Wednesday, August 31, 2011

Comparison of surgical outcomes and implant wear between ceramic-ceramic and ceramic-polyethylene articulations in total hip arthroplasty.

For those of you who are in the process of discussing the options for the materials used in the hip revision, I found these results interesting.  My only question from this abstract is what is the time duration over which these observations were made?  Worth looking into.
J Arthroplasty. 2011 Sep;26(6 Suppl):72-7. Epub 2011 Jun 15. Amanatullah DF, Landa J, Strauss EJ, Garino JP, Kim SH, Di Cesare PE.

Source

Department of Orthopaedic Surgery, University of California at Davis Medical Center, Sacramento, California.

Abstract

The results of a prospective multicenter trial comparing 357 hips randomized to total hip arthroplasty with either ceramic-ceramic or ceramic-polyethylene couplings are presented. No statistically significant difference in clinical outcomes scores between the ceramic-ceramic and ceramic-polyethylene groups was observed at any time interval. The mean linear rate was statistically lower (P < .001) in the ceramic-ceramic group (30.5 μm/year) when compared with the ceramic-polyethylene group (218.2 μm/year). The rates of ceramic implant fracture (2.6%) and audible component-related noise (3.1%) were statistically higher in the ceramic-ceramic group when compared with the ceramic-polyethylene group (P < .05). Lastly, there was no statistically significant difference in the dislocation or revision rate between the groups at the time of last clinical follow-up.

Tuesday, August 30, 2011

MRI After Arthroplasty: Comparison of MAVRIC and Conventional Fast Spin-Echo Techniques

( I am on a business trip all week.  Will try my best to keep up my daily posts.  If I miss a day, apologies in advance.)

In prior posts, I have discussed the importance of choosing the right type of MRI in order to detect underlying issues with your hips that may not have YET resulted in pain or any obvious symptoms.  While a number of surgeons order the sonogram (in my mind completely useless in this instance), the surgeons who order MRIs, use the Mars protocol.   I traveled to NYC in order to have a Mavric protocol run in order to provide optimal resolution to any underlying issues.  This is the first publication I have found on the Mavric protocol.  Here is the URL to the prior post on this subject.  In fact, the same author (Hollis Potter MD, presented on  the panel I published on earlier-What do plain radiographs, ultrasound, MRI and CT offer the Depuy hip patient (6 of 7)- is also  a co author on the article below.)

I think you can see how well the Mavric protocal  recognizes underlying pathology that the customary Mars MRI might not pick up. My only suggestion is that you speak with your surgeon about using this protocol up front in conjunction with monitoring post replacement or revision with this protocal.

This protocol selection is VERY important for patients who are interested in understanding what underlying issues might be present without out any presenting signs or symptoms.

Source

Department of Radiology and Imaging, Hospital for Special Surgery, 535 E 70th St, New York, NY 10021.

Abstract

OBJECTIVE:

The goal of this study was to evaluate the quality of images obtained with a prototype imaging technique, multiacquisition variable-resonance image combination (MAVRIC), compared with fast spin-echo (FSE) images in the evaluation of patients who have undergone hip, shoulder, or knee arthroplasty.

MATERIALS AND METHODS:

MRI with metal-artifact reduction FSE and MAVRIC sequences was performed in the care of 122 patients who had undergone 74 hip, 27 shoulder, and 21 knee arthroplasties. The FSE and MAVRIC images were subjectively graded for visualization of the synovium, prosthesis-bone interface, and hip abductors or supraspinatus tendon. The presence of synovitis, osteolysis, or supraspinatus tendon tear was recorded.

RESULTS:

Visualization of the synovium was significantly better on MAVRIC images than on FSE images of the hip (p < 0.0001), shoulder (p < 0.01), and knee (p < 0.01). Synovitis was detected only on the MAVRIC images of nine subjects (12%) who had undergone hip arthroplasty and five subjects (18%) who had undergone shoulder arthroplasty. Visualization of the periprosthetic bone was significantly better on MAVRIC images of the hip (p < 0.0001), shoulder (p < 0.0001), and knee (p < 0.01). Osteolysis was detected only on the MAVRIC images of 12 subjects (16%) who had undergone hip arthroplasty, six (22%) who had undergone shoulder arthroplasty, and five (24%) who had undergone knee arthroplasty. Visualization of the supraspinatus tendon was significantly better on MAVRIC images (p < 0.0001). Supraspinatus tendon tears in 12 subjects (44%) were detected only on MAVRIC images.

CONCLUSION:

MAVRIC complements the information on FSE images after arthroplasty and is a useful additional sequence, particularly when there is concern about synovitis, periprosthetic osteolysis, or the presence of a supraspinatus tendon tear.

Sunday, August 28, 2011

Safety of Medical Devices: Views From the Industry


The Sunday Review

Letters  Published: August 13, 2011

To the Editor:

Re “How Safe Are Medical Devices?” (editorial, Aug. 5), about the Institute of Medicine report on the Food and Drug Administration’s review process for medical devices:

The answer to your question is, Overwhelmingly safe. As you highlight, the institute found no evidence that medical devices reviewed through the current process pose a risk to public health. Yet the institute proposes abandoning the current review program — which has a strong track record of protecting American patients — and replacing it sometime in the future with a new, unspecified process.

Fortunately, the F.D.A. has indicated its support for the current review process and will move forward carrying out its own comprehensive improvement plan. If properly executed, the F.D.A.’s plan will address the lack of clarity and the inconsistencies plaguing the current review process, which negatively affect patients’ timely access to life-changing, lifesaving medical technology.

America’s medical technology companies are committed to working with the F.D.A. and Congress on these improvements.

STEPHEN J. UBL
President and Chief Executive
Advanced Medical Technology Assn.


Washington, Aug. 10, 2011

To the Editor:

Americans can be proud that one of our most innovative industries is also one of our safest. Medical devices have played a central role in increasing life expectancies and improving the quality of life for patients, and have a tremendous safety record.

In fact, Dr. William Maisel, before he became the chief scientist in the Food and Drug Administration’s medical device unit, conducted a study demonstrating that approximately 99 percent of medical devices cleared by the F.D.A.’s 510(k) process (the most common pathway for devices) were not subject to Class 1 recalls.

The medical device community considers even one adverse outcome unacceptable, and we constantly strive for perfection. Medical device manufacturers continue to work with the F.D.A. and other stakeholders to ensure that patients and providers have timely access to safe and effective products, and that the United States remains the global leader in innovation.

MARK LEAHEY
President and Chief Executive
Medical Device Manufacturers Assn.
Washington, Aug. 5, 2011

Friday, August 26, 2011

Financial results of the top 6 producers of hips

Biomet reported $715.2 million in net sales during the fourth quarter of the 2011 fiscal year, a 2 percent increase over last year. The United States net sales decreased by 3 percent during the last quarter, which was offset by the 7 percent increase in European net sales and 11 percent increase in other international sales. The company's reconstructive sales were flat while the extremities sales grew by 17 percent worldwide. The spine business reported $55.4 million in net sales, a 10 percent decrease from last year.
DePuy Orthopaedics, a Johnson & Johnson company, reported $1.4 million in worldwide sales during the second quarter of 2011, which is a slight increase over last year. The company is still reeling from expenses related to litigation stemming from the DePuy ASR Hip recall. Johnson & Johnson spent $233 million on litigation and recall expenses last year.
Smith & Nephew's second quarter 2011 financial report showed a 9 percent increase in revenues to $1 billion for the quarter. The company's orthopedics, trauma, sports medicine and endoscopy markets experienced growth while hip sales were flat. Knee sales grew by 7 percent due to the VERILAST bearing technology.

Stryker reported $2.05 billion in net sales, which is a 12 percent increase over last year. However, the company experienced a 2.1 percent decrease in net earnings to $309 million. The company's hip business reported an 11 percent increase, spine business an 8 percent increase and knee business a 4 percent increase over last year. The company completed the acquisition of Orthovita during the second quarter as well

Wright Medical Group reported $132.5 million in net sales during the second quarter of 2011, which is a 4 percent increase over last year. Total net income also increased from $4.8 million to $6.1 million, due to success in the foot and ankle market. The company's sales were carried by the international market, which grew by 11.5 percent. By contrast, domestic market net sales decreased by 1.5 percent.

Zimmer Holdings reported $1.1 billion in net sales during the second quarter of 2011, a 7.5 percent increase over last year. The increase was driven by the European and Asian Pacific markets, which grew by 17 and 19 percent, respectively. The American market experienced flat sales during the second quarter. The U.S. knee market experienced a 5 percent decrease and the reconstructive and spine markets reported a 2 percent decrease, while the hip market experienced a 2 percent increase.
 Excerpts from an article : Successes and Failures: 18 Orthopedic and Spine Device Companies Battling a Tough Market Written by Laura Miller | August 25, 2011 

Thursday, August 25, 2011

My Rants

Have been watching the rants in the press  re 4 allegations which seem to reoccur over and over and over again and reprinted over and over and over again.  I think they are  blown way out of proportionand are in my mind quite unfair to Depuy.

1) Depuy hired Broadspire (their claims agent to):

  • gain control of patient medical records to be used against them in court.
  • distance themselves from patients
  • take the control of the case out of the hands of the patent's physician.
2) Depuy sent out medical packets requesting a signed medical release by the patient to:
  • make patient files available to Depuy and persuade patients to give up their privacy rights
3)  Depuy has offered payment to the physicians to encourage the physicians to help them get control of the records for some underhanded reason.

4)  Depuy is trying to settle claims directly with the patients  before the patient fully understands their legal rights or the likely hip related medical costs in the future.


My perspective (for whatever its worth):

1) It is perfectly reasonable that a company like Depuy, or any company for that matter might want to outsource claims.  Depuy is not in the claims business.  I am unsure as to why any company would want to undertake a business which is outside of their core competency, in this case, producing medical devices.  It is too cost prohibitive to stray from what you know best.  Companies should stick to their core competencies and outsource to others what they do best.  There should be nothing unusual about that.  it makes good business sense to do it.

2) Outsourcing insurance claims has been around for many years.  It is a large market with numerous players in it.  Depuy is not the first company to have done this. 

3)  Broadspire has done a great job with the claims that I have been involved with.  I would say I have personally dealt with my agent  on about 10 occasions and have nothing but great things to say about them.  Frankly, I would rather deal with them than with my own insurance company.  I have said that before.  I have found them to be nothing less than completely cooperative.  Perhaps when I talk with them about the surgery, the process will be much more problematic. I will let you know.

4)  If people think that paying a surgeon $50 per case to deal with that paper work is going to unduly incentivize  a surgeon to do something unethical or inappropriate, I have a nice bridge in Brooklyn to sell to you.  I will guess that compensation for orthopedic surgeons might range from $350K to $500K and up.  $50 per case means nothing to them.  I doubt whether that would cover the costs of dealing with those records.  It is just folly to contemplate a payment of this size influencing anyone  let alone an orthopedic surgeon to act inappropriately.  Who needs that hassle?

5)  Any patient can decline to sign a release form for medical records.  I did.  The only implication of doing that is my surgeon needs to come to me to send anyone any information from my file.  I remain the decision maker, no one else. 

6)  If you are seeking assistance from a company of mine  for reimbursement, I would want to be able to verify your claim before I pay you anything.  What is the issue with that?  What business would send out a check without evidence that a problem occurred with their product?

7)  Patients are not stupid.  If Depuy approaches someone with  a settlement, how many people do you think would sign a release statement without checking with an attorney?  1 of 10?  If someone figured out how to find the right physician to remove their hip, they are likely to seek out the help of an attorney before settling a case with Depuy. 

8) I can think of no physician who would  cooperate with a company (any company) in a conspiracy  plot against the patient to give up their rights.   I can imagine a situation where a physician would encourage cooperation with a manufacturer to provide feedback to them on what went wrong.  Do you know of any physician who would actively try to deceive their patient out of their rights?  I don't.

Remember how the Insight story closed which I posted yesterday?

"This is the absolute worst thing that ever happened to my practice," Barba, the Rockford surgeon, said of the recall. "It keeps me up at night wondering how to treat these patients whose future is so uncertain. It has been difficult for all of us emotionally."
I think most medical professionals care deeply about their patients.  I know my surgeon does and the thought of having someone accuse them of attempting to actively deceive their patients out of their rights is just .........stupid and inflammatory.

My rants for what their worth.  I wish we could concentrate on the real  issues.

Wednesday, August 24, 2011

Insight: DePuy's handling of hip recall sparks questions





BOSTON (Reuters) - Johnson & Johnson, which could face billions of dollars in costs over an artificial hip recall, is taking an unusual approach to managing the crisis -- one that could limit its financial exposure, legal experts say.

J&J's DePuy Orthopaedics Inc unit recalled its metal ASR hip system a year ago after it failed at a higher-than-expected rate, with some patients experiencing pain, swelling, joint dislocation and sometimes systemic damage to the central nervous system, thyroid and heart.         
                                  
The company now faces more than 2,000 lawsuits in state and federal court in the United States.

In a highly unusual move, DePuy has hired a third party -- Broadspire Services Inc, which manages workers compensation and other medical claims on behalf of insurance companies and employers -- to administer patient claims for out-of-pocket medical costs associated with the recall.

The move has prompted debate among industry and legal experts. Some see it as an efficient way to outsource a process that is unrelated to making artificial hips. Others see it as a way for J&J to limit payments while gaining control of medical records and other material that could be used against patients in court.

In general, companies and their lawyers handle recalls directly. They answer patient queries and pay claims for reimbursement. Typically, companies accept a treating physician's recommendation when it comes to determining if a device should be removed or replaced.

In DePuy's case, it is Broadspire's physicians, not the patient's own doctor, who, in effect, make the final decision on whether a patient's hip should be replaced. While Broadspire physicians cannot directly override a patient's doctor in terms of treatment, they make the decision on whether to pay. That can effectively rule out surgery for patients who cannot pay.

"Doctors who are evaluating these cases are being paid indirectly by DePuy, and research suggests that even when we are very well-intentioned we can be influenced by conflicts of interest," said Kristin Smith-Crowe, associate professor of management at the University of Utah, who specializes in business ethics. "This is a bit of a red flag in terms of the way this situation is set up."

Lorie Gawreluk, a spokeswoman for DePuy, said Broadspire's role is entirely benign. The company conducts its own reviews to ensure that a patient's hip problems are the result of the recall, and not some other cause, such as a fall.

"Similar to the process insurance companies use to evaluate claims from subscribers, medical records are collected by Broadspire if a patient requests financial assistance," she said in an email. "Broadspire requires no more information than a typical insurance provider would request, and like an insurance provider, Broadspire has a team of reviewers who review claims."

EVOLVING STRATEGY

Patients and lawyers argue that the hip recall claims should not be treated in the same way as a standard medical claim. An insurance company, after all, does not decide whether to reimburse policyholders for medical costs related to a problem it caused itself. Moreover, lawyers representing patients say the amount of information being collected by Broadspire is excessive.

"This is an evolving strategy that is outside the norm of what companies have done in the past," said Edward Blizzard, partner with the law firm Blizzard, McCarthy & Nabers. Blizzard is representing plaintiffs in the case.

"Normally a company would not get the kind of information Broadspire is asking for until a case was in litigation, and even if the case was in litigation, in no circumstance would the defendant be allowed to have their own physician talk to the patient's physician privately, as Broadspire is demanding," he said.

Last August, DePuy wrote to orthopedic surgeons asking them to forward to their patients a package of information about the recall. It contained a form letter from doctor to patient, written by DePuy, asking the patient to set up an appointment to discuss any concerns and to bring with them a signed medical release giving the physician permission to share information with DePuy.

"It is important to share this information with DePuy so that DePuy may contact you directly regarding any additional information regarding the ASR Hip System and process your claims efficiently," the letter said. "Please complete the form and bring it with you to your next appointment."

DePuy offered doctors $50 for each completed set of forms.

"I have been doing this work for 35 years and it is almost unprecedented for a large corporate defendant to run out and preemptively attempt to identify potential claimants," said Alex MacDonald, a partner at MacDonald Rothweiler Eisenberg, who helped negotiate billions of dollars in settlements over the diet-drug cocktail Fen-Phen. He is not representing clients in the DePuy case.

"J&J is reaching out to doctors and asking them to use their influence with their patients in the hope that the doctor will help identify potential claimants in a lawsuit," MacDonald said.
DePuy, which is based in Warsaw, Indiana, denies that it is doing anything out of the ordinary, or that it might be seeking to influence doctors with its upfront offer of payment, as some critics charge.

"It is standard practice for, and indeed healthcare professionals require, reimbursement for the costs of producing the medical records," Gawreluk said.

                            
But some doctors say they have not previously been asked by a product manufacturer to persuade patients to give up their privacy rights, or been directly offered payment to do so.

"It made me uncomfortable," said Mark Barba, an orthopedic surgeon at Rockford Orthopedic Associates, a surgical center in Rockford, Illinois. "I've never faced anything like that before. Never."

METAL POISONING

Some 93,000 people have been implanted with DePuy's ASR hip system worldwide.

With wear, the grinding of the hip's ball-and-socket structure causes metal debris to collect in the tissue surrounding the implant, damaging muscle and tendons and complicating replacement surgery. In some cases, metal ions released into the blood causes broader health problems.

Aubie Brennan, a 56-year-old teacher on the Hawaiian island of Oahu, had replacement surgery for each hip in 2007 and 2008 due to bone deterioration.

In 2009, he began to be plagued by flu-like symptoms, rashes, swollen lips and debilitating fatigue. Doctors were unable to locate the cause. They thought he might have allergies, or be depressed, or poisoned by a substance in the ocean surrounding his home.

But last August, Brennan said he received a letter from his health insurance company, Kaiser Permanente, alerting him to the recall and urging him to come in for tests. These showed that his left hip was crooked and that his blood contained significantly elevated levels of chromium and cobalt ions. The surgeon told him he wasn't sure if the elevated metal levels were causing his symptoms, and to return for further testing in six months.

Brennan could not wait. He sought a second opinion, and in February met with a surgeon at The Queen's Medical Center in Honolulu, the leading medical referral center in the Pacific Basin.

"He looked at my results and said, 'I think you need surgery, on both hips, and you need it now,'" Brennan said. He declined to name either surgeon.

The Honolulu surgeon was not part of Kaiser's network, so Kaiser declined to pay, Brennan said. He turned to Broadspire for reimbursement.

Broadspire told Brennan it would not agree in advance to pay. His only option would be to pay for the surgery himself. Then he would have to submit the doctor's report to Broadspire, whose physicians would review the case and make a decision on whether the procedure had been necessary.

Brennan could not afford to pay the $43,467 that the surgery would have cost -- or take the risk that Broadspire would decline coverage. He canceled the scheduled procedure.

"I was really devastated," he said. "Emotionally, and as far as my job went, it really devastated me."

Ultimately, Kaiser reversed itself and agreed to pay for the surgery, which took place in July.

Broadspire would not comment on individual claims, or its payment process in general. DePuy said patients first file for reimbursement through their insurance company, and DePuy later repays the insurance company.

RECALL UPON RECALL

Over the past two years, J&J -- for decades one of the most trusted brands in America -- has recalled more than 50 products, ranging from Children's Tylenol to insulin cartridges to contact lenses. The company's handling of the recalls has in some cases sparked Congressional and federal criminal investigations.

Particularly disturbing to regulators was an older "phantom recall" of painkiller Motrin. J&J hired a contractor to secretly buy the product from stores well before it alerted the general public in 2009 that the pills did not dissolve properly.

To critics, DePuy's handling of its hip implant recall is designed to save money by potentially settling claims with patients before they fully understand their legal rights, or the likely cost of their hip-related medical costs in the future.


                                
DePuy is adamant in its denial.

"To be very clear: the sole purpose of the Broadspire process is to assist patients and health care providers as efficiently as possible," Gawreluk said.

David Prince, professor of law at William Mitchell College of Law, said that while the hiring of Broadspire may make economic sense for J&J by saving the company the trouble of gearing up and organizing in-house, it also has the effect of distancing the company from patients.

"By pawning this process off on a third party, they don't have to deal face to face with patients, and may be less sensible to the human cost of what their product has done," he said.

Prince, who has represented both plaintiffs and defendants in the past and specializes in product liability, said he can see both perspectives.

"In a larger sense, this is a clash between the individual and his or her needs, and the broad corporate interest," he said. "If I were a patient I'd be very unhappy if someone I trusted, my own doctor, recommended a procedure and someone stood in the way. I would find that intolerable."

On the other hand, he said, "You can see how the company wants to make sure they only pay what they consider in their own mind legitimate claims."

J&J has taken special charges of about $400 million associated with the ASR recall through the second quarter of this year. The company's litigation expense also includes a component for increased product liability reserves related to the recall. Gawreluk declined to quantify that component or say what DePuy has paid out so far in claims.

Some experts say the ultimate cost to J&J could run to the billions of dollars.

In January 2001, Swiss medical device maker Sulzer Medica AG recalled a hip implant after a manufacturing glitch caused it to loosen. The company settled the case in 2002 for $1 billion. Of the 31,000 patients who received the Sulzer Medica implants, more than 2,760 had them replaced.

The DePuy recall is three times larger and much more complex. The revision rate has not yet been established, but data from a study released in March by the British Orthopaedic Association and the British Hip Society showed the ASR system had a failure rate of up to 49 percent after six years -- nearly four times the rate cited by DePuy when it recalled the device.

"This is the absolute worst thing that ever happened to my practice," Barba, the Rockford surgeon, said of the recall. "It keeps me up at night wondering how to treat these patients whose future is so uncertain. It has been difficult for all of us emotionally."

Tuesday, August 23, 2011

Hip Implant Complaints Surge, Even as the Dangers Are Studied


The federal government has received a surge in complaints in recent months about failed hip replacements, suggesting that serious problems persist with some types of artificial hips even as researchers scramble to evaluate the health dangers.
The New York Times
                                                        
An analysis of federal data by The New York Times indicates that the Food and Drug Administration has received more than 5,000 reports since January about several widely used devices known as metal-on-metal hips, more than the agency had received about those devices in the previous four years combined.

The vast majority of filings appear to reflect patients who have had an all-metal hip removed, or will soon undergo such a procedure because a device failed after only a few years; typically, replacement hips last 15 years or more.

The mounting complaints confirm what many experts have feared — that all-metal replacement hips are on a trajectory to become the biggest and most costly medical implant problem since Medtronic recalled a widely used heart device component in 2007. About 7,700 complaints have been filed in connection with that recall.

Though immediate problems with the hip implants are not life-threatening, some patients have suffered crippling injuries caused by tiny particles of cobalt and chromium that the metal devices shed as they wear.

Hip replacement is one of the most common procedures in the United States and, until a recent sharp decline, all-metal implants — one in which both the artificial ball and cup are made of metal — accounted for nearly one-third of the estimated 250,000 replacements performed each year. According to one estimate, some 500,000 patients have received an all-metal replacement hip.

One of the most problematic devices, the A.S.R., or Articular Surface Replacement, was recalled last year by Johnson & Johnson and accounted for 75 percent of the complaints reviewed by The Times. A precise count of failed implants reported to the F.D.A. is hard to come by because of the agency’s overlapping reporting system, though The Times sought to eliminate duplicate reports about the same incident. Some complaints came from outside the United States.

Under F.D.A. rules, many all-metal devices were sold without testing in patients or without a requirement that producers track their performance. But in an unusual intervention, the F.D.A. in May ordered producers to study how frequently the devices were failing and to examine the threat to patients. Now, researchers say, producers face substantial hurdles in recruiting the hundreds of patients needed to conduct sound studies because of the lack of patient registries.

“They are grasping at how they are going to get this information,” said Dr. Robert S. Namba, an orthopedic surgeon with Kaiser Permanente.

In addition, researchers are struggling to understand the tissue damage caused by the metallic debris. While some patients experience pain, other patients with the same damage have no pain, complicating decisions about whether to remove devices.

As problems and questions grow, most surgeons are abandoning the all-metal hips, saying they are unwilling to expose new patients to potential dangers when safer alternatives — mainly replacements that combine metal and plastic components — are available. Some researchers also fear that many all-metal hips suffer from a generic flaw. Current use of all metal devices has plummeted to about 5 percent of the market, though a few of the models are performing relatively well in select patients.
“It is like playing Russian roulette,” said Dr. Geoffrey H. Westrich, an orthopedic surgeon at the Hospital for Special Surgery in New York, who has stopped using all-metal implants.
       
Dr. William Maisel, the chief scientist of the F.D.A. division that oversees medical devices, said he believed that producers would mount rigorous studies and find answers. But he acknowledged that it could take several years.

“There is not an existing infrastructure for studying this kind of information,” Dr. Maisel said.
For many patients, it is too late. In 2008, Ann Morrison, a physical therapist from Newark, Del., received all-metal replacements for both of her hips. But Ms. Morrison, 50, soon experienced pain, rashes and inflammation.


Last year, the devices were replaced, but by then, she said, debris-caused tissue damage was so extensive that she now needs a brace to walk and still cannot work. She called the F.D.A.’s order for medical studies a “joke.”

“We will be the little crash test dummies here until they figure out the health ramifications for us down the road,” said Ms. Morrison, who has sued the DePuy division of Johnson & Johnson, which made her implants.
 
To conduct its analysis, The Times reviewed complaints filed with the F.D.A. from 2007 through this June for several implants, including the A.S.R. and the Durom cup, a component sold by Zimmer Holdings.

Typically, the number of complaints filed with the F.D.A. about a product understates a problem because while companies must file reports, doctors and patients do not have to. The filing volume for the A.S.R. and the Durom cup probably reflects a surge of lawsuits filed against their makers.
The Times review found some 7,500 complaints about the A.S.R., nearly 5,000 of them coming since January. In the case of the Durom cup, about 1,600 complaints were filed with the regulator from 2007 to this June.

Because complaints to the F.D.A. are not uniform, it is impossible to say how many adverse reports about all-metal hips have been submitted. For example, the Times analysis found some 200 complaints about an all-metal version of another DePuy device called the Pinnacle as well as 400 additional complaints that noted metal-related problems in Pinnacle patients. But the Pinnacle is sold in several versions, so it was not clear how many of the metal-related complaints were linked to the all-metal device.

A spokesman for Zimmer Holdings said the Times review was “in the ballpark” of the company’s assessment of the drug administration’s filings. A DePuy spokeswoman declined to disclose the number of A.S.R. complaints that the company forwarded to the F.D.A. She maintained that the Pinnacle was performing well.

DePuy, Zimmer and another producer of metal hips, Wright Medical, declined to discuss the study proposals they had submitted to the F.D.A. to comply with its May order. A fourth company, Biomet, said it had proposed mounting a study of 400 patients who received its devices that would draw in part on studies already under way. The F.D.A. declined to release producers’ proposals, saying that they contained “confidential commercial information.” The agency has until November to decide on the plans’ adequacy.

In an effort to recruit patients, companies have recently contacted, researchers said, health systems like Kaiser Permanente and hospitals that operate their own implant registries.

Meanwhile, researchers say it may be a year before standard protocols are formulated that may be central to the future studies, like a uniform procedure to measure metallic ions in a patient’s blood or how to calibrate diagnostic equipment to best detect tissue damage.

Monday, August 22, 2011

Chromium induced Genotoxicity with BOTH Chromium 3 and Chromium 6

Often times, physicians dismiss the genotoxic effects (changes in DNA caused by the chromium from the hip) of the less toxic chromium 3 (trivalent chromium) which is purportedly the chromium in the hip. NOTE, CHROMIUM 3 IS LESS TOXIC THAN CHROMIUM 6 (hexavalent chromium).  THIS DOES NOT MEAN THAT ONLY CHROMIUM 6 IS A PROBLEM.

This study was just released.


J Toxicol Environ Health A. 2011 Aug;74(15-16):1030-9.

Chromium-induced genotoxicity and interference in human lymphoblastoid cell (TK6) repair processes.


Source

Grup de Mutagènesi, Departament de Genètica i de Microbiologia, Edifici Cn, Universitat Autònoma de Barcelona, Cerdanyola del Vallès, Spain.

Abstract

Two model chromium (Cr) compounds, one hexavalent (sodium chromate) and one trivalent (chromium chloride), were investigated in a human lymphoblastoid cell line (TK6) to increase our knowledge regarding Cr-induced genotoxicity mechanisms. Both selected compounds were genotoxic using the comet assay, although the percentage of DNA in tail obtained after treatment with Cr(VI) was significantly higher than that obtained with Cr(III), at the higher concentrations tested. To determine the nature of the induced damage, enzymes recognizing oxidized bases were used. Treatments with formamidopyrimidine (FPG) and endonuclease III (EndoIII) displayed a greater degree of DNA damage, indicating that the induction of oxidized bases accounts for an important proportion of the damage induced by Cr compounds. In addition, the kinetic repair studies showed that generated DNA damage is removed in approximately 8 h, with the damage induced by Cr(III) being removed/repaired more rapidly than damage produced by Cr(VI). To detect Cr interferences with the repair process, a post-treatment was applied after exposure to 2 Gy gamma radiation. Post-treatment significantly delayed the repair kinetics of DNA damage induced by radiation. This interference effect induced by Cr(VI) was more pronounced. In conclusion, evidence indicates that a high proportion of the Cr-induced DNA damage is correlated with oxidative damage, and that both Cr compounds interfere with repair mechanisms involved in repair of DNA damage induced by gamma radiation.

[genotoxicity is important because In genetics, genotoxicity describes a deleterious action on a cell's genetic material affecting its integrity. Genotoxic substances are known to be potentially mutagenic or carcinogenic, specifically those capable of causing genetic mutation and of contributing to the development of tumors.

This is a subject of great importance to me because I believe that patients get the idea that there is no issue with Chromium 3 contained in the Depuy hip.  This is not a true statement.  A true statement would reflect the clear uncertainty surrounding the question as to whether the genotoxicty question in chromium 3 is mutagenic or carcinogenic.  I have many many posts on this.  If you go to the home page and click on medical studies, and then scroll down the list, you can see them all.

Sunday, August 21, 2011

Early markers of nephrotoxicity in patients with metal-on-metal hip arthroplasty.

I am returning  to the medical literature which has been published in the last 2 months as the focus of this blog has been on other issues in the past 8 weeks or so.  This week I will review the new medical literature that has surfaced around the hip replacement.

Just as a reminder/ Metal on metal hips should not be placed in patients with compromised Kidney function....Recall in prior posts, I asked the question:  What does compromised/impaired Kidney function mean?  Does it mean low creatinine levels?  Does it mean one Kidney?   Both? 

This article is relates to the testing involved in identifying  systemic issues  the metal ions may have on the kidney, a topic I have discussed in previous posts.

Metal ions are cleared in the kidney which is why this is a topic of discussion.

Clin Orthop Relat Res. 2011 Jun;469(6):1651-9.

Corradi M, Daniel J, Ziaee H, Alinovi R, Mutti A, McMinn DJ.

Source

Nephrology and Health Sciences, University of Parma, Parma, Italy.

Abstract

BACKGROUND:

Metal ions released from arthroplasty devices are largely cleared in urine, leading to high exposure in renal tissues. Validated early markers of renal damage are routinely used to monitor workers in heavy metal industries, and renal risk can be quantified in these industries. It is unclear if the ion levels in patients with metal-on-metal hips are sufficient to cause renal damage.

QUESTION:

Does metal-on-metal (MOM) bearing use over a 10-year period lead to elevation of early renal markers compared with the levels expected in subjects with no metal exposure?

METHODS:

We retrospectively reviewed 31 patients who underwent MOM hip resurfacings 10 years earlier. Whole blood specimens were collected for metal ion analysis, serum for creatinine estimation, and urine for timed metal ion output and renal markers. The renal marker levels of 30 age- and gender-matched subjects with no metal exposure and no known renal problems or diabetes mellitus were used as controls for renal markers.

RESULTS:

Median serum creatinine level in the MOM group was 1.1 mg/dL (interquartile range, 1.0-1.2 mg/dL) and median creatinine clearance was 79.2 mL/min. In this cohort, the number of patients with markers of renal damage above the reference range was comparable to the controls. None of the renal markers were associated with metal levels.

CONCLUSION:

The absence of elevation of renal markers in this cohort 10 years after MOM bearing implantation is reassuring. However, we believe surveillance through further longer-term, large-scale controlled trials are needed to monitor this arthroplasty-induced low-intensity (but long-term) trace element exposure to rule out potential nephrotoxicity.

[ I totally agree with their conclusion in light of the Stanford study that was published back in April of this year.  Recall the April 11th post on the study by the Stanford researchers?]  Here is that summary:

Department of Orthopedic Surgery, Stanford University, Stanford, California.

Abstract


Metal-metal total hip arthroplasty (THA) is contraindicated in patients with impaired renal function due to increased metal ion output relative to other bearings and renal excretion of metal ions. Although one can avoid a metal-metal THA in a patient with renal disease, a patient may be destined to develop renal disease later in life. In this study, we sought to determine the incidence of newly diagnosed renal disease in the 9 years after THA. Using the Department of Veterans Affairs national database, we identified 1709 patients who had a primary THA in 2000 without preexisting renal disease. We found the 9-year risk of developing chronic renal disease after primary THA to be 14% and severe or end-stage renal disease to be 6%.

[my comments.  What I like about the Parma Italy study above is that they are seeking early signs of systemic issues assocaited with hip replacement.  There are not a lot of medical people out there really looking at the early testing for any systemic issues.  Ditto for the carcingogenic issues.  If you want tests done, you have to advocate for yourself.  It is highly doubtful that an orthopedic surgeon is going to initiate such such tests to look at early  systemic effects of the hip.  Yes, they will order tests to determine the  metal levels and the infection levels but that is about the extent of the testing.  There is not a lot published on this topic which is why I spend so much time on it.

Friday, August 19, 2011

FDA and Depuy answer questions on the Recall and metal on metal hips -resources for new patients looking into the recall

Thought I would offer up two sites to new site visitors  for general information.  I would suggest two sites:
  • The FDA site
  • The Depuy ASR hip recall guide 
Questions below on the FDA site.  Answers can be found right on their site:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241766.htm
 (scroll over to get the full URL.)


  The Depuy ASR Hip Replacement Recall Guide
http://www.depuy.com/asr-hip-replacement-recall

They cover 5 areas in this guide and have helpful information which can take you through the process:

  • Reasons for the recall
  • What to do
  • Symptoms and Causes
  • Testing
  • Treatment
  • Reimbursment

Thursday, August 18, 2011

My Pinnacle Summary and remaining questions

1) Below, you can see the cumulative conventional hip revisions as a percent of total vs the Depuy ASR which has a high cumulative revision rate (taken from the Australian 2010 Joint registry data.)


1 year
3 years
5 years
7 years
9 years
Depuy ASR
1.8%
5.9%
9.3%


Total conventional hip revisions
1.5%
2.6%
3.4%
4.3%
5.3%

2.  Below are the revision rates at 5 years for the Pinnacle with different Femurs

<><> <><>

Revision rates @5 years from the 2009 report
Revision rates @5 years from the 2010 report
Depuy Corail** Pinnacle*
2.6%
2.9%
Depuy S-Rom Pinnacle
3.7%
3.7%
Depuy Summit Pinnacle
1.6%
2.0
Depuy Summit ASR (FYI)

7.1%
 * acetabular component.
** femoral component
So it looks to me as though the revision rates for the Pinnacles above are well within normal revision rates.  What I don't know for certain  is whether the acetabular metal on metal  component in question is the same component as those above  in the chart.  As I understand it, Pinnacle provides  three   choices:

metal-on-metal,

ceramic-on polyethylene

or metal-on-polyethylene

So which components above are combined to yield Metal on metal in the chart?  I don't know.

Pinnacle® Acetabular Cup System (48mm-66mm)
Pinnacle Hip Solutions was designed to help provide a more fluid range of natural motion. DePuy Orthopaedics remains the leader in metal-on-metal technology, offering several advantages, including larger diameter bearings that can improve hip range of motion and stability. In fact, one study conducted since the device was approved in 2002 observed that an estimated 99.9 percent* of Pinnacle Hip components remain in use. Only Pinnacle Hip Solutions feature TrueGlide™ technology, allowing the body to create a thin film of lubrication between surfaces. The result is a smooth, more fluid range of natural motion.
3)  So in terms of questions, these are mine before I would ok the use of this acetabular component:
  • Are there data on the revision rates broken down by the  combinations that indicate which combinations are in fact MOM?  (MoM/C on Poly/Metal on Poly)?
  • What is behind the surge in complaints to the FDA on the Pinnacle component recently? 
  • Are the complaints summarized by MoM/Con Poly/Metal on Poly 
  • Has the Pinnacle market penetration surged in which case  revisions would rise as well?

I will be moving off this topic for now until I can get some answers to questions.  Will come back and complete this post at that point.

Wednesday, August 17, 2011

Review of the 2010 Australian Joint Registry Results for hips having higher than anticipated revision rates(4 of 4) : The Depuy ASR

1)  Reason for revision of the ASR vs other total conventional hips


Revision diagnosis
 ASR number
ASR
%revision
ASR
% of all primary procedures
Other conventional hips
(number)
Other conventional hip revisions
 (% revision)
Other conventional hips
(% primary)
Loosening/lysis
92
43.8%
2.1%
1427
29.3%
.9%
Prosthesis
dislocation
15
7.1%
.3%
1385
28.5%
.8%
infection
42
20%
1%
804
16.5%
.5%
fracture
19
9%
.4%
725
14.9%
.4%
pain
7
3.3%
.2%
97
2%
.1%
Other (14 categories)
35
16%
.9%
429
1%
0
revisions
210
100%
4.8%
4867
100%
2.9%
Primary
4406


16,698



[ comments from connie: When you look at these numbers, you begin to see why a surgeon would have used this  Depuy ASR device.  This chart shows several likely reasons:
  • Prosthesis dislocation is 400% higher in the Other hips vs Depuy ASR
  • Fracture is 60% higher in the other hips vs the Depuy ASR
On the other side of the equation, you can see the downside:
  • loosening of the prosthesis and lysis is about 70% higher in the Depuy ASR (Lysis (Greek λύσις, lýsis from lýein "to separate") refers to the breaking down of a cell, often by viral, enzymic, or osmotic mechanisms that compromise its integrity)
You have to pick your risks.  The surgeon likely looked at younger patients who were more active-like me- and chose the hip with the lower chance of dislocating and fracture.  Unfortunately, as it turned out, in the long run, the lysis turned out to be a major issue.

This little exercise reaffirms the concept that with every reward in medicine there are risks.  Somehow, surgeons have to balance them out sometimes absent complete information.]

2.  Number of revisions of ARS by year of implant (remember the data here is all from Australia joint registry.)  Note:  Primary procedures performed in later years have had less follow up time therefore the number revised is expected to be less than the number revised in early years which is why you wouldn't calculate percents.

In the early years, you can see that the percents are relatively high comparatively:
  • 4.7% /2004
  • 7%/ 2005
Year of Implant
Number revised
Total Number
2004
4
84
2005
41
583
2006
60
958
2007
56
2284
2008
45
1172
2009
4
425
total
210
4406

this is kind of interesting as well because if you look at the calculation of these rates in the last few posts, something seems to be incongruous...not sure what?  Likely the cumulative numbers would be better to look at not the annual numbers.  These were published in the last few posts.

Anyway, this was very interesting especially the first point above.  It provides perspective on the surgeon's dilemma doesn't it?