An Expert Explains the Failure of Metal-on-Metal Hip Implants

I recommend watching this British Medical Journal video interview of Dr. David Langton, a Researcher Fellow and orthopedic surgeon from Newcastle University. Dr. Langton has won numerous awards and accolades related to his engineering research on failed metal-on-metal hip joints, including the Smith & Nephew Birmingham hip, the DePuy ASR and the DePuy Pinnacle hip implant systems.

In this video, Dr. Langton discusses the safety of metal-on-metal hips (specifically the DePuy ASR) and his findings after studying all metal hip replacements, for the past three years under Dr. Antoni Nargol, in pursuit of his Ph.D.

He states the long-term systemic effect of cobalt metal toxicity is unknown; however some studies show cognitive related issues. The main concern is the localized effects of the metal ions in the hip cavity; cobalt and chromium metal ions concentrate in hip fluid and can cause soft tissue and bone damage around the hip joint. Additionally, the metal particles get in the blood stream, and medical studies conclude it can cause rashes and headaches. Most patients with a metal-on-metal device have hip and groin pain while some suffered femoral fractures. Even though women typically have a quicker response to cobalt, it is necessary for all recipients of an all-metal hip to obtain a cobalt and chromium blood test.

Dr. Antoni  Nargol, a consultant orthopaedic surgeon at the University Hospital of North Tees, worked on the study that DePuy submitted to the F.D.A. and later became a critic of the DePuy ASR. Dr. Nargol told the New York Times in February 2012 “that [DePuy] had never informed him that its application for approval [of the recalled DePuy ASR XL] in the United States had been rejected.” 

Langston says that revision surgery shows a puss like fluid in the joint and some [doctors] say it’s an infection opposed to an adverse local tissue reaction to cobalt.

“I would definitely advise against anyone, at the moment, having a large diameter total hip replacement.”  - Dr. David Langton

Site: David Langton on Metal on Metal Hips

Consumer Reports Investigates Defective Medical Devices such as Metal-on-Metal Hips, Vaginal Mesh Slings & Cardiac Defibrillators

Consumer Reports published an investigative report entitled "Dangerous Devices" in their May 2012 magazine. This article describes several medical devices such as metal-on-metal hips, vaginal mesh slings, and three cardiac devices that have failed and harmed thousands of Americans. Unfortunately, consumers were told these devices were safe when in fact they lacked proper testing.

Consumer Reports concludes that however shocking it may sound, most implanted medical devices are never tested for efficacy and the few that are do not undergo stringent testing.

  

The article quotes Diana Zuckerman, Ph.D., president of the National Research Center for Women & Families, a nonprofit advocacy organization saying “Standards for [medical] devices exist, they just don’t make sense.”

Consumer Reports interviewed three people who were injured from different implants that the FDA grandfathered onto the market.

Metal-on-Metal Hips
Dr. Stephen Tower, an orthopedic surgeon in Alaska, who has written articles about cobalt toxicity from metal-on-metal hips after he suffered from side effects of a metal-on-metal hip replacement. The DePuy Orhopaedics ASR XL (chromium and cobalt metal hip replacement) was substantially equivalent to its predecessors and was grandfathered onto the market without clinical testing. Althuogh Dr. Tower experienced great short term results, after a year he began to experience detrimental heart, brain and thyroid problems. He noted the product of his metal on metal hip implant as "profound poisoning". 


New studies have revealed metal-on-metal hips fail prematurely and at a higher rate than conventional hip implants with a plastic liner. Many patients with metal-on-metal hips are experiencing pain, popping/click, high cobalt levels (referred to as cobaltism/metallosis), and pseudotumors, which necessitates a revision surgery.  

Vaginal Mesh
Surgical Vaginal Mesh is often used to for prolapse repair and bladder support. However, women are experiencing complications that include: chronic pain, hemorrhage, infection, urinary problems and even recurrence of prolapse. These complications require another surgery to remove and replace the mesh. 

This month, Johnson & Johnson notified the FDA it wishes to discontinue sales of vaginal mesh implants in 2013 - read more about this here: http://faultyimplants.blogspot.com/2012/06/j-to-stop-sales-of-vaginal-implants-in.html.


Cardiac Devices
Other dangerous findings in the article discuss implantable cardioverter-defibrillators. Consumer Reports says "since 2009, the FDA has received reports of close to 29,000 deaths or injuries from these devices, by far the most for any device type, according to our analysis of the FDA’s database of adverse events."  More than 500,000 people abnormal rhythms have defibrillators implants that administer shocks to correct the abnormal rhythm.  Two recalls related to defibrillators involved component parts called leads, which are the wires that connect the defibrillator to the heart.  

In 2007, Medtronic recalled the Sprint Fidelis and in 2011 St. Jude recalled the Riata/Riata ST lead. Patients with the leads require close monitoring and potentially may have to have them surgically removed.


I highly recommend you read the article "Consumer Reports Investigates Dangerous Medical Devices" and watch the CBS report above. 

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If you or someone you know has a faulty medical device, contact attorney Jon Mann by phone at 1-866-515-8880 or by email for a free case evaluation.

Stryker offers $33 Million to Settle Claims with US Department of Justice

Seal of the United States Department of Justice (Photo credit: Wikipedia)

Stryker Corp, an orthopedic device manufacturer headquartered in Kalamazoo, MI, offered the United States Department of Justice $33 million last month to resolve allegations regarding marketing practices of the OtisKnee device. 


In 2010, Stryker received  two subpoenas from the U.S. Department of Justice regarding the marketing of its OtisKnee and PainPump devices. 

The DOJ sent the subpoena alleging violations of laws prohibiting sales of a medical device not cleared for marketing by the FDA (Food and Drug Administration).

Stryker Corp. aquired OtisMed, a software technology firm, in  2009 for $103 million. OtisMed Corp., now a subsidiary of Stryker Corp., focuses on customizable instrumentation that was designed to help surgeons custom fit, or "custom cut" Stryker knee implants such as the Triathlon Knee System.  This "custom cut" sought to produce higher success rates of a Total Knee Arthroplasty. 


The company recognizes that this offer is preliminary and it is indefinite as to whether a "resolution will be reached". Stryker's filing, signed by interim CEO Chris Hartman, with the Securities and Excahnge Commission stated, "We recently entered into discussion with the DOJ regarding the potential settlement of this matter, and on May 31, 2012, we offered $33 million to the DOJ." The company claimed that the $33 million represented "our best estimate of the minimum of the range of probable loss to resolve this matter," but there is no assurance the USDOJ will accept this offer.

For more information see these related articles: 

• Fox Business
• Reuters
• Michigan Business Review

CONTACT US TODAY

If you have suffered serious injuries from a knee or hip implant, contact Jon Mann of Pittman, Dutton & Hellums toll-free at 866.515.8880 or by email for a free case evaluation.  PDH has the resources to help navigate you through the judicial system and the experience to protect your rights. 

J&J To Stop Sales of Vaginal Implants in 2013

WHAT ARE VAGINAL MESH IMPLANTS?

Vaginal mesh implants, also called pelvic mesh or bladder slings are used to treat stress urinary incontinence and pelvic organ prolapse. Unfortunately, these devices are failing at alarming rates causing women extraordinary pain and severe side effects such as: chronic pain, recurrence of prolapse and/or incontinence, urinary problems, bleeding, mesh shrinkage or migration, scar tissue formation, dysuria (painful urination), dyspareunia (painful sexual relations), neuropathic pain or mesh erosion.

JOHNSON & JOHNSON PLANS TO DISCONTINUE
VAGINAL MESH IMPLANT SALES IN 2013

Ethicon, a subsidiary of Johnson & Johnson, told a West Virginia federal judge it will discontinue the sales of four vaginal mesh implants worldwide after lawsuits are beginning to mount in America.

Ethicon plans to discontinue the sale of four pelvic mesh implants which include the Prolift, Prolift+ M, TVT Secur and Prosima systems. This is a very interesting move for Ethicon as they are not recalling meshes already sold or implanted and Johnson & Johnson says “it’s decision isn’t based on any safety concerns.”  

However, a report issued by the FDA last year found a fivefold increase in deaths, injuries or malfunctions tied to vaginal mesh for prolapsed organs because of weakened support. Also last year, an advisory panel urged the FDA to reclassify the devices as “high-risk” products needing human testing.

120 DAYS NEEDED FOR THE MARKET WITHDRAWAL

Ethicon wrote a letter to the FDA requesting 4 months (120 days) to end sales so it can “notify its customers and provide those hospitals and surgeons with sufficient time to select alternative treatment options for their patients.” Additionally, Ethicon stated “[we] will also discontinue or revise, as appropriate, all marketing materials during this time.” It is believed that the FDA has not responded to Johnson & Johnson/Ethicon’s letter to discontinue sales.

Ethicon also said, in their letter to the FDA, it will continue selling the Gyencare Gynemesh, but change the label to restrict its use. 

CONTACT US TODAY

If you have suffered serious complications following pelvic organ prolapse (POP) or stress urinary incontinence (SUI) surgery involving a Transvaginal Mesh implant, please contact Jon Mann of Pittman, Dutton & Hellums toll-free at 866.515.8880 or by email for a free case evaluation. 

PDH has the resources to help navigate you through the judicial system and the experience to protect your rights. 

Smith & Nephew Withdraws Metal Liner used in Hip Replacement From Market

DO YOU HAVE A DEFECTIVE METAL-ON-METAL HIP REPLACEMENT?

Another metal-on-metal hip implant component has been withdrawn from the market due to poor clinical results. DePuy Orthopaedics recalled the ASR XL metal-on-metal hip in August 2010 due to higher than expected failure rates and patients reporting cobalt toxicity issues.

Business Week reports that Smith & Nephew PLC, a London based medical device company, announced on Friday (June 1, 2012), that it is voluntarily withdrawing a metal liner used in its R3 Acetabular Metal-on-Metal hip replacement system. This metal liner was introduced in 2009 and approximately 7,700 of the devices have been implanted. 

The company stated that it pulled the optional metal liner from the hip replacement system because it was "not satisfied with the clinical results" of the liner, and some patients needed an additional surgery to have the liner removed.  The clinical results showed "1.6% of patients with this system needed revision surgery each year, which is above the 1% guideline set by Britain's National Institute for Health and Clinical Excellence."  Patients needing hip replacement surgery will be offered the traditional plastic liner instead of the metal-on-metal configuration.

(Photo credit: okadots)

Smith & Nephew says the issues with the metal liner in the R3 Acetabular hip system are different than those seen in other all metal implants such as the recalled DePuy ASR hip. Smith & Nephew contends patients with this metal liner experienced problems including infections, fractures and dislocations, but no reports causing "metallosis" or the build up of other metallic debris in the body. Smith & Nephew claims the voluntary withdrawal of this device is a precautionary move and that patients who already have the device implanted are at low risk and do not need to have it removed. 

Metal-on-Metal hip implants generally have been linked to high rates of revision surgery and systemic complications because of component erosion and leaching of metal ions both locally and into blood circulation. In 2010, DePuy Orthopaedics issued a recall of its ASR metal-on-metal hip due to early failure rates. Problems surrounding the ASR device include increased blood levels of cobalt and chromium ions, intense hip, thigh, and groin pain, a loss in overall mobility, component misalignment and loosening,  and possible tissue and bone necrosis.

CONTACT US TODAY!

If you or someone you know suffered pain and/or had to undergo additional surgery as a result of having a metal-on-metal hip replacement, contact attorneys Jon Mann or Chris Hellums at 1-866-515-8880 so we may evaluate your potential claim. You may be entitled to financial compensation.  Don’t delay, you don't want to let your statute of limitations expire.

Doctors Conclude Early Cobalt & Chromium Blood Testing is Vital to Successful Revision Surgery

Dr. Scott Ball, an orthopedic surgeon specializing in joint replacements at UC San Diego Medical Center, discusses the importance of a cobalt and chromium blood test for patients with metal-on-metal implants.

Ultimately, Dr. Ball believes success of a revision surgery is directly related to "identifying patients early and treating them early".

The risk with metal-on-metal hip implants is the potential release of cobalt and chromium metal ions into the blood stream due to every day movements. This "wear debris generated by the articulation" of the artificial joint can cause pain and discomfort in the hip, stiffness or simply a general decline in function. Dr. Ball noted that at times patients experienced a "clicking sensation or ratcheting sensation" which occurs when the "ball is riding up onto the rim of the implant".

EARLY TESTING NECESSARY TO PREVENT FURTHER HARM TO YOUR HIP JOINT

Dr. Ball believes that the earlier the issue is recognized, the better the outcome of revision surgery will be. If the problem is treated too late, bone or soft tissue necrosis (the premature death of cells in living tissue) can "compromise the outcome of a revision surgery". 

Doctors can detect cobalt and chromium ions with a physical examination and a specific blood test to measure cobalt and chromium ion levels. Some doctors perform diagnostic tests such as an MRI or an ultrasound.

CONTACT US TODAY!

If you or someone you know has a metal-on-metal hip implant contact attorney Jon Mann at 1-866-515-8880 or by email for a free case evaluation.


For more information, also visit: FaultyHipAttorneys.com

Metal-On-Metal Hips Failing at High Rates

DO YOU HAVE A DEFECTIVE HIP REPLACEMENT?

Pittman, Dutton & Hellums, P.C. is currently representing individuals across America that have metal-on-metal hip implants and were injured as a result of being implanted with this hip replacement device. 

Metal-on-metal implants are hip replacement components that have both a metal ball and a metal socket.  These implants are prematurely failing at unusually high rates causing metal ions to be released from the implant into the blood stream which can cause pain, pseudo tumors, and often requires revision surgery.

PROBLEMS WITH METAL ON METAL HIP IMPLANTS

Many patients are having unexplained intense hip, thigh and groin pain, component loosening, component misalignment, difficulty walking or standing, loss of muscle mass, bone fractures, dislocation, and infections. Additionally, patients with metal-on-metal hip implants are subjected to increased risk of metallosis (toxic cobalt levels), ALVAL (aseptic lymphocyte dominated vasculitis associated lesion), which is an adverse tissue reaction to metal particles and ions, and pseudotumors (a soft tissue mass that may be the result of a toxic reaction to an excess of particulate metal wear debris) from cobalt metal ions released from the implant into the blood stream.

SCIENTIFIC STUDIES REVEAL HIGHER THAN EXPECTED REVISION RATES

Artificial hip implant surgery is one of the most common joint replacement procedures in America. It is estimated that there are over 250,000 hip implant surgeries performed every year in the United States. It is believed that one-third of patients from 2003-2011 received a metal-on-metal hip implant.  New studies have revealed that some metal-on-metal implants are failing early at extra ordinary rates.  


In March 2011, the British Orthopedic Association held its annual conference where they discussed the recalled DePuy ASR XL device, but warned that all metal-on-metal hip devices with any large diameter may also be showing similar results.
Researchers at the meeting presented new revision rates of metal-on-metal hips. Results of the DePuy ASR XL hip device showed a 21% revision rate at 4 years (potentially rising to 35% if all currently known painful implants progress to revision) to 49% at 6 years.  Results for other devices showed a revision or impending revision rate of 12 – 15 % at 5 years.
These statistics are alarming since functioning hip implants are marketed to last up to 15 years before requiring revision surgery.  

CONTACT US TODAY!

If you or someone you know has a metal-on-metal hip implant contact attorney Jon Mann at 1-866-515-8880 or by email for a free case evaluation.