Friday, December 30, 2011

The High Cost of Failing Artificial Hips


Multimedia
Medical and legal experts estimate the hip failures may cost taxpayers, insurers, employers and others billions of dollars in coming years, contributing to the soaring cost of health care. The financial fallout is expected to be unusually large and complex because the episode involves a class of products, not a single device or just one company.

The case of Thomas Dougherty represents one particularly costly example. He spent five months this year without a left hip, largely stuck on a recliner watching his medical bills soar.

In August, Mr. Dougherty underwent an operation to replace a failed artificial hip, but his pelvis fractured soon afterward. The replacement hip was abandoned and then a serious infection set in. Some of the bills: $400,776 in charges related to hospitalizations, and $28,081 in doctors’ bills.

“I’m sitting here on a La-Z-Boy meant for someone who is 80 and I’m 55,” said Mr. Dougherty, who lives in Groveland, Ill., and works at Caterpillar, the heavy equipment manufacturer. His bills are “five times as much” as he paid for his home.

The so-called metal-on-metal hips like Mr. Dougherty’s, ones in which a device’s ball and joint are made of metal, are failing at high rates within a few years instead of lasting 15 years or more, as artificial joints normally do. The wear of metal parts against each other is generating debris that is damaging tissue and, in some cases, crippling patients.
       
The incidents have set off a financial scramble. Recently, lawsuits and complaints against makers of all-metal replacement hips passed the 5,000 mark. Insurers are alerting patients that they plan to recover their expenses from any settlement money that patients receive. Medicare is also expected to try to recover its costs.

While his insurer has covered his bills so far, Mr. Dougherty said he was preparing to sue his surgeon, who may have implanted the device incorrectly, and Johnson & Johnson, which produced his artificial hip, to help recoup some of the insurer’s money.

“All these payers want to be paid back,” said Matt Garretson, the founding partner of the Garretson Resolution Group, a firm in Cincinnati that manages product liability cases.

Until a recent sharp decline, all-metal implants accounted for nearly one-third of the estimated 250,000 hip replacements performed each year in the United States. Some 500,000 patients have received an all-metal replacement hip, according to one estimate. A new study found that no new artificial hip or knee introduced during a recent five-year period — implants that included some of the all-metal hips — were more durable than older devices, and 30 percent were worse.
       
One troubled all-metal model, implanted in 40,000 patients in the United States, was recalled last year by the DePuy division of Johnson & Johnson. As of October, some 3,500 patients had filed a lawsuit involving that device.

There is no data on the number of all-metal hips that have failed prematurely in this country because the outcomes of orthopedic procedures are not formally tracked by the government or private companies.

But extrapolating from overseas data and the estimate of metal hip use here, tens of thousands of patients in the United States may have to undergo operations over the next decade to replace the implants, said Dr. Art Sedrakyan, a researcher at Weill Cornell Medical College of Cornell University, who is studying the hip problem.

A decade ago, Sulzer Orthopedics paid a record $1 billion to settle claims by 6,800 patients who received artificial hips and knees that were contaminated with industrial oil during the manufacturing process. “We have been dwarfed by this,” said Teresa Ford, a lawyer who worked at Sulzer at the time and is now in private practice.

Device producers have taken differing stances to covering patient expenses. Zimmer Holdings, which says its all-metal implants are safe, has settled hundreds of patient claims, lawyers involved in those cases say. Also, DePuy is covering costs related to the device it recalled last year, the A.S.R., or Articular Surface Replacement.

DePuy would not comment on how much it had paid in recall-related costs. But a spokeswoman, Mindy Tinsley, said in a statement that DePuy was working with patients and insurers.

Things have not gone smoothly for everyone who has taken DePuy’s payment offer. One patient, Paula Laverty, received a hospital bill for $41,578 and a call from the facility warning her that the bill would be turned over soon to a collection agency


Ms. Laverty, of Cape Elizabeth, Me., said she spent weeks calling the firm handling claims related to DePuy’s A.S.R. She said she eventually learned that the implant maker had paid the hospital $18,000 for her replacement procedure and that the $41,578 represented the remaining charges.
This month, DePuy made an additional payment to the hospital, according to Ms. Tinsley, the company spokeswoman.

Along with A.S.R.-related cases, DePuy also faces over 560 lawsuits in connection with the all-metal version of another hip model, called the Pinnacle, the device that Mr. Dougherty received. Because the company says that the model is performing well, costs for its replacement are being borne by Medicare, insurers or patients themselves.

To recoup their expenses, insurers typically notify patients through lawyers that they expect to be reimbursed from any settlement money that patients receive, rather than pursue their own lawsuits with the device makers. Also, Medicare is expected to enforce new laws next year that will make it easier for the agency to recover taxpayer dollars spent treating patients injured by problem drugs and medical devices, legal experts said.

Still, some patients are weathering some of the financial impacts on their own. While Charmin McCune, a teacher in Wylie, Tex., is recuperating well from a recent replacement operation, she said that she and her husband, also a teacher, have had more than $12,000 in expenses that have not been covered by insurance.

Mr. Dougherty, the Illinois patient, underwent a procedure this month to get a new hip implant. All went well, he said, so he hopes to spend next year back on his feet and at work.

“You can’t do anything,” he said of his current situation. “You see your wife doing everything for you. It is just not right.”

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Wednesday, December 28, 2011

More DNA studies with nanoparticles such as Chromium and Cobalt and the possiblity of limiting the systemic damage from such particles (Part Two)

This is a continuation of the last post yesterday on the same subject which was published in 2009.  Recall that the subject matter in the last post:http://www.mydepuyhiprecall.com/2011/12/more-on-dna-changes-with-chromium-and.html

The increasing use of nanoparticles in medicine has raised concerns over their ability to gain access to privileged sites in the body. Here, we show that cobalt–chromium nanoparticles (29.5 plusminus 6.3 nm in diameter) can damage human fibroblast cells across an intact cellular barrier without having to cross the barrier.
 
This article furthers the study to make the point If the importance of barrier thickness in signalling is a general feature for all types of barriers, our results may offer a principle with which to limit the adverse effects of nanoparticle exposure and offer new therapeutic approaches.
 
 
 
 
In this case you might make the link from article one to article two (by the same authors) that  wear debris from Chromium and cobalt nanoparticles  can damage DNA by crossing cell barriers and the barrier thickness plays a role, the results from article two may offer a way to limit the adverse effects of this nanoparticle exposure and offer new therapeutic approaches alternatives to Cr and Co?  that is how I read this research.....

xxxxxxxxxx

Signalling of DNA damage and cytokines across cell barriers exposed to nanoparticles depends on barrier thickness

Nature Nanotechnology

Volume:

6,

Pages:

824–833

Year published:


 
 

Abstract

Tuesday, December 27, 2011

More on DNA changes with Chromium and Cobalt

Recall that I have been examining the data in the field to try and understand the DNA damage that might occur as a result of the Chromium and Cobalt metal seeping into the body. Recall that my concerns were based in part with on the work done by C.P. Case and his colleagues since 1996. Their concern was that particulate wear debris accumulates in tissue adjacent to the prosthesis and disseminated in the body to liver, spleen, bone marrow and lymph nodes, with the highest levels being detected in the local bone marrow and lymph nodes.  Some of these metals were known to be clastogens and to damage DNA.  Therefore, it is important to investigate the possible long-term effect of exposure to wear debris.

A clastogen is a material that can cause breaks in chromosomes, leading to sections of the chromosome being deleted, added, or rearranged. This is a form of mutagenesis, and can lead to carcinogenesis, as cells that are not killed by the clastogenic effect may become cancerous.

Here is an article published in 2009 which is the most recent research I found on this topic until the one printed in november of this year which I will print tomorrow.

Nature Nanotechnology 4, 876 - 883 (2009)
Published online: 5 November 2009 | doi:10.1038/nnano.2009.313

Nanoparticles can cause DNA damage across a cellular barrier

Gevdeep Bhabra1,10, Aman Sood1,10, Brenton Fisher1, Laura Cartwright2, Margaret Saunders2, William Howard Evans3, Annmarie Surprenant4, Gloria Lopez-Castejon4, Stephen Mann5, Sean A. Davis5, Lauren A. Hails5, Eileen Ingham6, Paul Verkade7, Jon Lane7, Kate Heesom8, Roger Newson9 & Charles Patrick Case1

The increasing use of nanoparticles in medicine has raised concerns over their ability to gain access to privileged sites in the body. Here, we show that cobalt–chromium nanoparticles (29.5 plusminus 6.3 nm in diameter) can damage human fibroblast cells across an intact cellular barrier without having to cross the barrier. The damage is mediated by a novel mechanism involving transmission of purine nucleotides (such as ATP) and intercellular signalling within the barrier through connexin gap junctions or hemichannels and pannexin channels. The outcome, which includes DNA damage without significant cell death, is different from that observed in cells subjected to direct exposure to nanoparticles. Our results suggest the importance of indirect effects when evaluating the safety of nanoparticles. The potential damage to tissues located behind cellular barriers needs to be considered when using nanoparticles for targeting diseased states.
Top

  1. Bristol Implant Research Centre, Southmead Hospital, Bristol BS10 5NB, UK
  2. Biophysics Research Unit, Department of Medical Physics & Bioengineering, Bristol Haematology & Oncology Centre, University Hospitals Bristol NHS Foundation Trust, Horfield Road, Bristol BS2 8ED, UK
  3. Department of Medical Biochemistry and Immunology & Wales Heart Research Institute, Cardiff University, Cardiff CF14 4XN, Wales
  4. Faculty of Life Sciences, University of Manchester, Michael Smith Building, Oxford Road, Manchester M13 9PT, UK
  5. School of Chemistry, University of Bristol, Bristol BS8 1TS, UK
  6. Faculty of Biological Sciences, University of Leeds, Leeds LS2 9JT, UK
  7. Department of Biochemistry, University of Bristol, Bristol BS8 1TD, UK
  8. School of Medical Sciences, University of Bristol, Bristol BS8 1TD, UK
  9. Medical Statistics, National Heart and Lung Institute, Imperial College London SW7 2AZ, UK
  10. These authors contributed equally to this work

Monday, December 26, 2011

New Hip Implant Discovery - (Second article...con't from yesterday's post)

Lubricant in metal-on-metal hip implants
found to be graphite, not proteins

[Implication, better wear hopefully not at the cost of a new wear debris:  graphite?]

Discovery May Lead to Hips That Function Better and Last Longer

CHICAGO — A team of engineers and physicians have made a surprising discovery that offers a target for designing new materials for hip implants that are less susceptible to the joint's normal wear and tear.

Researchers from Northwestern University, Evanston, IL, Rush University Medical Center, Chicago, and the University of Duisburg-Essen Germany found that graphitic carbon is a key element in a lubricating layer that forms on metal-on-metal hip implants. The lubricant is more similar to the lubrication of a combustion engine than that of a natural joint.

The study will be published Dec. 23 by the journal Science.

Prosthetic materials for hips, which include metals, polymers and ceramics, have a lifetime typically exceeding 10 years. However, beyond 10 years the failure rate generally increases, particularly in young, active individuals. Physicians would love to see that lifespan increased to 30 to 50 years. Ideally, artificial hips should last the patient's lifetime.

"Metal-on-metal implants can vastly improve people's lives, but it's an imperfect technology," said Laurence D. Marks, a co-author on the paper who led the experimental effort at Northwestern. "Now that we are starting to understand how lubrication of these implants works in the body, we have a target for how to make the devices better."

Marks is a professor of materials science and engineering at Northwestern's McCormick School of Engineering and Applied Science.

The ability to extend the life of implants would have enormous benefits, in terms of both cost and quality of life. More than 450,000 Americans, most with severe arthritis, undergo hip replacement each year, and the numbers are growing. Many more thousands delay the life-changing surgery until they are older, because of the limitations of current implants.

"Hip replacement surgery is the greatest advancement in the treatment of end-stage arthritis in the last century,"said co-author and principal investigator Dr. Joshua J. Jacobs, the William A. Hark, M.D./Susanne G. Swift Professor of Orthopedic Surgery and professor and chair of the department of orthopedic surgery at Rush. "By the time patients get to me, most of them are disabled. Life is unpleasant. They have trouble working, playing with their grandchildren or walking down the street. Our findings will help push the field forward by providing a target to improve the performance of hip replacements. That's very exciting to me."

Earlier research by team members Alfons Fischer at the University of Duisburg-Essen and Markus Wimmer at Rush University Medical Center discovered that a lubricating layer forms on metallic joints as a result of friction. Once formed, the layer reduces friction as well as wear and corrosion. This layer is called a tribological layer and is where the sliding takes place, much like how an ice skate slides not on the ice but on a thin layer of water.

But, until now, researchers did not know what the layer was. (It forms on the surfaces of both the ball and the socket.) It had been assumed that the layer was made of proteins or something similar in the body that got into the joint and adhered to the implant's surfaces.

The interdisciplinary team studied seven implants that were retrieved from patients for a variety of reasons. The researchers used a number of analytical tools, including electron and optical microscopies, to study the tribological layer that formed on the metal parts. (An electron microscope uses electrons instead of light to image materials.)

The electron-energy loss spectra, a method of examining how the atoms are bonded, showed a well-known fingerprint of graphitic carbon. This, together with other evidence, led the researchers to conclude that the layer actually consists primarily of graphitic carbon, a well-established solid lubricant, not the proteins of natural joints.

"This was quite a surprise," Marks said, "but the moment we realized what we had, all of a sudden many things started to make sense."

Metal-on-metal implants have advantages over other types of implants, Jacobs said. They are a lower wear alternative to metal-on-polymer devices, and they allow for larger femoral heads, which can reduce the risk of hip dislocation (one of the more common reasons for additional surgery). Metal-on-metal also is the only current option for a hip resurfacing procedure, a bone-conserving surgical alternative to total hip replacement.

"Knowing that the structure is graphitic carbon really opens up the possibility that we may be able to manipulate the system in a way to produce graphitic surfaces," Fischer said. "We now have a target for how we can improve the performance of these devices."

"Nowadays we can design new alloys to go in racing cars, so we should be able to design new materials for implants that go into human beings," Marks added.

The next phase, Jacobs said, is to examine the surfaces of retrieved devices and correlate the researchers' observations of the graphitic layer with the reason for removal and the overall performance of the metal surfaces. Marks also hopes to learn how graphitic debris from the implant might affect surrounding cells.

The science of tribology is the study of friction, lubrication and wear. The term comes from the Greek word "tribos," meaning rubbing or sliding.

The National Institutes of Health (through an American Recovery & Reinvestment Act of 2009 grant: RC2-AR-058993) supported the research.

The Science paper is titled "Graphitic Tribological Layers in Metal-on-Metal Hip Replacements." In addition to Marks, Jacobs, Fischer and Wimmer, other authors are Yifeng Liao (first author), from Northwestern, and Robyn Pourzal, from the University of Duisburg-Essen, Germany.

[Here is the abstract of this article:  Note the last sentence.]

Science. 2011 Dec 23;334(6063):1687-90.

Graphitic tribological layers in metal-on-metal hip replacements.

Source

Department of Materials Science and Engineering, Northwestern University, Evanston, IL 60201, USA.

Abstract

Arthritis is a leading cause of disability, and when nonoperative methods have failed, a prosthetic implant is a cost-effective and clinically successful treatment. Metal-on-metal replacements are an attractive implant technology, a lower-wear alternative to metal-on-polyethylene devices. Relatively little is known about how sliding occurs in these implants, except that proteins play a critical role and that there is a tribological layer on the metal surface. We report evidence for graphitic material in the tribological layer in metal-on-metal hip replacements retrieved from patients. As graphite is a solid lubricant, its presence helps to explain why these components exhibit low wear and suggests methods of improving their performance; simultaneously, this raises the issue of the physiological effects of graphitic wear debris.

Sunday, December 25, 2011

Metal hip lubricant reduces wear and tear: study


Reuters
12:03 p.m. MST, December 22, 2011
CHICAGO (Reuters) - A substance that forms in patients with all-metal artificial hips turns out to contain the common lubricant graphite, a discovery that could help in designing longer lasting implants, researchers said.

Such "metal-on-metal" hips were developed to be more durable than traditional implants that combined metal and polyethylene for its ball-in-socket structure.



But a recent study sponsored by the U.S. Food and Drug Administration showed that patients who received all-metal hips were more likely to need repeat surgery than those who got implants made of other materials. Last year, Johnson & Johnson's DePuy Orthopaedics Inc unit issued a massive recall of a metal-on-metal hip that failed at a higher-than-expected rate.

In a new study, U.S. and German scientists have found graphitic carbon in a lubricating layer that forms on the surfaces of the ball and socket in implanted metallic hips as a result of friction when the two surfaces slide together. Previous research had identified the existence of the layer, but it was assumed to be made of proteins.

The substance is more like the lubricant in a combustion engine than a natural joint and paves the way for new approaches to designing the devices that could lead to implants that work better and last longer, the researchers said.

"Graphite has been used as a lubricant for over a century," said study co-author Laurence Marks, a professor of materials science and engineering at Northwestern University near Chicago. "It is a classic lubricant, and it appears to form naturally."




The researchers included engineers and physicians from Northwestern, Rush University Medical Center in Chicago and the University of Duisburg-Essen in Germany. Using tools including electron and optical microscopes, they studied seven implants that were retrieved from patients for various reasons.

Their findings could help scientists design future metal hips that are less vulnerable to wear and corrosion, Marks said in an interview. For example, device makers could try to enhance the formation of the graphite or develop a way to make it adhere better to the metal, he said.

"Now that we have a handle on how they are working and why they are working well, we can start to design them to make them better," Marks said.

The study, funded by the National Institutes of Health, was published in the journal Science.

Metal-on-metal hips were designed to wear longer and can accommodate larger femoral heads, which lowers the risk of hip dislocation. But they produce debris in the body that can release metal ions into the blood stream.

More than 450,000 Americans, most with severe arthritis that limits their ability to walk, undergo hip replacement each year. The devices, made of combinations of metals, polymers and ceramics, typically last more than a decade, but their failure rates rise beyond 10 years.

Manufacturers include Zimmer Holdings Inc, Wright Medical Group Inc, Smith & Nephew Plc and DePuy.

xxxxx

[The study will be published Dec. 23 by the journal Science.  the coauthors are Josh Jacobs and Laurence Marks 

Prosthetic materials for hips, which include metals, polymers and ceramics, have a lifetime typically exceeding 10 years. However, beyond 10 years the failure rate generally increases, particularly in young, active individuals. Physicians would love to see that lifespan increased to 30 to 50 years. Ideally, artificial hips should last the patient’s lifetime.

“Metal-on-metal implants can vastly improve people’s lives, but it’s an imperfect technology,” said Laurence D. Marks, a co-author on the paper who led the experimental effort at Northwestern. “Now that we are starting to understand how lubrication of these implants works in the body, we have a target for how to make the devices better.”]

Friday, December 23, 2011

Financial summaries from the 3rd quarter of 6 Othopedic Companies

Written by Laura Miller | December 20, 2011 

Biomet experienced a 4 percent increase in net sales during 2Q of the 2012 fiscal year, despite a 5 percent drop in worldwide spine sales. This comes after a 10 percent drop in spine sales during 1Q of FY 2012. The company reported worldwide net sales of $725 million in 2Q, while U.S. net sales increased by 2 percent.

Johnson & Johnson's DePuy Orthopaedics reported a 1.5 percent decrease in U.S. sales during the third quarter of 2011. Worldwide sales increased by 5.7 percent. Johnson & Johnson reported $109 million in total expenses due to litigation matters related to the recall of the DePuy ASR Hip implant in the summer of 2010.

Revenue was up for Smith & Nephew during 3Q, despite poor market growth from its orthopedics business. The company's overall revenue increased by 10 percent to $1 billion over the same period last year, but orthopedics sales only increased by 3 percent to $548 billion. As a result, CEO Olivier Bohuon said the company would take steps to reduce the cost base in orthopedics.

Stryker's net sales showed a 14.9 percent increase during 3Q. The company reported $2 billion in net sales, but net earnings decreased by 3 percent. The company's reconstructive products reported 8 percent increase in sales, driven by acquisitions of Orthovita and Memomental earlier this year. The company's spine business grew by 121 percent to $184 million, offsetting low growth by its hip and knee businesses.

Wright Medical Group reported a 3 percent decrease in net sales during 3Q to $118.2 million. Domestic sales decreased by 7 percent while international sales only grew by 3.6 percent. Knee, hip and biologics sales decreased for the company, while extremities sales grew by 7.5 percent.

Overseas markets drove Zimmer's 6.9 percent sales increase during 3Q. The company reported net sales of $1 million, due to a 17 percent increase in the European market and 19 percent increase in the Asian Pacific market. Sales in the American market remained flat.

[Well, it's nice to see that all of the orthopeidic companies are doing really well financially!]

Wednesday, December 21, 2011

Progress on Connie's hip about 8 weeks post op

I get a lot of questions on how my recovery is going.  Well, in short, it is very slow. 

  1. I am still on a 3 wheel walker.  My leg is not yet strong enough to support my weight.
  2. I can't stand for a long period of time.
  3. I do go to PT 2 xs per week and feel as though I will get stronger but that will occur only after my second round of PT (an additional 20 sessions minimum run after having gone through the intensive daily PT at the rehab for a week ( 2 hour sessions per day).
  4. My non surgical leg has become worn out and quite painful due to the weight I put on it.
  5. I have numbness in both my fingers and toes.
  6. Cold chills constantly  on the outside of my thighs (both legs.)
  7. I have not gone for a post op appointment yet but do have a time set for the end of February.
I do think I will recover.  I have concerns about a number of things but I think it is best to wait and see. You must do your excersizes every day to gain back strength in the surgical leg.

Thanks for asking about my recovery.  If anyone else is experiencing similar things, let us know.  the readers are curious about the recovery process and while they are all different, I am sure there are some common threads. 

Oh, one other thing, I went back to work in the office after the third week.  I am not sure that was a good idea.  If you can work from home for 4 weeks, likely I would reconsider my plans again.  I just wasn't prepared for the severity of this surgery vs my minimally invasive surgery in the first round.

Have a happy holiday!

Connie.

Tuesday, December 20, 2011

Conflicting reasons for the recall from different Depuy spokespeople?

DePuy Denies All Allegations (reported from the Rottenstein law firm web site) From a British spokesperson from Depuy:

A worldwide recall, joint registries reporting high failure rates, and thousands of lawsuits, it’s hard to envy DePuy, but the manufacturer stands by its actions. Not only does it claim that the recalled hip replacements were not harmful, but it also adds that safety concerns had no bearing on the recall. A spokesperson told the BBC, “The product was withdrawn because of declining demand and to allow the company to focus on developing the next generation hip technologies to better meet the needs of patients and surgeons.”
 Vs

Another Depuy spokeswoman said in another release (US spokesperson for Depuy):

She said "all orthopedic implants, no matter what materials are used,  generate debris."   Particles from metal on metal hip implants “do not cause problems for most patients, but a small number of patients have an adverse reaction to them,” she said.


She said DePuy monitors data from a variety of sources and “We believe we made the appropriate decision to recall at the appropriate time given the available information.”

“Depuy is committed to working with patients and their health insurers to address medical costs directly associated with the recall she said.

[It would seem that the two depuy spokespersons have a different take on the reason for this  recall?]

Monday, December 19, 2011

A motion filed to Consolidate yet another group of Hips for litigation (Wright conserve hip)

Posted by Shezad Malik MD JD
December 15, 2011 5:43 PM

A motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation (JP) to consolidate and centralize all federal Wright Conserve hip replacement lawsuits. These lawsuits have been brought in courts throughout the United States by individuals who experienced injury problems after receiving the metal-on-metal artificial hip system.

Several lawsuits have been filed against Wright Medical in different federal district courts through the nation by individuals who complain that their metal-on-metal Wright Conserve Plus hip system failed within a few years of implant, often resulting in the need for revision surgery.

Since the FDA approved the Wright metal-on-metal hip replacement system under their 510(k) approval system, more than 200 adverse event reports have been submitted by patients or physicians, which likely only represents a small percentage of the total number of problems with Wright Conserve hip replacements.

All of the lawsuits involve similar allegations of design defects involving the Conserve Acetabular cup, which plaintiffs claim has a tendency to loosen and fail as metal particles are shed into the body from the metal parts rubbing against each other.

The Wright Conserve hip system is a metal-on-metal design, which consists of cast cobalt chromium molybdenum that provides the cup (socket) for the cobalt chromium molybdenum femoral head (ball). The metal femoral head turns within the metal monoblock Conserve Cup, which does not have a protective liner. This may result in the release of metal particles, through the metal on metal grinding. The metal ions can cause metal toxicity in the blood, soft tissue and bone. This condition can result in metallosis, tissue necrosis and pseudotumors, according to the complaints.

In May 2011, the FDA asked Wright Medical and other metal-on-metal hip makers such as DePuy, Smith and Nephew, Stryker and Zimmer, to obtain more information about the level at which the metal particles released by hip replacements becomes dangerous, how much metal they actually release and to quantify the potential side effects of metallosis.

The Wright Conserve Cup features a similar design to the DePuy ASR Cup, which was recalled in August 2010 after medical data suggested that a higher-than-expected number of people had their artificial hip fail within a few years.

Due to the similarities between the designs, the MDL motion suggests that a Wright Conserve hip recall is likely to be issued as well.

The plaintiffs argue that centralizing the Wright Conserve metal-on-metal hip lawsuits as part of an MDL will serve the convenience of the parties, prevent duplicative discovery and avoid conflicting pretrial rulings from different judges.

[Well, it sure looks like most of the metal on metal devices have consolidated lawsuits through multi district litigation.  Depuy formed one.  Pinnacle formed one.  Now Wright Conserve hip.]

Sunday, December 18, 2011

India State FDA Files Complaint against DePuy with Mumbai Police

excerpts from a post on Rottenstein Law group's site

State Food and Drug Administration Asks Recipients to Step Forward

Mumbai—formerly called Bombay—is an Indian commercial metropolis located on the county’s west coast in the state of Maharashtra. According to an article in Daily News & Analysis, the state’s Food and Drug Administration (FDA) filed a complaint with the Mumbai police against DePuy. The primary problem for Indian authorities is that they don’t know how many people in their country received the hip replacements, though the article suggests 4,700 implants were sold there. Few Mumbai residents, however, appear to have received one, so the police are asking residents to step forward and report if they are among them.

One FDA official stated, “The Police are investigating. Once the implant recipients come forward, we will know how many are affected, and accordingly take action against the company.”

Indian Orthopedists React

As soon as the DePuy hip recall began in August 2010, orthopedists in Mumbai claim they immediately ceased using the ASR. One also said that until now, no one has reported hip replacement problems, and tests have not shown symptoms of metal poisoning. Although no one has undergone revision surgery of an ASR, some have received care for parts loosening or wearing out. As in the United States and elsewhere, DePuy has promised to reimburse recipients up through revising a failed implant.

Friday, December 16, 2011

Medical Devices Need Greater Follow Up After U.S. Approval, Senators Say




Thursday, December 15, 2011

Clarifications on the question: Does the MDL protocol for examining the explants adequately address the key questions?

Well, in short, I still don't know exactly.  Remember, the key question we have as patients is:  tell me how much of this metal has gone into our body.  Part two of this question can be addressed later...( what is the implication of the MoM levels for the last 5 years and what are the long term systemic effects?)


Most of the CMM machines are used to measure a dimension, the distance between two points in space.  This is how  the CMM specified in the MDL (multi district litigation) protocol is to be used...to give the spherical diameter of the femoral head and the spherical diameter of the acetabular cup.  Where is the volume of wear though?

It is now possible with the newer machines to measure many thousands of points accurately so you can take the CMMs dimensional measurements and convert these to a volume.  The first publication related to the ware measurement of these hips was back in 1996..some 15 years ago.  Essentially we are back to the following conclusion from my sources:


*   Need to know how much metal has been removed from the articulating surfaces of the acetabular cup and femoral head of an explanted ASR - this will be a quantitative measurement rather than a qualitative assessment as inferred by the MDL protocol.  Also, the MDL protocol suggests that "wear" can be inferred from scratching.  Scratching is associated with surface topography and not necessarily with wear (loss of material.)

 *   Need to know how much damage has occurred to the taper junction between femoral head and femoral stem and they can use the  CMM to give a wear depth AND wear Volumes not just depth.

I will be interested in seeing how this explant endeavor turns out.


Connie

Wednesday, December 14, 2011

Accelerating failure rate of the ASR total hip replacement: 6 year post surgical rate of 48.8%

J Bone Joint Surg Br. 2011 Aug;93(8):1011-6.

 

Source

Northern Deanery, Goldcrest Way, Newcastle upon Tyne NE15 8NY, UK. djlangton22@doctors.org.uk

Abstract

There is widespread concern regarding the incidence of adverse soft-tissue reactions after metal-on-metal (MoM) hip replacement. Recent National Joint Registry data have shown clear differences in the rates of failure of different designs of hip resurfacing. Our aim was to update the failure rates related to metal debris for the Articular Surface Replacement (ASR). A total of 505 of these were implanted. Kaplan-Meier analysis showed a failure rate of 25% at six years for the ASR resurfacing and of 48.8% for the ASR total hip replacement (THR). Of 257 patients with a minimum follow-up of two years, 67 (26.1%) had a serum cobalt concentration which was greater than 7 μg/l. Co-ordinate measuring machine analysis of revised components showed that all patients suffering adverse tissue reactions in the resurfacing group had abnormal wear of the bearing surfaces. Six THR patients had relatively low rates of articular wear, but were found to have considerable damage at the trunion-taper interface. Our results suggest that wear at the modular junction is an important factor in the development of adverse tissue reactions after implantation of a large-diameter MoM THR

 xxxxx (information below is not a part of the article above but is taken from the Langton, Joyce slides which I published a week ago.

I wanted to reprint From the Langton slides the bands of progressive problem metal levels as it is the best one I have found and I get this question continuously....

If the ion levels are elevated above 7ppb for either Cr or Co (parts per billion or 7 micrograms/liter) second set of tests should be performed.

Cobalt ladder

1ppb
physiologic

2ppb
upper normal limit for patients with hip resurfacing

5ppb
abnormal ware

10 ppb
60% show ARMD (adverse reaction to metal debris) within 3 years

20ppb
metalosis

(remember ppb and micrograms per liter are the same.)


Tuesday, December 13, 2011

Popular Hip Replacement Made Patients Sick (CBS news Chicago)

CHICAGO (CBS) – They trusted that the hip replacement device approved by the Food and Drug Administration was safe and would help them. Instead it made the already painful condition for some patients worse.

And as CBS 2’s Pam Zekman reports, after it was voluntarily recalled, serious and painful health problems still plague patients even after the device is removed.
“I had a job and a career that I loved,” Mary Ann Doornbos, 53 said. “I went around the world doing things.” But she also had osteoarthritis and needed hip replacement surgery in 2007.

Doornbos recalls her doctor told her, “there was a hip replacement that was new, innovative and geared towards younger people and that I would be back to work in a very short period of time.”
It was known as the ASR made by DePuy Orthopaedics. The ASR was first introduced in 2004 outside the United States, and then approved for sale in the U.S. in 2005.

That approval came under the FDA’s 510K regulatory process which does not require clinical trials on patients. Under that process, manufacturers can get an expedited FDA approval if their device is “substantially similar” to another already on the market.

But the ASR differed from other metal models because it had a shallower socket.
Dr. James Kudrna, an orthopedic surgeon at NorthShore Glenbrook Hospital, implanted about 400 of them.
“It lent for great mobility so patients could get the motion back in the hip,” he said.
But like others, he later learned that also reduced lubrication of the bearing causing excessive wear. As a result tiny particles of chromium and cobalt flaked off. “It can lead to the destruction of muscles tendons and ligaments surrounding the hip area,” Dr. Kudrna said.
       
That’s what happened to Doornbos, who had an ASR implanted by another doctor in 2007. After two other surgeries to repair a mass that formed around her hip bone and damaged tissue that doctor replaced the ASR in 2009. But she’s still in constant pain, cannot walk without a cane, and unable to return to work.

There have been case reports of a small number of patients who had high levels of metal ions in their bloodstream that effected their nervous system and heart, which worries Doornbos.
Now she’s suing Depuy Orthopaedics charging the ASR had “dangerous design defects.”
 
“DePuy knew or should have known in Europe, in Australia these devices were failing at a ridiculously high rate,” said her attorney, Peter Flowers, who represents hundreds of patients who have had adverse reactions to the metal debris generated by normal use of the ASR.

“This device never should have been released in the United States.” Flowers said.
Then, in 2010, after the United Kingdom National Joint Registry reported the ASR had a 13 percent failure rate after five years, DePuy voluntarily recalled it saying the action was “in the best interests of patients.”

“The United Kingdom has an outstanding registry of every prosthetic device implanted in their citizens,” said Attorney Thomas Prindable, who also represents Doornbos and others suing DePuy. “The United States doesn’t track that,” he said, and it should. “The FDA trusts the manufacturers too much to do their own policing.”

Now, in a study published last August in the Journal of Bone and Joint Surgery, a group practice of orthopedic surgeons in the United Kingdom reported a 48.8% failure rate after 7 to 8 years.
“That’s huge.” Said Dr. Kudrna. “Based upon that certainly there is an ominous future for this device.”
Like other doctors after the recall, Kudrna contacted all of his patients for follow up examinations and tests. Those who had elevated metal levels or other symptoms of tissue damage underwent revisions. Patients who do not have problems now, “need to be followed essentially the rest of their lives,” he said.

As for Doornbos, “Even before I get out of bed it’s just pain, constant pain,” she said. “And I can’t understand how or when it’s going to stop.”

A DePuy spokeswoman said the company is now facing 4,500 lawsuits and will not comment on any pending litigation. In a written statement, she noted that the recently reported 48.8 percent failure rate was from just for one medical practice, cannot be verified, and is out of line with previously reported failure rates.


She said all orthopedic implants, “no matter what materials are used,” experience generate debris. Particles from metal on metal hip implants “do not cause problems for most patients, but a small number of patients have an adverse reaction to them,” she said.
She said DePuy monitors data from a variety of sources and “We believe we made the appropriate decision to recall at the appropriate time given the available information.”
“Depuy is committed to working with patients and their health insurers to address medical costs directly associated with the recall,” she said.

The company encourages patients to visit the DePuy website or call its help line at 888-627-2677.
Meanwhile, the FDA has asked manufacturers of all metal on metal hip replacements to research how well their devices are performing and monitor adverse reactions.

Hip Replacement Devices are All the Same, Study Says

 
Hip replacement implants all work the same regardless of the material used, according to a new study.
The newer, metal-on-metal implants appear to be no more effective than older implants and may sometimes even be more problematic, the researchers said, according to HealthDay News.

"Metal-on-metal and ceramic-on-ceramic hip implants might not be associated with any advantage, compared with traditional bearings such as metal-on-polyethylene or ceramic-on-polyethylene," lead researcher Dr. Art Sedrakyan, director of the Patient-Centered Comparative Effectiveness Program at Weill Cornell Medical College in New York City, told HealthDay.

While there is some evidence from three large national registries that higher rates of replacement surgery are associated with metal-on-metal implants, compared with metal-on-polyethylene implants, there is simply not enough information about these implants to determine if one type is better or safer than the other, Sedrakyan continued. Even for newer implants such as metal-on-metal or ceramic-on-ceramic bearings, their advantage over traditional implants is not clear, he told HealthDay.

"There are very successful implants on the market today for hip replacement," Sedrakyan told HealthDay. "We need to have stronger data on improvement in clinical outcomes for new hip implants."
Sedrakyan and his colleagues, along with the U.S. Food and Drug Administration, looked at the safety and effectiveness of various types of hip replacements in 18 studies that included more than 3,000 patients and 800,000 operations. The researchers found no difference between the various types of implants in terms of the patients' quality of life or ability to function normally.

Dr. Peter Cram, an associate professor of medicine in the division of internal medicine at the University of Iowa Carver College of Medicine, told HealthDay: "The study highlights a critical issue in joint replacement surgery, which is there is not a lot of good data."

The best way for patients to ensure they are getting the best implant is to seek out “an experienced surgeon, who does lots of these procedures, in a hospital that does lots of these procedures," Cram added.

Dr. Joseph Zuckerman, professor of orthopedic surgery and chair of the orthopaedic surgery department at NYU Langone Medical Center in New York City, told HealthDay: "This study confirms what many surgeons already practice -- that in the pursuit of providing the best outcome, a surgeon must base his or her treatment recommendation on important factors that include each individual patient's health status and lifestyle, their own clinical experience, the documented evidence about outcomes, and the available technology."

This study was published in the Nov. 29 online edition of the BMJ

Evaluating the Hip Explant: What are we searching for in an explant analysis? (part 2 of 2)

This post is about the question:  What is the bottom line we are looking for in examining the explants?

In the process of screening evaluation lab methodology for the purpose of understanding what happened to the hip implant, the following points have been raised  about the exam protocol which was attached as exhibit A in the explant preservation and examination order issued by the MDL:

(1) There is  no requirement to obtain  exact wear measurements on the implant which will tell the patient at the end, how much metal went into their body.


(2) co-ordinate measuring machines  specified in the MDL order give wear volumes  and out-of-roundness machines  give wear depths, however the procedure appears to ignore the use of such machines for wear measurements.

(3) Instead, the procedure suggests studying articulating surfaces of failed hips by eye, and evaluating them qualitatively to determine the damage to them. 
  • In reviewing the summary of the requested inspection and capabilities, this is what they are requesting in the order:
    • photography of components as received
    • photography of the decontaminated components
    • Macro and sterocommicroscopic exam of each component
      • general shape, staining etc
    • Metrology
      • using a coordinated measurement machine (CMM) to do surface profiling for measurement to engineering drawings
      • Surface finish measurement.
(4)  There is no dimensional measurements requested in the procedure for the taper adapter or for the taper of the hip stem.  It has been demonstrated  that a loss of metal from these junctions contributes to the higher failure rate seen with the ASR XL – recently announced as a 29% revision rate at 6 years in the 2011 National Joint Registry for England and Wales.  Such dimensional measurements would again help to quantify how much metal has been released from the taper and has gone into a patient’s body.

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  • I can see in this order that  there are suggested machines to use during this evaluation by the MDL/Depuy agreement but I do not see any where in the exhibit a srequest to report  how much metal went into the patient's body as a result of this hip wear.  Here is the equipment recommended for use though:
    • digital camera with certain specs
    • Optical steromicroscope
The optical microscope, often referred to as the "light microscope", is a type of microscope which uses visible light and a system of lenses to magnify images of small samples. Optical microscopes are the oldest design of microscope and were possibly designed in their present compound form in the 17th century. Basic optical microscopes can be very simple, although there are many complex designs which aim to improve resolution and sample contrast. Historically optical microscopes were easy to develop and are popular because they use visible light so the sample can be directly observed by eye. The stereo or dissecting microscope is an optical microscope variant designed for low magnification observation or a sample using incident light illumination rather than transillumination. It uses two separate optical paths with two objectives and two eyepieces to provide slightly different viewing angles to the left and right eyes. In this way it produces a three-dimensional visualization of the sample being examined.

    • Coordinate measurement machine
A coordinate measuring machine (CMM) is a device for measuring the physical geometrical characteristics of an object. This machine may be manually controlled by an operator or it may be computer controlled. Measurements are defined by a probe attached to the third moving axis of this machine. Probes may be mechanical, optical, laser, or white light, amongst others. 
They are often used for:
  • Dimensional measurement
  • Profile measurement
  • Angularity or orientation measurement
  • Depth mapping
  • Digitizing or imaging
  • Shaft measurement
    • contact profilometer
Profilometer is a measuring instrument used to measure a surface's profile, in order to quantify its roughness.

xxx

As you all know, I have no science training whatsoever. I am merely sharing information  and observations that I find in my investigation for my own case.  I agree with the observation that what I want to know from the "wear analysis" is how much metal has gone into my body.  If the current protocol recommended by the MDL doesn't provide that answer, that is a problem.

Apparently, there are a few labs in the world that have the equipment capable of rendering the measurement which results in the answer to the question:  how much metal has gone into the person's body.  The equipment required to do that is a high precision coordinate measuring machine coupled with customized software written to determine the ware volumes (exact measurements).

As I uncover additional information on this subject, I will let you know.  I have a few weeks off over the holiday and was planning on focusing on the DNA testing but I need to finish this exploration first.