• guy in charge of testing safety of DePuy ASR was a automotive engineer.
• never tested in humans
• only ever tested at the “ideal angle”
• DePuy executive in charge of ASR got promoted to CEO – very evasive.

Related articles

• DePuy ASR Hip Lawsuit Update: Bernstein Liebhard LLP Weighs in On Latest Development in DePuy ASR Recall Trial (prweb.com)
• J&J Failed to Weigh Hip Metal Debris Risk, Witness Says – Bloomberg (earlsview.com)
• J&J Had ‘Inappropriate’ Risk Controls for Hip, Jury Told – Bloomberg (earlsview.com)
• DePuy ASR Trial Update: J&J Engineer-Suggested Redesign Meant to Minimize Metallic Debris Never Implemented, Parker Waichman LLP Reports (prweb.com)
• DePuy ASR Hip Lawsuit News: Expert Testifies on Toxicity of Metal Debris, Notes Bernstein Liebhard LLP (prweb.com)
• J&J Failed Own Safety Test in Hip Design, Witness Says – Bloomberg (earlsview.com)
• Trial underway in hip implant lawsuit – latimes.com (earlsview.com)
• Maker Aware of 40% Failure in Hip Implant – NYTimes.com (earlsview.com)
• During Trial, New Details Emerge on DuPuy Hip – NYTimes.com (earlsview.com)
• Hip Implant’s Risks Inadequately Assessed, DePuy Report Found in 2010 – NYTimes.com (earlsview.com)

I read your letters every day.  So many people having difficulties world wide.  I have the Stryker TritonCeramic-on Ceramic Alumina.

Recall reasons, contaminated parts from Cork Ireland, Fractures of the ceramics, loosening of the non-cemented stems, so on…

I am a previous X-ray, Special Procedure, Cardiac Cath tech, and EMT.  I worked with Ortho, Neuro ,Vascular  Ambulance……

In those areas I met many individuals from many companies.  Their knowledge of their products, their pride…… The one thing I seem to be seeing is not only are the companies spending millions in development and having FDA approvals, but a real pride in what they are doing.  In my surgery (I requested to be awake)  someone asked my Doctor why he was using the particular device that I have.  He answered with great confidence,” because she is young”.  I was 53 at that time.  My surgery went very well, recovery went very well.

Slowly my ability to be as active as I had been when I had my surgery went down hill. Arthritis in feet, neck and so on.  I knew of the FDA warning letters 3 weeks after my surgery and less than 3 months after my surgery (12/07/05) inFeb. the FDA sent out a more imposing letter to Stryker in Feb. 2006. regarding the hip that I have.

After 6 years I started squeeking, grinding, and making noises with pain at night. 

I frightened my patients in their homes the noises were so loud.  My Doctor checked with the hospital to see if he could do an off label not approved injection of an 2 part  Hyaluronan product that takes several weeks of injections.  He was told no.

I had also heard of HA from natural healing readings.  I tried a product that worked in only 1 week except when I was overheated working.

I tried higher molecular wts. (Dalton weights)  it took a few in combinations before all squeaking and grinding disapeared.  Then I tried to stop one of them at a time and squeaking and grinding came back.  For me it seems that I need different levels of the HA to help my body with lubercating thearthroplasty.

You have a great following.  I am committed to helping others. Seems to make sense. FDA will notrecognize natural supplements.  If I and you can help others from becoming sick, avoid more surgeries, at least try to help their bodies from ? not  lubercating? or ? rejecting ? their  arthroplasties, is it not worth a try to get the information out to them?  All of our hips and knees were dis-eased before the surgeries.

Please help me to help others.

Thank you

Lorraine Frechette

 Useful materials (click on links to download):

H.A.supplements and injections

Research Studies with Hyaluronic Acid

Reasons for squeaking hips

HMW HA

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• Stryker Rejuvenate Hip – Nothing but Agony (earlsview.com)
• Stryker Lawsuit – Hip Replacement – Rejuvenate, AGB & Trident (earlsview.com)
• Stryker Hip Implant Lawsuit | Stryker Trident Hip Recall (earlsview.com)
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No cancer rise in hip implant patients

Published on Saturday 1 September 2012 10:59

“There is no evidence that metal-on-metal hip replacements increase the risk of cancer,” the BBC reported today.

The story is based on a study that found that patients with metal-on-metal hip replacements did not have a higher risk than the general population of developing cancer up to seven years after surgery, or than patients with hip replacements made of other materials.

The study comes in the wake of recent concerns about metal-on-metal hip implants, including high failure rates and the possible risks of small amounts of metal (ions) being released into the body. While the findings are reassuring, this type of study has limitations. In particular, it only looked at the risk of cancer within a few years of having hip replacement surgery. Given that several cancers can take many years to develop, a study of longer-term outcomes of metal-on-metal implants is required and recommended by the researchers.

Recommendations from UK health regulators state that people with large metal-on-metal implants should be monitored annually. If they have any concerns, they can consult their doctor for patient-specific guidance.

Where did the story come from?

The study was carried out by researchers from the University of Bristol, University of Exeter and Wrightington Hospital, Wigan. It was funded by the National Joint Registry for England and Wales.

The study was published in the peer-reviewed British Medical Journal, which has recently published a number of pieces on the wear rate and safety of metal-on-metal hip implants. Most notably, it conducted a joint investigation with BBC’s Newsnight.

The research was reported fairly by the media. Both the BBC and The Daily Telegraph pointed out that the study only looked at cancer rates up to seven years after surgery, and that ongoing monitoring may need to be performed.

What kind of research was this?

The authors point out that metal-on-metal hip implants have become popular over the past decade. These consist of:

• resurfacing implants – where only the articulated surfaces of the existing hip joint are replaced with metal
• ‘stemmed’ implants – in which the ball replacing the top of the thigh bone and the artificial socket placed in the pelvis are made of metal. As their name suggests, stemmed implants feature an elongated metal stem that surgeons slide down into the thighbone to secure the implant in place

However, recent data show that all-metal stemmed implants have significantly higher failure rates and that metal-on-metal resurfacing implants have an above-average failure rate compared with implants made of other materials (such as ceramic or plastic).

In addition, the researchers say that little is known about the biological effects of the metals – predominantly cobalt, chromium and molybdenum – which are released into the body as the surface of the implants wears down. The researchers say that traces of these metals can be found in many organs, including the marrow, blood, liver, kidneys and bladder. They also say there is evidence that patients who have had joint replacements show a higher than normal incidence of DNA (genetic) damage, although there is no proven link between this and an increased risk of cancer.

To assess any raised risk of cancer, this study compared rates of cancer in patients with metal-on-metal hip implants to rates in patients with hip replacements made of alternative material, within seven years of surgery. It also compared cancer rates in patients undergoing hip replacements with those of a section of the general population, with predicted cancer rates matched for age and sex.

What did the research involve?

The researchers used data on hip replacements from the National Joint Registry of England and Wales, a database that holds records on over 1 million joint replacement procedures undertaken since its establishment in 2003. Researchers consulted all relevant data up until April 2011. The Registry is also linked annually to national hospital episode statistics data, in order to routinely monitor health information on patients who have had joint replacements. The hospital episode statistics data collection contains details of all admissions to NHS hospitals in England. It includes private patients treated in NHS hospitals, patients who were resident outside England and care delivered by treatment centres (including those in the independent sector) funded by the NHS.

For their study, the researchers used data from 289,571 patients in England who underwent hip replacements from 2003 to 2010, for whom joint registry data could be linked to hospital episode statistics. This comprised 40,576 patients who had metal-on-metal hip replacements and 248,995 who had hip implants made of other materials.

The researchers looked at hospital episode statistics data on these patients between 1997 and 2010, including any diagnoses of cancer (other than non-melanoma skin cancers) in the years after hip replacement. They also looked separately at specific cancers suspected of being related to metal ions, including blood cancers (such as leukaemia), malignant melanoma, prostate cancer and renal tract cancer (cancer of the bladder, ureter or kidney). They excluded from their analysis any patient who had a recorded diagnosis of the specific cancer before or at the time of their hip replacement.

They compared the outcomes in patients with metal-on-metal hip replacements (both stemmed and resurfaced) with patients who had hip implants made of other materials. They separated patients into three groups: those with stemmed metal implants, those with metal resurfacing, and total hip replacement with other materials. They adjusted their results for other factors that might affect the risk of cancer such as age, sex and general health.

In addition, they compared cancer rates in patients undergoing any type of hip replacement with those in the general population, using age- and sex-matched predicted incidence rates derived from national data.

What were the basic results?

The study found that, compared with patients who had hip implants made of other materials, there was no evidence that metal-on-metal implants were associated with an increased risk of any cancer diagnosis in the seven years after surgery. This was based on an average (mean) follow-up of three years, with 23% of patients observed for five years or more. Similarly, there was no increase in the risk of malignant melanoma or cancers of the blood, prostate and renal tract.

For men aged 60, the risk of being diagnosed with any cancer in five years after surgery was:

• 4.8% (4.4% to 5.3%) after metal-on-metal resurfacing
• 6.2% (5.7% to 6.7%) after a stemmed metal-on-metal implant
• 6.7% (6.5% to 7.0%) after a hip implant made of other materials

For women aged 60 the rates were lower:

• 3.1% (2.8% to 3.4%) after resurfacing
• 4.0% (3.7% to 4.3%) after a stemmed metal-on-metal implant
• 4.4% (4.2% to 4.5%) after other types of material

The researchers also found that one year after hip replacement, the incidence of new diagnoses of cancer was 1.25% (95% confidence interval [CI] 1.21% to 1.30%). This was lower than the predicted incidence of 1.65% (95% CI 1.60% to 1.70%) for the age- and sex-matched general population.

How did the researchers interpret the results?

The researchers said the findings are reassuring and pointed out that, compared with the general population, the risk of cancer for hip replacement patients is low. However, they also said that a study of longer-term outcomes is needed.

Conclusion

This study’s strength lies in its large sample of patients who have had hip replacements. However, it should be noted that:

• The study only shows results for up to seven years after surgery. Since some cancers take time to develop, an analysis of longer-term data is required.
• All hip implants produce some metal ‘debris’, even if the surfaces are not metal. It would, therefore, be better to compare the cancer rates of patients having metal implants with a control group of patients with osteoarthritis without any implants. The registry used does not include data on these people.
• The fact that the study found lower cancer rates after one year in patients with metal-on-metal implants compared with the age- and sex-matched ‘normal’ population is not easy to explain. It may indicate the influence of other factors (confounders) because patients undergoing hip replacements are checked to ensure they are healthy before surgery. People of the same sex and age in the comparison group may not be as healthy. In the comparison of different hip replacement types, those selected for resurfacing may also be younger and fitter as this is one of the reasons these devices are fitted. These confounders could have explained some of the effect reported.
• Using hospital statistics to identify cancers may underestimate cancer risk. This is because some patients are diagnosed and treated without hospital admission, for example only as outpatients.

While these findings offer some reassurance about the potential carcinogenic effect of hip replacement implants, further longer-term study of the effects of metal-on-metal implants is required. Given the various concerns about these types of implants, it is likely that their use will be reduced in future and that monitoring of any cancer risks will continue.

Related articles

• DePuy ASR Hip Implant Settlements Reached Prior To Jury Trial (earlsview.com)
• All-metal hips ‘wear down faster’ – Health – Warwick Courier (earlsview.com)
• GOOD NEWS – Smith and Nephew sees a decline Birmingham hip implant business (earlsview.com)
• ‘Toxic’ hip replacement fears – Health – Belfast Newsletter (earlsview.com)
• Stryker Orthopedics Recalls Metal Hip Implant Components (earlsview.com)
• Johnson & Johnson settles US hip replacement cases | Irish Examiner (earlsview.com)
• STRYKER REJUVENATE HIP IMPLANT RECALLED | West Palm Beach Personal Injury Attorneys Blog (earlsview.com)
• Solicitor says DePuy case may affect 600 in Cork | The Cork News (earlsview.com)
• Revision of hip resurfacing arthroplasty with a bone-conserving short-stem implant (earlsview.com)
• About Metal-on-Metal Hip Implants (earlsview.com)

by Howard Sadwin, 25 August 2012

I have been reading and reading the days I can re: MOM hips. It is sad to see the time wasted by not recalling and shelving MOM hips. The longer the Governments let the lobbyist and manufacturers continue

To sell these devices the longer it may take before someone receives treatment, that could mean the difference between walking or not.

Common sense is none existence, fewer surgeons use MOM hips if at all, the numbers of registered complaints has tripled in the USA in the past year alone and the year is not over. Scientist, surgeons, public says stop using these devices, the sales in the device manufacturers reports shows a drastic drop in MOM hip sales why are we being bullshitted around like we insignificant.

The truth will always be the truth regardless of understanding, disbelief or ignorance ( W Clement Stone) so  why do we put up with these lies ? Especially when the impact has taken away the quality of some of our lives forever.

Related articles

• ‘Toxic’ hip replacement fears – Health – Belfast Newsletter (earlsview.com)
• FiDA Failed Implant Device Alliance (earlsview.com)
• Three Quarters of Metal-on-Metal Hip Failures Occur in First Two Years, Study – DePuy Hip Replacement Lawsuit Information Site (earlsview.com)
• Cry from the Heart – Where is Mr Smith & his Nephew? (earlsview.com)
• Troubled Hip Implants Require Additional Patient Monitoring | Goldberg & Osborne (earlsview.com)
• MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA (earlsview.com)
• FDA panel sees little use for metal-on-metal hips – SFGate (earlsview.com)
• FDA Reports16,800 Metal On Metal Hip Implant Adverse Events (earlsview.com)
• Stryker Lawsuit – Hip Replacement – Rejuvenate, AGB & Trident (earlsview.com)
• All-metal hips ‘wear down faster’ – Health – Warwick Courier (earlsview.com)

Adverse outcomes in hip arthroplasty: long-term trends.

PMID:

22810410

[PubMed - in process]

Related articles

• Early Clinical Experience With the Use of the Birmingham Hip Resurfacing System | Orthopedics (earlsview.com)
• Enhanced recovery program in total hip arthroplasty Dwyer AJ, Tarassoli P, Thomas W, Porter P – Indian J Orthop (earlsview.com)
• Metal on Metal Total Hip Resurfacing As an Alternative to Total Hip Arthroplasty (earlsview.com)
• Metal on metal hip resurfacing using the BHR, Cormet 2000, or Conserve Plus devices does not meet CTAF criteria 3-5 for safety, efficacy and improvement in health outcomes for patients as an alternative to total hip arthroplasty (earlsview.com)
• Bone Cement Implantation Syndrome (earlsview.com)
• Hip resurfacing: A boon for Boomers or too risky? (earlsview.com)
• Total hip arthroplasty for failed aseptic Austin Moore prosthesis Bhosale P, Suryawanshi A, Mittal A – Indian J Orthop (earlsview.com)
• Hip Prostheses: New JRC report summarises current knowledge and identifies further research needs – Institute for Health and Consumer Protection – (JRC-IHCP), European Commission (earlsview.com)
• Stryker Recalls ABG II and Rejuvenate Modular-Neck Stems for Risks Posed by Corrosion and Wear : US Recall News (earlsview.com)
• Hip implant materials swing sharply to polyethylene | PlasticsToday.com (earlsview.com)

At any rate you will see that I notify the FDA in the body of text to follow that “I have attached three files that provided sufficient detail the premature failure of my Smith and Nephew metal on metal hip implant, and the recent revision necessitated by its’ faulty design“. While two of those files show ‘snapshots’ of my original THA surgery in March of 2009 and my revision in April 2012 , both of them were simply copies I’d  obtained from the hospital. Both provided summaries of my procedures, the ‘products’ that were ‘installed’ in me, with the record on the revision procedure covering well my pseudotumor (metalosis) removal, necrosis that filled the underside of the hollow metal femoral ball, etc. I am not posting those hospital records for public viewing here, as they were specifically intended for the eyes of the FDA convened panel. I sent in one additional Word file listing the relevant part and serial numbers of the recently explanted Smith and Nephew devices (in my possession) that I will cut and paste here:

Explanted Smith and Nephew BHR Acetabular Cup:

74122158

08GW17690 016

C 58 MM

Explanted Smith and Nephew CO/CR Modular Femoral Head:

C 52 MM (No other identifying numbers visible on component)

Below then is just an example of what anyone can do, especially if you are in the US. I would ask that even if you are not, but have similarly suffered at the hands of Mr. Smith and his Nephew or any other manufacturer (recalled or not) to please submit your stories as well. The more of us that speak up and are heard from, the closer we are to seeing some movement from the regulatory boards that are here to protect us. Here’s a copy of the message I sent:

Document Details

Document ID:FDA-2012-N-0033                       Document Type: Public Submission

This is a comment on : Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Docket ID:  FDA-2012-N-0293

Comment:

Dear Sir: I have attached three files that detail the premature failure of my Smith and Nephew metal on metal Hip implant, and the recent revision necessitated by its faulty design. The metal ions released from the metal on metal articulation of my Smith and Nephew BHR THR device poisoned my flesh, and created pseudotomors (Metalosis), foreign masses that had to be excised after the failed MoM hip was explanted. The details of this are found in the attached documents, and the Smith and Nephew BHR THR I received in March 2009 did not last three years. I received it when I was 55, and I am a very strong man. I have never experienced such pain as with this original device failure and the revision it required, my MoM THA being recently replaced on April 2nd, 2012. As an agency the public created to protect them from harm inflicted by such devices as this MoM, you have failed greatly in your task; you have not protected us from harm, and in fact have allowed our bodies to be used as a ‘test lab’ for the device manufacturers. We are human beings, not guinea pigs. I further submit that age and human strength must be factored into any success and/or failure numbers such as those provided by Smith and Nephew, because it is our younger demographic who actually tax these devices and subject them to heavier loading, as our bodies (and these devices) are simply utilized more than by us. A seventy or eighty year old does not make the same demands of an artificial joint. Demographics are an important factor and must be taken into consideration when looking at the success or failure rate associated with this Smith and Nephew MoM Hip Implant. Please see the attached files to receive more specifics of my device, as well as part and serial numbers and specific Smith and Nephew model numbers.

Thank you,

Brooks

So that’s all it takes. If you do choose to submit your story — and it can be on any device because it is MoM hips in general that should all be banned — carefully observe that your comment will be displayed publicly unless you indicate that you do not want it to be seen by all. I made this mistake myself and had the FDA take down that mistaken (my mistake) public posting of my piece. They informed me that a copy would still be held by the FDA for the Device Panel’s review, satisfying my primary objective. That FDA number again is 301-827-6860, if you have questions or need help on this. This is one way we can take action for the next few months, that our voices might be heard. I agree with Howard when he says that eventually they will hear us, that the truth will out! I will not think otherwise, as these injustices simply cannot stand.

These device manufacturers need to be held accountable, and they’re doing their level best to ‘paper over’ the whole problem. No human should have to undergo multiple surgeries, with the revision(s) costs involved and the pain and suffering that goes along with it.

I hope everybody’s doing a little bit better right now, and if not try to keep on keepin’ on (that’s my situation after my revision this month on my MoM ThA, and the size of the pseudotumors that had to be excised, as the doctors like to say. Just a little excision, a little metal mixed in with your flesh around the implant, nothing to be concerned about. It’s because you’re one of the few who are just plain sensitive to metal ions. How many living beings are not ‘sensitive’ to metal ions leaching into their bodies with every step they take?

I think mainly the only people who aren’t ‘sensitive’ are those who aren’t that aware of their symptoms because they’re very old and aren’t totally ‘with it’ (I have such a relative with a MoM), or those who simply do not use the joint all that often. I have noticed almost all of the problems here and on other sites (excepting those sponsored by the pharmaceutical companies), and reported by MoM victims telling their horror stories are younger and consequently much more active people. I believe it is this demographic where failure rates are at least twice what’s been reported, as we are ‘pooled’ in with the much older MoM THA recipient to ‘thin’ out possibly alarming failure numbers. When some company like Smith and Nephew trot out there statistics of success, they therefore rely and recite numbers and percentages that are very skewed based on their ignoring the ages of those who have had problems.

We can turn this thing around only if we expose the FDA or MHRA or any other country’s medical regulative body to the undeniable truth of ruined and at the very least painful, diminished lives.

I’m just trying to keep the ball rolling toward our ultimate goal, that being the urgent and necessary recall of all MoM hips, which we the public deserve from the health agencies formed for our protection. I’m convinced we can eventually win the battle, but only if we work together and are tireless in our efforts.

Related articles

• June 27-28, 2012: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (earlsview.com)
• Metal-on-Metal Hip Implants > Concerns about Metal-on-Metal Hip Implant Systems (earlsview.com)
• Researchers surprised by metal ion levels in 5-year follow-up of MoM THA implants (earlsview.com)
• Howard Sadwin’s Suffering from Metal-on-Metal Hip Implant | Mesh Medical Device Newsdesk (earlsview.com)
• FDA Will Review MoM Hip Safety – MedPage Today (drugstoresource.wordpress.com)
• Metals from hip replacements present toxic risk for millions, investigation warns (earlsview.com)
• Metal Hip Implant Concerns – Potentially Bigger Scandal Than Breast Implants (medicalnewstoday.com)
• What is the Status of Biomet Metal on Metal Hip Replacements | PA Law Blogs (earlsview.com)
• Howard shares more views (earlsview.com)
• Metal Hips in Britain Require Longer Monitoring, Regulators Say – NYTimes.com (earlsview.com)

Food and Drug Administration

[Docket No. FDA-2012-N-0293]

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA).  The meeting will be open to the public.

Name of Committee:   Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee.

General Function of the Committee:  To provide advice and recommendations to the Agency on FDA’s regulatory issues.

FDA is opening a docket to allow for public comments to be submitted to the Agency on the issues before the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee.  Submit either electronic or written comments by May 9, 2012.

Location: Meeting location is to be determined (TBD). Prior to the meeting, FDA will announce the meeting location in a future Federal Register notice. We will also provide the meeting location on FDA’s Advisory Committee Information line, 1-800-741-8138 (301-443-0572 in the Washington, DC area) and on the Agency’s Web site at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.

Contact Person:  Avena Russell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1535, Silver Spring, MD 20993-0002, 301-796-3805, Avena.Russell@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and follow the prompts to the desired center or product area.  Please call the Information Line for up-to-date information on this meeting.  A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice.  Therefore, you should always check the Agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

Agenda:  On June 27 and 28, 2012, the committee will discuss current knowledge about the safety and effectiveness of Metal-on-Metal (MoM) hip arthroplasty systems.  FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific data.

Hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

There are two categories of metal-on-metal hip arthroplasty systems:

1.    Metal-on-Metal total hip replacement (THR) systems consist of a metal ball (femoral head), a metal femoral stem in the thighbone, and a metal cup in the hip bone (acetabular component).  MoM THR systems are typically indicated for use in total hip arthroplasty in skeletally mature patients with the following conditions:
a.    Non-inflammatory degenerative joint disease (NIDJD) such as osteoarthritis, avascular necrosis, post-traumatic arthritis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
b.    Inflammatory degenerative joint disease such as rheumatoid arthritis;
c.    Correction of functional deformity; and,
d.    Revision procedures where other treatments or devices have failed.

2.    Metal-on-Metal hip resurfacing systems consist of a trimmed femoral head capped with a metal covering and a metal cup in the hip bone (acetabular component).  Hip resurfacing arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients having the following conditions:
a.    Non-inflammatory degenerative arthritis such as osteoarthritis, traumatic arthritis,  avascular necrosis, or dysplasia/developmental dislocation of the hip (DDH); or
b.    Inflammatory arthritis such as rheumatoid arthritis.

Resurfacing systems are intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring ipsilateral hip joint revision.

In February 2011, FDA published a Web site on MoM total and resurfacing hip systems with information for orthopedic surgeons and for patients with or considering hip replacement (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/default.htm).

Numerous recent publications, studies and registry reports have raised safety concerns for MoM THRs.  In February 2012, the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) published a Medical Device Alert with updated advice on the management and monitoring of patients implanted with MoM hip systems recommending more aggressive followup of patients with larger THR systems (≥36 millimeter (mm)). Further information about actions taken by MHRA, with links to information about MoM hip implants for patients and healthcare professionals, is available on their Web site at http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Product-specificinformationandadvice%E2%80%93M%E2%80%93T/Metal-on-metalhipimplants/index.htm. (FDA has verified the Web site address, but we are not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.)

In December 2011, the American Academy of Orthopedic Surgeons (AAOS) published an overview on MoM hip systems (total and resurfacing) (Ref. 1). The AAOS overview provides a summary of clinical outcomes in patients with MoM hip systems in comparison to other bearing surface combinations, addresses patient, implant and surgical factors that may predict successful/unsuccessful outcomes of MoM hip systems and discusses the prevalence of adverse clinical problems from MoM hip systems in comparison to other bearing surface combinations.  One item referenced in the report is the Australian registry, which reported higher revision rates for patients with implants that have large-diameter heads (>28 mm) (Ref. 2).

While current data are highly suggestive that a large percentage of patients with MoM hip systems have successful outcomes, a recent scientific publication raised serious concerns about the failure rates of MoM hip systems for the UK population (Ref. 3). This peer-reviewed journal article presented the following findings regarding primary MoM THR:  (1)  Increased failure rate at 5 years for MoM THR related to larger head sizes; (2) significantly higher risk for revision in female patients (Note:  In the United States, labeling discourages use of MoM hips in females of child bearing age with warnings in MoM THR labeling and contraindications in MoM hip resurfacing labeling); and (3) revisions for dislocation in men with MoM replacements were slightly lower, showing some benefit to larger head sizes.

The committee will be asked to discuss the following as it pertains to these devices in the U.S. population: Device mechanisms of failure, metal ion testing, imaging methods, local and systemic complications, preoperative and postoperative patient risk factors, as well as clinical followup considerations for patients with MoM hip systems (total and resurfacing).

FDA intends to make background material available to the public no later than 2 business days before the meeting.  If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.  Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.

Procedure:  FDA will work with affected industry, professional organizations, and societies that have an interest in the MoM hip arthroplasty systems and who wish to make a presentation separate from the general open public hearing; time slots on June 28, 2012, between approximately 9 a.m. and 10 a.m. Representatives from industry, professional organizations and societies interested in making formal presentations to the committee should notify the contact person on or before May 1, 2012.

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.  Written submissions may be made to the contact person on or before May 9, 2012.  On June 27, 2012 oral presentations from the public will be scheduled between approximately 9 a.m. and 10 a.m.  Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before May 1, 2012.  Time allotted for each presentation may be limited.  If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session.  The contact person will notify interested persons regarding their request to speak by May 2, 2012.

Comments:  FDA is opening a docket to allow for public comments to be submitted to the Agency on the issues before the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee beginning on [INSERT DATE OF PUBLICATION IN THE FEDERAL REGISTER], and closing on May 9, 2012.  Interested persons are encouraged to use the docket to submit electronic or written comments regarding this meeting.  Submit electronic comments to http://www.regulations.gov.  Submit written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.  It is only necessary to send one set of comments.  Identify comments with the docket number found in brackets in the heading of this document.  Received comments may be seen in the Divisions of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact James Clark, James.Clark@fda.hhs.gov or 301-796-5293 at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings.  Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

I.  References

The following references have been placed on display in the Division of Dockets Management (see Comments) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.)

1.     American Academy of Orthopedic Surgeons, “Modern Metal-on-Metal Hip Implants:  A Technology Overview” (July 15, 2011), accessed online at http://www.aaos.org/research/overviews/Metal_On_Metal.pdf .

2.     Adelaide: Australian Orthopaedic Association, Australian Orthopaedic Association National Joint Replacement Registry: Annual Report 2010, 2010.

3.     Smith, A.J., P. Dieppe, K. Vernon, et al., “Failure Rates of Stemmed Metal-on-Metal Hip Replacements: Analysis of Data From the National Joint Registry of England and Wales,” Lancet, (March 13, 2012), accessed online at http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60353-5/fulltext#article_upsell (doi:10.1016/S0140-6736(12)60353-5).

Dated: March 27, 2012.

Leslie Kux,

Assistant Commissioner for Policy.

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Hip Replacement Loosening

Resons for loosening of hip replacement implants over time

By Jonathan Cluett, M.D., About.com Guide Updated November 05, 2010 About.com Health’s Disease and Condition content is reviewed by the Medical Review Board

Hip replacement surgery is among the most common orthopedic procedures.  While the procedure has become more successful and safer, it has not been perfected. One of the most common concerns of both patients and physicians is the problem of hip replacements becoming loose over time.

Why do hip replacements wear out?
Hip replacements can go bad for a number of reasons. These include:

• Loosening of the hip replacement
• Infection of the hip replacement
• Breakage or wearing out of the implant
• Damage to the bone surrounding the implant

The most common problem with hip replacements is that they begin to loosen over time. Infections and breakage of implants are uncommon, but potentially severe complications.What is hip replacement loosening?
Hip replacement loosening occurs over time, and can cause problems with the normal function of the hip replacement prosthesis. When a hip replacement is placed into the body, it is either press-fit into the bone, or cemented into position. Either way, it is fit tightly into the bone of the thigh (femur) and pelvis so that the implant cannot move. When implants loosen, the hip replacement can begin to move small amounts. Usually this is associated with increasing pain and loss of motion experienced by the patient.

How long are hip replacements supposed to last?
Most hip replacements last an average of 20-25 years. Some hip replacements will last longer, while other hip replacement implants can fail much sooner. Occasionally hip replacement implants will fail immediately after surgery, while you may also hear about patients who have had implanted joints for 30 or more years with no problems.

Why is hip replacement loosening such a concern?
Both physicians and patients are very concerned about the problem of hip replacement loosening because a hip replacement revision surgery (replacement of a joint replacement) is a much more difficult operation. Hip replacement revisions are often not as successful as the first operation. After revision operations, patients tend to recover less overall motion of the joint. Also, the longevity of implant decreases with each revision. Therefore, physicians tend to avoid joint replacement surgery until absolutely necessary, and try to get as much mileage out of each replacement as possible.

Why do hip replacements fail and need to be replaced over time?
As stated previously in this article, there are several causes for hip replacements to fail, or go bad. Decades ago, when joint replacement surgery was new, there were different factors that determined how long a hip replacement implant would last. Some of the earliest implants failed because the metals were susceptible to breakage or the plastics quickly shattered. Because of improvements in the strength of the hip replacement prosthesis and the strength of the fixation of the implant, the hip replacements tend to last very well once implanted.

Furthermore, with improvements in sterile technique and medical treatment of infections, the very serious complication of joint prosthesis infection has also been reduced. Now, the most common cause of joint replacement loosening is due to wear of the implant surfaces, and the subsequent weakening of surrounding bone. This problem is called osteolysis, and it causes the hip replacement to loosen over time.

What happens when osteolysis occurs?
Osteolysis is a problem that causes the bone surrounding the implant to seemingly ‘melt away’. The weakening of bone around the hip replacement is seen on x-rays, and looks as though there are holes in the bone around the joint replacement. Because of the weakened bone, the hip replacement become loose, and begins to wobble within the bone. Patients experience symptoms of pain and limitations in motion of the hip. The technical name for this weakening of bone is called osteolysis.

What is ‘cement disease’, and how is this different from osteolysis?
In years past, this problem of holes in the bone seen on x-ray was called ‘cement disease’. This name comes from the fact that initially doctors did not know the cause of the weakening of bone. Because cement was used in the hip replacements, the problem was wrongly assumed to be due to the cement, thus the name cement disease. The name stuck, although it is now known that the cement is not the problem.

How does osteolysis occur?
Osteolysis occurs as a result of wearing out of the parts of the hip replacement. Over years of use, microscopic fragments of the hip replacement cause irritation to the tissues around the implant, and begin to cause the weakening of bone. Even though modern hip replacements are made of materials that can withstand wearing out very well, even small amounts of these microscopic particles can damage the bone around the hip replacement.

How can osteolysis be avoided?
In recent years, experimentation has started to investigate whether or not alternatives to the traditional metal-on-plastic (polyethylene) hip replacements would have less loosening. New implants made of ceramic-on-polyethylene, ceramic-on-ceramic, and metal-on-metal are being investigated to determine their longevity compared to the traditional metal-on-polyethylene.

How are these new implants thought to last longer?
The new implant devices tend to have much smaller wear particles; these are the debris particles that accumulate over years as the joint wears, much like the rubber wears off your car tires. In addition to having smaller wear particles, the overall volume of wear in these implants is also less than the traditional metal-on-polyethylene implants. However, it is not known yet if these different types of implants will actually lower the rate of loosening of the implants over time. Furthermore, there may be other complications associated with the use of these different types of hip replacement implants.

Unfortunately for patients there is no definitive answer as to which type of implant is “best.” The reason for this is in order to evaluate the long-term success of these newer types of implants, studies need to continue for many more years and include more patients. Many surgeons have a strong preference towards one type of hip replacement implant, and may use this in all patients because of their familiarity with that particular implant. If you have questions about what type of implant is being used in your hip replacement, you should discuss this with your doctor.

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The New Zealand Herald recently published a story regarding the withdrawal of the DePuy ASR hip system due to adverse results and higher than expected revision rates.

If you have had a hip replacement and are experiencing any pain or discomfort Arthritis New Zealand advises you to talk to your GP and get it checked out.

Although this issue is extremely serious for those affected, it is important to note that this particular joint replacement – the ASR – is only one of a number of possible replacement joints used in New Zealand.

While at first glance, the number of revisions may seem concerning, the New Zealand National Joint Registry reports that of the 35,000 hip replacements performed over the last five years, only 507 used the ASR implants.  From the registry 18 were replaced due to direct problems with the ASR system.

This withdrawal isn’t limited to New Zealand; the system has also been removed in Australia, United States, Canada, United Kingdom and South Africa.

For many people with osteoarthritis, the most common form of arthritis in New Zealand, having a hip replaced is a successful and safe procedure that is important part of reducing pain and increasing mobility.

For the thousands of people who need a hip replacement this year should not be put off by these reports.  Good communication between doctors, surgeons and patients is required to ensure you know what type of device is being used and to ensure that the follow up after surgery is undertaken.

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