcg/L due to a malfunctioning MoMHA.5-7 This Bulletin describes two Alaska patients who experienced notable neurologic and cardiac symptoms following MoMHA.
Case Reports
Patient A, a fit, otherwise healthy, 49 year-old male received a MoMHA for osteoarthritis. An echocardiogram performed prior to his MoMHA showed normal myocardial function. At 3 months post-op, he complained of bilateral axillary rashes. At 8 months post-op, he reported unaccustomed shortness of breath. Pulmonary function tests and allergy testing for metals were normal. At 18 months post-op, he reported anxiety, headaches, irritability, tinnitus, and hearing loss. An audiogram confirmed high-frequency hearing loss. At 30 months post-op, he reported pain interrupting sleep, hip creaking, hand tremor, diminished coordination, slow cognition, poor memory, and lassitude. At 36 months post-op, a non-refractive loss of peripheral visual acuity was noted; at this time, his SCoL was 122 mcg/L.
The patient was indicated for revision surgery due to progressive hip pain and high SCoLs. An echocardiogram performed prior to the revision showed diastolic dysfunction. The revision was performed 43 months after the first surgery. At revision surgery, the periprosthetic tissues showed necrosis and staining with metal debris and visible wear of the retrieved bearing. At 1 month post-revision, Patient A’s SCoL was 14 mcg/L. At 6 months post-revision, he reported that all symptoms were improved except the visual changes.
Patient B, a fit, otherwise healthy, 49 year-old male received a MoMHA for a failed arthroplasty. At 12 months post-op, he complained of mental fog, memory loss, vertigo, hearing loss, groin pain, rashes, and breathlessness. At this time, his serum cobalt level was 23 mcg/L. At 18 months post-op, an echocardiogram showed diastolic dysfunction. He was observed until 40 months, when revision surgery was performed for progressive hip pain. Just before the revision, Patient B’s SCoL was 23 mcg/L. At revision surgery, the periprosthetic tissues showed necrosis and staining with metal debris and his retrieved bearing showed visible wear. At 2 days post-revision, his SCoL fell to 11 mcg/L. At 3 months post-revision, his symptoms were improved.
Discussion
MoMHA patients for whom revision surgeries are indicated due to pain often have implant malposition and periprosthetic metallosis. Additionally, these patients often have high SCoLs despite normal renal function and are at risk for cobalt poisoning. Patients with impaired renal function may experience cobalt poisoning without the presence of pain despite a well positioned implant because the cobalt released by normal implant wear is not adequately cleared by their kidneys.
In April 2010, the United Kingdom’s Medical Products and Healthcare Devices Regulatory Agency published a medical device alert that recommended following MoMHA patients for cobalt toxicity symptoms at least annually for 5 years post-op.8 The alert also recommended considering SCoL testing and imaging studies for patients who report painful hip replacements, and performing follow-up SCoL testing 3 months after the first test in patients with SCoLs >7 mcg/L in order to identify patients who require closer surveillance.
These two Alaska case reports underscore the importance of monitoring MoMHA patients for signs and symptoms of cobalt toxicity.9
Recommendations
1. Health care providers should be aware that patients with a MoMHA implant are at risk for cobalt poisoning, and might present for medical attention to non-orthopedists with cardiac or neurologic symptoms resulting from cobalt poisoning.
2. Health care providers should ask MoMHA patients who are known to have shell malposition, persistent or worsening hip/groin pain, and renal insufficiency about cardiac and neurologic symptoms, including tinnitus and hearing loss, and consider obtaining a SCoL.
3. Health care providers should assess cardiac and neurologic function in patients with SCoLs >7 mcg/L.
4. In consultation with the patient’s orthopedist, health care providers should develop an individualized plan for symptom monitoring and possible revision surgery in symptomatic patients with an elevated SCoL.
References
1. Bozic KJ, Kurtz S, Lau E, et al. The epidemiology of bearing surface usage in total hip arthroplasty in the United States. J Bone Joint Surg Am 2009;91(7):1614-20.
2. Smet K, De Haan R, Calistri A, et al. Metal ion measurement as a diagnostic tool to identify problems with metal-on-metal hip resurfacing. J Bone Joint Surg Am 2008;90 Suppl 4:202-8.
3. Leavelle DE, Mayo Medical Laboratories. Mayo Medical Laboratories interpretive handbook: interpretive data for diagnostic laboratory tests. Rochester, Minn.: The Laboratories; 2001.
4. Smith IC, Carson BL. Volume 6-Cobalt An Appraisal of Environmental Exposure. 1st ed. Ann Arbor: Ann Arbor Science; 1981.
5. Oldenburg M, Wegner R, Baur X. Severe cobalt intoxication due to prosthesis wear in repeated total hip arthroplasty. J Arthroplasty 2009;24(5):825 e815-20.
6. Steens W, Loehr JF, von Foerster G, Katzer A. [Chronic cobalt poisoning in endoprosthetic replacement]. Orthopade 2006;35(8):860-4.
7. Rizzetti MC, Liberini P, Zarattini G, et al. Loss of sight and sound. Could it be the hip? Lancet 2009;373(9668):1052.
8. UK. Medicines and Healthcare Products Regulatory Agency; MDA/2010/033: All metal-on-metal hip replacements. Available at: http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON079157
9. ATSDR’s Toxicological Profile for Cobalt. Available at: http://www.atsdr.cdc.gov/toxprofiles/tp33-c3.pdf

DePuy hip recall lawyers are reviwewing cases nationwide for metal on metal hip implant metallosis or toxicity. call the Hip recall helpline for information.