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• Metal on Metal Long Term Risks Confirmed (earlsview.com)
• Products Included in the Ceramic Hip Replacement Recall (arthritis.answers.com)
• Risks, Benefits and Recovery From Birmingham Hip Procedures (arthritis.answers.com)
• Metal-on-metal hip implants more likely to need replacement (cbc.ca)
• Risks and Rewards of Cemented Hip Replacements (arthritis.answers.com)
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• Understanding Hip Revision Surgery: A Medical Overview (orthopedics.answers.com)

Friday, March 8, 2013

Steven L. Frick, MD

Central Program Commitee Chair, 2013 Annual meeting AAOS

Dear Dr. Frick,

Please consider this an open letter. Sunshine remains the best disinfectant and I remain concerned that unless the faculty of the panel that will address the complications of metal-metal hips at the rapidly approaching annual meeting of the AAOS is changed hundreds of thousands of patients implanted with metal-metal hips might suffer harm from the delayed diagnosis and treatment of the local and systemic complications of chrome-cobalt metallosis.

Figure 1: Symposium at AAOS 2013 addressing metal-metal hip complications.

First, you question the qualifications of Dr. Fehring to speak on the complications of metal-metal THA, and list him as a consultant for Biomet.     As a pediatric orthopaedic surgeon, I am not as familiar with the literature on THA as you are, but as I was the program director for the residency program in Charlotte and Dr. Fehring served on our faculty, I know him well and am very familiar with his practice and academic work. He does in fact have potential conflicts of interest, but as a consultant for DePuy, not Biomet, and his work for them involves metal- polyethylene THA (thus perhaps his conflict is that he would like for metal-metal THA to fail). He does not have any design or consulting involvement with metal-metal THA, has not advocated for metal-metal THA, or clinically used metal-metal THA, and his published and presented works (including at AAOS) involve the complications associated with metal-metal THA. I performed a brief literature search and quickly found the 5 publications listed below by Dr Fehring on complications of Metal-metal THA in the past two years. It is thus difficult for me to see how his presence on the symposium panel does not “balance” it to provide a perspective on the possible complications of metal-metal THA.

In conclusion, I strongly disagree with you about the symposium that will be held on metal-metal THA in Chicago. It has a highly knowledgeable and qualified faculty, and they will address the learning objectives noted above. As educating members of the AAOS about the potential adverse effects of metal-metal THA seems to be your primary objective, it is difficult for me to see how that objective is not met by the above symposium.

Sincerely,

Steven L. Frick, MD

2013 AAOS Annual Meeting Central Program Committee Chair

Related articles

• Open Letter – Surgeon-industry COI and the CME content of AAOS 2013 addressing MoM hip complications. (earlsview.com)
• J&J Failed to Warn of Metal Hip Implant Flaws, Lawyers Argue (earlsview.com)
• DePuy ASR Trial – Closing Arguments – Trial plaintiff says J&J hips defective, company says not liable (earlsview.com)
• Some Surgeons Do Speak & Shout – but Those that Should Listen Don’t Hear… (earlsview.com)
• What DePuy Orthopaedics Knew About Its All-Metal Hips – NYTimes.com (earlsview.com)
• J&J Profit Pursuit Led to Defective Hip, Lawyer Argues – Bloomberg (earlsview.com)
• DePuy ASR Hip Recipient Feared for His Life before Revision Surgery (earlsview.com)
• DePuy Pinnacle Hip Replacement Lawsuits: Bernstein Liebhard LLP Comments on New Study Finding that Hip Replacement Failure More Likely in Women (earlsview.com)
• DePuy Pinnacle Hip Lawsuits: Bernstein Liebhard LLP Notes New Order in Federal DePuy Pinnacle Litigation (earlsview.com)
• Stuart Cain Reports – A Warning for all MOM Patients – It is NEVER over, and your health is never, ever going to be the same! (earlsview.com)

March 11, 2013 by Arezu Sarvestani  FiDA hightlight

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.

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 defendingits timelinesor promising to improve them.

The federal watchdog agency is regularly citedas the biggest hurdle delaying new products from reaching the market and industry advocates in Congress occasionally prod the FDAto 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 withthe 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.”

Related articles

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• The Hip Replacement Case Shows Why Doctors Often Remain Silent – NYTimes.com (earlsview.com)
• FDA and mobile health apps (mypersonalphone.wordpress.com)
• FDA Issues Proposal To Improve The Safety Guidelines For Heart Defibrillators (medicaldaily.com)
• Judges side with FDA in rejecting stem cell device (wfaa.com)
• David Hauser, Co-Founder of Grasshopper Group, Shares his Entrepreneurial Journey, Lessons Learnt & More. (grasshopper.com)
• Building a Company That Stands for Something: A Video Interview With David Hauser (grasshopper.com)
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VICTORY & JUSTICE:

J.&J. Loses First Case Over Faulty Hip Implant

By BARRY MEIER

Published: March 8, 2013

Related articles

• The Hip Replacement Case Shows Why Doctors Often Remain Silent – NYTimes.com (earlsview.com)
• Damages awarded in J&J’s DePuy hip implant case (wfaa.com)
• Parker Waichman LLP Weighs-In on $8.3 Million Verdict in DePuy ASR Hip Implant Trial (prweb.com)
• Johnson & Johnson to award security guard $8.3m over faulty implant (guardian.co.uk)
• Recalls-R-US… Johnson & Johnson Confirms Inquiry Into Hip Devices – NYTimes.com (earlsview.com)
• DePuy ASR Hip Replacement Implant Lawsuit Trial Raises Questions About Johnson & Johnson’s Actions in Years Prior to DePuy ASR Hip Replacement Recall, According to Alonso (prweb.com)
• Johnson & Johnson Pays Out $8 Million In Lawsuit (huffingtonpost.com)
• Jury awards damages in Johnson & Johnson hip case (kfwbam.com)

FDA Safety Communication: Metal-on-Metal Hip Implants

Date Issued: Jan. 17, 2013

Audience:

• Orthopaedic surgeons
• Health care providers responsible for the ongoing care of patients with metal-on-metal hip implants
• Patients who are considering or have received a metal-on-metal hip implant

Medical Specialties: Orthopaedics, General Medicine, Family Practice, Radiology, Radiologic Technology, Clinical Laboratory Managers and Directors

Device:

Metal-on-metal hip implants consist of a ball, stem and shell, all made from cobalt-chromium-molybdenum alloys.

There are two types of metal-on-metal hip implants:

• Traditional total hip replacement systems
• Resurfacing hip systems

Purpose: In February 2011, the FDA launched a metal-on-metal hip implant webpage. The FDA is providing updated safety information and recommendations to patients and health care providers.  This new information is based on the FDA’s current assessment of metal-on-metal hip implants, including the benefits and risks, the evaluation of the published literature, and the results of the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel meeting.

Summary of Problem and Scope:

Metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants.

In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running. Metal can also be released from other parts of the implant where two implant components connect.  Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint. This is sometimes referred to as an “adverse local tissue reaction (ALTR)” or an “adverse reaction to metal debris (ARMD).”

Soft tissue damage may lead to pain, implant loosening, device failure and the need for revision surgery (a surgical procedure where the implant is removed and another is put in its place). Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body (systemic reactions).

Presently, the FDA does not have enough scientific data to specify the concentration of metal ions in a patient’s body or blood necessary to produce adverse systemic effects.  In addition, the reaction seems to be specific to individual patients, with different patients having different reactions to the metal wear particles.

Recommendations for Orthopaedic Surgeons:

Before Surgery

• Select a metal-on-metal hip implant for your patient only after determining that the benefit-risk profile of using a metal-on-metal hip implant outweighs that of using an alternative hip system (metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic or ceramic-on-metal).  Factors to consider include the patient’s age, sex, weight, diagnosis, and activity level.
  • Note that a 2012 FDA advisory panel of experts identified young males with larger femoral heads as the best candidates for hip resurfacing systems.
• Inform patients about the benefits and risks of metal-on-metal hip implants, including the risk that the hip implant may need to be replaced. Also discuss the patient’s expectations and review the potential complications of surgery with a metal-on-metal hip implant.
• Pay close attention to patient populations for which metal-on-metal hip systems are contraindicated.  Be aware of the risk factors that may predispose a device to excess wear and early failure.

Additional information on the FDA’s recommendations for orthopaedic surgeons before, during and immediately following metal-on-metal hip replacement surgery can be found in Information for Orthopaedic Surgeons.

Patient Follow-Up

• Follow-up of asymptomatic patients with metal-on-metal hip implants, including physical examinations and routine radiographs, should occur periodically (typically every 1 to 2 years).  If the hip is functioning properly, the FDA does not believe there is a clear need to routinely perform additional soft tissue imaging or assess metal ion levels in the blood.
• Be aware that there are certain patients who are at risk for increased device wear and/or adverse local tissue reactions (ALTR) and should be followed more closely. They may include:
  • Patients with bilateral implants
  • Patients with resurfacing systems with small femoral heads (44mm or smaller)
  • Female patients
  • Patients receiving high doses of corticosteroids
  • Patients with evidence of renal insufficiency
  • Patients with suppressed immune systems
  • Patients with suboptimal alignment of device components
  • Patients with suspected metal sensitivity (e.g. cobalt, chromium, nickel)
  • Patients who are severely overweight
  • Patients with high levels of physical activity.
• Pay close attention to signs and symptoms that may be associated with metal-on-metal hip implants. Please see the website for a list of common ALTRs and systemic symptoms/complications.
• Conduct a thorough evaluation if a patient with a metal-on-metal hip experiences local symptoms such as pain or swelling at or near the hip, a change in walking ability or a noise from the hip joint more than three months after metal-on-metal hip implant surgery.
• Follow symptomatic patients with metal-on-metal hip implants at least every 6 months.

Additional information on the FDA’s recommendations for patient follow-up can be found in Information for Orthopaedic Surgeons.

For additional information regarding soft tissue imaging or assessing metal ion levels, please review the FDA’s recommendations below.

Imaging

For some symptomatic patients with metal-on-metal hip implants, additional diagnostic imaging is required to assess and diagnose soft tissue findings surrounding the implant.  Please be aware of the FDA’s recommendations:

• Consider the benefits and risks of using different types of diagnostic imaging procedures (e.g. MRI with metal artifact reduction, CT, or ultrasound) as well as the availability of specialized radiology expertise when determining the most appropriate imaging modality for each patient.

If you determine that an MRI of a metal-on-metal hip implant patient is appropriate, the FDA recommends the following:

• Consult with the radiologist to evaluate the benefits and risks of utilizing MRI with metal artifact reduction;
• Review the available device-specific labeling from manufacturers for MRI Conditions; and
• Inform the MRI site that the patient has a metal-on-metal hip implant.

For additional information on the FDA’s recommendations about imaging a patient with a metal-on-metal hip implant, please see Imaging Evaluation.

Assessing Metal Ion Levels

Some patients with a metal-on-metal hip implant may have elevated metal ion levels (e.g. cobalt and/or chromium) in their bloodstream.  Several factors can impact the accuracy, reproducibility, and clinical interpretation of metal ion test results.  Please be aware of the FDA’s recommendations:

• The FDA does not believe there is a clear need to routinely check metal ion levels in the blood if the orthopaedic surgeon feels the hip is functioning properly and the patient is asymptomatic.
• Patients with metal-on-metal hip implants who develop any symptoms or physical findings that indicate their device may not be functioning properly, should be considered for metal ion testing.
• If measuring metal ions, consider obtaining and following serial measurements (using the same sample type, the same measurement method, and preferably the same laboratory) in determining metal ion levels in symptomatic patients.
• At this time, the FDA is not recommending a specific metal ion level as a trigger for revision or other medical intervention.  The metal ion concentration values, including increases in metal ion levels over time, should be considered in addition to the overall clinical scenario including symptoms, physical findings, and other diagnostic results when determining further actions.

For additional information on the FDA’s recommendations on metal ion test methods, selecting a test lab and interpreting test results, please see Metal Ion Testing.

Device Revision

The decision to revise a metal-on-metal hip implant should be made in response to the overall clinical scenario. In case of adverse local tissue reactions (ALTR), revision of a metal-on-metal hip implant may have a worse prognosis than revision of other types of bearing surfaces.

In selecting components for revision:

• Consider the benefits and risks of all bearing surfaces for each patient.
• Check the specific device labeling for compatibility of device components.
• If a patient is suspected to have developed metal sensitivity, carefully select the materials of the revision components (potentially avoiding materials with nickel or chromium).

For additional information, please review the FDA’s considerations on device revisions, which includes our recommendation for a retrieval analysis of every failed metal-on-metal hip implant.

Summary of FDA Recommendations for Orthopaedic Surgeons

*For chromium testing, a validated method that resolves potential interferences must be used.  Please reviewFDA’s recommendations for chromium testing.

Recommendations for Health Care Providers:

Metal-on-metal implant patients with systemic symptoms are more likely to visit their primary care practitioner than their orthopaedic surgeon, which makes it important for all health care providers to be aware of metal ion adverse events that may occur in metal-on-metal hip implant patients. Based on case reports, these events may include:

• General hypersensitivity reaction (skin rash)
• Cardiomyopathy
• Neurological changes including sensory changes (auditory, or visual impairments)
• Psychological status change (including depression)
• Renal function impairment
• Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold.

Patients with systemic findings that are thought to be related to a metal-on-metal hip implant should be advised to follow-up with his or her orthopaedic surgeon to determine the appropriate course of action.

For additional information, please review the FDA’s considerations to Health Care Professionals.

Recommendations for Patients Considering Hip Implants:

• Be aware that every hip implant has benefits and risks.
• Discuss your options for hip surgery with your surgeon.

A list of some questions to ask your orthopaedic surgeon can be found in Patients Considering a Metal-on-Metal Hip Implant.

Recommendations for Patients with Metal-on-Metal Hip Implants:

• If you are not having any symptoms and your orthopaedic surgeon believes your implant is functioning appropriately, you should continue to routinely follow-up with the surgeon every 1 to 2 years.
• If you develop new or worsening problems such as pain, swelling, numbness, noise (popping, grinding, clicking or squeaking of your hip), and/or change in your ability to walk, contact your orthopaedic surgeon right away.
• If you experience changes in your general health, including new or worsening symptoms outside your hip, let your physician know you have a metal-on-metal hip implant.

Additional information for patients with a metal-on-metal hip can be found in Patients who have a Metal-on-Metal Hip Implant.

FDA Activities:

The FDA is committed to providing reliable safety recommendations to patients and health care providers about the utilization of these devices.  Recent activities include:

1. On May 6, 2011, the FDA instructed manufacturers of metal-on-metal total hip replacement (THR) systems to conduct postmarket surveillance study of these devices.  Five manufacturers currently market metal-on-metal hip implants in the U.S. and all five have approved postmarket surveillance study plans.  Data from these studies will provide patients and health care providers with additional information about the safety profiles of the implants, including the effect of metal ion concentrations in the bloodstream.
2. On June 27-28, 2012, the FDA convened the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee to seek expert scientific and clinical opinion on the benefits and risks of metal-on-metal hip systems. Information from this panel meeting has helped form these recommendations.
3. On January 17, 2013 the FDA issued a proposed order requiring manufacturers of metal-on-metal total hip replacement systems to submit premarket approval (PMA) applications.  Metal-on-metal total hip replacement systems were evaluated under the 510(k) premarket notification program. Metal-on-metal total hip replacement systems were marketed in the U.S. prior to 1976 legislation that gave the agency premarket authority over medical devices. As “preamendment devices,” they were designated as Class III (higher risk) devices but were regulated under the 510(k) premarket notification program.

Additional information on FDA ongoing activities are provided in FDA’s Role and Activities.

Other Resources:

For additional resources, see Metal-on-Metal Hip Implants: Other Resources.

Reporting Problems to the FDA:

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with a metal-on-metal device, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.

Reports to the FDA about adverse events related to metal-on-metal hip systems include, but are not limited to: pain, malposition, adverse local tissue reaction, metallosis, hypersensitivity (allergy), loosening, and dislocation.

To help us learn as much as possible about the adverse events associated with metal-on-metal hip implants, please include the following information in your reports, if available:

• Date of implantation
• Date of implant removal (if applicable)
• Clinical cause for revision (if available)
• System components affected by the adverse event.

Contact Information:

If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) via e-mail at DSMICA@FDA.HHS.GOV or by phone: 800-638-2041 or 301-796-7100.

This document reflects the FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices.

Related articles

• FDA cracks down on all-metal hip replacements (earlsview.com)
• Metal-on-metal hip implant risks ‘unique’ – Health – CBC News (earlsview.com)
• DePuy ASR Hip Recipient Feared for His Life before Revision Surgery (earlsview.com)
• Smith & Nephew Failure Warning for Birmingham Hip Implant (earlsview.com)
• Metal hip patients ‘need annual checks’ – Health News – Filey and Hunmanby Mercury (earlsview.com)
• DePuy Pinnacle Hip Replacement Lawsuits: Bernstein Liebhard LLP Comments on New Study Finding that Hip Replacement Failure More Likely in Women (earlsview.com)
• US Drug Watchdog Now Urges All Metal Hip Implant Recipients Who Have Had Revision Surgeries To Call Them For The Names of Attorneys To Help Them Get Compensated (prweb.com)
• US Drug Watchdog Now Urges All DePuy ASR And Pinnacle All Metal Hip Implant Recipients To Get A Blood Test And To Call Them Before The Time Runs Out To Get Identified (prweb.com)
• US Drug Watchdog Now Urges All DePuy Pinnacle Hip Implant Recipients to Call Them For the Names of the Best Law Firms if a Blood Test Reveals Elevated Metal Levels (prweb.com)
• Iowa Resident Brings Suit Against Stryker For Damages Caused By Recalled Hip Implant – News Press Release | PharmiWeb.com (earlsview.com)

BS R US – Latest Obamacare casualty: 100 workers at Smith & Nephew

By Cheryl K. Chumley-The Washington Times Friday, February 1, 2013

Global medical technology firm Smith & Nephew announced Thursday the layoff of almost 100 workers at its Tennessee and Massachusetts plants — and placed blame for the drawdown firmly at the feet of Obamacare.

The London-based company makes orthopedic reconstruction products. It faces a 2.3 percent tax on its medical devices, due to Obamacare mandates, Fox News reports.

In a statement, the company said: “Unfortunately, and in order to absorb this cost burden into or business, this has meant less than 100 positions have been made redundant across various departmental functions in our Tennessee and Massachusetts sites,” according to Fox News.

The company employs more than 11,000 in 90 countries. And it’s not the latest firm to announce cuts due to Obamacare-related cost hikes. In November, Fox New reports, Stryker medical supply company announced cuts of 1,170 jobs — 5 percent of its global force — to help cut costs from Obamacare taxes and mandates.

Read more: http://www.washingtontimes.com/news/2013/feb/1/latest-obamacare-casualty-100-workers-smith-nephew/#ixzz2MbpEI6L4

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New Design Could Reduce Complications in Hip Replacement

ST. LOUIS – Andrew Murtha, a second-year medical student at Saint Louis University, hopes to specialize in orthopedic medicine.

A unique opportunity to collaborate with experienced researchers at the Missouri Bone & Joint Research Foundation not only gave him a head start in his medical career, but also allowed him to develop a new design for an artificial hip that should help reduce post-operative complications.

Andrew Murtha is a second year medical student at SLU.

The winner of the 48th annual Alpha Omega Alpha Medical Student Research Forum at SLU, Murtha presented his research that combines two recent advances in design to improve new hip implants to SLU School of Medicine students and faculty. Murtha was chosen as the winner from a group of six presenters.

“I always wanted to learn more about hip replacements,” said the Cedar Rapids, Iowa resident Murtha, who graduated from SLU with an undergraduate degree in biology. “I received great exposure through this project as we went about designing techniques for the model.”

The biomechanical study found that using a thinner plastic (polyethylene) liner to accommodate a larger femoral head, which replaces the highest part of the bone in the thigh, did not increase the risk of fracturing the liner. Prior research has shown that using larger femoral heads helps to reduce dislocation, a common complication of this procedure.

Traditionally, hip dislocation and degeneration of bone tissue from the liner’s wear debris are the two complications of hip replacements that require more operations. These have been addressed by two biomechanical designs – increasing the size of the femoral head that prevents the hip from getting dislocated and using newer types of wear-resistant polyethylene to avoid bone degeneration. In this study, Murtha worked with his collaborators to ensure that using both methods simultaneously would not compromise the structural design of the implant.

“We found that larger diameter heads can be used with this newer wear-resistant polyethylene in hip replacement surgeries without compromising the liner’s locking mechanism,” Murtha said, emphasizing that this is a promising modification in design to improve ball and socket systems currently in use.

“There are still limitations to this study as we have just looked at one liner design. However, our data supports developing current technologies to reduce complications.”
The panel of judges at the research forum was very impressed with Murtha’s in-depth knowledge of the study.

“Andrew was really involved in all stages of this project. He knew the ins and outs of it, how the hardware will be tested and what the questions were. It’s nice to see a student carry a project all the way,” said Michael Rauchman, M.D., associate professor of internal medicine at SLU and one of the judges at the research forum. “This was a basic, bio-mechanical engineering study that had clear translation and application in terms of what kinds of hardware would be used to reduce complications in a hip replacement without causing any adverse effects.”

Murtha will present his work at the 54th Annual National Student Research Forum in Galveston, Texas in April.

“I really enjoyed the experience of presenting my research to my colleagues and faculty and now I look forward to representing Saint Louis University at a national level,” Murtha said.

Ray Kreienkamp received the second place, Pei Zhang and Bharat Panuganti, both shared the third place, and Tiffany Adams and Sindu Vellanki received honorable mentions at the research forum.

Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a local, national and international level. Research at the school seeks new cures and treatments in five key areas: cancer, infectious disease, liver disease, aging and brain disease and heart/lung disease.

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The July 2012 recall of Stryker Rejuvenate and ABG II hip replacement devices has affected recipients worldwide, prompting government health agencies in various countries to issue directives to encourage citizens who have been implanted with the company’s devices to undergo regular monitoring.

According to an article published on February 20, 2013, on the medical device industry news Web site, MassDevice.com, Australia’s Therapeutic Goods Administration (a government agency similar to the U.S. Food and Drug Administration) has issued a set of guidelines in conjunction with Stryker’s Australian division, advising recipients of the recalled hip replacements to be mindful of symptoms that could be associated with failure of the devices.

Guidelines Recommend Regular Follow-Up

The guidelines recommend regular blood testing and imaging for asymptomatic patients, as well as additional follow-up and evaluation if symptoms of failure are present. If testing reveals evidence of increased levels of metals in the blood, revision surgery might be necessary to explant and replace the defective Stryker hip.

The recommendations were issued because the Therapeutic Goods Administration continues to receive reports that an increasing number of hip replacement recipients patients are being diagnosed with soft tissue injuries in addition to elevated levels of metal in the blood. At least one patient who developed symptoms shortly after an initial evaluation turned out to have both increased levels of metal ions in the blood, and soft tissue damage, according to the MassDevice article.

The United States, and other countries in addition to Australia, have also suggested that hip replacement recipients remain vigilant and undergo regular screening for symptoms of device failure. While pain and swelling of the hip are obvious concerns, many patients might not experience symptoms associated with elevated metal levels in the blood, and should undergo regular testing, even if they are not experiencing any other symptoms.

Stryker recalled the Rejuvenate and ABG II hip implants because of high failure rates brought on by fretting and corrosion of the device components. These hip replacements were originally intended to provide orthopedic surgeons with the ability to provide patients with a better fit, along with greater mobility and flexibility. Unfortunately, the Stryker devices proved problematic, along with other metal-on-metal hip replacement devices manufactured by other companies.

The Rottenstein Law Group Helps Patients Who Have Been Injured by Recalled Stryker Hips

It is important to consult your orthopedic surgeon to determine whether the symptoms you might be experiencing are consistent with a failed hip replacement and if that implant was manufactured and sold by Stryker.

Lawsuits are currently being filed across the country by recipients of the recalled Stryker implants. Plaintiffs are seeking compensation for pain and suffering, unforeseen medical expenses, lost wages, and other claims. The lawyers at the Rottenstein Law Group have over 25 years of collective experience advocating for individuals who have been harmed by dangerous drugs and defective medical devices. If you feel you have reason to sue Stryker, fill out our confidential contact form or call 1-888-224-9712 for a free case evaluation. One of our lawyers will be in touch with you shortly.

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Published: February 19, 2013

Researchers Say DePuy Hip Ancestry Shows 510(k) Flaws

By: Jim Dickinson

Researchers who used FDA documents to trace the decades-long ancestry of the DePuy ASR XL Acetabular Cup System metal-on-metal hip implant that received 510(k) clearance in July 2008 say their work demonstrates “serious flaws in the 510(k) procedure for metal-on-metal hips, which resulted in clearance of a new device that was never shown to be safe and effective.”

Writing in the New England Journal of Medicine, the researchers say that a “clinical trial might have highlighted the high revision rate…which became evident after nine months when it was compared with all other total conventional hip prostheses in the Australian Joint Registry…and which precipitously worsened over time.”

The company voluntarily recalled the ASR XL in Australia in 2009, citing “declining demand” as a reason, and then worldwide in 2010 because of the high revision rate (about 13%) reported by the National Joint Registry for England and Wales.

The researchers traced the device’s ancestry back more than five decades through a total of 95 different devices, including 15 different femoral heads and sleeves and 52 different acetabular components. They report that the 510(k) clearance for the ASR XL focused on three characteristics: the porous bone ingrowth surface, metal-on-metal articulation, and femoral head sizes that were larger than those of the predicate total hip prostheses.

“These three characteristics were uniquely combined in the ASR XL, but were evaluated for ‘substantial equivalence’ by comparing select characteristics to different predicate devices, none of which contained all of these characteristics,” the report says.

Thus, the porous bone ingrowth surface was not specific to the type of articulation and in most cases the predicates were not metal-on-metal and were substantially different in design from the DePuy unit.

CDRH clearance of the metal-on-metal articulation was based on a much smaller group of predicates, some of which differed substantially in design from the ASR XL or had poor clinical performance. Ultimately, the researchers found, clearance was based on the claim that the predicate devices were substantially equivalent to three prostheses that were used before 1976 and which were discontinued because of their high revision rates long before the ASR XL was cleared.

“As thousands of Americans are painfully learning, there are unknown risks with devices that enter the market without clinical data showing safety and effectiveness, and implanted body parts cannot be recalled as easily as defective auto parts,” the researchers conclude.

“The recently passed Medical Device User Fee and Modernization Act contains a provision that should make it easier for FDA to close the loophole for the remaining 19 Class 3 devices by allowing the agency to reclassify devices by order rather than through regulation. There would be value in an FDA-sanctioned registry.”

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