A 2011 article by D.H. Williams et al. published in that year’s December edition of Journal of Bone and Joint Surgery (US) titled “Prevalence of pseudotumor in asymptomatic patients after metal-on-metal hip arthroplasty.” sheds further important insight into the tendency for metal-on-metal hip replacements to release dangerous metal ions into the bloodstream.

One result of elevated metal ion levels in the blood can be pseudotumors.  The team writes “The primary purpose of this study was to assess the prevalence of pseudotumor formation in asymptomatic patients with a metal-on-metal total hip replacement after a minimum duration of follow-up of two years. A secondary purpose was to assess whether a correlation exists between elevated serum metal ion levels and pseudotumor formation.”

Patients evaluated in this study included “thirty-one asymptomatic patients with a metal-on-metal total hip arthroplasty, twenty-four asymptomatic patients with a metal-on-polyethylene total hip arthroplasty, and twenty asymptomatic patients with a metal-on-metal hip resurfacing arthroplasty.”

Results showed that 32% of metal-on-metal hip replacement patients “had a solid or cystic mass, with another three patients (10%) having a substantial fluid collection.”  Only 25% of hip resurfacing patients faced such ailments.  And, “Pseudotumor formation was significantly more frequent in the metal-on-metal total hip arthroplasty group compared with the metal-on-polyethylene total hip arthroplasty group.”

As such, Williams et al. (2011) concluded that “We recommend high-resolution ultrasound surveillance of all asymptomatic patients with a metal-on-metal implant that is known to result in high serum metal ion levels. Once a metal-on-metal implant is known to be associated with high serum metal ions, the measurement of ion levels does not helpfully contribute to surveillance.”

Because DePuy, the manufacturer of many metal-on-metal hip replacement systems such as the recently-recalled ASR™ and DePuy ASR™ XL models, has failed time and time again to warn of these potential side effects, a number of ASR lawsuits have been filed.

If you or a loved one used a metal-on-metal hip replacement such as the ASR, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, feel free to contact our team of DePuy ASR lawyers at the information provided below.  We have the experience, resources, and skills 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 2012 article by I.A. Malek et al. published in Journal of Bone and Joint Surgery titled “The sensitivity, specificity and predictive values of raised plasma metal ion levels in the diagnosis of adverse reaction to metal debris in symptomatic patients with a metal-on-metal arthroplasty of the hip.” helps demonstrate the rate at which patients have adverse reactions to metal debris from faulty metal-on-metal hip replacement systems.

The team states that “Plasma levels of cobalt and chromium ions and Metal Artefact Reduction Sequence (MARS)-MRI scans were performed on patients with 209 consecutive, unilateral, symptomatic metal-on-metal (MoM) hip arthroplasties.”  So, this study is admittedly fairly small.

However, results were clear, showing that “scans were positive for adverse reaction to metal debris (ARMD) in 84 hips (40%)” and the team concluded that “Metal ion analysis is not recommended as a sole indirect screening test in the surveillance of symptomatic patients with a MoM arthroplasty. The investigating clinicians should have a low threshold for obtaining cross-sectional imaging in these patients, even in the presence of low plasma metal ion levels.”

Because DePuy, the company that makes many metal-on-metal hip replacement systems, has failed to adequately warn users of these risks, a number of DePuy ASR hip replacement lawsuits have been filed.  If you or someone you know used the DePuy ASR or ASR XL metal hip replacement, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of ASR lawyers at the information provided below.  We have the experience, resources, and skills 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 2012 study appearing in Clinical Orthopaedics and Related Research titled “Pseudotumors are common in well-positioned low-wearing metal-on-metal hips.”, AK Matthies et al. write “Pseudotumors are sterile inflammatory lesions found in the soft tissues surrounding metal-on-metal (MOM) and metal-on-polyethylene hip arthroplasties. In patients with MOM hip arthroplasties, pseudotumors are thought to represent an adverse reaction to metal wear debris. However, the pathogenesis of these lesions remains unclear. Currently, there is inconsistent evidence regarding the influence of adverse cup position and increased wear in the formation of pseudotumors.”

As such, this team set out to determine “whether pseudotumor formation was associated with (1) adverse cup position, (2) raised metal ion levels, and (3) increased wear rates of the retrieved components.”

Studying 105 patients who used metal-on-metal hip replacement, the team compared “acetabular orientation, metal ion levels before revision, and component wear rates between patients with (n = 72) and without (n = 33) pseudotumors, according to findings on metal artifact reduction sequence MRI.”

After statistical analysis, Matthies et al. (2012) found that “The proportion of patients demonstrating evidence of a pseudotumor in well-positioned hips was similar to those with adverse cup positions (67% and 66%, respectively).”

Concluding that “Pseudotumors were not associated with increased wear or metal ion levels, suggesting patient susceptibility is likely to be more important,” this paper can be used in a metal-on-metal hip replacement lawsuit to demonstrate to court that the manufacturers of these devices knew, or should have known, of the dangers associated with metal-on-metal hips.

One such company is DePuy Orthopaedics, Inc., the manufacturer of the ASR and ASR XL hip replacements recalled in 2010.  As such, a number of DePuy ASR lawsuits have been filed.  If you or a loved one used a DePuy ASR and suffered premature device failure, pseudotumors, or another ASR complication, you too may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of ASR lawyers at the information provided below.  We have the experience, resources, and skills 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 article published in Journal of Orthopaedic Research by YM Kwon et al. titled “Lymphocyte proliferation responses in patients with pseudotumors following metal-on-metal hip resurfacing arthroplasty.” studied “the incidence and level of metal-induced systemic hypersensitivity in patients” who underwent metal-on-metal hip resurfacing arthroplasty (MoHRA), “both with and without pseudotumor by measuring lymphocyte proliferation responses to metals.”

The study including 92 patients in all, researchers found that “A higher incidence and level of enhanced lymphocyte reactivity only to [the metal nickel] was found in patients with MoMHRA compared to the patients without MoM implants, reflecting exposure and immune reactivity.”

Interestingly, these researchers found that ion levels of cobalt, chromium, and nickel did not differ much between patients with pseudotumors and those without, suggesting that “systemic hypersensitivity type IV reactions, as measured by lymphocyte proliferation response to these metals, may not be the dominant biological reaction involved in the occurrence of the soft tissue pseudotumors.”

Unfortunately, DePuy Orthopaedics, Inc., the manufacturer of the DePuy ASR and DePuy ASR XL hip replacement systems, has failed time and again to warn users of the risks associated with the DePuy ASR systems.  As a result of this, 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 or another ASR complication as a result, you too 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 2013, a paper published in Clinical Orthopaedics and Related Research titled “The natural history of inflammatory pseudotumors in asymptomatic patients after metal-on-metal hip arthroplasty.” by SA Almousa et al. provides background for itself, stating in part “Although pseudotumors have been reported in 32% of asymptomatic metal-on-metal hips, the natural history of asymptomatic pseudotumors is unknown.”  As such, the stated purpose of this study was “to assess changes over time in asymptomatic pseudotumors and the effect of revision on pseudotumor mass.”

“After the detection of 15 pseudotumors and five isolated fluid collections in a cohort of 20 asymptomatic patients (13 metal-on-metal, three metal-on-polyethylene, and four hip resurfacings)”, ultrasound was used at an average of about two years follow-up to monitor the growth of the pseudotumors.

Results showed that “Among the 15 nonrevised patients, pseudotumors increased in size in six (four solid and two cystic) of 10 patients, three of which had clinically important increases”.  Three pseudotumors “disappeared completely”, some others reduced in size.  “All revision patients had a reduction of chromium … and cobalt ions … Of five isolated fluid collections, four completely disappeared (two metal-on-metal and two metal-on-polyethylene) and one (metal-on-metal) increased from 26 cm(3) to 136 cm(3).”  That is, once metal-on-metal hips were replaced, metal ion levels were reduced.

Sadly, elevated metal ion levels and associated pseudotumors were not adequately warned for by DePuy Orthopaedics, the manufacturer of the recalled ASR and ASR XL hip replacement systems.  As a result, a number of DePuy ASR hip replacement lawsuits have been filed.  If you or a loved one has used a DePuy ASR hip replacement and suffered these or other complications as a result, including premature device failure, 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 skills, resources, and experience required to win the compensation 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.

An article appearing in the May, 2013 edition of Orthopedics titled “Prevalence of adverse reactions to metal debris following metal-on-metal THA.” by M. Hasegawa et al. lives up to its title and aimed to “determine the prevalence of adverse reactions to metal debris (ARMD) following large-diameter metal-on-metal total hip arthroplasty.”

In recent years, a number of articles have been published connecting the use of metal-on-metal hip replacements and the presence of pseudotumors.  These authors “examined the potential for using magnetic resonance imaging to screen for pseudotumors in 108 hips 2 years postoperatively” and “Serum cobalt and chromium concentrations were measured in 80 hips that underwent unilateral total hip arthroplasty.”

With MRI, Hasegawa et al (2013) found “9 patients (10 hips, 9%). Five of these 10 hips were symptomatic and underwent revision surgery. Two other patients underwent revision surgery due to symptomatic cup loosening” with evidence of pseudotumors.  In all, “Ten patients (12 hips)” had adverse reactions to metal debris.

Doctors found “Serum cobalt and chromium concentrations were significantly higher in hips with ARMD than hips without ARMD.”  So understandably, the authors concluded that “Elevated metal ion levels suggest that ARMD is associated with increased metal wear” and “Magnetic resonance imaging provides sensitive screening for pseudotumors following metal-on-metal total hip arthroplasty.”

Due to the fact that manufacturers of metal-on-metal hip replacements such as DePuy Orthopaedics, Inc. (manufacturer of the recalled ASR and ASR XL hip replacements) have failed time and again to notify users of these risks associated with their devices, a number of DePuy ASR lawsuits have been filed.  If you or a loved one has used an ASR hip replacement and suffered premature ASR failure or other complications such as those described above, 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.

(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 2008 article published by J. Antoniou et al. in The Journal of Bone and Joint Surgery titled “Metal ion levels in the blood of patients after hip resurfacing: a comparison between twenty-eight and thirty-six-millimeter-head metal-on-metal prostheses.”, the authors write “Metal ion toxicity, metal hypersensitivity, and metal carcinogenicity are causes for concern for patients with metal-on-metal hip replacements. Thus, understanding the biological fate of metal ions, and consequently their long-term systemic effects, is of great interest to patients and surgeons alike.”

Studying the levels of cobalt, chromium, and molybdenum ions (metals that are used in metal-on-metal hips) in the blood of control patients (no implant), patients who used metal-on-polyethylene total hip prostheses, patients who used metal-on-metal total hip prostheses “with either a 28 or 36-mm femoral head,” and patients who used hip resurfacing prostheses.

Researchers found patients who used metal-on-metal prostheses with 36-mm femoral heads had lower metal ion levels than those who used implants with 28-mm diameter heads and those who used hip resurfacing procedures at six months.  However, these differences seemed to even out by 12 months.

Because DePuy Orthopaedics, Inc., the manufacturer of a number of popular metal-on-metal hip replacements, failed time and again to adequately inform patients of the risk for elevated blood metal ion levels and other side effects such as femoral fracture and premature device failure, a number of DePuy hip replacement lawsuits have been filed against the company, particularly concerning the ASR and ASR XL systems.

If you or a loved one used a DePuy ASR hip replacement and suffered one of these or other complications, 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 compassion, 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 2011 report by JM Smolders et al. published in Acta Orthopaedica titled “Metal ion levels and functional results after either resurfacing hip arthroplasty or conventional metal-on-metal hip arthroplasty.”, a team of medical researchers aimed to determine whether larger cup sizes in metal-on-metal hip replacements led to higher levels of metal ions in the blood after continued use.

As such, the team wrote “Modern metal-on-metal hip resurfacing was introduced as a bone-preserving method of joint reconstruction for young and active patients; however, the large diameter of the bearing surfaces is of concern for potentially increased metal ion release.”

To carry out this study, Smolders et al. (2011) followed 71 patients who received either a resurfacing hip arthroplasty or “conventional metal-on-metal hip replacement”. “Functional outcomes were assessed preoperatively and at 6, 12, and 24 months. Cobalt and chromium blood levels were analyzed preoperatively and at 3, 6, 12, and 24 months.”

While functional outcomes were improved in both groups, “Cobalt concentrations were statistically significantly higher for [resurfacing] patients … at 3 and 6 months. Chromium levels remained significantly higher for [resurfacing] patients until 24 months.”

Due to the fact that DePuy Orthopaedics, Inc., the manufacturer of many popular metal-on-metal hip replacement systems (such as the recently-recalled ASR and ASR XL) failed to notify consumers of the risk for elevated metal ion levels, a number of DePuy ASR hip replacement lawsuits are currently being filed.

If you or a loved one used a DePuy hip replacement and suffered early failure of the device, you may be entitled to significant financial compensation for your injuries.  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 skills 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 2011, a paper titled “Early failure of articular surface replacement XL total hip arthroplasty.” in The Journal of Arthroplasty by GD Steele et al., stated “The ASR (articular surface replacement) XL (DePuy, Warsaw, Ind) metal-on-metal hip arthroplasty offers the advantage of stability and increased motion. However, an alarming number of early failures prompted the evaluation of patients treated with this system.”

As such, attempting to determine the rate at which DePuy ASR XL hip replacements fail and require revision (replacement) surgery, Steele et al. (2011) studied 95 patients (105 hip replacements) over a minimum of two years each and analyzed what they found.

At the end of the study, it was found that 16 revisions had been required.  Researchers write “Thirteen (12%) were aseptic acetabular failures. Eight were revised for aseptic loosening; 4, for metallosis; 1, for malposition; 2, for infection; and 1, for periprosthetic fracture.”

Concluding, Steele et al. (2011) write “The ASR XL with a revision rate of 12% is the second reported 1 piece metal-on-metal system with a significant failure rate at early follow-up” and “This particular class of implants has inherent design flaws that lead to early failure.”

With the publication of studies such as this, demonstrating a failure rate significantly higher than that reported by DePuy, a number of DePuy ASR lawsuits have been filed.  If you or a loved one used an ASR 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 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.

In 2011, Deborah Cohen, investigations editor for the British Medical Journal wrote a piece called “Out of joint: The story of the ASR,” which chronicles the ill-fated history of the DePuy ASR metal-on-metal hip replacement systems.  Illuminating the depth and breadth of lack of concern for patient well-being at DePuy, I encourage you to read it in its entirety.

Here is an excerpt:

It is one of the biggest disasters in orthopaedic history, according to one senior surgeon. On 24 August 2010, DePuy, a subsidiary of American giant Johnson and Johnson, recalled its ASR (articular surface replacement) hip prostheses from the market. The recall followed years of denial by the company that the ASR implants had caused pain and disability in patients. In a statement to the BMJ, DePuy claim that “given the available information, we believe we made the appropriate decision to recall at the appropriate time.”

Pathologically, the failing prosthesis had several effects. Metal debris from wear of the implant led to a reaction that destroyed the soft tissues surrounding the joint, leaving some patients with long term disability. Ions of cobalt and chromium—the metals from which the implant was made—were also released into the blood and cerebral spinal fluid in some patients.1

The long term effects are uncertain. But the US Food and Drug Administration recommends that patients should be monitored for systemic effects, particularly cardiovascular, neurological, renal, and thyroid signs and symptoms.1

With more than 93 000 ASR implants sold and ongoing litigation in many countries, the situation may prove costly for DePuy. And if lessons are not learnt from this latest episode in the chequered history of hip implant failures, it may also prove costly for the reputations of the regulators and the orthopaedic community.

The ASR is not the first hip implant to be recalled—there have been many others. One such recall in the late 1990s—the 3M Capital Hip—prompted questions about European device regulation2 and a parliamentary investigation by then health minister, Lord Hunt.3 But nor may it be the last—concerns are now being raised about the failure rates of other metal on metal hip implants.4

As a result of this failure to warn by DePuy, a number of ASR lawsuits are currently being filed.  If you or a loved one used a metal-on-metal hip replacement by DePuy such as the ASR or ASR XL, 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 experience, resources, and skills 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.