Wednesday, October 31, 2012

Metal-On-Metal Hip Implant Use To Be Suspended in Netherlands

Bernstein Leiphard

In light of growing concerns and studies showing the dangers of metal-on-metal hip implants, the Dutch Orthopaedic Association (NOV) has advised that doctors stop using all metal-on-metal hip implants with a large head of 36mm or greater. The NOV recommends that patients with metal-on-metal hip replacements attend annual check-ups, with an examination that includes measuring metal ion levels and X-rays. Depending on the results from the medical tests and the metal ion level measured, patients may be advised to undergo revision surgery to remove the implant.

The NOV isn’t the first health regulatory agency to weigh in on the risks of metal-on-metal hips. In June 2012, the U.S. Food and Drug Administration convened a special panel to discuss concerns about metal-on-metal hip systems, including problems with metallosis and high failure rates. Although the FDA did not issue an official ban of metal-on-metal devices, many orthopaedic surgeons spoke out against using the devices. Reports of metal-on-metal hip problems include higher than expected revision rates, and side effects such as soft tissue swelling, groin pain and tissue necrosis.

The U.K. medical regulatory agency, the MHRA, issued a medical device alert for metal-on-metal hip side effects in 2010. They released subsequent alerts warning doctors and patients about issues with the now recalled DePuy ASR hip implant and the high failure rates of metal-on-metal hip implants. They also recommended regular patient follow up and metal ion testing.
Dr. Susanne Ludgate, clinical director of the MHRA, noted that although a study in the British Medical Journal had called for a ban of all metal-on-metal hip implants, as an agency it was difficult to ban an entire class of devices. Health Canada had also issued an advisory on metal-on-metal implants. They recommended close monitoring of patients, especially for those at high risk for hip replacement failure.

Studies have also found problems with metal-on-metal hip resurfacing procedures. The 2012 report from the Australian Orthopaedic Association National Joint Replacement Registry found that metal-on-metal bearing surfaces in total hip replacements had higher failure rates than other bearing surfaces. A study published October 2012 in The Lancet medical journal concluded that metal-on-metal hip resurfacing failure rates were “unacceptably high” in women.

Medsafe says it has received another alert for a metal-on-metal hip implant device but patients' health is not at risk.

New Zealand City News

More hip-replacement patients are being contacted after the fifth international alert for metal-on-metal implants in two years.
The medical regulatory agency Medsafe said it had been advised the Durom acetabular cup, which was used in 252 hip implants in New Zealand from 2003 but had been discontinued by its manufacturer in June 2011, might wear out earlier than expected.
Medsafe group manager Dr Stewart Jessamine said patients' health was not at risk but some people might need a second implant sooner than thought.
"There is a greater awareness by manufacturers and regulators about these devices, which is why we are seeing more of these alerts," he said.
Medsafe would continue to work with manufacturers to ensure surgeons were fully informed and followed up with their patients.
"If patients have any concerns or experience any discomfort or pain, they should see their GP or surgeon, as they normally would following any surgery on a joint."
Metal-on-metal implants had been used in around 8 per cent of hip operations in the past decade and that rate was declining, Medafe said.
The five alerts involve around 1300 patients.

Age, gender influence hip arthroplasty revision risk

By Nikki Withers, medwireNews Reporter

Patient age and gender have a significant effect on the risk for revisions after primary total hip replacement, show study findings.

The researchers found that men had significantly higher rates of revisions than women, and that younger patients (those aged between 65 and 75 years at the time of primary total hip replacement) had a higher rate than older patients.

The findings are published in The Journal of Bone and Joint Research.
The research team, led by Jeffrey Katz (Brigham and Women's Hospital, Boston, Massachusetts, USA), retrospectively analyzed data from more than 51,000 Medicare beneficiaries who had primary total hip replacements between July 1995 and June 1996. Patients were followed up until 2008.
Overall, the risk for revision after total hip replacement for patients remaining alive was approximately 2% per year for the first 18 months and 1% per year for the remainder of the follow-up period.

Multivariate analysis showed that men were 23% more likely to undergo revision than women, something that the researchers say should be addressed in further investigations.

Patients aged 65-75 years at the time of primary total hip replacement were 47% more likely to undergo revision than their older counterparts.

This, say Katz et al, has "important implications for patient decision-making, quality improvement and research."

The researchers also found that patients of surgeons who performed fewer than six total hip replacements per year were at a 21% higher risk for revision than those whose surgeons performed more than 12 per year.

"Our findings suggest that the development of innovative technologies to improve implant longevity should target younger populations with advanced arthritis who have a longer anticipated time span in which the implants might fail and require revision arthroplasty," write the researchers.
  bbb 
Arthroplasties "should be targeted at revisions occurring in the first 18 months following the index arthroplasty, when revision risk is higher, and in younger patients, who are more likely to survive long enough to require revision," the team concludes

Monday, October 29, 2012

Smith and Nephew Issues Failure Warning on Metal Hip Implant

Smith & Nephew (S&N), a British company that was one of the first makers of metal-on-metal (MoM) hip implants, has issued an “Urgent Field Safety Notice” concerning the Birmingham Hip Modular Head implant. Issued to the Hong Kong Department of Health, S&N reported the failure rate exceeds the 1 percent benchmark established by the United Kingdom.

In data gathered since 2010 from the National Joint Registry of England and Wales, the failure rate of the implant was 1.29 percent and 1.12 percent based on the Australian Orthopaedic Association National Joint Replacement Registry.

The company said its highest priority is to deliver safe and effective medical devices and it’s notified regulatory bodies and customers of, “a change to the indications” for use of the Hip Modular Head, used in total hip replacements.

However the company stopped short of issuing a recall. Smith & Nephew said when used with the S & N Synergy stems, the failure rate was a more acceptable 1.07 percent.

In a letter to healthcare providers, the company said patients may experience, “pain and limited mobility, potentially leading to revision surgery. Females of child bearing age are at greater risk with metal-on-metal implants. Severely overweight individuals have been observed to be at greater risk of revision surgery.”

Where does this news leave doctors and patients?

S & N says the Birmingham Hip Modular Heads should be used only in the case of a revision surgery or when the patient shows no sign of metal sensitivity or has an uncemented Synergy stem or a Birmingham Hip acetabular cup.

In the U.S., the Birmingham Hip Modular Head does not have FDA approval to be used in a primary hip replacement.

Its cousin, the Birmingham Hip Resurfacing (BHR) implant, which is used in the U.S., is not affected by this action, however, one of our clients who received the BHR spent 10 months in the hospital near death from the amount of infection surrounding the hip implant.

In 2006 it was approved by the FDA and the BHR remains on the market despite the many complications associated with it similar to other MoM hips including metal debris, pseudotumors, auto-immune reactions, and necrosis of the muscle and tissue, among other complications.
The inventor, Dr. Derek McMinn walked away with more than $100 million when he sold the device to Smith & Nephew and the MoM industry erupted with the Zimmer Durom, and Johnson & Johnson DePuy ASR models.

On August 24, 2010, Johnson & Johnson voluntarily recalled the DePuy ASR total hip system because studies from the UK showed a 13 percent revision rate within five years. On July 22, 2008, the Zimmer Durom Acetabular Component (Durom Cup) was voluntarily recalled because of inadequate instructions for use and surgical technique, according to the FDA. That doesn’t reflect well on the S & N original MoM device that served as the model for the Durom and ASR.

Rise of the Hip Specialist: Symposium Discusses Breakthroughs in Treatments for Hip Conditions

Source:Hospital for Special Surgery

Newswise — One of the fastest growing fields in orthopedic surgery is that of a hip specialist. To cater to this burgeoning field, a recent symposium with Hospital for Special Surgery brought together international experts in hip surgery to provide a comprehensive overview of recent advances and trends in treating a range of hip disorders.

Selected research from the summit is published in the September issue of the HSS Journal, the Musculoskeletal Journal of Hospital for Special Surgery. One of the studies is provided with open access online and the others are available free of charge through Dec. 1, 2012, at http://www.springerlink.com/content/1556-3316/8/3/.

“The meeting is a comprehensive look at a wide spectrum of hip disorders, from conditions that affect children, to things that affect adolescents and young athletes, going all the way up the spectrum to arthritis and degenerative conditions,” said Edwin Su, M.D., an orthopedic surgeon in the Adult Reconstruction and Joint Replacement Service at Hospital for Special Surgery in New York City. “It is important to understand that these things are all related. A disorder that happens in children can lead to arthritis later, which is why there is a lot of focus on trying to preserve the hip joint.”
In recent years, a growing number of academic centers have begun to open specialized hip centers, in which several physicians provide a continuum of care for various hip conditions that impact individuals of varying ages. The Joint Preserving and Minimally Invasive Surgery of the Hip Symposium has been held nine times since 2001. This most recent meeting was a collaborative effort between Hospital for Special Surgery and the University of Ottawa, Ottawa, Canada.

“This is a collaborative effort between two academic centers who have a number of hip specialists and have frequent discussions about these conditions,” said Dr. Su. “But this gathering involved international researchers, so it was also an international collaboration.”

A large number of studies in the special HSS Journal issue discuss new research avenues for treating osteoarthritis of the hip, including advances in hip replacement. Osteoarthritis is now the number one cause of disability in the United States. HSS researchers discuss the ideal size of the head of the hip replacement, and experts from Sydney Hip and Knee Surgeons, North Sydney, New South Wales, Australia, discuss the pros and cons of using ceramic-on-ceramic materials in hip prostheses.

While metal-on-metal hip replacements have fallen out of favor in recent years due to adverse effects, a study by French researchers at the University of Lille, Lille, France, shows that the use of metal-on-metal bearings should not be discarded and provides favorable outcomes.

Another study performed by researchers from the University of Lille on behalf of the French Orthopedic Society, Lille, France, identified a new treatment to prevent total hip replacement dislocation.

Investigators from the University College London Hospitals describe a new assessment tool, a hip score, to evaluate the success of hip procedures. Current instruments are unable to differentiate between a high performing hip replacement and a routine hip replacement, and the new score could help.

The special hip journal issue also focuses a great deal of attention on treatments for hip impingement, otherwise known as femoracetabular impingement (FAI). “Treatment of FAI is one of the most rapidly growing surgeries in hip surgery,” said Dr. Su.

FAI is caused by abnormal contact between the ball and socket of the hip joint, which causes friction during hip movements that can damage the joint. “As we have developed imaging techniques and an understanding of the pathology of FAI, our ability to treat these problems has increased,” said Dr. Su. “There is the promise of trying to prevent the development of arthritis in patients with FAI.”

A study by investigators at the Mayo Clinic, Rochester, Minn., concludes that surgical hip dislocation should be used to treat FAI only in specific patients over the age of 40, those who do not have joint degeneration. Another project by scientists from the University of Berne, Berne, Switzerland, and the Schulthess Clinic, Zurich, Switzerland, showed that patients had better outcomes when surgeons treating FAI made attempts to preserve the ring of cartilage that surrounds the hip joint socket rather than remove it.

Other studies discuss the phenomenon of groin pain after hip resurfacing (University of Ottawa) and validate using cementless hip resurfacing (University of Lille). “Hip resurfacing is done for arthritis, but is generally done in younger patients. The average age for a hip replacement is mid 60s and the average age for resurfacing is about 50,” said Dr. Su.

The Center for Hip Preservation was established at Hospital for Special Surgery in 2010. It aims to provide care for patients of all ages with hip pathology, ranging from developmental dysplasia of the hip, to sports-related injuries, to degenerative arthritis. Physiatrists, pediatric orthopedic surgeons, sports medicine surgeons, and arthroplasty surgeons all practice in the center, allowing for a spectrum of non-operative and operative treatments.

About Hospital for Special Surgery
Founded in 1863, Hospital for Special Surgery (HSS) is a world leader in orthopedics, rheumatology and rehabilitation. HSS is nationally ranked No. 1 in orthopedics, No. 3 in rheumatology, No. 10 in neurology and No. 5 in geriatrics by U.S. News & World Report (2012-13), and is the first hospital in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center three consecutive times. HSS has one of the lowest infection rates in the country. From 2007 to 2011, HSS has been a recipient of the HealthGrades Joint Replacement Excellence Award. HSS is a member of the NewYork-Presbyterian Healthcare System and an affiliate of Weill Cornell Medical College and as such all Hospital for Special Surgery medical staff are faculty of Weill Cornell. The hospital's research division is internationally recognized as a leader in the investigation of musculoskeletal and autoimmune diseases. Hospital for Special Surgery is located in New York City and online at www.hss.ed

International hazard alert on Durom hip implants

Surgeons in New Zealand have been asked some months ago to carry out annual monitoring of all patients with metal-on-metal hip implants following alerts some devices need to be replaced earlier than expected.

Medsafe have been advised the Durom Acetabular Cup, a device no longer being used in New Zealand, is subject to an international hazard alert.

The New Zealand Joint Registry reports the device, which was discontinued by its manufacturer in June 2011, was used in 252 hip implants in New Zealand.

Medsafe Group Manager Dr Stewart Jessamine says patient health is not at risk - some people will simply require their implant to be replaced earlier than expected.

"On average 90 per cent of people with a metal on metal hip implant will have no problems with their implant at 10 years - a revision rate of 1.00 per 100 component years.

"For the Durom device around 84 per cent of patients will not have problems at 10 years. The slightly higher revision rate of 1.68 per 100 component years is the reason why the product is being recalled. They do not pose any additional health risk to patients.

"There is a greater awareness by manufacturers and regulators about these devices, which is why we are seeing more of these alerts, say Dr Jessamine.

"Regulators around the world, including Australia, have responded in a similar way as Medsafe to the finding that some hip device products have higher revision rates.

Medsafe will continue to work with manufacturers to ensure that when an alert is issued, surgeons are fully informed and follow up with their patients.

"If patients have any concerns or experience any discomfort or pain, they should see their GP or surgeon, as they normally would following any surgery on a joint."

Metal-on-metal implants have been used in around 8% of the total hip implants during the last decade and this rate is declining.

Information for consumers about metal-on-metal implants has been published on the Medsafe website at: http://www.medsafe.govt.nz/profs/device-issues.asp#17April2012 and made available to surgeons.

Following Hip Implant Recalls, Stryker Corp. Sales Slip in Third Quarter



Drug Watch

Stryker Corp. has reported that its third-quarter sales did not meet expectations, in part because of a decline in its orthopedics business after a recall of two of its hip implant devices.

Sales of reconstructive joints dropped 1 percent overall. Stryker’s international markets turned in the worst performance in the division, with artificial hip sales down 9.6 percent and knee implants down 4.3 percent, according to The Wall Street Journal.

In the United States, the unit had total growth of 5.3 percent. Hip implants, though, only posted an increase of 2 percent, which company officials partially attributed to the recalls. In an Oct. 17 conference call, they said the recalls had a “modest impact” on revenue.

Metal-on-Metal Complications Led to Recall

In July, Stryker recalled its Rejuvenate and ABG II modular-neck stems, which are used in hip replacement systems. The Rejuvenate and ABG II do not share the same defective hip implant design as other recently recalled devices, but they do have a common element. The Stryker components have all-metal conjunctions, which are to blame for complications similar to those seen in DePuy and Zimmer hip implant patients.

The metal parts in all of these hip replacement systems grind against each other, weakening the device and shedding metal particles. The loosening of the implant leads to painful, early failure of the device, and ultimately, a corrective surgery. The metal shavings can poison the bloodstream, causing a condition called metallosis. There is some concern among researchers that the metal debris may also prompt nearby tissues to change and become pre-cancerous.

But it wasn’t just the Rejuvenate and ABG II recalls and subsequent related lawsuits that contributed to the orthopaedic implant sector’s downturn, Reuters reports. Because replacing joints largely is considered elective surgery, the poor economy has played a role in patients putting implants on hold. Patients may not have insurance, have out-of-pocket expenses they cannot afford or fear taking time off work when jobs are scarce.

CEO Separation Package Totals $1.5 Million

Stryker, too, recently revealed the costly separation package for its former Chief Financial Officer and Vice President Curt Hartman. He will receive $1.5 million, according to an agreement filed Oct. 17 with the U.S. Securities and Exchange Commission. The payout equals Hartman’s annual salary of $750,000 plus his 2012 bonus.

After 20 years with Stryker, Hartman has served as the interim chief executive officer since February. He will remain with the company through Feb. 28, 2013, as an adviser and continue to draw his salary. Through that time, he will have the choice to become vested in performance stock shares. In return, Hartman signed noncompetition and nonsolicitation agreements.

Stryker recently selected Kevin Lobo, the head of its orthopaedics division, as its new president and chief executive officer.

U.S. Senate: Leading Medical Device Company Ghost-Wrote Articles, Paid Physicians

Medtronic ghost-wrote and edited articles released in medical journals, and paid physicians millions of dollars in "consulting" fees, the United States Senate's Finance Committee stated in a report today.
The United States Senate's Finance Committee released a report today, which stated that Medtronic ghost-wrote and edited articles released in medical journals, and paid physicians millions of dollars in "consulting" fees.
Medtronic is a leading company in the medical device industry, and is the world's largest maker of heart-rhythm products. The report mostly concerns Medtronic's care of the InFuse device, which uses a genetically engineered protein to create bone growth for spinal fusion surgery along with a fusion device. For a time, the InFuse device, which was approved for use in 2002, was a huge moneymaker for Medtronic, garnering the company $800 million a year. Its sales have since plunged since a series of articles written in The Spine Journal showed that InFuse elevated risk for infertility, infections, and cancer. Since then, sales of the device are a fraction of what they once were, at $141 million during the second quarter of 2011.

The Senate's report, written after the committee reviewed 5,000 of Medtronic's documents over 16 months, found that the company was heavily involved in "drafting, editing, and shaping the content of medical journal articles". While 13 articles about the device stated that InFuse had no side effects, the documents released by the Food and Drug Administration found that as many as half of the patients enrolled in trials experienced pain, infection, cysts, and other complications. The report also states that "[an] e-mail exchange shows that a Medtronic employee recommended against publishing a complete list of adverse effects possibly associated with InFuse in a 2005 Journal of Bone and Joint Surgery article" and that Medtronic officials inserted language into articles that would make InFuse seem better than the alternative, a bone graft procedure, by emphasizing the pain of the surgery.
The report also stated that Medtronic paid $210 million to physician authors from November 1996 to December 2010. But Drs. Glassman and Dinar, who co-authored a 2007 Amplify study with Dr. Boden, stated that they wrote and edited the articles themselves, and that they mentioned InFuse's adverse effects in numerous peer-reviewed publications. They say that the $9.7 million that they received from the company were for royalties. But their Amplify article did not disclose the contributions that they received from Medtronic. According to The Wall Street Journal, the disclosure read in part, "No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript."

Medtronic said in a statement about the matter, "Medtronic vigorously disagrees with any suggestion that the company improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the report, or that Medtronic intended to under-report adverse events. In fact, Medtronic reported to the FDA the potential adverse events addressed in the staff report, and these risks were reflected on the product's FDA-approved label. In addition, the staff report's characterization of payments received by physicians is also misleading and unfair. The vast majority of such payments were royalty payments made to compensate physicians for their intellectual property rights and contributions, not consulting payments. In general, royalty and consulting payments are a commonplace and appropriate practice in the medical device industry."


Johnson & Johnson: Dividend Stock Analysis

The Dividend Guy



Johnson & Johnson (JNJ) Business Description

JNJ is another US mammoth (both in terms of age and size) operating in the manufacturing, marketing, distribution of consumer goods. It is well known for its healthcare orientation. Its operations are divided into three segments:

Consumer includes baby care, skin care, oral care, wound care, women's health and over the counter pharmaceutical products. Their best known brands are Aveeno, Clean & Clear, Neutrogena, Stayfree & Carefree, Tylenol, Sudafed, Motrin and Pepcid.

Pharmaceuticals include products for infection prevention, antipsychotics, contraceptives, dermatology, gastrointestinal, hematology, immunology, infectious diseases, neurology, oncology, pain management, thrombosis and vaccines. I'm not going to outline their best known brands since they are full of high point Scrabble names.

Medical Devices & Diagnostics includes all kinds of hospital equipment ranging from diabetes care to spinal care.


The pharmaceutical segment is the biggest segment of Johnson & Johnson. Unfortunately, sales are stagnating for the division. While it is growing outside of the US, it has been the opposite in its own country. On a more positive note, the medical devices / diagnostic systems division is showing strong sales growth over the past five years in both US and non-US regions.


JNJ shows both strong five- and 10-year sales growth of 4.0% and 7.2% worldwide. To be honest, most of this growth is coming from the international segment as the USA sales have stagnated over the past five years. JNJ is also part of most sustainable investment indexes and focuses mainly on water and waste reduction.

JNJ Stock Graph

Click to enlarge

JNJ Dividend Growth Graph


JNJ has a strong history of dividend growth. In fact, most investors buy this stock for the dividend and not necessarily for the company's growth forecast. We can almost consider JNJ as a bond that pays increasing interest over time. With a five-year dividend growth of over 8%, JNJ will double its dividend every nine years or so.

The Company Ratios and Financial Info:

Ticker JNJ
Name Johnson & Johnson
Dividend Metrics
Current Dividend Yield 3.51
5 year Dividend Growth 8.36
1 year Dividend Growth 6.31
Company Metrics
Sales Growth (1 year) 5.59
Sales Growth (5 year) 2.76
EPS growth (5 year) 4.7
P/E ratio 13.77
P/E Next Year 12.67
Margins growth -0.87
Payout ratio 63.65
Return on Equity 17.02
Debt to Capital Ratio 0.09

It seems that some big consumer companies are having the same problem: pressure on margins. This problem is also reflected in the JNJ EPS over the past five years (from 2007 to 2011) as you can see on the following chart:


You can see an important dip in 2011 and, hopefully, the estimated EPS for 2012 is much higher. So where did the money in 2011 go? I don't know if you remember, but JNJ had some major recall problems. In fact, its whole manufacturing quality was at stake. This had cost a lot to the company ($1,712M of litigation losses, $1,600M in product liability, $656M of non-recurrent restructuring costs and $521M for the Depuy ASR Hip recall).

If you exclude the above "extraordinary events", the EPS in 2011 would have been $5.00. The company has since then made some important changes and earnings are exceeding analysts' expectations in 2012. We just hope that none of the extraordinary events will happen again in 2012.

JNJ Stock Technical Analysis


JNJ is currently trading on a strong uptrend due to strong results in Q3 and a rising forecast for Q4. It might be a good time to acquire this stock. Click here to get a free stock analysis report on JNJ.

Johnson & Johnson Upcoming opportunities and dangers

Quality control has been the biggest challenge JNJ faced back in 2011. While it also suffered from smaller product recalls in 2012, it seems to have its quality control… under control. Nonetheless, that reminded us how important is to manufacture perfect products in the pharmaceutical and healthcare industries.

Another challenge I see is the lack of vigorous sales in the US over the past five years. Johnson & Johnson seems to have lost its grip over its main market. The recession might have been a factor, but a big company like Johnson & Johnson should have been able to consolidate its market share instead of losing sales during this period.

On the other hand, like many other consumer product companies, Johnson & Johnson is very strong in the international markets. Then again, emerging markets growth is not infinite. Johnson & Johnson will have to continue its innovations to keep its sales growing over time.

Johnson & Johnson's 7.5 billion R&D budget makes it an important player in new products. In fact, in 2011, 25% of its products sold were introduced in the last five years. Let's hope that it doesn't cannibalize its own brand and grows its market share with its innovations.

On a positive note, North America's aging population should push JNJ sales to a higher level. Since it is concentrated in healthcare and pharmaceutical products, Johnson & Johnson should grow its customer base as the population ages. Its wide portfolio of products makes it one of the most diversified companies on Earth. I like to say that JNJ is more diversified than a balanced mutual fund.

Final Thoughts on Johnson & Johnson

Knowing that Johnson & Johnson's quality problems seem to be behind it and that the company is driving better-than-expected results (it is already showing an EPS of $3.92 and there is one quarter left to do), I think that JNJ is a great pick. Another interesting fact is that the current P/E ratio (13) is the lowest of the past 10 years. So the company is not only heading in the right direction, but its stock may be undervalued too.



Hip fracture trials do not include enough patients with dementia

Hebert-Davies J. Injury. doi:10.1016/j.injury.2012.08.061.

  • October 24, 2012
Patients with dementia are often excluded from hip fracture clinical trials due to their inability to answer quality of life questionnaires; however this practice may potentially impact study results, according to Canadian researchers.
“When investigating hip fractures, choosing appropriate objective endpoints is essential to ensure results are also applicable to patients with dementia,” Jonah Hebert-Davies, MD, and colleagues stated in the abstract of their study.

In reviewing excluded patients in the Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH) and Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemi-Arthroplasty (HEALTH) clinical trials, researchers found the FAITH study excluded 375 of 1,690 (22.2%) patients due to cognitive impairment, according to the abstract. The HEALTH study had similarly excluded 207 of 575 patients for dementia or cognitive impairment.

The researchers’ systematic review revealed that two studies evaluated patients with hip fractures with and without dementia, both of which identified significant increases in complications and mortality, according to the abstract

Saturday, October 27, 2012

Zimmer Holdings Management Discusses Q3 2012 Results - Earnings Call Transcript



"Hip sales in the third quarter increased 1.6%, reflecting positive volume and mix of 4.4%, and negative price of 2.8%. In the quarter, our Americas and Europe, Middle East and Africa operating segments delivered an improved performance, while in Asia-Pacific, sales declined slightly compared with prior year due primarily to the previously discussed pricing pressure in Japan. Across our hip portfolio, we continue to drive benefit from our proprietary technology platforms, including Trabecular Metal Technology, which offers a differentiated advantage in the revision market, as well as its applications and primary acetabular cups and stems.

In the quarter, we also continued the introduction of our VIVACIT-E Highly Crosslinked Polyethylene in the United States, and will soon make this advanced material available to certain European markets."

xxx

I guess we are still using metal technology.

Trabecular metal technology:

Trabecular Metal Technology is a
three-dimensional material, not an implant
surface or coating. Its structure
is similar to cancellous bone.


Trabecular Metal Material’s consistent,
open and interconnected network of pores
is designed for bone on-growth
and in-growth, or osseoincorporation


In a study of Trabecular Metal Implants
placed in canine mandibular models,
evidence of in-growth by maturing bone
has been documented as early as
two weeks after implantation.33,34
Further research is required to
determine the rate of bone in-growth
and its effects on secondary stability
in human dental applications. 
  

The Best Thing Next To Bone™
The cellular structure of Trabecular Metal* resembles bone and approximates its physical and mechanical properties more closely than other prosthetic materials. The unique, highly porous, trabecular configuration is conducive to bone formation, enabling rapid and extensive tissue infiltration and strong attachment.1,2,

Physical Properties

Trabecular Metal consists of interconnecting pores resulting in a structural biomaterial that is 80% porous, allowing approximately 2-3 times greater bone ingrowth compared to conventional porous coatings and double the interface shear strength.1,+
Trabecular Metal Technology
Trabecular Metal implants are fabricated using elemental tantalum metal and vapor deposition techniques that create a metallic strut configuration similar to trabecular bone. The crystalline microtexture of aTrabecular Metal strut is conductive to direct bone apposition.2
The crystalline microtexture of aTrabecular Metal strut
Elemental tantalum unites strength and corrosion resistance with excellent biocompatibility. These characteristics help explain tantalum's surgical use for more than 50 years in applications such as cranioplasty plates and pacemaker leads.3

Mechanical Properties

Trabecular Metal possesses a high strength-to-weight ratio, with mechanical properties capable of withstanding physiologic loading. The compressive strength and elastic modulus of Trabecular Metal are more similar to bone than are other prosthetic load-bearing materials.2,4 The material's low stiffness facilitates physiologic load transfer and helps minimize stress shielding.
Mechanical Properties
The Trabecular Metal struts generate a friction coefficient that is 76% greater than a sintered bead coating, providing increased initial stability.5
Trabecular Metal struts generate a friction coefficient

Exceptional Bone Ingrowth

The bone-like physical and mechanical properties of Trabecular Metal contribute to extensive bone infiltration. A transcortical implant animal study demonstrated that new bone rapidly infiltrated the Trabecular Metal.1,2 Only 8 weeks after surgery, bone had grown into and filled the majority of available pore space. Consequently, fixation strength developed more rapidly. At 4 weeks, the bone interface shear strength of Trabecular Metal material was double that of sintered beads.1,2
Exceptional Bone Ingrowth

Histologic Micrographs

Filling of prepared cortical holes with new bone is comparable with Trabecular Metal implants (top) and without (bottom). 2 Bone filled the majority of the available pore space at 8 weeks.
Trabecular Metal has been shown to permit physiologic bone healing. In 24 week animal studies of Trabecular Metal acetabular cups, the density of ingrown bone was comparable to the density of peri-implant trabecular bone.6

Soft Tissue Attachment

The pore size and high volume porosity of Trabecular Metal supports vascularization and rapid, secure soft tissue ingrowth. In the canine model, soft tissue adherence and vascularization occurred quickly with extensive tissue ingrowth 4 to 8 weeks after surgery.
Soft Tissue Attachment
Soft tissue attachment strength was five times greater than with sintered bead coatings at 4 and 8 weeks.7,8

xxx

I wonder what you would do if you needed a revision with this kind of approach?  it would seem that you might have remove a lot of bone rather than just the implant becuase the implant and bone become one?

Thursday, October 25, 2012

Metal-on-metal hips: cobalt can induce an endotoxin-like response

Ann Rheum Dis doi:10.1136/annrheumdis-2012-202468
  • Letter

Metal-on-metal hips: cobalt can induce an endotoxin-like response

  1. John A Kirby1
+ Author Affiliations
  1. 1Institute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK
  2. 2Department of Orthopaedics, Freeman Hospital, Newcastle upon Tyne, UK
  1. Correspondence to Dr Alison Jane Tyson-Capper, Institute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, William Leech Building, Framlington Place, Newcastle upon Tyne NE2 4HH, UK; Alison.tyson-capper@ncl.ac.uk
  • Accepted 11 September 2012
  • Published Online First 17 October 2012
 
Recent studies have highlighted significant risks associated with metal-on-metal (MoM) hip joint replacement,1 leading Smith et al2 to recommend that research should be ‘focused on understanding the biological consequences of exposure to orthopaedic metals’. One of these consequences may be the development of solid or fluid-filled inflammatory lesions, termed pseudotumours, which have been reported in areas around MoM joints.3 ,4
The articulating surface of MoM joints is fabricated from a hard alloy containing approximately one part chromium to two of cobalt. Ionic forms of both these metals can be detected at a high level (≤5 mM Cr, ≤0·25 mM Co) in the synovial fluid surrounding MoM joints, with lower levels present in distant body tissues, blood and urine.5 Although …

Faulty medical implants investigation: 'We’re paid by manufacturer so want deal to succeed'

The Telegraph


10:14PM BST 24 Oct 2012

 

But, earlier this month, in a meeting on the 14th floor of the building in South Korea, two undercover reporters from The Daily Telegraph posing as representatives from a Chinese company were discussing just such a licence.
As the air conditioning hummed in the background, the four smartly dressed Korean men began their presentation — in reality, a sales pitch about how they would effectively be able to guarantee that a metal-on-metal hip implant which should be banned could soon find its way legally into British operating theatres.
 
The president of the company, Dr Gong, said that the firm was the “best in the world” and the “exclusive partner” of a medical devices regulator in the Czech Republic. As part of their relationship with the regulator they did “all the results” for Asian companies that applied for the necessary CE certification.
 
With more than 1,000 clients, they could offer a “competitive” fee to the undercover reporters sitting before them. “We only focus on how to help our clients”, said one of the employees as he flicked through the presentation.
Towards the end of the meeting, when asked by an undercover reporter why features of the European system were so attractive, Dr Gong rubbed his fingers together, saying “money”.

Flaws in EU regulation of medical devices, says BMJ

Medical Technology Europe

A joint undercover investigation by the BMJ and the Daily Telegraph has exposed flaws in the EU system used to grant market access for devices such as replacement hips, cardiac defibrillators, and breast implants.

The investigation involved submitting a fake application for a large diameter metal-on-metal total hip prosthesis for approval by a notified body in Slovakia—the commercial organisations charged with evaluating the safety and performance of medical devices across Europe by granting them a CE certificate.

The hip — whose specification was designed for the purposes of the investigation — had similar specifications to the DePuy ASR XL acetabular system — a device that has been recalled from the market after failing at unacceptable rates and releasing metal ions into patients’ blood. Nevertheless, last week the notified body provisionally allowed the product to go forward to certification.
One notified body authorised to certify products for medical use across Europe, has been secretly recorded admitting that it is “on the side of the manufacturer”.

ITC, a regulatory organisation in the Czech Republic was also prepared to consider licensing the product, despite widespread concerns about the use of large diameter metal-on-metal hip prostheses. In some countries, surgeons have been told not to use them.

One representative of ITC told reporters that his company would not put “obstacles” in the way of approving the device and said it was “on the side of the manufacturer and their products, not on the side of the patients”. Another notified body was recorded admitting that some of the dossiers for products legally on sale were “horrible” because of the deficiencies of the regulatory system. The ITC did not respond directly to any points later raised but said it complied “in full accordance with the law.”

The investigation raises serious questions over the safeguards protecting patients. The system of licensing medical devices and surgical implants works on a pan-European basis and regulators in this country refuse to disclose where products have been certified.
 
More than 70 private agencies are competing for business — meaning the system is susceptible to corrupt practices, such as those uncovered during the recent PIP breast implant scandal.
The regulatory system works in a similar way to the licensing process for household electrical appliances and toys rather than the far more rigorous system applied to approving drugs.
Medical experts last night condemned the regulators and demanded an urgent review to protect patients from another “inevitable” scandal in the wake of the problems surrounding PIP breast implants earlier this year.

Dr Carl Heneghan, a medical expert at Oxford University, who provided advice on the BMJ / Daily Telegraph investigation, said last night: “To put it bluntly device regulation is in disarray: the evidence requirements at the time of approval are woeful, the conduct of notified bodies is substandard, and individuals supposedly representing the regulatory system are conflicted and in many cases under qualified.

“This all means that the system now heavily favours manufacturers at the expense of patient safety.”

Stryker Rejuvenate – What Went Wrong

Last June 27 and 28th, the U.S. Food and Drug Administration (FDA) convened an expert panel of orthopedic surgeons. They were gathered to discuss whether the medical community should continue to trust the technology of metal-on-metal (MoM) hip replacements.

The group concluded there were few reasons to continue using MoM hips; too many patients had suffered a host of complications including metal debris in their blood stream, the creation of pseudo-tumors, dead tissue (necrosis), and an early failure rate of the implant.
This was particularly true for women and the obese.

At the time, the panelists were discussing the Johnson & Johnson DePuy ASR which had been recalled in 2010 and the Zimmer Durom Cup, taken off the market in July 2008.
Just one week later, two hip implant devices, thought to be an improvement over metal-on-metal hips, would join the ranks of the recalled amid a growing number of reports of remarkably similar and devastating patient injuries.

On July 4, 2012, Stryker Orthopaedics Corporation issued a voluntary recall of its Rejuvenate and ABG II modular-neck hip stem systems.

Stryker issued its flagship line of improved hip implants – the Rejuvenate was approved by the FDA in June 2008 while the ABG II received approval in 2009.



With a typical hip replacement, there is a ball that fits into a cap. Using a modular-neck hip stem component system, Stryker offered surgeons different sizes of stems and necks to custom fit the device to the size and activity level of their patients. That way the younger, more active patient could get back into the swing of things. At least that’s what the advertising and sales representatives said.
And since the Rejuvenate has a ceramic ball that fits into a socket with a plastic liner, there were no metal surfaces to rub, therefore no problem with metal debris. At least that was the theory.
Remember that unlike drugs, the bulk of medical devices do not have to prove safety and efficacy before they are sold to you, the public. It was in the landscape of patient use that that theory was put to the test.

That was where we saw the Rejuvenate’s similarity to MoM hips.

A modular system is a two piece system. The metal stem and metal neck attach and then connect to the ball. It is at the area where the neck meets the stem where the device failed and we now know is causing the same problems as metal hips, the same problems patients thought they had avoided.
The neck of the Stryker hip is made of chromium and cobalt, the stem has a coating of titanium and there is a metal-on-metal intersection that can deposit metal debris into the body from a degree of grinding.

Back in April, the company knew it had problems.
Stryker issued an Urgent Safety Alert that went to surgeons and hospitals warning that metal ion debris could be generated by “fretting and/or corrosion at or about the modular neck junction.” That junction could increase metal particles in the surrounding joint space causing adverse tissue reaction including:
  • Metallosis (metal toxicity from grinding metal components)
  • Necrosis (premature tissue death)
  • Osteolysis (bone dissolution)
  • Pseudotumor formation
  • Pain requiring revision surgery
While most hip implants are expected to last 15 years on average, the Rejuvenate and ABGII began failing after just several months.

So far, there have been 60 adverse event reports and those have been increasing dramatically since the beginning of 2012.

Searcy Denney now represents well over 100 Rejuvenate and ABGII victims from 15 states and we were the first law firm to file litigation on behalf of those suffering multi-organ injuries from toxic metals of cobalt chromium and titanium as well as requiring multiple surgeries to remove the defective devices.

We predicted Stryker’s products would be next from the reports we’ve been hearing. It’s too bad the company did not let the medical community know what it was planning last June.

Jeremy Hunt: I will not tolerate British patients being put at risk

The Telegraph

Like many people, I was shocked and appalled to read in The Telegraph that a regulator in Europe said that it was “on the side of the manufacturer” when it comes to licensing products — such as hip replacements — for use in British patients.


9:57PM BST 23 Oct 2012

 
These words undermine everything I believe about the health sector in Britain. Anyone working in health care must always be on the side of patients, and patients – not profits – should always be the number one priority.
Hip replacements are so important because they can make such a significant difference to the quality of life of patients. Unfortunately, they have often hit the headlines for the wrong reasons in the past two years.
 
A brand of metal-on-metal devices was recalled after evidence showed they were not performing well enough. These implants were taken off the market, but yesterday, The Telegraph exposed a worrying and completely unacceptable weakness in the regulatory system which means, in theory, a device with similar problems could legally be sold in the UK.
 
I want to be absolutely clear that I will not tolerate British patients being put at risk. I have asked the regulator — the Medicines and Healthcare products Regulatory Agency (MHRA) — and the British Orthopaedic Association to bring forward plans to do more to make sure patients can be confident they will get the highest quality of devices when they need them.
 
I can reassure patients that in this country we do not just rely on European approval before we use implants. Thankfully, we can be confident that approval by a European regulator alone would not mean a device finds its way into the NHS. We have our own checks and balances in place so the hip replacement mentioned in the Telegraph article yesterday would not automatically be used in the NHS.

Faulty medical implants investigation: Regulators’ trail of deception has been exposed, says chairman


The Telegraph

Andrew Miller, the chairman of a parliamentary select committee investigating the sub-standard regulation of medical devices in Britain, has said that a “trail of deception” has been exposed in the system.

Mr Miller, the chairman of the science and technology committee, said that features of the system were “wrong” and that patients were “clearly entitled” to a process which guaranteed the safety of products being “inserted into their body”.

The committee is preparing to publish a report into the regulation of medical devices in the coming days which is expected to call for a sweeping overhaul of the system.

In the wake of The Daily Telegraph’s disclosures about loopholes in the system, dozens of patients and doctors contacted this newspaper to demand immediate reform.

Mr Miller said that the investigation had exposed behaviour that is “not within the current spirit of the regulation and my judgment of that is it is not within the legal interpretation of the regulation”.

He said that the companies which regulated the approval of medical devices should be focusing on protecting the patient.

Faulty medical implants investigation: 'We can help you label it European so China is not on packaging'


Telegraph

Firm tells reporters posing as representatives of hip implant maker how to bend the law.


9:56PM BST 23 Oct 2012


For the female executive from the Hungarian firm which is authorised to approve medical devices throughout Europe, the brochure outlining a proposal for a new “metal-on-metal” hip implant should have rung alarm bells.
 
The two people purporting to be executives from a Chinese firm called “Changi” should politely have been told that such a product could be risky and certification might be a problem.
 
But Anna Szabo, an executive at SGS in Budapest, offered advice on how to “market” the questionable product to unsuspecting patients in Britain and elsewhere. While the product would still need approval, Ms Szabo said: “What we suggest is that you make a certification so that the, on the product itself, the label would be from a Hung- … European country and therefore the Chinese producer will not be on the packaging.”
 
“Why is that a good idea?” asked the person Ms Szabo thought was representing a potentially lucrative client from a Chinese firm, but was, in fact, an undercover reporter from The Daily Telegraph.
 
“This is better from a marketing point of view,” the SGS executive replied. Ms Szabo said they could find someone in Hungary to represent the Chinese company. “The point would be on the packaging of the things … is much better if you have a European kind of origin country,” she said. “It’s much more of a paperwork kind of thing,” she said.

Tuesday, October 23, 2012

Faulty hip implants have ruined lives says Orthopaedic Professor

Telegraph
Britain

As the Telegraph investigates the licensing process for hip implants, Professor Tom Joyce of Newcastle University explains some of the problems that can arise from poorly designed or manufactured prosthetics.

For the patients that Professor Joyce meets, the consequences of a hip replacement which fails are devastating: "Often, especially with these metal on metal hips, they have been in pain, there's been swelling. I've even had some cases where adults have ended up back at home with their (elderly) parents looking after them."

As Professor of Orthopaedic Engineering at Newcastle University, Prof Joyce has seen hundreds of hip replacement joints that have failed after being implanted and had to be removed.

There are three main faults which Prof Joyce sees recurring and they all relate to wear on the hip joint causing material to rub off the prosthetic and be absorbed by the body leading to potential tissue damage and infection.

"You can get metal wear from the cup (the replacement socket for the hip) and the head (the new ball joint) and unfortunately we are just discovering that a third source of metallic wear can be inside where the head fits on the taper of the long stem (the piece of metal which is fixed to the leg)," explained Prof Joyce.

As the Telegraph investigation shows, the checks and balances put in place to avoid painful and costly mistakes in the certification of hip replacements may not be strict enough to ensure that no more patients are fitted with a 'dodgy' hip.

See the video:  http://www.telegraph.co.uk/health/9626757/Faulty-hip-implants-have-ruined-lives-says-Orthopaedic-Professor.html#.UIcA7TCkTyg.wordpress

Faulty medical implants investigation: 'Sometimes we cross the line'


6:55AM BST 23 Oct 2012
 
The Telegraph
 
(More details on the story)
 
The offices of the firm in a former Communist town in Slovakia were lined with burnt-out kettles and toasters, testimony to the “safety” tests which take place in the building.
 
EVPU is one of the private companies given the task of assessing, on behalf of the Slovakian government, whether electrical products are safe to be sold throughout the European Union.
But the company’s activities are not restricted to licensing domestic appliances to see if they blow up when plugged in. Under European rules, the firm is also authorised to license medical implants such as artificial hips and knees.
 
The European system of regulation has prompted widespread concern over whether medical experts are really at the vanguard of deciding which devices can be implanted in patients.
 
The Daily Telegraph and the British Medical Journal therefore decided to investigate the rigour of the licensing process, amid allegations that dozens of private companies are competing with one another to offer licences for medically questionable devices. Was profit being put before patient safety?
 
Undercover journalists from this newspaper approached EVPU, claiming to represent a fictitious Chinese company that wanted to get a new hip implant approved for use in Europe.

In order to test the system, the “new” hip implant was in fact based on a device now withdrawn throughout the world which had been produced by DePuy.

DePuy had to recall thousands of hip implants after it emerged that it wears down and deposits potentially toxic metal deposits in the blood. The company has put aside £2 billion in case of compensation claims.

Medical experts advised this newspaper that any regulatory body seeing a supposedly new artificial hip of the metal-on-metal variety should immediately raise concerns about approving the product. In the meeting in Nova Dubnica, executives from EVPU were happy to “sell” the benefits of seeking EU-wide approval using their services.

Describing their approach as a “very fast and easy, easy process,” they explained the procedure for gaining approval. The representatives pointed out the company had only closed, or rejected, four cases in five years “without success”.

Instead of carrying out independent research on the device, the fictitious Chinese company could simply submit a “literature review” on the planned materials using information from similar devices already on the market.

“They can even prepare the clinical evaluation report according to literature review. Take some journals, make research and prepare some reports. Make comparative study, read the product used from article and make comparative study,” Lubica Skrovanova, an EVPU executive said.

EVPU would not even have to see an example of the proposed hip implant when its representatives reviewed the dossier — and would be able to rely on drawings of the device.

Notified bodies are strictly banned from acting as consultants to companies on how to gain approval and are meant to assess the dossier as it is presented.

Peter Luley, one of the company’s representatives, indicated that the rule was not watertight.
“We kind of can give them [the Chinese company] advice and some push on … this certification process, but with some borders, often, sometimes we cross the line,” he said, “and say just do this and it will be OK.”

This is how they had a “high rate of successful certification”, he said.

EVPU would charge €2,750 (£2,241) to carry out the approval. As Miss Skrovanova explained in the meeting, although the rules are meant to be applied identically throughout the EU, “each notified body has different requirements”.

After the meetings with the notified bodies, the reporters sent an email outlining some of the device’s specifications, including the materials used to make the product and the sizes available.
Peter Luley responded the following day, asking the company to complete an application form so that he could provide a quotation.

On Aug 9, he emailed, saying: “So I have finally the total costs of certification. Please find attached price offer and let me know whether are you [sic] interested.”

After contracts had been signed and money paid, the reporters submitted a full technical dossier, prepared with the help of medical experts, at the end of August. Alarm bells should have sounded and the product been immediately rejected because the medical studies that were cited were those for the banned hip implant.

But Miss Skrovanova emailed her comments, which were unexpectedly positive. Miss Skrovanova marked the sections “product features” and “principle features of the device” as “OK”.

She said her company needed to see the companies’ “risk analysis” and information on the manufacturing process. She also said that the clinical evaluation “must be approved by responsible person” – but this was a minor administrative point.
In a telephone call last week, Miss Skrovanova confirmed again that the firm was happy with the design of the device.
A medical company is only supposed to submit its application to one notified body, but there is no system in place to prevent a company from “forum shopping” around different countries, until eventually approval is granted. This issue was raised when The Daily Telegraph also visited a company called Szutest in Brno in the Czech Republic.

Michal Bauer of Szutest said that his company had raised concerns about other notified bodies and admitted the sub-standard products were being approved.

“Some manufacturers do it so that they come to one notified body and they have very poor dossier, very poor technical file or their system is not working well and something,” he said. “So they [say] okay, 'you won’t do it for us,’ and they go to another one.

“When I have seen some certificates issued for some products, it was horrible,” he said.

At ITC, another notified body, based in Zlin in the Czech Republic, its representative Tomas Zavisek was open about where its loyalty lay. “We are on the side of the manufacturer and their products, not on the side of patients,” he said.

The company insisted that the approval would be as straightforward as possible.
“We normally do not have big obstacles to not issue certificate,” he said.

It also boasted about its success rate — in ITC’s case the pass rate was 90 per cent: “We try, we try to solve it and to complete.”

Following the meeting, the undercover reporters sent an email to ITC confirming again the key details of the product for which approval was sought. Again, no safety concerns were raised — just a quotation was provided for licensing the artificial hip.

EVPU refused to comment. ITC said it complied “in full accordance with the law”.

Undercover Investigation exposes scandle with implants

Britian
The Telegraph

Faulty medical implants investigation: Patients’ health put at risk by unscrupulous EU regulators

British patients’ health is being put at risk by unscrupulous European regulators who are prepared to license potentially dangerous medical implants for sale in this country, The Telegraph discloses.




A joint undercover investigation with the British Medical Journal has exposed loopholes in the “woeful” EU system to approve devices including replacement hips, knees and other joints.
Regulatory bodies were prepared to approve a “toxic” hip replacement, meaning that it could be sold to the NHS and legally used in British patients.
The hip – designed by experts for the purposes of the investigation – had specifications similar to a banned product suspected of poisoning thousands of health service patients.
 
One regulator, based abroad but authorised to license products for medical use in this country, was secretly recorded boasting that they were “on the side of the manufacturer”.
 
Last night, Jeremy Hunt, the Health Secretary, said that the situation was “unacceptable”.

“The safety of patients is paramount so it is completely unacceptable that patients could be subject to substandard implants,” he said. “I will ask the Medicines and Healthcare Products Regulatory Agency and British Orthopedic Association what we can do to ensure that patients can be confident they will receive the highest quality of devices.”

The investigation involved submitting a formal application for a “metal-on-metal” implant for approval in Slovakia.

The official regulatory body there last week offered provisional approval for the design of the artificial hip, despite the specifications being similar to a product that had been withdrawn in the UK, America, Australia and other developed nations outside Europe.

Another regulatory organisation in the Czech Republic, ITC, was also prepared to consider licensing the product. One representative of ITC told reporters that his company would not put “obstacles” in the way and said it was “on the side of the manufacturer and their products, not on the side of the patients”.

The disclosure raises serious questions over the safeguards for British patients. Licensing of medical devices and surgical implants is Europe-wide and regulators in this country refuse to disclose where products have been approved.
 
More than 70 private regulators compete for business, leaving the system susceptible to corrupt practices, such as those uncovered during the PIP breast implant scandal earlier this year. It works in the same way as licensing of household appliances and toys rather than the far more rigorous system for drugs.

Medical experts last night demanded an urgent review to prevent another “inevitable” scandal.
Dr Carl Heneghan, of Oxford University, who provided advice on the investigation, said: “Device regulation is in disarray: the evidence requirements at the time of approval are woeful, the conduct of notified bodies is substandard, and individuals supposedly representing the regulatory system are conflicted and in many cases underqualified.”

Reporters purporting to represent a Chinese company contacted the regulatory organisations – known as notified bodies – about approving a hip implant for the European market.

The proposed product was a metal-on-metal total hip implant made from chromium cobalt. Experts said it should have been rejected immediately because of concerns that these products have a high failure rate and pose a risk of metal ions being deposited in the bloodstream. But some regulators said clinical studies would not be necessary since similar implants were already on the market.

The reporters submitted a detailed technical dossier to a notified body in Slovakia. The firm is only supposed to approve or reject a product, but it appeared willing to give advice while its fee depended on passing the implant. At a meeting in northern Slovakia, Peter Luley, a representative of EVPU, said that they could not give “exact advice”. But he added: “We just cross the line and say just do this and it will be OK. Therefore we have so high rate of successful certification [sic].”

The cost of approval would be €2,750 (£2,240), with half paid up front. A colleague, Lubica Skrovanova, said that only four applications had failed in five years.

The Telegraph and BMJ submitted a dossier explicitly based on the DePuy ASR XL Acetabular System, which surgeons are no longer allowed to use in Britain and that is subject to legal complaints worldwide. But Miss Skrovanova indicated she would provisionally approve the fake implant. The technical file included a test report which said that it had performed badly in tests to assess “wear”.
Once the contract was signed and payment made, EVPU emailed their comments. They noted that some sections of the dossier were missing but the pages detailing the “product” features and “principle features of the device” were described as “OK”.

Miss Skrovanova said the fictional company needed to submit documents relating to the manufacturing process for final approval and the licence to be issued. But these were not related to the design specifications.

At ETI/Szutest in Brno, Czech Republic, an executive admitted that the system was riddled with problems. Michael Bauer said: “When I have seen some certificates issued for some products, it was horrible.” He added: “I have seen some notified body… that certified some product that, well, was from South Korea and the product was completely different …And it caused here in Czech Republic some issue and it [caused] some injury.”

EVPU declined to comment.

ITC said that they “comply in full accordance with the law” and that in the last 10 years they had “seen serious problems in practice and medical devices”.

ETI/Szutest said that their organisation “fully complies” with EU procedures and the meeting was “merely an introductory session before commencement of the contract”. It said that even had they accepted the order, it would not have guaranteed success. It said that Mr Bauer’s statements were “entirely his personal opinion”.

Monday, October 22, 2012

Biomet Hip Replacement Lawsuit Update: First Status Conference for Federal Biomet M2a Magnum Hip Replacement Lawsuits Scheduled for November 16th

New York, New York (PRWEB) October 21, 2012
 
posted by Bernstein Liebhard

A federal judge has scheduled the first status conference for federally-filed Biomet M2a Magnum Hip Replacement lawsuits for November 16, 2012, Bernstein Liebhard LLP reports. According to a Case Management order issued on October 12, 2012, Judge Robert L. Miller of the U.S. District Court, Northern District of Indiana, will appoint the plaintiffs’ steering committee and liaison counsel at that time. (In re: Biomet M2a Magnum Hip Implant Products Liability Litigation, No. 3:12-md-02391-RLM-CAN)*

All-federally filed Biomet hip replacement lawsuits involving the Biomet M2a Magnum Hip Replacement devices were consolidated for pre-trial proceedings and transferred to the Northern District of Indiana by the U.S. Judicial Panel on Multidistrict Litigation on October 2nd. According to the Transfer Order, eight Biomet hip replacement lawsuits are currently pending in six federal jurisdictions. The Panel also noted that it had been notified of 57 additional, potentially related actions. All of the complaints share similar allegations that the metal-on-metal design of the Biomet M2a Magnum Hip Replacement can shed dangerously high levels of metal ions into surrounding tissue and blood stream. According to the complaints, this phenomenon can cause metallosis in the surrounding tissue, as well as premature failure of the implant.**

Hip disorder cured using stem cells

Zee News in India

Bangalore: A multi-specialty hospital here has successfully used stem cells to cure a hip joint disorder, relieving affected patients from expensive surgery and conservative treatment.

"We have so far treated seven patients, including two non-resident Indians (NRIs) suffering from hip joint disorder using their stem cells and helped them to resume normal life within months," Live 100 Hospital chairman HN Nagaraj said.

Known medically as avascular necrosis, the uncommon disease leads to temporary or permanent loss of blood supply to hip joint bone and causes disorder. If not treated early, the dislocation of the hip bone with joint surface can result in disability. Any serious injury, medications such as steroids, blood coagulation or excessive alcohol can cause blood loss.

"Stem cell therapy has been used for the first time in the world to treat the hip bone disorder by rejuvenating its tissues with the bone marrow of the patient. Stem cells in the marrow of the affected bone are separated from red blood cells and blood plasma through a clinical process and injected into the hip joint of the patient," Nagaraj said, demonstrating a case study.

The private hospital on the city`s outskirts has tied up with a Pune-based laboratory to harvest the stem cells and transplant them through four injections over four weeks to restore the hip joint function lost due to damage to its cartilage. The stem cells also repair bone cells as they can differentiate between bone and cartilage cells.

"The novel treatment has no bleeding or scar formation as the process does not involve surgery. The patient has to visit our hospital for a day in a week for each of the four injections," Nagaraj said.

Though the treatment costs a patient Rs.350,000 currently, the hospital hopes to bring it down over time when awareness of the stem cell therapy spreads and more patients opt for the treatment.

The hospital will soon submit the therapy treatment protocol for publication in the Journal of Mass & Heat Transfer in the United States and Britain and file for international patent and intellectual property rights.

Among the patients cured at the hospital are two NRIs from the United States - Jayadeep Panduranga, 37, and Aishwariya, 18, who could not get relief from shooting pain due to hip disorder despite years of conventional treatment like core decompression.

"Though I underwent core decompression for nine years in California, there was no relief. Stem cell therapy has reduced pain and hip movements are almost normal," Panduranga said.

Similarly, Aishwariya, an under-graduate in Detroit, suffered pain in the right hip and faced difficulty in moving around.

"I`m able to walk again with a walker," Aishwariya said.

Sunday, October 21, 2012

Stryker Rejuvenate Recall Weighs on 3rd Quarter Earnings

New York, New York (PRWEB) October 20, 2012

Stryker Corp. has reported disappointing third quarter sales, including a hit to its hip implant business resulting in part from the recent Stryker Rejuvenate recall, Bernstein Liebhard LLP reports. According to a report from Reuters, Stryker said sales of reconstructive joints, including hips and knees, fell 1.1% overall in the third quarter.* During an October 17th conference call to discuss earnings, the company acknowledged that an approximate 2% increase in hip implant sales reflected, among other things, a “modest” hit from the recent Stryker hip recall.**

“In light of the fact that thousands of these implants were sold prior to the Stryker hip recall, it’s not surprising the company is already starting to see some impact on its bottom line. A number of plaintiffs have already filed Stryker Rejuvenate lawsuits since the recall, and we expect that trend will continue in the coming months,” said Bernstein Liebhard LLP, a nationwide law firm that represents the victims of defective drugs and medical devices, including Stryker hip implants. The firm continues to investigate Stryker Rejuvenate lawsuits on behalf of individuals who experienced premature failure of their hip implant, metallosis, or other injuries allegedly caused by one of these devices.

Stryker Rejuvenate Recall Stryker recalled its Rejuvenate and AGBII modular neck-stems on July 6, 2012, due to a potential for fretting and corrosion at the modular-neck junction. Stryker warned in its recall notice that patients with the Rejuvenate or AGB II hip implant components may develop adverse local tissue reactions that could manifest with symptoms of pain and/or swelling. According to the company, some 20,000 of the affected implants had been sold prior to the Stryker hip recall.***

According to a recent report from NorthJersey.com, at least eight plaintiffs have filed suit in New Jersey Superior Court, Bergen County, alleging Stryker negligently sold the Rejuvenate hip stem. The plaintiffs claim to have suffered metal poisoning, pseudo tumors, and infections, which led to revision surgery.****

Researchers Warn Against Hip Resurfacing

A major study finds high failure rates for this alternative to total hip replacement.

By Linda Rath
 
10/19/12 Hip resurfacing – an alternative to total hip replacement surgery – has unusually high failure rates, according to a new study published online in The Lancet. And for that reason the study authors recommend the procedure should be used only in very carefully selected male patients, and rarely in women.

Hip resurfacing is similar to total hip replacement, or THR, except the top portion of the thighbone, or femur, is left in place and capped with a metal, dome-shaped covering. The result is a larger hip ball – called femoral head – that more closely resembles a normal joint. That capped ball then fits into a metal cup that serves as the hip socket.

Using data from the National Joint Registry for England and Wales, the observational study looked at more than 400,000 patients who underwent hip surgery between 2003 and 2011. Of these, 31,932 had resurfacings.

Theoretically, hip resurfacing should reduce the risk of dislocation, a leading cause of joint failure (along with fractures and loosening) since the femoral head is larger than in traditional total hip replacements.

But University of Bristol researchers found the opposite. Hip resurfacing was associated with significantly higher failure rates than total hip replacement, or THR, especially in women. Failure rates were related to femoral head size, with the smallest sizes more prone to early failure.
Predicted five-year revision rates (ie: those expected to need a second surgery to correct an implant failure) ranged from 6.1 percent for women with a 46 mm femoral head to 8.3 percent for those with a 42 mm head. In comparison, women who received a traditional THR with a 28 mm head had a predicted five-year revision rate of between 1.5 and 2.6 percent (depending on the material used).
Men who underwent resurfacing with smaller-diameter heads also experienced more failures – although at about half the rate of women.

Ashley Blom, MD, a study author and professor of orthopaedic surgery at the University of Bristol, says hip anatomy, poor bone quality or the presence of osteoporosis might account for the greater number of failures in women.

Failure rates for hip resurfacing in both sexes were so high researchers recommended against the procedure in women and in men with smaller body frames.

Dr. Blom sees little room for exceptions. "The evidence that hip resurfacing gives better function is not strong," he says. "A recent paper in the BMJ [described] a randomized controlled trial that showed no difference in pain and function between hip resurfacing and [conventional] stemmed hip replacement. However, the evidence that [resurfacing] implant failure is much higher in women is very strong."

Resurfacing was originally targeted to active younger adults because of better wear resistance and because the preserved bone may make it easier to perform total hip replacement later on.

But according to Art Sedrakyan, MD, an associate professor at Weill Cornell Medical College in New York and an authority on comparative effectiveness research, hip resurfacing wasn't limited to this relatively small population. "Thousands of people on Medicare received these implants," he says. "Any technology adopted in the world can be adopted in very unexpected ways. That's why it's important to have clear criteria about who is going to benefit."

Dr. Sedrakyan wrote a commentary accompanying the Lancet report but was not involved in the study. In the commentary, he brings up the issue of the metal-on-metal bearings in resurfacing implants.

A growing number of serious complications including bone damage and cardiovascular and neurological problems have been linked to THR with a metal ball and socket (called metal-on-metal, or MoM) due to the microscopic metal particles that are released into the surrounding tissues and bloodstream as the ball and socket components rub together.

The current study did not look at the safety of resurfacing implants, but researchers say they could present the same risks as metal-on-metal THRs.

Dr. Sedrakyan notes – as he has in the past when speaking about the potential hazards of metal on metal hips – that there are no good studies on the long-term effects of chromium and cobalt ions produced when these metal bearings rub together.

"People get resurfacing implants at a relatively young age, and we don't know what happens after 20 or 30 years of metal ion exposure," he says. "If hip resurfacing devices are found to be unsafe, then the implications are grave."

Regulatory agencies in the U.K. advise annual checks and imaging tests for people with metal-on-metal hip systems, but no such guidelines exist in the U.S. In June, a Food and Drug Administration advisory panel took the first step by recommending that patients experiencing symptoms from all-metal hips have annual X-rays and metal ion testing.

Dr. Blom tells resurfacing patients not to worry too much, but suggests similar precautions: "If you have pain, I would advise an annual review by surgeons, have your metal levels checked and a MARS MRI of the hip," he says. A MARS (Metal Artifact Reduction Sequence) MRI cuts down on distortions to the image caused by the metal implant.

As to whether female patients should continue to undergo hip resurfacing, Thomas Vail, MD, chair of the department of orthopaedic surgery at the University of California, San Francisco, agrees with the researchers. "I would concur with the findings of the authors that indications for metal-on-metal implants should be stringently applied,” he says. “Based upon the emerging information, it would seem that the indications for metal-on-metal hip resurfacing in women are increasingly limited to surgeons with technical expertise in resurfacing and female patients with special cases where total hip replacement might be less desirable."