December 2013

A 2013 article published in Hip International titled “Blood levels of cobalt and chromium are inversely correlated to head size after metal-on-metal resurfacing arthroplasty.” by a team of researchers led by MC Parry from the UK aimed to “assess the effect of head size, implant design and component positioning on metal production by resurfacing arthroplasties.”

Stating that “Resurfacing arthroplasty has fallen out of favour in recent years due to unfavourable survivorship in joint registries and alarming reports of soft tissue reactions around metal on metal prostheses”, the team “measured whole blood cobalt and chromium and component position in matched populations implanted with two designs of resurfacing arthroplasty over a two-year period.”

While “both implants resulted in a significant increase in blood metal levels”, the DePuy “ASR design generated significantly higher metal levels”.

Finding that smaller metal hip replacement components was correlated with an increase in blood metal ion levels, the team concluded that “As increased metal generation has been correlated to wear and therefore failure, caution must be used on implantation of smaller components and indeed, in those who require smaller components, alternative bearing materials should be considered.”

Because DePuy failed time and again to notify users of the risk for metallosis and elevated blood metal ion levels associated with the ASR and ASRXL metal hip replacement systems, a number of DePuy ASR lawsuits have been filed.

If you or a loved one used a DePuy ASR hip replacement system and suffered elevated blood metal ion levels as a result, contact our team of DePuy ASR lawyers at the information provided below.  You may be entitled to significant financial compensation from the manufacturer for your undue injuries.

For a free, no-obligation DePuy ASR lawsuit consultation, call or e-mail our team at your convenience.  We have the skills, resources, and experience required to win the justice you deserve.

(855)  452 – 5529

justinian@dangerousdrugs.us

Our DePuy ASR™ / ASR™ XL Hip Replacement Lawsuit Information page is a great place to start if you have any questions about DePuy ASR metal-on-metal hip replacements.

In a paper titled “Hip arthroplasty with the articular surface replacement (ASR) system: survivorship analysis and functional outcomes.” published in European Journal of Orthopaedic Surgery and Traumatology, the authors begin by stating “The articular surface replacement (ASR) hip resurfacing system, now withdrawn, has the highest all-cause revision rate (24.2 % at 7 years) compared with other resurfacing brands.”  As such, the DePuy ASR has prompted many lawsuits.

This medical research team, led by one S. Shemesh, “reviewed the medical records and examined all 55 patients (57 hips) who had THA by the senior author between March 2005 and November 2008” and “recorded the Oxford Hip scores, metal ion levels, need for revision, the indication for revision, and the intra-operative findings” for each patient.

This team found that after five years, the survival rate for the ASR implants was 85.1%; that is, 14.9% of the metal-on-metal hip replacements failed at five years – a dramatic increase in failure rate over that disclosed by DePuy.

“At the time of recall, 10 (17.5 %) of fifty-seven THAs were already revised. Four (40 %) of the ten revisions were performed within 1 month of the operation due to a periprosthetic fracture. Three other revisions were due to avascular necrosis at a mean time of 3.6 years. One patient was revised due to infection. The two remaining revisions were due to ongoing groin pain, in one of whom the cup was found to be loose.”

Due to the fact that DePuy disclosed a failure rate for its ASR/ASRXL hip replacement systems significantly lower than that reported by independent researchers, a number of DePuy ASR lawsuits have been filed.

If you or a loved one used a DePuy ASR / ASRXL hip replacement system and suffered premature ASR failure or another ASR complication, contact our team of DePuy lawyers at the information provided below.  We have the skills, resources, and experience required to win the justice you deserve.

(855)  452 – 5529

justinian@dangerousdrugs.us

Our DePuy ASR™ / ASR™ XL Hip Replacement Lawsuit Information page is a great place to start if you have any questions about DePuy ASR metal-on-metal hip replacements.

In 2013, a team of medical researchers from Uppsala University Hospital in Uppsala, Sweden led by NP Hailer published a paper titled “High Metal Ion Levels After Use of the ASR™ Device Correlate With Development of Pseudotumors and T Cell Activation.” in Clinical Orthopaedics and Related Research studying the safety of the DePuy ASR hip replacement system.

The authors state “Pseudotumors and immunologic alterations are reported in patients with elevated metal ion levels after resurfacing arthroplasty of the hip” but that “A direct association of increased cobalt and chromium concentrations with the development of pseudotumors has not been established.”

Among other things, the team hypothesized that “patients with higher blood cobalt and chromium concentrations are more likely to have pseudotumors develop” and that “elevated metal ion levels, small implant size, cup inclination angle, and patient age are risk factors for the development of pseudotumors.”

For data, the team studied 78 patients in whom 84 DePuy ASR hip replacements were implanted between 2006 and 2010.  The team found that “Cobalt and chromium concentrations were greater in patients with pseudotumors than in those without”, thus demonstrating that elevated metal ion levels from metal-on-metal hip implants are associated with pseudotumor development.

Further, the paper demonstrated that “patients with larger implants were less likely to have them develop … age and cup inclination were not risk factors.”

Due to the fact that DePuy Orthopaedics, Inc. failed time and again to notify users of these risks, a number of DePuy ASR lawsuits have been filed.  If you or a loved one used a DePuy ASR hip replacement and suffered premature device failure, femoral fracture, elevated blood metal ion levels, or another DePuy ASR complication, you may be entitled to significant financial compensation.

For a free, no-obligation case consultation, contact our team of DePuy ASR lawyers at the information provided below.  We have the skills, resources, and experience required to win the justice you deserve.

Call today and see how we can help!

(855)  452 – 5529

justinian@dangerousdrugs.us

Our DePuy ASR™ / ASR™ XL Hip Replacement Lawsuit Information page is a great place to start if you have any questions about DePuy ASR metal-on-metal hip replacements.

A 2013 article published in The Journal of Bone and Joint Surgery titled “Relationship of Plasma Metal Ions and Clinical and Imaging Findings in Patients with ASR XL Metal-on-Metal Total Hip Replacements.” evaluated the health outcomes of 156 consecutive ASR total hip replacement patients in a particular clinic and studied the plasma metal ion levels of those patients.

In recent years, a number of studies have demonstrated that metal ions can wear off metal-on-metal hip replacement systems and enter the blood, potentially causing a number of health problems including metallosis, kidney and liver problems, and increased risk for cancer mortality.

Of the 156 patients, “Eighty patients were asymptomatic, and seventy-six patients were symptomatic. The median cobalt level was 1.8 ppb, and the median chromium level was 1.0 ppb (at or below measurement threshold). Pseudotumors that could be detected on magnetic resonance imaging were seen in 69% (107) of 156 patients, and radiographic osteolysis was evident in 7% (eleven patients).”

Further, “An abnormal cobalt level was significantly associated with the presence of periprosthetic lucency on radiographs and pseudotumor on magnetic resonance imaging (p ≤ 0.05). An abnormal chromium level showed a similar pattern, but the relationships did not reach significance. Both abnormal plasma cobalt and chromium levels were associated with larger sizes of pseudotumor when present”.

In conclusion, the authors state that “Metal ion analysis should be used in conjunction with clinical and imaging evaluation and not as a sole indirect screening test when evaluating patients following metal-on-metal hip arthroplasty.”

Due to the fact that many people have entered into metal-on-metal hip implantation unaware of the risks associated with these products, a number of DePuy ASR lawsuits have been filed.  If you or a loved one used a metal-on-metal hip replacement and suffered premature device failure, elevated plasma ion levels, or another ASR complication, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of DePuy ASR hip replacement lawyers at the information provided below.  We have the skills, resources, and compassion required to win the justice you deserve.

(855)  452 – 5529

justinian@dangerousdrugs.us

Our DePuy ASR™ / ASR™ XL Hip Replacement Lawsuit Information page is a great place to start if you have any questions about DePuy ASR metal-on-metal hip replacements.

A 2013 article titled “Clinical and radiographic outcomes of 139 hips with articular surface replacement total hip arthroplasty*.” published in The Israel Medical Association Journal by A. Kadar et al. examined 139 uses of the Articular Surface Replacement (ASR; DePuy Orthopaedics Inc.) in a particular clinic and evaluated health outcomes and implant vitality.

Kadar et al. write “Between 2007 and 2010 139 hips were operated on and evaluated in our clinic. All patients underwent a clinical interview, function and pain evaluation, as well as physical examination and radiographic evaluation. When necessary, patients were sent for further tests, such as measuring cobalt-chromium levels and magnetic resonance hip imaging.”

While this small study did not show an excessively-high rate for revision surgery, this research team found that “For patients who required further tests, clinical and radiographic outcomes were significantly poorer than for the rest of the cohort. Average blood ion levels were high above the normal (cobalt 31.39 ppb, chromium 13.32 ppb), and the rate of inflammatory collection compatible with pseudotumors on MRI was 57%.”

Due to the fact that DePuy Orthopaedics, Inc. failed time and again to warn users of the risk for elevated blood metal ion levels associated with the ASR/ASRXL metal-on-metal hip replacement systems, a number of

DePuy ASR hip replacement lawsuits have been filed.  If you or loved one used a metal-on-metal hip replacement system and suffered elevated blood metal ion levels, premature device failure, or another ASR complication, you may be entitled to significant financial compensation.

For a free, no-obligation case consultation, contact our team of DePuy ASR hip replacement lawyers at the information provided below.  We have the compassion, resources, and experience required to win the justice you deserve.  Call today and see how we can help!

(855)  452 – 5529

justinian@dangerousdrugs.us

Our DePuy ASR™ / ASR™ XL Hip Replacement Lawsuit Information page is a great place to start if you have any questions about DePuy ASR metal-on-metal hip replacements.

In 2011, a report published in The Journal of Bone and Joint Surgery by RN de Steiger et al. “summarizes an analysis by the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) of the outcome of arthroplasties involving the ASR prostheses.”

The Articular Surface Replacement (ASR) “metal-on-metal” hip implant by DePuy Orthopaedics, Inc. was recalled worldwide in 2010 due to a rate of premature device failure found by the UK National Joint Registry to be dramatically higher than advertised by the company.

Of the 4406 recorded uses of the ASR XL Acetabular System in Australia between 2004 and 2009 9.3% required reoperation at 5 years follow-up, “compared with 3.4% … for total hip arthroplasties involving all other conventional prostheses.”  For the ASR system, the rate for revision at 5 years follow-up was 10.9%, compared to a rate of four per cent for all other comparable hip resurfacing systems.

The authors stated that “These results are consistent with those derived from other registries and from published studies of individual cohorts” and as such, this paper could be used in a DePuy ASR lawsuit to demonstrate to a court the consistency with which high revision rates are associated with the ASR and ASRXL hip replacement systems.

Due to the fact that it has become increasingly clear the DePuy knew, or should have known, the risks associated with its products including the rates for surgical revision, a number of DePuy ASR lawsuits have been filed.  If you or a loved one used an ASR hip replacement system and suffered premature device failure or another complication, you may be entitled to significant financial compensation.

For a free, no-obligation case consultation, contact our team of DePuy ASR hip replacement lawyers at the information provided below.  We have the compassion, experience, and resources required to win the justice you deserve.  Call today and see how we can help!

(855)  452 – 5529

justinian@dangerousdrugs.us

Our DePuy ASR™ / ASR™ XL Hip Replacement Lawsuit Information page is a great place to start if you have any questions about DePuy ASR metal-on-metal hip replacements.

In a 2010 report by the UK National Joint Registry, it is noted that at five years, the revision rate for metal-on-metal hip replacements is 7.8%.

That means that after five years’ of using metal-on-metal hip replacement systems, 7.8% of patients required the implantation of a new hip due to device failure for one reason or another.

As a result of this and other publications by the UK National Joint Registry, DePuy Orthopaedics, Inc. recalled its popular ASR/ASRXL metal-on-metal hip replacement models.  And while this may seem like a proactive, positive step by DePuy, it was really more a last-minute, attempt at face saving: DePuy knew well its products failed at a higher rate than they advertised and continued marketing and selling the ASR/ASRXL models without disclosing accurate complication and failure rates.

In the years prior to the 2010 DePuy ASR recall, a number of scientific studies demonstrated clearly that failure rates for the ASR and similar metal-on-metal hip replacement systems were between 5 and 10 per cent, rather than the company’s reported 1-2% failure rate.  Furthermore, surgeons noted that the ASR metal-on-metal hip replacement systems were associated with metal dissemination – that is, the wearing off of tiny metal particles into the blood.  This elevation in blood metal ion levels can lead to metallosis (metal poisoning), kidney and liver problems, skin irritation, pseudotumors, and increased cancer mortality.

These risks were not disclosed by DePuy.  Instead, the company touted the novelty and relative success of its implants, and continued selling these dangerous and defective products for years.

As such, a number of DePuy ASR hip replacement lawsuits have been filed.  If you or a loved one used an ASR hip replacement system and you suffered device failure or another ASR complication, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of DePuy ASR hip replacement lawyers at the information provided below.  We have the skills, resources, and experience required to win the justice you deserve.  Call today and see how we can help!

(855)  452 – 5529

justinian@dangerousdrugs.us

Our DePuy ASR™ / ASR™ XL Hip Replacement Lawsuit Information page is a great place to start if you have any questions about DePuy ASR metal-on-metal hip replacements.

A 2010 Medical Device Alert by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) – the equivalent of the FDA in the United States, made the following announcement regarding the safety of metal-on-metal (MoM) hip replacement systems.

“The majority of patients implanted with MoM hip replacements have well functioning hips and are thought to be at a low risk of developing serious problems.

A small number of patients implanted with these hips may, however, develop progressive soft tissue reactions to the wear debris associated with MoM articulations. The debris can cause soft tissue necrosis and adversely affect the results of revision surgery. Early revision of poorly performing MoM hip replacements should give a better revision outcome.

Following extensive consultation with orthopaedic experts and using information from the National Joint Registry for England and Wales, the MHRA is issuing this interim advice to healthcare professionals involved in the management of patients implanted with MoM hip replacements.  The MHRA is continuing to monitor the situation in consultation with orthopaedic experts and may issue further advice.”

Due to the fact that DePuy Orthopaedics, Inc., the manufacturer of the recently-recalled ASR/ASRXL metal-on-metal hip replacement systems has failed time and again to warn users of the risks associated with its products, a number of DePuy ASR hip replacement lawsuits are currently being filed.

If you or a loved one used a metal-on-metal hip replacement system, particularly one manufactured by DePuy, and suffered premature device failure, elevated blood metal ion levels, other complications, or required revision surgery, you may be entitled to significant financial compensation for your undue injuries.

For a free, no-obligation case consultation, contact our team of DePuy ASR hip replacement lawyers at the information provided below.  We have the skills, resources, and experience required to win the justice you deserve.

(855)  452 – 5529

justinian@dangerousdrugs.us

Our DePuy ASR™ / ASR™ XL Hip Replacement Lawsuit Information page is a great place to start if you have any questions about DePuy ASR metal-on-metal hip replacements.

We are no longer accepting cases regarding these products.  Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device.  We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers.  For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.

Published in a 2012 edition of Advances in Clinical and Experimental Medicine, a study titled “Long term efficacy of laparoscopic adjustable gastric banding–retrospective analysis.” aimed to determine the safety and efficacy of laparoscopically-inserted adjustable gastric banding systems, such as the Allergan LAP-BAND.

Reviewing the health outcomes for “172 consecutive patients who had undergone laparoscopic adjustable gastric banding between May 2005 and February 2011” by the same surgeon, the authors found that “band removal rate was 19.1%” and that one patient had died.

“The main reason for band removal was slippage followed by band erosion” and “Overall satisfaction index was rated as ‘good’ for 42% of patients.”

Due to the fact that the rate of LAP-BAND erosion observed by doctors is often much higher than the expected rate of erosion by the manufacturer (which is said to be only about 1.33%), a number of LAP-BAND lawsuits were filed.

 

Our Allergan LAP-BAND Lawsuit Information page is a great place to start if you have any questions about the Allergan LAP-BAND.

A presentation at the 2010 annual meeting of the American Academy of Orthopaedic Surgeons titled “Clinical Follow-up and Metal Ions in Blood of Patients with Hip Resurfacing” demonstrated how different metal-on-metal hip replacements are associated with different levels of metal ions in the blood, a potentially-dangerous complication frequently observed in metal-on-metal hip replacement patients.

This research team, led by Dr. Alain Petit of Montreal, stated that “Metal-on-metal bearings composed of cobalt, chromium, and molybdenum alloys are subject to corrosion and wear with subsequent local systemic ion release.  A number of causes have been associated to an increase in metal ions following hip arthroplasty with metal-on-metal implants.  However, little is known regarding the effect of different surgical variables on the concentration of metal ions in the blood of patients with resurfacings.”

Studying 90 metal-on-metal hip replacement patients over a minimum of 2 years follow-up, the Petit et al. (2010) team found that “larger [femoral] head and cup diameters decreased the level of metal ions in blood of patients with hip resurfacing whereas the acetabular inclination and the neck-shaft angle had no effect.”

This is good news.  However, many metal-on-metal hip replacement manufacturers, such as DePuy Orthopaedics, Inc. — the manufacturer of the recently-recalled ASR/ASRXL hip replacement systems — fail to notify users that the use of metal-on-metal hip replacements is associated with increased levels of metal ions in the blood.

Elevated blood metal ion levels are associated with, understandably, metallosis (metal poisoning), which may be fatal if left untreated, pseudotumors, and increased cancer mortality, not to mention kidney and liver problems.

Because of this failure to warn, a number of DePuy ASR lawsuits have been filed across the country with a great deal of success.  If you or a loved one used a DePuy hip replacement, you too may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of DePuy ASR lawyers at the information provided below.  We have the compassion, resources, and experience required to win the justice you deserve.

Call today and see how we can help!

(855)  452 – 5529

justinian@dangerousdrugs.us

Our DePuy ASR™ / ASR™ XL Hip Replacement Lawsuit Information page is a great place to start if you have any questions about DePuy ASR metal-on-metal hip replacements.