But I digress. My story is a familiar one, replete with metalosis/AVAL(aseptic lymphocyte dominated vasculitis associated lesion), and my explant next to me here shows signs of the pieces of necrotic flesh that remain on the underside of my BHR Modular Head. My implant has been through the autoclave, so it is not a bio-hazard, as the hospital contended in their effort to send it back to S&N (“To allow their experts to examine it and help me understand what went wrong”). Funny, though, I no longer trust any of these people in this God-awful charade. Not my hospital, surgeon, or S&N — they are all colluding to cover their behinds, to the point where the only direct and informative information I get is from my GP and Physiatrist.

I want to INDEPENDENTLY ANALYZE THIS BHR AND ALL OF ITS PIECES, AND ANY OF YOU WHO HAVE IMPENDING REVISIONS MAKE SURE TO GET YOUR EXPLANTED DEVICE SENT HOME WITH YOU FOR SAME. THIS IS INVALUABLE IN OUR COLLECTIVE NIGHTMARE’S LEGAL STAGE, WHICH WE ARE NOW ENTERING WITH S&N AND IS GATHERING STEAM AROUND THE GLOBE. Smith and his nephew can run, but they cannot hide. They are trying to conceal themselves behind their FDA PMA (pre-market approval) on the BHR, as this two-piece, brand new resurfacing product that was not substantially equivalent enough to warrant the rubber stamp of the FDA’s 510k approval process and went through in vivo PMA (We have now read here how bogus this trial was). The FDA’s 510k is where the device manufacturer places a paper request in front of an FDA clerk that simply says “This one is kind of or at least looks like that last one you stamped”, whereupon said clerk promptly rubber stamps it — ready for the market place, the human body! I have heard of a number of lawyers who will now give a very long look at BHR victims, but only those who have been revised and suffered great harm from AVAL, etc., and have all documented on their surgical record shown on hospital letterhead. PMA or not, S&N simply cannot get away with destroying flesh and bone along with people’s lives. We are human beings, and we should regain our dignity through each and any channel available to us, including writing our stories w/updates on this site to encourage others. We must fight now — we will emerge victorious if we persevere, and any failure to recognize the importance of that will (personally) send me back into depression over the whole fiasco, another revision complication I am just emerging from. Writing to you fellow victims, and having you write to me helps with my staying on an even keel.

One other issue re: the infamous BHR and what my surgeon called a BHR THA. This is where I find S&N most nefarious in the whole BHR ‘shell game’, as it were. I have learned just how unctuous a four billion a year company can be when playing an expensive legal version of hide and seek, and I will try to impart that here.

I was a 55 year-old, lifelong athlete in 2009 who was in great shape, and my new surgeon told me I would be a candidate for the wondrous new BHR, ideal for the middle-aged man who has significant musculature and plans to actively exercise with this new wonder product. I was told by my surgeon that he would attempt to use the new BHR if he could, saying if my bone was not suitable he would move to a total hip (THA) intraoperatively. (We never discussed what that THA product would be composed of). When he came into the recovery room he told me he had performed the THA, but said nothing else. (I didn’t know I had MoM until the THA failed)! But what S&N are saying to all is this: once you have tried to go with the BHR — which has only the two parts, as we know — you are always going to be viewed as a BHR recipient! Even though only the BHR acetabular cup was ‘installed’ in me, I can’t go after S&N because — because — they tried to do a BHR? I’m no attorney, but…?

So this is the ploy they’re using at S&N, and it’s been working well because there has been low-hanging (recalled) fruit for the legal legion. But that is now beginning to change, and if you are a BHR person who has been revised, whether BHR, BHR THA or not, you should email bengordon@levinlaw.com, a good man who only wants to help those lives that have been disrupted and/or decimated by S&N (He has too much work and doesn’t want to advertise, but insisted people like me on this site get in touch). AGAIN, FOUR PARTS IN MY THA, AND ONLY THE BHR ACETABULAR CUP WAS PMA! THE OTHER THREE PARTS ARE ALL FDA 510K approved. They are simply using the BHR cup as a legal shield, and their position stands logic upon its head. It cannot possibly prevail and I feel recall of the product imminent.

All right then, that’s about it from this windbag for now, but just think of it: I have a total of FOUR PARTS that comprised my S&N THA: BHR Acetabular Cup, S&N Modular Head, S&N Modular Head Sleeve, and the S&N Anthology Femoral Component (stem and neck). Yet S&N seeks to hide behind their PMA for the TWO-PIECE BHR, even though there was no in vivo trial for the BHR Cup in any configuration separate from the resurfacing system itself! And no lawyer has yet been willing to take them on. But ‘The teams are on the pitch – the whistle blows – the game is afoot’ and the swelling legal ‘wave’ is soon to crash upon them! Let us all tell our tale loudly!

The Truth Will Out!

BTW — The original Op Report from 2009 lists one BHR Acetabular Cup (it’s always listed first), one BHR Modular Head and Sleeve and one S&N Anthology System. My new report lists ‘specimens removed and given to patient’, none of which use the acronym BHR in regard to any piece other then their acetabular cup. That is because there IS NO BHR MODULAR HEAD AND SLEEVE, as the hospital originally showed, and I have searched S&N’s catalog for hours.

Related articles

• Smith And Nephew Hip Replacement Recall Lawsuit Attorney (earlsview.com)
• Anthony’s BHR hell. Just like DePuy. Come on Mr Smith & your Nephew – own up. (earlsview.com)
• UK – S&N BHR HELL – Trevor (General Practitioner) Gets Rude Response from Smith & Nephew (earlsview.com)
• FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR… (earlsview.com)
• Smith & Nephew – BHR PMA – FIRST OF A KIND PMA – WHO PULLED WHAT STRINGS???? (earlsview.com)
• Smith & Nephew’s :Response to Wright Medical Technology’s Citizen’s Petition to Deny PPrIA P040033 (earlsview.com)
• Attachments to Wright Medical’s request to Deny PMA to Smith & Nephew BHR (earlsview.com)
• Despite the Reasons AGAINST – FDA Advisory Panel Recommends Conditional Approval of Smith & Nephew’s BIRMINGHAM HIP Resurfacing Technology (earlsview.com)
• Wright Medical’s Response to Smith & Nephew’s Response to WMT request to Deny BHR PMA (earlsview.com)
• Long-Term Health Risks Associated with Genotoxic Nanoparticles Released by Failing Metal-on-Metal Hip Implants (earlsview.com)

I am a GP and after months of pain and disability I had a Hip Replacement in September 2007. This was done by Mr ******* , who in view of my age (then 53yo) recommended Birmingham resurfacing with a Metal on Metal prosthesis – by Smith and Nephew. I suffered considerable post-operative pain but was out of hospital after 6 days and back at work after 6 weeks.

I regained a fairly active lifestyle, including some cricket and skiing, but have found that this year I have experienced increasing pain and stiffness in the hip, worst in the morning. I was seen in the orthopaedic clinic and have had my Cobalt and Chromium levels measured:-

May 2012

Cobalt *                     555 nmol/L N 0 – 17
Chromium *              304 nmol/L N 0 – 20

MHRA Thresholds:-
Cobalt                       7ppb equivalent to 120 nmol/L
Chromium                7ppb equivalent to 135 nmol/L

Analysed at Southampton University Hospitals NHS Trust

I assume that the symptoms I am currently experiencing are due to the Cobalt/Chromium causing local inflammation.

At any rate when Mr ***** saw the results he advised me to have the prosthesis removed and listed me for surgery on the NHS 4 weeks later.

While I appreciate that the surgery needs doing I am nevertheless apprehensive about the experience.

I spoke to the complaints department at Smith & Nephew to enquire if they would be able to defray some of the expenses of being off work. They were less than helpful, to the point of being a little rude.

I think that if they had been more polite I might have left it at that. As it is however I feel I would like to take this further.

Related articles

• Smith And Nephew Hip Replacement Recall Lawsuit Attorney (earlsview.com)
• Anthony’s BHR hell. Just like DePuy. Come on Mr Smith & your Nephew – own up. (earlsview.com)
• Smith & Nephew – Class 2 Recall R3 Constrained Acetabular Liner (earlsview.com)
• Smith & Nephew – BHR PMA – FIRST OF A KIND PMA – WHO PULLED WHAT STRINGS???? (earlsview.com)
• Kathryn’s Story – More Smith & Nephew Birmingham Hip Resurfacing Misery… (earlsview.com)
• Attachments to Wright Medical’s request to Deny PMA to Smith & Nephew BHR (earlsview.com)
• Despite the Reasons AGAINST – FDA Advisory Panel Recommends Conditional Approval of Smith & Nephew’s BIRMINGHAM HIP Resurfacing Technology (earlsview.com)
• S&N tries to fade out of Metal on Metal QUIETLY… Smith & Nephew Voluntarily Withdraws Hip Component (earlsview.com)
• P040033: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM by SMITH&NEPHEW ORTHOPAEDICS – FDAzilla Devices (earlsview.com)
• Smith & Nephew pulls metal-on-metal hip component – Reuters (drugstoresource.wordpress.com)

in 2008 and still complaining about it i was given a ultra sound scan,it was found my hip implant was surrounded by a fluid and metal shavings and my blood was infected with foreign matter from implant, also in my kidneys.

i had a total hip replacement in feb 2008, i was told untill more people with this type of implant come forward nothing can done as regards to any claim

A two-day hearing held at the end of June in Washington, D.C. put an unusual, very public focus on the types of materials used in medical implants, specifically hip replacement and resurfacing systems.

On the docket were a Who’s Who of medical device manufacturers and international medical professional associations. Precipitating the hearings by the Food and Drug Administration’s Orthopaedic and Rehabilitation Devices panel was a rising tide of failures of metal-on-metal hip implants.

There have been two metal-on-metal (MoM) total hip replacement device recalls in the United States: the Zimmer Durom Total Hip System (2008) and the DePuy ASR Total Hip System (2010).

“Wear of articulating components may lead to the production and accumulation of metal ions and debris,” said Elizabeth Frank, biomedical engineer with the FDA. She said the purpose of the hearings was to:

• Review currently available data regarding MoM hip systems,
• Create open and transparent dialogue of the issues,
• Characterize any potential and real safety risks, and
• Generate scientifically based recommendations for the clinical and patient communities on how to best communicate and mitigate risks

Dr. Paul Manner, associate professor in the Department of Orthopaedics and Sports Medicine at the University of Washington (Seattle, WA) said there was a push for new materials after a report in 2001 identified ultra-high molecular weight polyethylene (UHMWPE) wear debris generated at the articulating surface as a principal culprit in hip failures. Engineers took two approaches to solve the problem: decrease opportunities for wear and change materials. “Hard-on-hard” bearings looked like an attractive alternative. New MoM Systems were approved for use in the United States in 2005 and 2006.

Other materials’ technologies including improved polyethylene were also developed in an effort to improve outcomes for total hip arthroplasty (THA) and hip resurfacing arthroplasty (HRA). These included:

• Metal on Polyethylene (MoP),
• Ceramic on Polyethylene (CoP),
• Ceramic on Metal (CoM), and
• Ceramic on Ceramic (CoC).

Dr. Manner noted, however, that: “Data comparing metal metal-on on-metal THA/HRA to other bearing surfaces are sparse and drawing conclusions is difficult.”

Data from a survey conducted this year by the American Association of Hip and Knee Surgeons, however, shows a massive move to bearing combinations using polyethylene. Metal on polyethylene systems were used for 85% of operations; ceramic on polyethylene for 14%, and metal on metal for 1%.

Meanwhile, improvements are being made in metal systems, and in some cases their use may be preferred, according to testimony in the hearing.

“Metal-on-metal implants allow for larger femoral heads to be used, which provide greater stability and lower risk of dislocation,” said Paul Voorhorst, director of biostatistics & data management at DePuy Orthopaedics.

Device manufacturers also pointed out there are differences in various metal-on-metal systems, ranging from metals used to processing methods that affect metallurgy.

One questions that still lingered at the end of the hearing:

What steps can be taken to improve predictability of device effectiveness prior to approval? And this comes amidst growing pressure to speed approvals.

Related articles

• Stryker Recalls Two Metal-on-Metal Hip Implants (earlsview.com)
• About Metal-on-Metal Hip Implants (earlsview.com)
• Stryker Recalls ABG II and Rejuvenate Modular-Neck Stems for Risks Posed by Corrosion and Wear : US Recall News (earlsview.com)
• ‘Toxic’ hip replacement fears – Health – Belfast Newsletter (earlsview.com)
• No cancer rise in hip implant patients – Health – Fleetwood Weekly News (earlsview.com)
• Defective Hip Implant Lawyers Offer Free Case Reviews for Stryker Hip Implant Claims (prweb.com)
• The US Drug Watchdog Now Offers To Find The Best Possible Attorneys For All Recipients Of The Recalled DePuy ASR Hip Metal on Metal Hip Implant-Before Time Runs Out (prweb.com)
• Defective Hip Implant Lawyers Offer Free Case Reviews for Stryker Hip Implant Claims – Times Union (earlsview.com)
• As lawsuits climb, J&J may have new hip trauma – Pinnacle metal-on-metal hip system has nearly 1,600 lawsuits pending (earlsview.com)
• US Drug Watchdog Now Offers To Assist All DePuy Pinnacle Hip Implant Recipients Get The Names Of The Best Attorneys And Provides Symptoms Of All Metal Hip Implant Failure (prweb.com)

Smith & Nephew BHR FDA-required Post-Approval Studies

Post-Approval Studies

• In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
• The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
• CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH’s effort to ensure that all PAS commitments are fulfilled in a timely manner.
• In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant’s reporting status for each submission due.

Links

• Guidance Document: “Procedures for Handling Post-Approval Studies Imposed by PMA Order”
• PAS Webpage FAQs

• Letter to IRB Chairs (formerly referred to as “IRB Letter from Dr. Schultz (dated 2/9/09)”
• Letter to PAS Participants
• Letter to PAS Investigators

• Post-Approval Studies Workshops

• Report on Implementation of Post-Approval Studies for Medical Devices Workshop (June 2009)

Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

UK Study Schedule

Show All Studie

10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)
Email FDA

Related articles

• FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR… (earlsview.com)
• Smith & Nephew – BHR PMA – FIRST OF A KIND PMA – WHO PULLED WHAT STRINGS???? (earlsview.com)
• Post-Approval Studies for Smith & Nephew BHR – NOT USEFUL (earlsview.com)
• FDA Pre Market Approval (PMA) of Birmingham Hip Resurfacing (BHR) System – P040033 (earlsview.com)
• Smith & Nephew’s :Response to Wright Medical Technology’s Citizen’s Petition to Deny PPrIA P040033 (earlsview.com)
• Despite the Reasons AGAINST – FDA Advisory Panel Recommends Conditional Approval of Smith & Nephew’s BIRMINGHAM HIP Resurfacing Technology (earlsview.com)
• Wright Medical’s Response to Smith & Nephew’s Response to WMT request to Deny BHR PMA (earlsview.com)
• SUMMARY OF SAFETY AND EFFECTIVENESS DATA PREMARKET APPROVAL APPLICATION P040033 SMITH & NEPHEW BHR BIRMINGHAM HIP RESURFACING SYSTEMf (earlsview.com)
• FDA PMA – how this hides the guilty and stops The Damaged and Suffering from getting Justice – Smith & Nephew (earlsview.com)
• Attachments to Wright Medical’s request to Deny PMA to Smith & Nephew BHR (earlsview.com)

MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA

Cheryl Clark, for HealthLeaders Media, July 5, 2012

As health providers focused on the Supreme Court’s ruling last week, a quieter but much more human drama about medical harm and suffering—and what federal policymakers should do about it—was unfolding inside a hotel just beyond the Maryland beltway.

For two days, a parade of orthopedic surgeons, biomedical device reps, safety experts, poison specialists, risk managers, lawyers, and patients appeared before a U.S. Food and Drug Administration panel to talk about the disastrous problems, questions, and fear surrounding MoMs.

MoMs, or metal-on-metal hip replacement or hip resurfacing systems, represent between 27% and 40% of the estimated 500,000 hip surgeries performed a year in the U.S., an industry valued at about $12 billion a year in 2009, although new procedures are apparently in decline.

Presumably, after this meeting, the FDA’s 18-member Orthopaedic and Rehabilitation Devices Panel is thinking about what to do to clarify the safety of these devices. Should they recommend suspension of all further MoM implants as many patients and physicians recommend? And how should they further inform fearful patients who as yet have no symptoms what they should do in the meantime?

During the two days, panel members heard a mind-boggling array of words and phrases to describe the damage to bone, tissue, and blood resulting from MoM devices:

Tribocorrosion, trunnions, fracture of resurfacing systems, edge wear, microseparation, pseudotumors and asceptic lymphocytic vasculiis-associated lesions, voltage effects, infections, post-operative nerve palsy, prosthesis loosening, implant breakage or fracture, femoral neck fractures and heterotopic ossification, loss of mobility and pain, and mechanically assisted corrosion, to name just a few.

Starting a decade ago, newer MoM devices were seen as a safer alternative to prostheses made of polyethylene or ceramic, which wore out faster, and which released particles that could accumulate in local tissue and erode the bone.

Metal devices, which would last longer, held a promise to solve that problem, because they were seen as more appropriate for younger people who wanted to remain active in their 60s and 70s and beyond without having to undergo a revision surgery.

But all hell broke lose four years ago when a raft of failure and toxicity issues surfaced among patients who had received two major MoM devices sold under the name DePuy, the ASR Acetabular System, and the ASR Hip Resurfacing System, both manufactured by Johnson & Johnson. In a statement announcing it was recalling these devices in 2010, DePuy officials acknowledged that 12% to 13% of patients required revision surgery after five years.

Class action lawsuits tumbled in.

Then more complaints and concerns came flooding in from many more patients, including many who received other MoM protheses made by five manufacturers.  Many patients, like Steve Lorenz of Whitehall, PA, said that when they told their doctors that they weren’t recovering from their hip surgeries, but were getting worse, they were brushed off.

“He disregarded every symptom, and then he equated what happened to him when he took a Pilates class with his wife,” recalls Lorenz’ wife, Pat, who testified before the FDA panel about the surgeon’s reaction to her husband’s complaints.

How did hundreds of thousands of potentially unsafe devices get into the market?

Many blame the fact that all of these MoM devices were approved by the FDA over the years under the 510(k) process. It presumes that a new device that is very similar to an approved device, does not need to undergo rigorous safety testing, since the device it is being compared to, has already passed those tests The 510(k) essentially gave such  devices a free ride.

In February, 2011, the FDA launched a MoM Hip Implant System website, which emphasizes some symptoms patients and their doctors should look out for, including ion toxicity in the blood from cadmium or cobalt particles resulting from metal contact with bone.

“At this time, it is not possible to know who will experience a reaction, what type of reaction they might have, when the reaction will occur, or how severe the reaction will be. However, it is known that over time, the metal particles around some implants can cause damage to bone and/or tissue surrounding the implant and joint,” the FDA website says.

David Langton, an orthopedic surgery resident at University Hospital in North Tees, Great Britain, has focused on MoM device research for the last four years and believes MoM devices of all types have been an “an absolute disaster,” with failure rates or required revisions in far more than 12%-13%.

His research discovered revision surgeries required in 49% of patients, many of whom experienced toxicity from excessively high levels of cobalt and cadmium in their blood.

“The 49% failure rate…we expect will be 80% in eight years, and there are three other [centers] in the UK which have quoted similar figures at meetings,” Langton wrote in an e-mail Wednesday.

Langton says he is “not so concerned about gross hip failures. I am very concerned about the theoretical risks that these blood levels may lead to.”

He adds that in the UK, which has the benefit of a hip surgery registry that the United States lacks, problems have shown up with the other devices too. “We do not believe this is a problem specific to DePuy,” he wrote. “I have seen similar failures with most of the other manufacturers’ hips, too,” he says.

In May 2011, the FDA issued 145 orders for post-market surveillance to 21 manufacturers of MoM total hip systems to develop a research protocol that addresses these complaints. Manufacturers, who are responsible for funding these studies, should track patients for eight years after surgery, conduct a failure analysis.

But in a New England Journal of Medicinearticle published Thursday, Joshua Rising, MD, Ian Reynolds and Art Sedrakyan, MD, of the Medical Device Initiative of the Pew Health group, lamented not only that these studies are taking a long time to start, they may never produce meaningful information.

Three weeks ago, “the FDA and manufacturers had reached agreements on study protocols for less than one quarter of the devices, most of the study plans had not been finalized, and it was unclear whether any studies had begun.  Moreover, methodologic issues will limit the usefulness of the information that emerges from these studies,” they wrote.

“One significant shortcoming (of FDA’s order) is that each manufacturer is permitted to conduct its own independent study on its product or products,” they wrote. “The resulting lack of harmonization among studies will lead to challenges in pooling data and making cross-product comparisons.”

Companies may measure chromium and cobalt levels differently and introduce “uncertainty into attempts to pool results.”

The authors advise the FDA to use “warning letters, fines, and removal from the marketplace to demonstrate its commitment to post-market surveillance.

“While the FDA and other stakeholders struggle with these systemic issues, the problems with metal-on-metal hip implants will continue to occupy the agency, clinicians, manufacturers, and thousands of affected patients for the foreseeable future.”

Some aren’t sure the problem is that extensive. Stephen Kantor, MD, an orthopedist with a high-volume hip surgery practice at Dartmouth-Hitchcock Medical Center in Lebanon, NH, doubts that the problems with MoM devices approaches that many patients. At his hospital, patients have normal blood work and feel fine.

And he wonders if some of the concern isn’t fear caused by the publicity over some bad DePuy cases.

But to be safe, he’s stopped putting MoM devices in his patients and thinks it’s reasonable for the FDA to put a temporary hold on their use until safety issues can be clarified. “I don’t know that they’re bad. But I don’t know for certain that they’re safe, and I don’t want to take that chance with my patients,” he says.

Cheryl Clark is a senior editor and California correspondent for HealthLeaders Media Online. 

Related articles

• Long-Term Health Risks Associated with Genotoxic Nanoparticles Released by Failing Metal-on-Metal Hip Implants (earlsview.com)
• Biomet M2a Magnum Metal-on-Metal Hip Replacement Lawsuit (earlsview.com)
• Recipients Injured By Metal-On-Metal Hips Speak Out Against Dangers of MoM Hips – SFGate (earlsview.com)
• DePuy ASR Hip Lawsuit | DePuy Hip Lawyer (earlsview.com)
• Metal on Metal Hip Disaster – F.D.A. Hearing to Focus on Replacement Hips (earlsview.com)
• DePuy Pinnacle Hip Implant Failure Initiative Considered “Vital” (earlsview.com)
• FDA Considers Metal Hip Injuries – A Bit Too Late for Some Victims – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts (earlsview.com)
• Stryker recalls two metal-on-metal hip products for fear of corrosion (earlsview.com)
• Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today (earlsview.com)
• Suffering of Thousands Prompts FDA Hearing about Hip Implants (earlsview.com)

www.google.com.au/url?sa=t&rct=j&q=&esrc=s&source=web&cd=42&ved=0CFIQFjABOCg&url=http%3A%2F%2Fwww.ctaf.org%2Ffiles%2F769_file_Hip_resurfacing_W.pdf&ei=Ovr4T5bGI-yUiAfA5tzhBg&usg=AFQjCNGpF8andIjM3eQZ9JGMI58FwHyo7w&sig2=IPuN6AUkPw1Tt6yzEYt32Q.

Or download the PDF here: CTAF METAL ON METAL TOTAL HIP RESURFACING AS AN ALTERNATIVE TO TOTAL HIP ARTHROPLASTY

Related articles

• SUMMARY OF SAFETY AND EFFECTIVENESS DATA PREMARKET APPROVAL APPLICATION P040033 SMITH & NEPHEW BHR BIRMINGHAM HIP RESURFACING SYSTEMf (earlsview.com)
• Smith & Nephew – BHR PMA – FIRST OF A KIND PMA – WHO PULLED WHAT STRINGS???? (earlsview.com)
• Hip replacement and resurfacing equally effective at improving joint function | Arthritis Research UK (earlsview.com)
• FDA Pre Market Approval (PMA) of Birmingham Hip Resurfacing (BHR) System – P040033 (earlsview.com)
• P040033: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM by SMITH&NEPHEW ORTHOPAEDICS – FDAzilla Devices (earlsview.com)
• Attachment B – Ragab AA., validity of Self-Assessment Outcome Questionnaires: Patient-Physician Discrepancy in Outcome Interpretation, 39 Biomed. Sci. Instrum. 579-84 (2003) (earlsview.com)
• Bone Cement Implantation Syndrome (earlsview.com)
• Despite the Reasons AGAINST – FDA Advisory Panel Recommends Conditional Approval of Smith & Nephew’s BIRMINGHAM HIP Resurfacing Technology (earlsview.com)
• June 27-28, 2012: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (earlsview.com)
• Total hip arthroplasty for failed aseptic Austin Moore prosthesis Bhosale P, Suryawanshi A, Mittal A – Indian J Orthop (earlsview.com)

Hip resurfacing: A boon for Boomers or too risky?

By Annie Hayashi

Although some orthopaedic surgeons say hip resurfacing is a viable alternative procedure for some patients, others raise serious concerns about the surgical learning curve, the incidence of femoral neck fractures, and metal ions toxicity.

With aging “baby boomers” looking for ways to maintain their active lifestyles, hip resurfacing has been getting a lot of media attention. Proponents of the procedure see it as the ideal alternative to a total hip arthroplasty (THA) for younger patients, while its detractors express a broad range of concerns—from the technical difficulty of the procedure to toxicity from metal-on-metal ions.

Unlike THA, which requires the removal of the top of the femur and insertion of a stem into the bone shaft, hip resurfacing puts a metal “cap” over a reshaped femoral head, thus saving both the head and neck and eliminating the need to enter the intramedullary canal. Proponents point to these benefits, as well as to the greater stability and decreased risk of dislocation due to the larger femoral head size, as reasons for surgeons and patients to choose resurfacing rather than replacement.

Critics caution, however, that the procedure is far more difficult to perform than THA, that few patients meet the criteria for the surgery, and that an increased risk of femoral neck fracture and an unknown potential for metal-on-metal ion toxicity exist.

Not a panacea
Hip resurfacing is certainly not a panacea, according to James C. Kudrna, MD, PhD, but it is a good alternative to THA in the “younger patient population that has end-stage hip disease that requires some form of arthroplasty.”

Dr. Kudrna has been performing hip resurfacing procedures since the late 1970s, and has seen the procedure change significantly since its inception. Cemented polyethylene acetabular and cemented metal femoral components have been replaced by cementless metal, porous-coated acetabular components, and a cemented stemmed metal femoral component.

The field continues to evolve as manufacturers, particularly in the United States, introduce new products and the surgical technique improves, according to its proponents.

“Hip resurfacing is a conservative procedure,” says Harlan C. Amstutz, MD, who has performed more than 1,100 metal-on-metal hip resurfacings. “It preserves the bone. During preparation, only the pathologic bone is removed, normalizing the anatomy and biomechanics. Unlike the first generation of hip resurfacing arthroplasty, today no more bone is removed from the acetabulum than with a THA.

“You don’t have to worry about creating a leg length discrepancy as you do with a THA,” he continues. “One of the most important advantages of hip resurfacing is the ease of revision. The sockets are likely to be durable for 20 or more years—possibly forever—so that if revision is necessary, it is much like performing a primary THA.”

Both doctors agree on what they believe are the many benefits of hip resurfacing: preservation of bone stock on the femoral side, little to no limb length discrepancy, and the patient’s ability to resume a very active lifestyle.

Paul F. Lachiewicz, MD, also agrees that hip resurfacing is a “conservative” procedure on the femoral side, with less bone removal than conventional THA. But he points to a retrospective, case-control study that compared the volume of acetabular bone removed during resurfacing with the Birmingham Hip Resurfacing system (BHR) and that removed during a hybrid THA. The study found that a larger amount of acetabular bone (mean: 5.4 mm) was removed with hip resurfacing. Dr. Lachiewicz concludes, “Resurfacing was less bone-conserving for the acetabulum than hybrid THA.”

The study is valid, agrees Dr. Kudrna, but he doesn’t believe that acetabular bone loss will be a long-term issue. He thinks that component manufacturers will soon be offering more incremental sizes, which will help conserve acetabular bone and reduce the difference between the amount of bone removed in a regular hybrid hip procedure and the amount removed for hip resurfacing.

Patient selection is key to success
Patient selection is important to the success of the procedure, says Dr. Kudrna. “Hip resurfacing has a narrow focus. I think that primary osteoarthritis, secondary osteoarthritis due to trauma, and perhaps a mild slipped capital femoral epiphysis with secondary osteoarthritis are reasonable indications. I don’t perform hip resurfacing on people with osteonecrosis; I do not think that is a good indication.”

Dr. Amstutz does take cases with risk factors—patients with osteonecrosis and cystic defects. His patients include both men and women, some of whom are older than age 60. He stresses the importance of optimal bone preparation and cementing technique for the femoral component. His recently published study in the Journal of Arthroplasty shows how improving surgical techniques enables patients with risk factors to become candidates for hip resurfacing.¹He admits, however, that the “best patients are males with osteoarthritis and those who have more normal bone stock with a large head/neck ratio. Male patients have larger hips with more surface area to get fixation.”

Dr. Kudrna restricts hip resurfacing arthroplasty to younger patients—those younger than age 55 years. He performs the procedure on both men and women, although 80 percent of his patients are men.

The patient selection criteria for hip resurfacing are so selective, counters Dr. Lachiewicz, that the procedure is not that useful. “In my opinion,” he says, “metal-on-metal hip resurfacing is truly indicated for only a limited number of patients. The proponents of the procedure have suggested that young men—younger than age 50 years old—with osteoarthritis and a body mass index of less than 35 are good candidates.^2,3,4

“In addition, a biomechanical study recommended there should not be a leg length discrepancy greater than 1 cm and the hip should have a ‘high’ horizontal femoral offset,”⁵ he points out. In his own practice data, only 6 percent of patients fit these criteria.

With such a small patient population, Dr. Lachiewicz believes it would be difficult for any surgeon to develop “a large surgical experience of resurfacing for the proper indications.”

The ideal hip resurfacing candidate for Dr. Kudrna meets all of these same conditions as outlined by Dr. Lachiewicz. However, Dr. Kudrna will not do the procedure on patients who are taller than 6’6” to 6’8”, particularly if they have hypermobile joints. He also lists anatomic abnormalities of the femoral head and neck, a very small femoral head (which excludes many female patients), Legg-Calve-Perthes disease, slipped capital femoral epiphysis, or severe osteopenia as other contraindications. About 10 percent of his surgical cases are hip resurfacings.

Technically challenging with a long “learning curve”
All three agree on one aspect of hip resurfacing—the “learning curve.” Even the two proponents (Drs. Kudrna and Amstutz) admit that hip resurfacing is technically more difficult than THA and should not be performed by all orthopaedic surgeons.

“Exposure is more difficult because you have to work around the hip to get to the socket,” explains Dr. Amstutz. “The second issue has to do with pin placement, so the femoral component is placed in an optimal position. From my perspective, pin placement is an art and is dependent on the patient’s anatomy and pathology. More emphasis is needed on the technique of preparing the bone and optimizing the cementation of the femoral component.”

When the BHR was released, he recalls, several U.S. surgeons flew to England for a one-day training session on using the device. One day of training is not adequate, according to Dr. Amstutz, who would like to see more extensive “hands-on” cadaver training and mentoring of inexperienced surgeons by those who are skilled in the procedure.

Although reluctant to specify the number of procedures needed to reach a level of minimum proficiency, Dr. Amstutz believes that a surgeon should not get the experience at the expense of his or her patients. That is one reason he promotes mentoring.

“It’s not an operation that every orthopaedic surgeon should be doing,” says Dr. Kudrna. “My practice is restricted to surgery of the hip and has been throughout my career. I don’t know that hip resurfacing is a procedure that a surgeon in general orthopaedics who does 30 THAs a year should be doing.” He estimates that about 30 percent to 40 percent of orthopaedic surgeons who do THAs would have enough volume to do hip resurfacing.

Dr. Lachiewicz is also concerned about the technical difficulty of this procedure and its impact on patients. In one study, he notes, the author reports that femoral neck fractures occurred in 22 percent of his first 50 resurfacing procedures.⁶ “If the so-called ‘learning curve’ for an experienced hip surgeon is 50 to 100 resurfacing procedures, how can this procedure be ‘mastered’ by community surgeons who perform fewer than 10 or 15 THAs a year?” he asks. He advocates that hip resurfacing be done by a “select group of experienced surgeons and specific hands-on learning centers be established.”

Dr. Kudrna agrees that the occurrence rate of femoral neck factures could be cause for concern. He supports experienced surgeons working with those who are interested in the procedure, not simply to show them how it’s done, but to take them through the entire learning process. “We’re not just talking about ‘saw-bones’ work, but cadaver work,” he says.

Computer-based navigation techniques are currently being developed that will facilitate reproducible pin insertion. Dr. Kudrna believes this technology will improve the quality of femoral component placement and enable more orthopaedic surgeons to perform this procedure.

The range of motion question
Proponents of hip resurfacing arthroplasty have claimed that it provides a greater range of motion and a lower rate of dislocation than conventional THA. Study results, however, are mixed. A three-dimensional computer simulation study, for example, showed that resurfacing resulted in less flexion and extension and reduced hip motion with simulated dislocation activities than hip replacement.⁷But, a retrospective study that compared 53 patients who had hip resurfacing (54 hips) with 51 patients who received hybrid THAs (54 hips) did show higher activity scores for the group with resurfaced hips.⁸

What is truly important, according to Dr. Kudrna, is functional range of motion. “It’s one thing to do a computer simulation and say this thing is going to impinge here and here, but how many people are going to flex their hips to 130 degrees? When you look at range of motion from a functional standpoint, there is very little difference between a hybrid THA and hip resurfacing. The real advantage of resurfacing is stability. That’s the big issue.”

Aging femoral heads and fractures
The issue of decreased bone mineral density (BMD) in the aging femoral neck is one Dr. Lachiewicz believes has been largely ignored by the proponents of hip resurfacing. According to one study, 18 percent of men and 25 percent of women lose BMD in the femoral neck between the ages of 30 and 70 years.⁹ As a result, he believes the chances of a femoral neck fracture will be greater in resurfaced hips over the long term.

Dr. Kudrna concurs that those changes do occur, but he points to several studies in which increases in bone density in specific “Gruen zones” of the femoral head have been reported following hip resurfacing.¹⁰ Finite element analysis work currently being done shows that increased stress concentration in the medial aspect of the femoral neck leads to improved bone density. As a result, he does not think that resurfacing will increase the incidence of femoral neck fractures.

Metal-on-metal articulation
The issue of metal-on-metal articulation raises the most concern among opponents of hip resurfacing. Dr. Lachiewicz, for example, is concerned that increased levels of chromium and cobalt in the blood and urine of patients may not be related to activity levels.^11,12,13Although the clinical significance is not yet known, two studies report that lymphocytic perivascular aggregates were found in patients who required reoperation.^14,15 He is also concerned about reports of hypersensitive reactions to metal-protein complexes, which may be linked to osteolysis.

Dr. Kudrna believes that the issue of metal ions could become negligible. “We now have data showing that as you improve the clearance of the bearing, you actually improve wear. We’ve also noted that as you go to larger metal bearings, the wear rates actually decrease. For example, with a 36-mm hip ball, cobalt and chromium levels are about 1 part per billion; the levels drop to ½ part per billion with a 45-mm bearing. That’s now equivalent to what you see in a metal-on-polyethelene hip.”

Conclusions
Though Drs. Kudrna, Amstutz, and Lachiewicz have different views about various aspects of hip resurfacing, they agree on three specific issues:

1. Patient selection is very important. The patient criteria for this procedure are quite specific.
2. Hip resurfacing is a difficult procedure to perform and has a longer learning curve than many other orthopaedic procedures. Experienced surgeons should act as “mentors” with those who want to learn the procedure. This learning process should include work with cadavers.
3. More prospective studies of hip resurfacing need to be done. Until they are, the issue will remain open and the discussions will continue.

Annie Hayashi is the senior science writer for AAOS Now. She can be reached at hayashi@aaos.org. References for the studies cited in this article can be found online at www.aaos.org/now

References

1. Amstutz HC, Le Duff MJ, Campbell PA, Dorey FJ. The effect of technique changes on aseptic loosening of the femoral component in hip resurfacing, results of 600 Conserve Plus with 3 to9 year follow-up. J Arthroplasty. 2007;22,4: 481-489.
2. Beaulé PE, Dorey FJ, LeDuff MJ, Gruen T, Amstutz HC. Risk factors affecting outcome of metal-on-metal surface arthroplasty of the hip. Clin Orthop Relat Res. 2004;418:87-93.
3. Mont MA, Ragland PS, Etienne G, Seyler TM, Schmalzried TP. Hip resurfacing arthroplasty. J Am Acad Orthop Surg. 2006;14:454-463.
4. Schmalzried TP, Silva M, de la Rosa MA, Choi E-S, Fowble VA. Optimizing patient selection and outcomes with total hip resurfacing. Clin Orthop Relat Res. 2005;441:200-204.
5. Silva M, Lee KH, Heisel C, de la Rosa MA, Schmalzried TP. The biomechanical results of total hip resurfacing arthroplasty. J Bone Joint Surg Am. 2004;86:40-46.
6. Katz JN, Losina E, Barrett J, Phillips CB, Mahomed NN, Lew RA, Guadagnoli E, Harris WH, Poss R, Baron JA. Association between hospital and surgeon procedure volume and outcomes of total hip replacement in the United States Medicare population. J Bone Joint Surg Am. 2001;83:1622-1629.
7. Doherty SD, Thompson MT, Usrey MM, Muirhead-Allwood S, Noble PC. (Paper 276). Does hip resurfacing restore normal range of motion and provide better joint motion than THR? Transactions from the 53^rd Annual Meeting of the Orthopaedic Research Society.San Diego, CA. February 2007. Rosemont, IL. Paper. 0276.http://www.ors.org/web/Transactions/53/0276.PDF.
8. Schmalzried TP, Buttman D, Grecula M, Amstutz HC. The relationship between the design, position, and articular wear of acetabular components inserted without cement and the development of pelvic osteolysis. J Bone Joint Surg Am. 1994;76:677-688.
9. Beck TJ, Looker AC, Ruff CB, Sievanen H, Wahner HW. Structural trends in the aging femoral neck and proximal shaft: analysis of the Third National Health and Nutrition Examination Survey dual-energy x-ray absorptiometry data. J Bone Miner Res.2000;15:2297-2304.
10. Kishida Y, Sugano N, Nishii T, Miki H., Yamaguchi K, Yoshikawa H. Preservation of the bone mineral density of the femur after surface replacement of the hip. J Bone Joint Surg Br. 2004;86:185-189.
11. Clarke MT, Lee PT, Arora A, Villar RN. Levels of metal ions after small- and large-diameter metal-on-metal hip arthroplasty. J Bone Joint Surg Br. 2003;85:913-917.
12. Jacobs JJ, Skipor AK, Doorn PF, Campbell P, Schmalzried TP, Black J, Amstutz HC. Cobalt and chromium concentrations in patients with metal-on-metal total hip
13. MacDonald SJ, Brodner W, Jacobs JJ. A consensus paper on metal ions in metal-on-metal hip arthroplasties. J Arthroplasty. 2004;19(Suppl 3):12-16.
14. Davies AP, Willert HG, Campbell PA, Lear month ID, Case CP. An unusual lymphocytic perivascular infiltration in tissues around contemporary metal-on-metal joint replacements. J Bone Joint Surg Am. 2005;87:18-27.
15. Willert HG, Buchhorn GH, Ing D, Fayyazi A, Flury R, Windler M, Koster G, Lohmann CH. Metal-on-metal bearings and hypersensitivity in patients with artificial hip joints. A clinical and histomorphological study. J Bone Joint Surg Am. 2005;87:28-36.

August 2007 AAOS Now 
http://www.aaos.org/news/bulletin/aug07/cover3.asp

Related articles

• SUMMARY OF SAFETY AND EFFECTIVENESS DATA PREMARKET APPROVAL APPLICATION P040033 SMITH & NEPHEW BHR BIRMINGHAM HIP RESURFACING SYSTEMf (earlsview.com)
• FDA Pre Market Approval (PMA) of Birmingham Hip Resurfacing (BHR) System – P040033 (earlsview.com)
• Smith & Nephew – BHR PMA – FIRST OF A KIND PMA – WHO PULLED WHAT STRINGS???? (earlsview.com)
• Despite the Reasons AGAINST – FDA Advisory Panel Recommends Conditional Approval of Smith & Nephew’s BIRMINGHAM HIP Resurfacing Technology (earlsview.com)
• P040033: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM by SMITH&NEPHEW ORTHOPAEDICS – FDAzilla Devices (earlsview.com)
• Hip replacement and resurfacing equally effective at improving joint function | Arthritis Research UK (earlsview.com)
• Kathryn’s Story – More Smith & Nephew Birmingham Hip Resurfacing Misery… (earlsview.com)
• More Controversy over MoM Devices (defectivedruganddeviceresourcecenter.com)
• FDA Considers Metal Hip Injuries – A Bit Too Late for Some Victims – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts (earlsview.com)
• Press release: MHRA tells surgeons to stop using R3 metal cup liner and extends patient monitoring advice : MHRA (earlsview.com)

www.ctaf.org/UserFiles/File/2011 Oct/Metal_on_Metal_Hip_Resurfacing_100611.pdf.

CONCLUSION

The 2007 CTAF assessment stated that “It is not possible to conclude from the current peer reviewed literature that the currently approved hip resurfacing systems in the United States improve health outcomes comparably with the current standard of care, total hip arthroplasty”.

In 2010, when CTAF reviewed this topic, several questions which were of concern during the 2007 assessment remained  and we reiterate them here:  What is the long term durability of the resurfaced hip compared with THA? What will be the short and long term results when this generation of younger patients who have undergone hip resurfacing are eventually converted to THA? Will there be unforeseen long term complications that will make this revision more problematic than anticipated? What are the long term health consequences of increased low levels of circulating metal ions produced by MoM hip resurfacing?

Now at the time of this assessment, the same questions remain unanswered. Particularly in light of the  registry evidence showing an increased revision rate with  HRA compared with THA and increasing concerns about elevated metal ion levels, it is incumbent upon the hip resurfacing community to prove the efficacy and safety of MoM hip resurfacing in randomized clinical trials, rather than subjecting young patients to significant potential harm over their lifetimes.

DRAFT RECOMMENDATION

It is recommended that 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.

Download full report here: CTAF REPORT Metal on Metal Hip Resurfacing as an Alternative to Total Hip – Metal_on_Metal_Hip_Resurfacing_100611

Related articles

• SUMMARY OF SAFETY AND EFFECTIVENESS DATA PREMARKET APPROVAL APPLICATION P040033 SMITH & NEPHEW BHR BIRMINGHAM HIP RESURFACING SYSTEMf (earlsview.com)
• Smith & Nephew – BHR PMA – FIRST OF A KIND PMA – WHO PULLED WHAT STRINGS???? (earlsview.com)
• Despite the Reasons AGAINST – FDA Advisory Panel Recommends Conditional Approval of Smith & Nephew’s BIRMINGHAM HIP Resurfacing Technology (earlsview.com)
• P040033: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM by SMITH&NEPHEW ORTHOPAEDICS – FDAzilla Devices (earlsview.com)
• FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR… (earlsview.com)
• Attachment B – Ragab AA., validity of Self-Assessment Outcome Questionnaires: Patient-Physician Discrepancy in Outcome Interpretation, 39 Biomed. Sci. Instrum. 579-84 (2003) (earlsview.com)
• Jack’s call for help – Legal help sought – Cormet Hip -Isn’t there some way to get beyond PMA preemptive device approval? (earlsview.com)
• Hip replacement and resurfacing equally effective at improving joint function | Arthritis Research UK (earlsview.com)
• FDA Considers Metal Hip Injuries – A Bit Too Late for Some Victims – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts (earlsview.com)