Sunday, March 31, 2013

Profile of an FDA critic: Q&A with patient safety advocate Dr. Robert Hauser

Veteran cardiologist and patient safety advocate Dr. Robert Hauser tells MassDevice.com about his new vision for healthcare surveillance, his long struggle to spur change at the FDA and what FDA regulators can learn from aviation regulation.

Dr. Robert Hauser

Veteran cardiologist Dr. Robert Hauser is eager for change, even if he has to go straight to Capitol Hill himself to make it happen.

The patient safety advocate and vocal critic of the FDA announced at this year's American College of Cardiology conference that he's working on a proposal to fundamentally change the way federal regulators monitor medical devices and drugs once they hit the market.

He's looking to "recruit a couple people and go to Congress" with a proposal that would separate the FDA's approval functions from its surveillance functions, he told MassDevice.com here in San Francisco yesterday.

In an in-depth interview, Hauser, a prominent cardiologist from the Minneapolis Heart Institute, told us about his drive to protect patients from faulty devices, his disappointment with the FDA and what healthcare regulators can learn from their counterparts in aviation.

Inspiration and disappointment
Hauser's passion for healthcare safety was inspired in part by an experience he had in the mid-1970s, when a patient died when the pacemaker that he was dependent on short-circuited, he told us.
"A 40-year-old guy dropped dead on the doorstep of his home. His wife found him," Hauser said sadly. "We then found out that it was due to moisture getting into the electronics through a defect in the circuit that the manufacturer knew about."

At the time the FDA was considering what would become the Medical Device Amendments of 1976, which put into place the 3-tiered class system by which FDA assesses the potential risk and regulatory pathway for medical devices. Hauser "totally supported the amendment" at the time, he said, in part because of his experiences with faulty pacemakers. But in the intervening 40 years he's grown pessimistic about the FDA's ability to satisfy its duty to protect U.S. patients from potentially dangerous products.

He's made it something of a life goal to promote changes at the FDA, but is growing increasingly discouraged, he told us.
"I've done everything I can to encourage the FDA to change. Nothing changes." 
Hauser has been instrumental in several discussions surrounding medical device risks and recalls, most recently in the January issue of the Journal of the American College of Cardiology, in which he warned physicians clamoring over Boston Scientific's (NYSE:BSX) "leadless" implantable defibrillator to curb their enthusiasm.

He was also at the center of an April 2012 scandal over St. Jude Medical's (NYSE:STJ) recalled Riata defibrillator leads, in which the medical device maker called for the retraction of a Hauser study attributing 22 deaths to failures in the Riata or Riata ST leads.

Hauser was also 1 of the physicians who helped uncover problems with Guidant Corp.'s pacemakers after a patient he was treating died. Boston Scientific, which acquired Guidant for about $26 billion in 2006, is still dealing with the legal fallout from those issues.

"I've done everything I can to encourage the FDA to change," Hauser told us. "Nothing changes."
His remaining alternative, as he sees it, is to change the fundamental structure of medical device and drug surveillance in the U.S.

Even as he prepares to advocate for a new regulatory agency to take some responsibility away from the FDA, Hauser is acutely aware of the hurdles that stand in his way, perhaps foremost among them "inertia" at the FDA.

"There's 1 chance in 100, but it's worth taking the chance," he said. "It's worth the effort, because maybe in the conversation something will happen that'll change things."

And the FDA under the Obama administration has not welcomed recommendations for change. When the Institute of Medicine recommended in 2011 that the federal watchdog agency completely scrub its 510(k) fast-track review of medical devices, the FDA quickly responded that it was "not bound to adopt IOM recommendations."

The agency has since signed, and the White House approved, new deals with the medical device industry that raise the fees companies pay for agency review in exchange for the FDA meeting performance goals and getting applications out the door more efficiently.

What's the hurry?
Medical device companies and lawmakers often chide the FDA for taking too long to get new, potentially life-saving products to the U.S. market. The agency frequently finds itself defending its timelines or promising to improve them.

The federal watchdog agency is regularly cited as the biggest hurdle delaying new products from reaching the market and industry advocates in Congress occasionally prod the FDA to speed the review process
"I don't think we really help people by making drugs or products available more rapidly."

Hauser fundamentally disagrees with those efforts, he told us, challenging the underlying assumption that faster is better.

"I don't think we really help people by making drugs or products available more rapidly," Hauser said. "There are occasional drugs and devices that really are game-changers, that deserve expedited study and review and approval. Many, many drugs and devices are incremental improvements – or they are in competition with other drugs or devices that are safe and effective.

"Thank God we've got pharma, thank God we've got the medical device companies. There have been revolutionary products, there will continue to be revolutionary products," he added. "But there's rarely great urgency to get something into the marketplace."

The healthcare industry thrives, Hauser said, by pushing out new products and marketing incremental differences, no matter how small, in order to get a leg up on the competition.

Part of that is sustained by what he called "loopholes" in the FDA's approval process, problems that Hauser said go beyond the scope of an independent monitoring authority.

The FDA's unintended loopholes
"There are other issues that need to be addressed, separate from a National Drug & Device Safety Board," Hauser told us. "We need to get rid of these loopholes that allow drugs or allow devices to get approved without adequate testing."

He named the FDA's premarket approval supplement system among the vulnerabilities in the agency's review that allow potentially dangerous products to reach patients.

"Supplements to the original PMA allow manufacturers to make changes to medical devices that presumably improve design, manufacturing or labeling," Hauser told an audience during a presentation at the ACC meeting on Saturday. "However, the PMA supplement has been employed – I should say abused – to introduce essentially new products that are significantly different than the original PMA devices.

"This is another pathway whereby high-risk Class III devices have been FDA-approved for widespread use without clinical trials or any human testing," he added.

A classic example of how that process may fail, Hauser said, involved medical device giant Medtronic (NYSE:MDT) and its Sprint Fidelis ICD lead. The Sprint Fidelis, which was approved as a supplement to the Transvene lead, was the cause of a high-profile, precedent-setting recall after it had already been implanted in some 268,000 patients.
 
Medtronic pulled the Sprint Fidelis in 2007, when it was announced that they were prone to fracture – meaning they could either fail to deliver life-saving therapy or else send unneeded shocks.
The defective leads were implicated in more than 100 deaths, although Medtronic has said that only 13 fatalities listed the leads as a "possible or likely contributing factor."

Hauser further targeted the FDA's popular 510(k) medical device fast-track as an antiquated system that has outlived its usefulness. He agreed with a 2011 report released by the Institute of Medicine, the culmination of nearly 2 years and $1.3 million dollars, which recommended that the FDA scrub the 510(k) program completely.

The institute took issue with the foundation of the 510(k) program, that devices which are "substantially equivalent" to already-approved products (so-called "predicate devices") need not be subject to the more stringent pre-market approval process required for entirely new medical technologies.

The IOM report also found that 3 out of 4 devices recalled between 2005 and 2009 had been approved under 510(k) applications or had escaped review entirely.

The FDA's failure to respond to recalls

The FDA has the authority to mandate recalls and investigate medical devices and drugs after they have been cleared for the U.S. market, but it rarely does so, Hauser explained.

"It's a passive regulator," he told us. "It tends to wait for manufacturers to voluntarily recall devices rather than pro-actively compelling manufacturers to take their products of the market or even, perhaps, to stop distributing while the potential problem is investigated."
"How objective can a group be, inside the agency, when it's discussing, potentially, the performance of another group inside the agency?" 
Part of the problem is that the FDA is responsible for both approving devices and as well as monitoring them for problems, creating a fundamental conflict of interest within the agency, as Hauser sees it.

"Right away, you have a conflict because the group that approved the drug is going to question the group that is now criticizing the drug," he said. "They're all in 1 agency, and I doubt that the lines of authority, responsibility, accountability are clear. How objective can a group be, inside the agency, when it's discussing, potentially, the performance of another group inside the agency?"

Hauser's solution is to separate those responsibilities and task a new healthcare regulatory organization with monitoring and investigating healthcare products after the FDA has cleared them for the U.S. market. Lucky for Hauser, a model exists that exemplifies the segregation of approval and monitoring: the U.S. government's regulatory oversight of the airline industry.

Learning from the FAA and the NTSB
The FAA and the National Transportation Safety Board are 2 sides of the same coin, regulating the aviation industry and monitoring it for issues, but the agencies are entirely separate. The NTSB has independent authority to investigate potential issues and reports only to Congress.

The pair of agencies were originally lumped into a single authoritative body that Congress later separated on the grounds that "no federal agency can properly perform investigatory functions unless it is totally separate and independent," Hauser highlighted in his Saturday ACC presentation.

The NTSB has no regulatory authority and can't induce airline companies to make changes or ground flights. It conducts investigations and makes recommendations, leaving it up to the FAA to take action.

That's precisely what Hauser prescribed for U.S. healthcare regulation.

"We need an independent organization to look at major adverse events associated with drugs and devices, separate from the FDA and which has no regulatory authority, whose only job is to investigate and then report their findings," Hauser said. "The other thing NTSB does that we need on the medical side is they then share what they've learned about an accident with all the stakeholders. That doesn't happen now with drugs and devices."

He proposed that the NTSB participate in post-market studies, watch registries from around the world and make the data completely transparent and available to the public at large.

Hauser's National Drug & Device Safety Board
Hauser aims to form the new healthcare regulatory agency by spinning out the FDA's post-market surveillance efforts into an independent body modeled after the NTSB in purpose and structure.
"There would be a chairman appointed by the president and 4 board members, all of whom would have 3-5 year terms," he told us. "The chairman would report to Congress, the board would report to Congress. They'd be an organization separate from any agency in the federal government, entirely independent."

The new bureau would include engineers, scientists, statisticians and administrators to help monitor healthcare products on the market and collaborate with registries around the world to create a global network and public database of medical device and drug information.

The database might confer an added benefit for medical device companies and drug makers, giving them access to a comprehensive database of adverse events to help them avoid similar problems in newer products, Hauser noted, but the boon to industry is incidental to Hauser's goal.

"It's the end user that we're really concerned about," he said. "I'm not interested in helping the companies, necessarily. I'm interested in making a safer device or drug for a patient."
 

DePuy Worker Warned Of Hip Design Problems, Jury Hears

Law360, Chicago (March 26, 2013, 4:14 PM ET) -- A former DePuy Inc. marketing director testified via video Tuesday at the second trial over the company's ASR XL metal hip, describing a colleague's email — sent more than year before the product's recall — that said issues were most likely linked to the implant's design.

Paul Berman, once director of U.S. hip marketing for the Johnson & Johnson subsidiary, confirmed under questioning by attorneys for plaintiff Carol Strum that a vice president of marketing for DePuy's international operations had connected the implant's design to issues...

[sorry, I don;t have the rest of the story.....subscription only.]

The Hero Scientist...will likely never exist!

Great article and cover story of Time Magazine in Britain (April 1st issue)

I found this article to be very interesting and applies to the situation we are now facing re the approach  which should be undertaken to get at the heart of the question:  What are the long term systemic effects of the MoM hips?

I have been a long time believer that uncovering BIG medical problems like cancer for example, will never be solved by physicians working solo.  This article is about the need for collaboration in facing medical issues which involve  physicians and researchers from other disciplines to address problems.  I believe that to be the case with MoM issues, epically those that are long term and especially those that involve cancer claims.  I see no way in which the orthopedic community will get to the bottom of any of this without a collaborative cross disciplinary team consisting of cancer specialists, metal specialists, pathologists in collaboration with the orthopedic research community.

The highlights below are important to keep in mind for those patients who are advocating for addressing solutions to uncovering the long term  MoM issues.  While this article addresses cancer, I see no reason why all of these concepts shouldn't apply to the quest to understand and clarify the systemic issues with MoM hips or, for that matter, any major medical quest to solve problems.

The medical model as it stands today is outdated and need of complete revision to encourage shorter time lines on "cures and answers to complex medical issues of the day.  Here are some highlights:

1.  The idea of a  hero scientist in a concept of the past..  That paradigm is, for the most part, gone.  "no exalted individual, no victory celebration by a sole researcher."

2.  In the cancer community, leaders are recruiting "special-forces" of sorts to address the disease...dream teams  are being  funded by a group of "investors" from the business community to attack this disease who fund generously, oversee the teams and their progress rigorously and shoot for big payoffs on a tight schedule....[Imagine that in medicine!  this is what we would call, a game changing approach to solving problems and a disruptive one at that vs the old approach in medical research of the lead "alpha dog" researcher who commands a majority of the dollars and attribution.  This approach involves dispelling egos and working as a team where the experts are equal contributors in their respective discipline.]

3.  No more silos..."you no longer do science and medicine differently".... this approach "brings science and medicine together."

4.  So what does it take to transform the way and entire medical ecosystem functions?

  • large funders (corporations)
  • unignorable amounts of money
  • best and most talented people
  • generous funding
  • oversight by Nobel science level committee people to "monitor the progress that can sometimes  make top scientists feel like grad students."  there is a need for oversight by objective onlookers who can change team members if the progress isn't being made.
  • big payoffs for the patients
  • tight schedules...in this case...3 years of initial funding.
5.  What does this mean for investigators that are asked to join these teams?
  • changes in the way careers are developed, data is shared and credit on the team is shared....[I can't tell you how often I have thought having such a team in place to address this medical issue re the MoM hips.]
  • less independent fiefs pursing their own goals
  • more collaborators that can be teamed up to answer common and complex questions
  • building dream teams of cross disciplinary cross institutional research teams.,
  • judgement is rendered by patient outcomes not by the numbers of research papers published.
  • In the cancer arena, the physcians/researchers are judged only by the following:  did you reduce mortality of the population you are studying?...cancer in the case of this article.
6.  How has this approach worked so far since the SU2C initiative began funding in this manner?

 The results have been nothing short of "dazzling scientific  and technological advances"...with drugs being delivered in "lightening speed" by employing these types of teams.

7.  What type of participants are on the teams and leading them?

Players who are all at the top of their game from the top institutions in medical research...Harvard (Dana Farber), MD Anderson, Vanderbilt, Columbia, Sloan- Kettering..

8.  How do the scientist/research physicians view this disruptive model after 3 years?

" The traditional researcher, sitting alone or with a couple of post docs in a lab somewhere working on that eureka moment will always have a nice in the new ecosystem.  'We still need people looking under rocks' says Dr William Nelson, Director of the Johns Hopkins Cancer Center, and a vice Chariman of SU2Cs scientific advisory board, and a successful rock looker underer, having discovered the most common genome alteration in prostate cancer.  But the shift to team science is permanent.  When he first considered SU2C's team structure, Drebin was skeptical. 'My feeling was that this was a naivete on the part of the excutives' he says.  'You can make a movie that way  but not science.  I take that back.'

Its a new script for an old plot and there is still a lot to be written as researchers learn more.......

I do hope there are patients becoming involved in thinking about what type of collaborations need to be forged in order to get answers to important medical questions we all have.  I agree with the the premise of the approach used here....there is no one person who can address this issue.

Thursday, March 28, 2013

Reminder of the Tony Nargol interviews

Hi, Just a reminder of the interviews I posted on Tony Nargol which I printed a year ago.  Now as you can see, Dr Nargol is testifying in the 2nd Chicago hip recall suit.  Dr Nargol's video is quite compelling from a year ago and in fact mimics the experiences my surgeon encountered when revising my hip.

http://www.mydepuyhiprecall.com/2012/03/three-video-interviews-of-triumvirate.html

Orthopedic Surgeon Blasts Johnson & Johnson in Court for Hiding Problems with ASR Hip

Maglio, Christopher & Toale Law Firm

March 26, 2016 – Chicago, IL) --DePuy and Johnson & Johnson caused one of Britain’s top orthopedic surgeons to question his own skills as a doctor. That was Mr. Tony Nargol’s dramatic testimony in a Chicago courtroom earlier this week (British surgeons are referred to as “Mr.” rather than “Dr.”). Nargol says he told DePuy Orthopaedics about problems with the ASR in his patients long before the company recalled the hip implant.

Nargol says DePuy showed him data to persuade him the hip was working well, even though the company’s own internal research showed there was a huge problem. DePuy also told Nargol that the patients of other surgeons were not reporting the same difficulties. This information made Mr. Nargol believe he was doing something wrong as a surgeon, when in reality there was something very wrong with the ASR hip. Nargol testified that only after the ASR was recalled did he learn that other leading orthopedic surgeons had stopped using it years earlier because of premature failures.

Johnson & Johnson’s attorneys highlighted that orthopedic surgeon, Tony Nargol, initially gave excellent reviews of the ASR. In response, Mr. Nargol testified that had he known that a 2007 internal company study showed a 10% failure rate at 2 and a half years, he would have stopped using the ASR. He also stated that the literature he published in support of the ASR was completely wrong because Johnson & Johnson withheld important information about the hip device. Nargol says that he unfortunately never learned of the wide spread performance problems of the ASR until after the recall.

Mr. Nargol told the jury that as of today his patients’ failure rate for the ASR is over 50%, while the failure rate for his patients with a similar metal on metal hip replacement, the BHR, is only 3.5%. Ironically, Nargol also stated that once he began reporting failures of the ASR to J&J and DePuy, the company stopped funding his research.

DePuy ASR Litigation Update: Surgeon Testifies in Second DePuy ASR Trial Underway Chicago

Parker Waichman LLP

Orthopedic surgeon, is the second of some 10,700 to go to trial. Parker Waichman LLP continues to inform consumers about recent developments in the litigation and offer legal advice to patients implanted with the DePuy ASR hip implant.

Law suits outside the US

Excerpts from Rottenstein's Law firm Blog

 

DePuy Lawsuits Outside the United States

The ASR XL Acetabular System and ASR Hip Resurfacing System were both sold outside the United States, and it was thanks in part to artificial joint registries in Great Britain and Australia that evidence of the devices’ high failure rates came to light. Accurate information on the number of lawsuits pending is not easy to come by; however, estimates of the number of ASR recipients by country can be broken down as follows.
  • 10,000 in the United Kingdom
  • 4,000 in Australia and New Zealand
  • 3,300 in Ireland
  • 900 in Finland
  • 300 in Czech Republic

Wednesday, March 27, 2013

J&J pressured to settle Australian hip lawsuits

March 26, 2013 | By

Johnson & Johnson's ($JNJ) $8.3 million defeat in a U.S. jury trial over its ASR metal-on-metal hip implant could force it to settle a massive class action lawsuit in Australia over the same product.
Lawyers representing 4,500 ASR implant patients in Australia may ask the country's Federal Court to order Johnson & Johnson (and executives from DePuy division that made the implants) to focus on negotiating a settlement in the wake of the company's defeat at the hands of a Los Angeles jury earlier this month, the Sydney Morning Herald reports this week. The negotiations would take place through a week of mediation in May.
Beyond the outcome itself, some of the testimony during the Los Angeles trial has also given their case a shot in the arm: J&J executives appear to have been told they didn't act to address faulty ASR implants even though they knew about the product's mounting safety and mechanical problems.



Presumably, J&J is prepared. The company pursued a global recall of the ASR implant system in 2010, and has boosted the amount of money set aside to handle rising legal costs stemming from lawsuits and settlement cases around the world. To date, J&J has already spent nearly $1 billion on ASR-related settlements.

More than 10,000 ASR-related lawsuits against J&J remain, and, since the Los Angeles case, a New Jersey jury ordered it to pay $11.2 million to an ASR plaintiff whose device failed and then faced a number of repeat surgeries. The lawsuits allege J&J designed a defective product and didn't pursue proper safety and regulatory practices, but J&J denies any wrongdoing and has countered that patients complaining of ASR-related health problems endured unrelated issues. Many plaintiffs claim the implant damaged tissue around it and released metal fragments into their bodies.

Meanwhile, as the Sydney Morning Herald reports, the ASR hip implant had a 44% failure rate in Australia within seven years, according to Australian registry data cited by the story


Read more: J&J pressured to settle Australian hip lawsuits - FierceMedicalDevices http://www.fiercemedicaldevices.com/story/jj-pressured-settle-australian-hip-lawsuits/2013-03-26#ixzz2OitCmoi4
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Hip revision surgery

From Smith and Nephew's site (a manufacturer of hips)
 
If your orthopaedic surgeon has determined you need revision hip surgery, it is most likely because your hip has unrelieved pain and X-rays show damage has occurred to the hip replacement, causing its failure. The purpose of this procedure is to remove your failed implants, and replace them with new ones, which will help make your hip strong, stable and flexible again.
Over 30,000 revision hip replacement surgeries are performed in the United States every year, and new advanced technologies have made this a safe and effective way to restore the function of your joint.


 
ComponentfailureWhile your hip implant may shift slightly after surgery, thus leading to unbalanced weight distribution and premature implant failure, the most common reason for hip implant failure is the wearing down of the plastic insert in the hip socket.

In the years following your first hip replacement surgery, the metal portion of your implant slowly wears down this plastic portion. In fact, your regular daily activities may produce as many as 2 million cycles per year on these parts.

Depending on the amount of wear to this plastic piece, your surgeon may be able to replace only the plastic piece alone. In other cases, though, you may have worn through it and damaged the metal components as well. In this case the entire implant will be replaced.

Osteolysis
The wearing down of the plastic component has an unfortunate side effect. The tiny plastic particles that wear off are attacked by your body’s immune system, and this immune response also attacks the healthy bone around your implant. This leads to a condition called osteolysis, in which the bone in the area around the joint implant softens as it is absorbed by the body, thus making your implant unstable and in need of revision. Your orthopaedist usually will be able to detect osteolysis on your standard X-rays.


Dislocation
Some patients do experience dislocation of the implant after surgery. In approximately half of these cases, your physician may be able to put your hip implant back in place without surgery. However, if your surgeon determines the implant was damaged, certain components of the ball-and-socket joint may need to be replaced in a revision procedure.

Fracture
If the bone next to your primary implant is fractured in an accident, revision surgery may be required in order to provide a safe, stable joint. In this case, the original implant may need to be removed, the fracture addressed and a revision joint implanted.

Infection
In a low percentage of cases, your hip may become infected after surgery. Although it may be successfully treated with antibiotics, there are severe cases where a follow-up revision surgery may be required. In this surgery, the primary implants will be removed, and temporary, antibiotic-laced “spacers” are implanted. These spacers allow for joint function and are intended to give your body time to heal before the new revision prostheses are surgically implanted. Most likely, you will be put on a six-week course of antibiotics in order to eliminate the infection. At a follow-up evaluation, your surgeon will determine if your body is ready for the revision procedure.

TheImplant
Some questions you are probably thinking about are: what kind of implant device you will be receiving, what is it made of, and why is your surgeon using a particular kind of device? If you haven’t discussed this with your surgeon, you should, because not all revision hip implant devices are made of the same material.

Due to significant advancements in technology, there is a new material for revision hip implant devices called OXINIUM Oxidized Zirconium that is a superior metal for use in hip implants. This is due to its hardness, smoothness and resistance to scratching and abrasion. It also exhibits superior performance characteristics over the alternative material options of cobalt chrome and ceramic. Ask your orthopaedic surgeon about OXINIUM and if it is the right implant option for you.

The revision hip implant is comprised of four parts that work together to restore the original function of your ball-and-socket joint.

  • A metal hip stem that is inserted into the top of your thighbone
  • A metal cup which holds the cup liner
  • A cup liner which holds the femoral head
  • The femoral head or ball which is attached to the top of the hip stem and is inserted into the liner to form the ball-and-socket joint

Hip implants are not one-size-fits-all, therefore your surgeon will choose the right hip implant for your body. Your surgeon will determine which of the four component’s design options will work best together to restore your accurate leg length, while minimizing the risks of post-operative dislocation and premature implant wear.

The clinical implications of elevated blood metal ion concentrations in asymptomatic patients with MoM hip resurfacings: a cohort study

BMJ Open3:e001541 doi:10.1136/bmjopen-2012-001541

  1. Antoni V F Nargol
 

Abstract

Objective To determine whether elevated blood cobalt (Co) concentrations are associated with early failure of metal-on-metal (MoM) hip resurfacings secondary to adverse reaction to metal debris (ARMD).
                               
Design Cohort study.
                                
Setting Single centre orthopaedic unit.
                               
Participants Following the identification of complications potentially related to metal wear debris, a blood metal ion screening programme was instigated at our unit in 2007 for all patients with Articular Surface Replacement (ASR) and Birmingham MoM hip resurfacings. Patients were followed annually unless symptoms presented earlier. Symptomatic patients were investigated with ultrasound scan and joint aspiration. The clinical course of all 278 patients with ‘no pain’ or ‘slight/occasional’ pain and a Harris Hip Score greater than or equal to 95 at the time of venesection were documented. A retrospective analysis was subsequently conducted using mixed effect modelling to investigate the temporal pattern of blood Co levels in the patients and survival analysis to investigate the potential role of case demographics and blood Co levels as risk factors for subsequent failure secondary to ARMD.
                               
Results Blood Co concentration was a positive and significant risk factor (z=8.44, p=2×10–16) for joint failure, as was the device, where the Birmingham Hip Resurfacing posed a significantly reduced risk for revision by 89% (z=−3.445, p=0.00005 (95% CI on risk 62 to 97)). Analysis using Cox-proportional hazards models indicated that men had a 66% lower risk of joint failure than women (z=−2.29419, p=0.0218, (95% CI on risk reduction 23 to 89)).
                               
Conclusions The results suggest that elevated blood metal ion concentrations are associated with early failure of MoM devices secondary to adverse reactions to metal debris. Co concentrations greater than 20 µg/l are frequently associated with metal staining of tissues and the development of osteolysis. Development of soft tissue damage appears to be more complex with females and patients with ASR devices seemingly more at risk when exposed to equivalent doses of metal debris.
this is an open-access article distributed under the terms of the creative commons attribution non-commercial license, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. see: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

Metal-on-Metal Hip Implant Pain Linked to Tissue Damage, Study Shows

Drug Watch

Unexplained pain in patients with metal-on-metal (MoM) implants is more often an indication of tissue damage rather than implant wear, according to researchers from the Hospital for Special Surgery (HSS). Dr. Danyal Nawabi and his colleagues from HSS presented their findings in Chicago during the annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) that took place March 19-23.

Hip replacement surgery helps hundreds of thousands of patients each year regain mobility and relieve osteoarthritis pain. However, the HSS has seen a rise in patients presenting with unexplained hip pain after being implanted with metal-on-metal hips, and around the country thousands of patients filed lawsuits against manufacturers of these implants, claiming the implants are defective.

Researchers conducted the study to determine the cause of the pain in patients with metal-on-metal implants who came to HSS for revision surgery – about 10 percent of the hospital’s 9,000 annual hip replacement surgeries are revisions.
The results revealed more than half of the study participants had “moderate to high adverse tissue reactions.”

Early Identification of Pain Can Avoid Damage

Dr. Timothy Wright, Kirby Chair of Orthopedic Biomechanics at HSS, said: “We found that some patients had a significant amount of tissue damage but not a lot of wear, suggesting that factors other than wear are contributing to the problem regardless of whether the patients have pain.”

Lead researcher Douglas Padgett added that patients with metal-on-metal hips should be followed closely by their surgeons and that “early identification of patients with unexplained pain is vital to avoid significant tissue damage.”

This is not the first study to reveal evidence of tissue damage caused by metal debris from MoM implants. Based on its own studies, the FDA released a 2013 safety communication warning that tissue damage resulting from excessive metal debris released by these implants can lead to revision surgery.

Tissue damage has already led to thousands of lawsuits filed by people who suffered from complications from certain brands of metal-on-metal hips, such as the DePuy ASR and Stryker Rejuvenate and ABG II because of metal debris.

Aside from metal-on-metal implants, however, several benefits of hip replacements were also discussed at the annual meeting.

Research Points to Benefits of Hip Replacement

From reducing the risk of heart failure, depression and diabetes to improving patients’ sex lives, other studies presented at the AAOS meeting focused on the benefits of total hip replacement.
Results of other studies presented at the meeting include:
  • People with osteoarthritis who had a total hip replacement had lower mortality risk and reduced risk of heart failure, diabetes and depression than those who did not.
  • 98 percent of people who received a total knee replacement were able to return to work and regular life following surgery.
  • MRIs can detect potential failures of metal-on-metal hips early on.
  • 90 percent of people who received total knee or hip replacements reported improvement in sexual function.
Another study highlighted that hip and knee replacement surgery affects overall improvement in activity and quality of life. Anne Lübbeke-Wolff, a Swiss orthopaedic surgeon and lead study author, told Science Daily: “Surgery substantially and durably improved physical activity levels in men and women of all age categories, but the level remained somewhat lower than just before the onset of osteoarthritis symptoms.”

Doctors at the Hospital for Special Surgery said they intend to use the results from their studies to compose new guidelines for patients.

Last modified: March 26, 2013

DePuy ASR Hip Recall: Bernstein Liebhard LLP Comments on New Study Which Found Revision Rates Continue to Increase, Two Years after DePuy ASR Hip Replacement Recall

York, NY (PRWEB) March 25, 2013
 
Excerpts
 
As DePuy ASR lawsuits continue to move through the courts, Bernstein Liebhard LLP notes that a new study has found revision rates associated with the Articular Surface Replacement XL system continue to rise, two years after the DePuy ASR hip replacement recall was announced. The study, which was presented at this year’s Annual Meeting of the American Academy of Orthopaedic Surgeons, looked at repeat surgeries among patients who received the ASR hip at one facility in 2006 and 2009. At 3-years of follow-up, 19% of ASR patients had undergone revision surgery to replace their implant, according to the study abstract. By 4-years, the revision rate had risen to 24%, with almost half of the women who'd received the new hip requiring repeat surgery. The facility where the study was conducted terminated use of the hip 18 months before the DePuy ASR hip recall was announced in August 2010. By that time, 359 ASR hips had been implanted in 314 patients.*

“The study’s findings really aren’t that surprising given the revision rates we are seeing in our own clients. We continue to hear from patients affected by the DePuy ASR hip replacement recall who have allegedly suffered failure of their implant. What this research indicates is that many more ASR hip recipients could still be at risk for premature failure of their device,” says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. The firm is actively filing DePuy ASR lawsuits on behalf of individuals who allegedly suffered metallosis, early device failure and other complications related to the DePuy ASR hip recall.


Read more: http://www.digitaljournal.com/pr/1147367#ixzz2OioTSIu8

Monday, March 25, 2013

On hip replacement, DePuy acted properly: Opposing view

USA today
3/25/13

When DePuy, a Johnson & Johnson company, decided to recall the Articular Surface Replacement (ASR) Hip System in August 2010, it was the right decision at the right time.

OUR VIEW: Where's the corporate responsibility?

Only at that point did new data from a United Kingdom national joint registry report that 13% of patients were undergoing a second hip replacement surgery, called revision surgery, sooner than expected. We immediately recalled the product in every country where it was sold.

We regret that the ASR hip product did not meet the needs and expectations of some patients and, as a result, our own expectations. Our first priority is patients, and we immediately set up a help line and a program to reimburse patients for medical and out-of-pocket costs related to the recall.
So far, this program has assisted thousands of patients. To our knowledge, this was the first program of its nature and scale ever instituted by a medical device company.

More than 10 years ago, DePuy scientists, working with expert surgeons, set out to design an improved metal hip implant as an option for the increasing number of younger, active patients who needed hip replacement surgery. That is our mission at DePuy: to develop products that meet the needs of patients.

Following years of design and testing, the ASR Hip System was cleared for sale through the regulatory processes of various countries around the world. After the system was on the market, DePuy continued to study the device and closely watched how it was performing.

The company looked at data from a variety of sources around the world and sponsored studies in which doctors monitored patients and reported data about ASR. The company openly and rigorously evaluated the data on the device and shared information with surgeons and regulators.

We firmly believe that DePuy acted properly and responsibly with the information it had and that the full history of ASR shows DePuy is a company working to improve patients' lives through innovation, taking action when necessary and standing by patients today.

We remain dedicated to serving patients who need joint replacement surgery.

Pam Plouhar is the worldwide vice president for clinical research at DePuy.



In response to:

Hip replacement throws Johnson & Johnson: Our view


USA Today 3/24/13

Subsidiary DePuy failed to alert the public of mounting failures of some implants, leaving a trail of pain.

When seven people died in 1982 after taking Tylenol spiked with cyanide, drugmaker Johnson & Johnson pulled millions of bottles off store shelves within days, fearing the unknown killer might have sabotaged more pills. Soon, the company introduced tamper-resistant packaging that became an industry standard. Its speed and candor during the Tylenol tragedy became the textbook case for handling corporate crises.

Now, it seems, J&J has thrown out that textbook.

OPPOSING VIEW: DePuy acted properly

In the late 2000s, as evidence mounted that two of its hip implants were failing at high rates, a J&J subsidiary left the devices on the market for several years. It finally recalled them in 2010 — but not before surgeons had put them in 93,000 patients, more than a third in the U.S.

This month, a Los Angeles jury found the design of the ASR XL implant defective and awarded $8.3 million to a retired Montana prison guard — one of 10,000 patients who have sued J&J and its DePuy unit.

Hip replacements have become big business, as Baby Boomers age and seek implants with more stability and longer lives. In 2001, DePuy set out to produce a new metal device with those qualities.
But all-metal hip devices shed metallic debris, which can inflame and damage tissue and bone. The ASR implants, according to J&J's own statistics, will fail in about 37% of patients in fewer than five years, forcing a second painful operation to remove and replace the device. Artificial hips are supposed to last 15 years.

J&J isn't the first pharmaceutical company to keep bad news under wraps. But its shift away from more responsible practices is a notable violation of its own policies, which state that the company's "first responsibility" is "to the doctors, nurses and patients ... who use our products and services."

Letters and e-mails introduced at the Los Angeles trial raise serious questions about how J&J lived up to that credo. In 2006, a DePuy executive wrote that an influential surgeon in the Netherlands was seeing significant failure rates with one of the ASR products. In 2007, an Australian surgeon wrote to DePuy that one ASR device was "a flawed prosthesis and should be withdrawn from the market." In 2008, one of DePuy's own highly paid consulting surgeons warned of problems, adding, "I do not use the ASR."

How did DePuy respond?

The company says it studied the device and monitored its performance. But in December 2008, it also ran a full-page ad in an orthopedic journal touting the device's "99.2% survivorship" — a far cry from statistics released this year showing that more than a third will have to be removed and replaced within five years. Finally, in August 2010 — four years after the first hint of trouble — DePuy issued its recall.

Blame for this mess goes beyond DePuy. Congress approved the loophole that allowed swift government clearance for such products without clinical trials. And surgeons warned DePuy about problems but didn't blow the whistle publicly.

Ultimately, though, makers of medical devices have the best data on whether their products work. Had J&J followed the precedent it set in the Tylenol case, the company would have saved patients a lot of pain and, judging from the lawsuit awards likely to come, saved itself a lot of money.

Saturday, March 23, 2013

Joshua J. Jacobs, MD, Takes Helm in AAOS

Chicago native named 81st president of AAOS  (American Orthopedic Association)

He has already served as president of the Orthopaedic Research Society and the U.S. Bone and Joint Initiative. He is a nationally known researcher and educator, the William A. Hark, MD-Susanne G. Swift professor and chairman of the Rush Medical College department of orthopaedic surgery, a partner and member of the executive committee of Midwest Orthopaedics at Rush, and an adjunct professor in the department of materials science and engineering in the McCormick Technological Institute at Northwestern University.

But for Joshua J. Jacobs, MD, being named president of the American Academy of Orthopaedic Surgeons (AAOS) in his home town of Chicago is a pinnacle honor. When he took the stage at McCormick Place during the 2013 Ceremonial Meeting, he acknowledged the impact of his predecessor John R. Tongue, MD, and thanked his colleagues for the honor and privilege of serving.



Joshua J. Jacobs, MD

Dr. Jacobs’ family joined him on stage: (from left) sons Max and Ross, Mrs. Jacobs, Dr. Jacobs,
daughter Eve.


“I am humbled and honored to serve as your President during these interesting times,” said Dr. Jacobs, referencing the first of three “curses” he discussed during his presidential address.

“In the past year, the Patient Protection and Affordable Care Act (PPACA) and its architect Barack Obama have been tested—and they have withstood the challenge. Healthcare reform is the law of the land, and it has created a new reality for our patients and our profession. It is time to move forward and clearly demonstrate how we are part of the solution to our nation’s healthcare crisis,” said Dr. Jacobs.

Matching priorities
As a clinician, educator, and researcher, Dr. Jacobs noted that his priorities are well aligned with the Academy’s. He has served on all the Academy’s major governing bodies—the Council on Education, Council on Research and Quality, Council on Advocacy, and Communications Cabinet—and on numerous committees and project teams since his first committee assignment in 1993.

“The Academy has a tremendous opportunity to leverage and grow our educational programs throughout the world,” said Dr. Jacobs. He recently led a workshop for the AAOS Board of Directors on international opportunities that focused on ways to expand the Academy’s reach and establish cooperative programs with other national orthopaedic associations around the world.

In addition, he wants to make quality a top priority. “With our quality initiatives and patient satisfaction data, we can advocate for our patients and communicate the invaluable role orthopaedic surgeons can and do play in the improvement of both quality and efficiency of overall healthcare delivery in this country,” he said.

A focus on quality
It is this focus on quality, he noted, that will help turn the second curse—“May the government be aware of you”—into a blessing.

Our goal will be to make sure that patients are well represented and continue to have access to high-quality musculoskeletal health care,” said Dr. Jacobs. “Working with the talented AAOS staff, we will develop and implement initiatives that show our commitment to excellence in orthopaedics and to the patients we serve.”

In his address, Dr. Jacobs noted that orthopaedists and orthopaedic procedures have come under scrutiny from the government, the media, and other healthcare stakeholders.

“Such a steady stream of scientific papers, editorials, op-ed pieces, and media reports have been released about the so-called overutilization of joint replacement procedures that the idea is threading its way into the fabric of the discussion of healthcare costs and threatening to affect healthcare policy,” he warned.

As a result, he said, “this steady stream of negative attention has fostered a distorted image of who we are and what we do. We need to urgently address this distorted image to restore the public’s confidence and policymakers’ trust in our recommendations.”

“The AAOS is the premier advocacy organization for the specialty of orthopaedics,” he noted. “We will continue to be active in making sure that patients have access to orthopaedic care and that the care given is excellent, high-quality care.”

One voice, delivering value
It was under Dr. Tongue’s leadership, noted Dr. Jacobs, that the Academy undertook an exhaustive economic analysis to identify the value to society of several orthopaedic procedures, including total knee replacement, rotator cuff repair, anterior cruciate ligament repair, fixation of hip fractures, and repair of a herniated intervertebral disc. This study, he said, will help transform the third “curse”: “May you find what you are looking for,” into a blessing.

“Dr. Tongue is an inspiring, passionate leader,” said Dr. Jacobs. “He focused on programs at the Academy that prioritized communication between surgeons and also between patients and surgeons. He is keenly interested in improving patient care, and led the implementation of a large-scale research study on the social and economic value of orthopaedic care. These results, once published, will help the AAOS in advocating for access of the public to the effective services we provide and will help in communicating our specialty’s effect on patients’ lives.”

“The challenge before us,” he continued, “is communicating that value to policymakers and politicians while simultaneously improving quality and reducing costs.”

Dr. Jacobs called for enhanced advocacy efforts focused on regulatory issues such as the implementation of PPACA and urged the orthopaedic community to work together.

“The fact that the Academy, with its equity partners—the Arthroscopy Association of North America, the American Orthopaedic Society for Sports Medicine, the American Association of Hip and Knee Surgeons, and the Orthopaedic Learning Center—will relocate into a modern, efficient building together with 21 other orthopaedic organizations is a powerful expression of unity,” he noted.

“I am an optimist,” he concluded. “Although we face many difficulties and challenges in the implementation of healthcare reform, we can meet these challenges. Our profession is populated by the best and brightest minds in our society, and our premier professional organization is strong, credible, and accomplished. We have a wonderful opportunity to demonstrate the value we provide to society and to each and every citizen of our country.”

Personal background
Dr. Jacobs is a board-certified and practicing adult reconstructive orthopaedic surgeon with an expertise in total joint replacement and a research interest in the biocompatibility of orthopaedic biomaterials.

A graduate of Northwestern University with a bachelor of science in materials science and engineering, Dr. Jacobs earned his medical degree with honors from the University of Illinois College of Medicine, and then completed an orthopaedic surgery residency in the Combined Harvard Orthopaedic Surgery Program in Boston. Subsequently, he completed a fellowship in joint replacement surgery at Rush University Medical Center in Chicago under the tutelage of Jorge O. Galante, MD.

In addition to his multiple positions with the Academy, Dr. Jacobs has also served as a trustee of the Orthopaedic Research and Education Foundation and is past chair of Committee F04 on Medical and Surgical Materials and Devices of the American Society for Testing and Materials International (ASTMI). He completed a 4-year term on the National Institute of Arthritis and Musculoskeletal and Skin Diseases Advisory Council and has chaired multiple National Institutes of Health study sections.

Dr. Jacobs has been a leading researcher investigating the impact of metal-on-metal implants for joint replacement patients and has published many articles on this topic. He has won several research awards, including the Ann Doner Vaughan Kappa Delta Award, the Otto Aufranc Award from the Hip Society, and the Mark Coventry Award from the Knee Society. Among his published works are more than 200 peer-reviewed manuscripts, five books, and more than 35 book chapters. He has presented extensively at a variety of national and international continuing medical education venues.

Despite his busy schedule of operating, teaching, lecturing, and research, Dr. Jacobs enjoys spending time with his wife, Faye, and their three children—Ross, Max, and Eve. He also enjoys long-distance cycling and being a “frustrated baritone saxophonist.”

When a Patient Already Has a MoM Hip… (American Association of Orthopedic Surgeons meeting)

Thursday March 21st 2013

AAOS symposium will look at optimizing management


Controversy over the use of metal-on-metal (MoM) hips has led to a reduction in the popularity of such devices in recent years, but many patients still retain legacy MoM arthroplasties. MoM hips have been associated with several conditions, most notably adverse local tissue reaction, which itself has been linked with pain, loosening, device failure, and a need for early revision.

At this time, it is not possible to predict which patients will experience a reaction, what type of reaction he or she might have, when the reaction will occur, or how severe it will be. Because patients who have undergone arthroplasty with MoM hips can react in such a variety of ways, or have no reaction at all, management of patients with MoM hips can be a challenge.

Beginning at 8:00 a.m. tomorrow, Adolph V. Lombardi Jr, MD, will moderate Symposium U: Optimizing Management of Patients with Metal-on-Metal Hips. The symposium will feature experienced speakers from across the United States, along with a series of case-based presentations that will offer practical knowledge on the management of patients with MoM hips. Speakers will illustrate challenges in diagnosis and patient, and present current evidence and recommendations, including a systematic diagnostic algorithm.

Topics to be covered include the following:

  • Risk Stratification for MoM Hip Arthroplasty, presented by Dr. Lombardi
  • Causes of Pain in MoM Hip Arthroplasty Other than Adverse Local Tissue Reaction? presented by Thomas P. Schmalzried, MD
  • Significance of Serum Metal Ions in MoM Hip Arthroplasty, presented by Thomas K. Fehring, MD
  • Use of MRI in Evaluating Soft-Tissue Reactions around MoM Hip Arthroplasty, presented by Young-Min Kwon, PhD
  • The Addictive Effect of Taper Corrosion in MoM Hip Arthroplasty, presented by Joshua J. Jacobs, MD
  • A Summary of the Clinical Results to Date with MoM Hip Arthroplasty, presented by Michael A. Mont, MD

Each presentation will be followed by a series of cases and discussion among the panel members. Stop by the Grand Ballroom for this important event!

Thursday, March 21, 2013

Mixed Results for Metal Ions Test in MoM Hips

By Nancy Walsh, Staff Writer, MedPage Today
Published: March 21, 2013
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco
 
 
CHICAGO -- Measurement of metal ion levels in whole blood in patients with metal-on-metal (MoM) hip implants is useful -- but imperfect -- for identifying those whose new hips are functioning poorly and may be likely to fail, a researcher said here.

Ions of chromium and cobalt typically are elevated in patients with metal-on-metal hip implants, and authorities in all countries agree that patients with these implants should be followed, said Alister Hart, MD, of University College London.

The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has proposed that these ions be used in surveillance for failing hips, but the FDA has been less sure. Their actual diagnostic ability is unknown, Hart said at the annual meeting here of the American Academy of Orthopaedic Surgeons.

"We've revised more than 300 metal-on-metal hips, and have collected more than 2,000 implant failures and we now run a multidisciplinary clinical advisory service to guide surgeons on who, when, and why to revise," he said.

Their experience has shown that there are three groups of patients. "Those with either very severe or very few symptoms are straightforward. The difficult group includes patients who have moderate hip pain or abnormal metal ion tests," he said.

Hart's group previously demonstrated that the metal ion tests, which are simple and cheap, have good ability to identify poorly functioning implants, but there has not yet been a large cohort study examining the usefulness of these tests for predicting negative outcomes in patients with moderate pain.

They conducted a prospective case-control study that included 597 patients who had undergone either total hip replacement or resurfacing and who had been followed for at least 1 year after the surgery.
Patients with poorly functioning hips were classified as those who had already undergone revision, those with pain and awaiting revision, and those with continued inadequate function as defined by scores below 30 on the Oxford Hip Scoring System.

Comparing blood metal ion levels overall found significant elevations in the poor function group (P<0.01), and similar elevated levels in patients who had undergone total hip replacement as well as in those treated with hip resurfacing.

The ability of the metal ion levels to discriminate between well functioning and poorly functioning hips was shown by the finding of areas under the curve of 0.72 to 0.84, with cobalt being more useful than chromium, Hart said.

When they looked at different cutoff levels of the ions, they found that a maximum level of 7 µg/L, which is the recommended MHRA cutoff, had a specificity of 87.7% and a sensitivity of 53.2% for identifying a failed hip implant.

In contrast, using a threshold level of 25 parts per billion give almost perfect specificity, at 99%, but only 24.5% sensitivity for hip failure.

"No cutoff for levels of chromium and cobalt ions had ideal test characteristics. This is a poor screening tool, which would pick up many who don't need revision," he said.
Therefore, he declined to recommend any threshold as the optimal cutoff for revision of total hip arthroplasty.

"We continue to use conventional assessment supplemented by metal ions, but none of the tests in isolation provide the key," he concluded.

Hart disclosed relationships with Johnson & Johnson, Biomet, and DePuy.

Primary source: American Academy of Orthopaedic Surgeons
Source reference:
Hart A, et al "Surveillance of metal-on-metal hip arthroplasties: is blood metal ion measurement useful?" AAOS 2013; Abstract 66.

Wednesday, March 20, 2013

Tissue damage causes unexplained pain among metal-on-metal hip implant patients

Published on March 20, 2013 at 12:43 PM (2nd printing of this subject.)

The cause of unexplained pain among metal-on-metal hip implant patients is more likely to be tissue damage than wear of the implant, Hospital for Special Surgery researchers have found. The study, performed by Dr. Danyal Nawabi, orthopedic surgery fellow, and research collaborators at HSS, will be reported at the upcoming annual meeting of the American Academy of Orthopaedic Surgeons, March 19-23, in Chicago.

Researchers set out to determine causes of unexplained pain among patients with metal-on-metal hip implants (in which the ball and socket are both made of metal) who came to the hospital for revision surgery. Metal-on-metal implants have potential advantages, said Timothy Wright, Ph.D., Kirby Chair of Orthopedic Biomechanics at Hospital for Special Surgery (HSS): "If they remain well lubricated, as happens with the oil in your car, it minimizes wear." In addition, surgeons can implant a bigger head, or ball, making the hip joint more stable. But nationwide, failure of metal-on-metal hip devices due to unexplained pain is rising.

The research group, which did not have any ties to hip implant manufacturers, was led by Dr. Douglas Padgett, chief of the Adult Reconstruction and Joint Replacement Division and chief of the Hip Service at HSS, and Dr. Hollis Potter, chief of the Division of Magnetic Resonance imaging (MRI). They compared 50 patients (33 with total hip arthroplasties and 17 with hip resurfacing arthroplasties) who came to HSS for revision surgery because of unexplained pain, to a control group of 48 patients (23 with total hip arthroplasties and 25 with hip resurfacing arthroplasties) who came to HSS for revision surgery because of loosening, malalignment, infection or fracture. The investigators combined results from clinical examinations of the patients, magnetic resonance imaging, wear analysis studies on the removed implants, and pathology studies of tissues removed at surgery, including the degree of aseptic lymphocytic vasculitis-associated lesions (ALVAL), a sign of adverse tissue reactions to metal debris.

Thirty patients with unexplained pain (60% of the group) had an ALVAL score of at least 5 on a 10-point scale, indicating moderate to high adverse tissue reactions. Twelve percent of patients had some buildup of metal deposits in their soft tissue. The average synovial thickness was three times higher in the unexplained pain group compared to the control group, and the average synovial fluid volume was five times higher in the unexplained pain group compared to the control group. Ten times as many patients in the unexplained pain group had high-grade tissue damage scores compared to the control group.

Researchers found no differences between the unexplained pain group and the control group in terms of age, sex, body mass index, length of implantation, or size or positioning of the implants. Implants in both groups showed similar signs of wear.

"We found that some patients had a significant amount of tissue damage but not a lot of wear," Dr. Wright said, "suggesting that factors other than wear are contributing to the problem regardless of whether the patients have pain. We have used the information from our study to develop guidelines for patients and surgeons."

"Hip implant patients with unexplained pain should be followed closely by their surgeon," added Dr. Padgett. "Early identification of patients with unexplained pain is vital to avoid significant tissue damage. The work by Dr. Potter using novel MRI protocols has proven to be invaluable in diagnosing and monitoring these patients."

HSS doctors perform more than 9,000 joint replacement surgeries per year, of which about 10 percent are revision surgeries. Many patients who have had their joint replacement surgeries elsewhere come to HSS for revision surgery.

Source: Hospital for Special Surgery

Connie out of the country for 10 days

Hi guys,

My posts might be reduced in the next 10 days as I will be on line sporadically.  Will post as frequently as possible though!

Regards,

Connie

MRI may predict adverse tissue reaction in metal-on-metal hip replacement patients

CHICAGO – Magnetic Resonance Imaging (MRI) can detect a failing, or potentially failing, metal-on-metal hip implant (MoM) early on, according to a new study presented today at the 2013 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS). Early detection can result in timely revision surgery, decreasing the risk for further tissue damage and pain.

Researchers reviewed the MRI images of 70 patients who ultimately underwent revision surgery for a failed MoM implant. The images were assessed for the presence of tissue damage, swelling and other characteristics.

The study found that an MRI is highly sensitive and specific to identifying tissue damage in MoM total hip replacement (THR) patients. Early identification of at-risk patients can result in timely revision surgery, when necessary, decreasing pain and future damage to surrounding hip tissue.
Also today at the 2013 AAOS Annual meeting, the educational session "Optimizing Management of Patients with Metal-on-metal Hips," featured seven orthopaedic experts discussing the identification and treatment of MoM hip failure.

In December 2012, the Academy issued an Information Statement on Metal-on-metal Hip Arthroplasty (replacement) recommending a "low threshold" for commencing the evaluation of a patient with an MoM hip replacement, as "early recognition and diagnosis will facilitate the initiation of appropriate treatment prior to significant adverse biological reactions." The statement also provides a detailed overview of various diagnostic and treatment methods to limit patient discomfort, and outlines when to quickly initiate treatment, and if necessary revision

AAOS: Knee, Hip Arthroplasty Improves Sexual Function

Patients undergoing total knee and total hip arthroplasty (THA) have improved sexual function, while physical activity improves after THA, according to two studies presented at the annual meeting of the American Academy of Orthopaedic Surgeons, held from March 19 to 23 in Chicago.


TUESDAY, March 19 (HealthDay News) -- Patients undergoing total knee (TKA) and total hip arthroplasty (THA) have improved sexual function, while physical activity improves after THA, according to two studies presented at the annual meeting of the American Academy of Orthopaedic Surgeons, held from March 19 to 23 in Chicago.

Parthiv A. Rathod, M.D., an orthopedic surgeon from Flushing, N.Y., and colleagues prospectively assessed the effect of TKA and THA on sexual function using questionnaires completed preoperatively and at six months and one year after surgery. The researchers found that 67 percent of patients reported physical problems with sexual activity, and 91 percent reported psychological issues before surgery. Postoperatively, improvements were reported in libido, intercourse duration, and intercourse frequency for 42, 36, and 41 percent of patients, respectively. In addition, 84 and 55 percent reported improvements in general well-being and sexual self-image. Sixteen percent reported that surgery adversely affected sexual function.

Anne Lubbeke-Wolff, M.D., D.Sc., from Geneva University Hospitals, and colleagues assessed the level of physical activity prior to disease onset, before THA, and at five and 10-years post THA using the University of California Los Angeles (UCLA) activity score. The researchers found that 61 percent of patients reported a sedentary lifestyle before surgery, compared with 45 percent at five years post-operation. From 2000-2003 to 2004-2007, there was a decrease in the proportion of patients with a sedentary lifestyle before surgery (68 to 54 percent) and five years after surgery (53 to 39 percent). UCLA scores were lower for women than men at all time points.

"Primary THA substantially and durably improved physical activity levels in men and women and in all age categories," Lubbeke-Wolff and colleagues write

Tuesday, March 19, 2013

Trial Update News : DePuy ASR Replacement Hip Implant Recall Lawsuit News

Excerpts from Wright and Schulte LLC Law firm

DePuy ASR Trial Update


The first DePuy ASR hip replacement lawsuits were scheduled for trial in 2013 in both state and federal courts. The DePuy ASR trials are being eagerly anticipated by plaintiffs and attorneys alike, as the outcomes will help predict how juries might rule in similar DePuy ASR lawsuits, possibly even moving the massive DePuy ASR hip litigation towards global settlement.

DePuy ASR MDL Trials

Most of the 11,000 DePuy ASR hip replacement lawsuits filed since the recall are pending in a multidistrict litigation in U.S. District Court, Northern District of Ohio (MDL 297). A series of bellwether trials are scheduled to begin the spring of 2013.

DePuy ASR Trial Maryland

Maryland’s Prince George’s Court Circuit Court was to have been the venue of the first DePuy ASR trial in January 2013. However, one day into the trial, the Plaintiff decided to re-file in the Ohio MDL, and voluntarily withdrew her case.

DePuy ASR Trial Los Angeles, California

After the DePuy ASR trial in Maryland came to an early end, a Los Angeles Superior Court jury began hearing claims in a state DePuy ASR lawsuit in February 2013. In the end, the jury hearing the DePuy ASR trial in Los Angeles ordered Johnson & Johnson and DePuy Orthopaedics to pay $8.3 million to a retired prison guard who said he suffered metal poisoning and other health problems as a result of a DePuy ASR hip replacement he received in 2007.

DePuy ASR Trial Illinois

A second DePuy ASR trial began in Illinois, just as the Los Angeles proceeding came to an end. The plaintiff, who had to have her failing DePuy ASR hip implant removed just three years after implantation, alleges DePuy and Johnson & Johnson knew the ASR was defective, even after she received her artificial hip.

Wright Hip Replacement Lawsuit News: Bernstein Liebhard LLP Notes New Case Management Order in Federal Wright Conserve Hip Litigation

New York, New York (PRWEB) March 18, 2013
 
Wright hip replacement claims involving Wright Conserve hips continue to move forward in a multidistrict litigation currently underway in U.S. District Court, Northern District of Georgia. According to court documents, a new Case Management Order was recently issued by the Court that establishes a monetary fund to provide for expenses and the costs of legal services incurred for the benefit of all plaintiffs with cases pending in the Wright Conserver hip litigation. (In re: Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation -MDL No. 2329)
“We are pleased to see the Wright hip replacement litigation moving forward. We continue to hear from individuals who suffered metallosis, hip implant failure, and other painful complications, allegedly due to the Wright Conserve hip, as well as Wright Profemur hip implants,” says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. The Firm continues to offer free legal evaluations to individuals allegedly injured by either of these Wright hip replacements.

Wright Hip Replacement Lawsuits

The Wright Conserve hip litigation involves lawsuits related to the Wright Conserve Total Hip Implant System, Conserve Total A-Class Advanced Metal Hip Implant System, and the Conserve Resurfacing System. All of these devices are metal-on-metal hip replacements, in which the femoral ball and cup are made from a chromium/cobalt alloy. On January 17th, the U.S. Food & Drug Administration (FDA) issued a Safety Communication warning that metal debris shed by all-metal hips can damage the bone and/or soft tissue surrounding the implant and joint. These metal ions cans also enter the bloodstream and travel to other parts of the body, where they may cause additional symptoms or illnesses, the agency said. The FDA has advised doctors to consider metal ion testing if patients are experiencing symptoms of hip implant failure. The agency also proposed a rule that would make all-metal hips ineligible for 510(k) approvals, which allowed devices like the Wright Conserve hip to come to market without premarket testing.*

Bernstein Liebhard is also investigating claims related to the Wright Profemur hip replacements. On September 4, 2012, the Honorable William J. Duffey, Jr., who is overseeing the federal Wright Conserve hip litigation in Georgia, issued a discovery order directing Wright Medical Technologies to produce certain documents pertaining to its Profemur hip neck stems after plaintiffs argued that the Profemur neck stem was an integral part of the flawed design for the Wright Conserve hip replacement system.

The Wright Profemur has a modular design similar to the Stryker Rejuvenate and ABG II hip stems that were the subject of a recall in July 2012. In a filing with the U.S. Securities and Exchange Commission (SEC) last August, Wright Medical Technology, Inc. conceded that there is a possibility that the Stryker hip recall might impact sales of the Profemur products.**

Individuals who experienced complications related to Wright Conserve hip implants or Wright Profemur hip replacements may be entitled to compensation for medical bills, lost wages, pain and suffering and other damages. To learn more about Wright hip lawsuits, please visit Bernstein Liebhard LLP’s website, http://www.consumerinjurylawyers.com/, or call one of the Firm’s attorneys today for a free case review, at 1-877-779-1414.


Read more: http://www.digitaljournal.com/pr/1133852#ixzz2Nyh0DflR

MAKO Surgical Corp. Showcases Pioneering MAKOplasty(R) Treatment Options for Total Hip Replacement and Partial Knee Resurfacing Surgeries at AAOS 2013 Annual Meeting


Innovative Procedure Uses Robotic Arm Tactile Technology to Assist Surgeons in Achieving a New Level of Accuracy


CHICAGO, March 18, 2013 (GLOBE NEWSWIRE) -- MAKO Surgical Corp. (Nasdaq:MAKO), the leader in robotic arm assisted partial knee and total hip arthroplasty worldwide, today announced that it will showcase its MAKOplasty® Total Hip Arthroplasty (THA) and Partial Knee Resurfacing applications at the American Academy of Orthopaedic Surgeons 2013 Annual Meeting (AAOS), March 20-23 at McCormick Place in Chicago. During the meeting, orthopedic surgeons will deliver presentations and provide hands-on demonstrations in MAKO's booth #212.

MAKOplasty THA is the company's latest application for its RIO® Robotic Arm Interactive Orthopedic System, which will be highlighted by the company during the meeting. The RIO system overcomes limitations of conventional arthroplasty surgeries by providing auditory, visual and tactile guidance that, when integrated with the touch and feel of the surgeon's skilled hand, provides consistently reproducible precision in total hip and partial knee surgeries. MAKO's robotic arm assisted THA may result in a reduction in complications associated with conventional hip replacement surgery.

"With total hip replacement using MAKO robotic-arm assistance, I am a better surgeon because I perform 95 percent of my operations with the implants always in the correct position," said Lawrence Dorr, M.D., clinical professor of orthopedics at Keck School of Medicine at University of Southern California in Los Angeles. "This is better than the Harvard data, which showed 47 percent of the implants in the correct position1. Even in my own practice, the MAKO robotic-arm assistance provides me with greater precision compared to when I perform the hip replacement using my experience only. Every patient who comes to me expects me to give him or her a precise operation. My consistent results allow me to fulfill the trust the patient puts in me," said Dr. Dorr.

"Knowing I have an accurate hip reconstruction gives me confidence I have minimized the risks for impingement and its consequent complications of dislocation, pain and accelerated wear. I also believe I have optimized the chance for durability of the hip replacement of 30 years," continued Dr. Dorr.

Hip replacement with MAKO's robotic-arm assistance builds upon the proven benefits of MAKOplasty Partial Knee Resurfacing, developed as an advanced treatment option designed to relieve pain for adults living with early to mid-stage osteoarthritis that has not yet spread to all three compartments of the knee. The use of the RIO system in MAKOplasty partial knee resurfacing leads to implant component placement that is two to three times more accurate than manual techniques2. Studies also show that patients with bicompartmental MAKOplasty have improved function over those with total knee replacement surgery, and that these MAKOplasty patients demonstrate better post-operative range of motion and quadriceps strength compared to total knee arthroplasty3.

"The MAKOplasty procedure with the RIO system for THA and partial knee resurfacing not only improves accuracy and reproducibility in surgery, it improves my patients' recovery," said Robert C. Marchand, M.D., a partner at South County Orthopedics in Wakefield, R.I., and one of the presenters in MAKO's booth during the AAOS 2013 Annual Meeting. "With partial knee resurfacing for example, I am able to use the RIO system to create an anatomical model of the patient's knee and develop a patient specific plan for optimal implant positioning based on the patient's individual anatomy. The RIO provides feedback and guidance, thereby preventing me from removing bone form outside the specified plan, and it allows for accurate implant placement. Our patients recover more quickly compared to conventional techniques and their post-operative range of motion is improved as well."

Additional studies describing the clinical success using MAKO's RIO system and its RESTORIS® family of implants when performing MAKOplasty procedures are beginning to appear in peer-reviewed journals, and a body of growing clinical data continues to be presented at academic meetings worldwide. In a recent oral presentation of a multi-center trial, the authors presented key results regarding the accuracy of robotic arm cup placement in total hip procedures, and reported 87 percent were positioned in an acceptable range. This compares favorably to data from a recently published Massachusetts General Hospital (MGH) study, which evaluated 1,823 hips receiving manual total hip arthroplasty, which reported 47 percent of cups were placed in an acceptable rage. Mal-positioning of acetabular cups in conventional hip replacement surgery may lead to impingement and implant wear that can cause dislocation4. Nearly 300,000 primary hip replacement surgeries are performed annually in the United States using conventional technique.

Another multi-center study of MAKOplasty partial knee cases using RESTORIS MCK onlay medial unicompartmental implants, found very low two year post-operative revision rates of 0.4 percent, compared to two year revision rates reported at 4.0 percent and 4.4 percent respectively in the Swedish and Australian registries5.

As of December 31, 2012, approximately 23,000 MAKOplasty procedures have been performed worldwide.

About MAKO Surgical Corp.

MAKO Surgical Corp. is a medical device company that markets its RIO® Robotic-Arm Interactive Orthopedic system, with specific applications for partial knee resurfacing and total hip replacement, and proprietary RESTORIS® Family of Implants for orthopedic procedures called MAKOplasty®. The RIO is a surgeon-interactive tactile surgical platform that incorporates a robotic arm and patient-specific visualization technology, which enables accurate, consistently reproducible bone resection for accurate insertion and alignment of RESTORIS knee and hip implants. The MAKOplasty solution incorporates technologies enabled by an intellectual property portfolio including more than 300 U.S. and foreign, owned and licensed, patents and patent applications. Additional information can be found at www.makosurgical.com.


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