Saturday, March 31, 2012

Consumer Reports Investigates: Dangerous medical devices

Most medical implants have never been tested for safety

Consumer Reports magazine: May 2012

Tens of millions of Americans live with medical devices implanted in their bodies—artificial joints, heart defibrillators, surgical mesh. And it’s a safe bet that most of them assume that someone, somewhere, tested the devices for safety and effectiveness.
But that is rarely the case. For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and pay the Food and Drug Administration a user fee of roughly $4,000 to start selling a product that can rack up many millions of dollars in revenue. Often, the only safety “testing” that occurs is in the bodies of unsuspecting patients—including two of the three people whose stories are told in this report.
As for the smaller number of high-risk products for which advance safety studies are required, government rules allow them to be sold based on studies that are smaller and less rigorous than those required for prescription drugs.
“Standards for devices exist, they just don’t make sense,” says Diana Zuckerman, Ph.D., a vocal critic of the current system and president of the National Research Center for Women & Families, a nonprofit advocacy organization.
In 2011, a panel from the prestigious Institute of Medicine said the FDA should overhaul its device regulatory system because it fails to ensure patient safety before and after products go on the market. Instead, Congress is now debating a new law that would keep the present system virtually intact and ratify an agreement between the FDA and industry to get devices on the market even faster.
The FDA believes “the program has served American patients well,” says Jeffrey Shuren, M.D., director of the agency’s Center for Devices and Radiological Health. “As a responsible guardian of public health, the FDA believes it’s a challenge to eliminate a program without having a better alternative.”
But an investigation by Consumer Reports, which included interviews with doctors and patients and an analysis of medical research and a device-safety database maintained by the FDA, shows the following areas of concern:
  •  Medical devices often aren’t tested before they come on the market. “What they’re doing is conducting clinical trials on the American public,” says Dan Walter, a political consultant from Maryland. His wife was left with heart and cognitive damage from a specialty catheter, cleared without testing, that malfunctioned during a procedure to treat an abnormal heartbeat.
  • There’s no systematic way for the government, researchers, or patients to spot or learn about problems with devices. “A coffeemaker or toaster oven has a unique serial number so if a problem is found, the company can contact you to warn you. Your artificial hip or heart valve doesn’t,” Zuckerman says. “Your doctor is supposed to notify you of a problem but may not be able to if he has retired or passed away.”
  • Without major changes in the system, there’s not much that patients can do to protect themselves.
Below are stories from three people, injured by three very different devices, that highlight the dangers consumers face in the current marketplace.

Surgical mesh: No testing


Janet Holt was “in such pain I couldn’t sit, I couldn’t stand, and I could hardly walk.”
Photo by: Alexander Aleman               
In 2007, Janet Holt of Floresville, Texas, felt swelling in her pelvic area. She went to her gynecologist, who told her that her bladder and uterus had prolapsed—dropped out of their normal position within her pelvis. The doctor recommended a hysterectomy and bladder lift.
“He talked about building a little bird’s nest to hold my bladder up,” Holt recalls. “He said I’d be back at work in two weeks.” She has yet to return to work full-time on the cattle ranch and small chain of restaurants she runs with her husband.
The “bird’s nest” turned out to be a sheet of synthetic mesh that was implanted by instruments inserted through the walls of her vagina. In the weeks and months after surgery, she says, “I was in such pain I couldn’t sit, I couldn’t stand, and I could hardly walk.” Over time, the mesh shrank and shifted, eventually working its way back out of the vaginal wall, an experience Holt likens to “open cigarette burns with each step you take. It’s complete torture.”
Today, after eight surgeries to adjust and remove the mesh, Holt, who is suing the device manufacturer, says she has been left with painful nerve damage in one leg. “I’m 54 years old and it has totally ruined my life,” she says.
Holt is one of hundreds of thousands of women implanted with transvaginal mesh for prolapse repair and bladder support since the first such products came on the market in the early 2000s. Manufacturers marketed the mesh packaged in a “kit” with tools for insertion and marketed them to doctors as an easier way to do a surgery that had traditionally required special additional training.
“The companies were saying, ‘The salesman will show you how to do it,’ ” said Lewis Wall, M.D., professor of obstetrics and gynecology at Washington University in St. Louis. Despite thousands of reports of adverse events, repeated alarms by women’s-health and consumer-health advocates, and multiple lawsuits, these products are still being sold—and are still classified as “moderate risk” devices.
In an August 2011 petition asking the FDA to take transvaginal mesh off the market, the consumer advocacy group Public Citizen called it “a ‘poster-child’ example of the fundamental failure ... to protect the public’s health and welfare.”
How did it happen? The mesh manufacturers took advantage of a loophole in the law that allowed them to grandfather their products onto the market without any advance safety testing.
Here’s how it works: Before 1976, a manufacturer could sell virtually any medical device at will. That year, a new law for the first time classified medical devices into three risk categories, with clinical data required only for devices in the highest-risk category, Class III.
The FDA has yet to fully enforce even that minimal testing requirement. The agency routinely clears new devices in all three risk classes without clinical testing as long as manufacturers can show they are “substantially equivalent” to a device that has already been on the market.
And that’s exactly what the makers of transvaginal mesh did. The mesh kits were cleared based on their “substantial equivalence” to an earlier mesh used to repair abdominal hernias that was sold as long ago as the 1950s, even though the kits were designed to be used in a different part of the body and inserted laparoscopically, not through open surgery.
“You’re putting a foreign object into the pelvis through a contaminated space, so there’s a very high potential risk of infection,” Wall says. “But there weren’t any clinical trials done with these products before they hit the market.”
“The paradox is that companies go to the FDA and claim that a device is ‘substantially equivalent,’ but when they market it, they claim it’s ‘new and better,’ ” says Rita Redberg, M.D., a professor of medicine at the University of California, San Francisco, and editor of the Archives of Internal Medicine. The clearance process costs manufacturers next to nothing; they pay the FDA a user fee of $4,049.
It was only in January 2012, about 10 years after the first kits hit the market, that the FDA took action. It ordered 33 companies to conduct the first-ever post-market safety studies of the products. The agency is thinking of reclassifying those mesh kits to the highest-risk Class III.
But Shuren, at the FDA, notes that with the government’s rule-making process, “from the time the FDA decides to upclassify a device to the time it can actually do it can take years.”

Lap-Band: Minimal testing


Lisa Wilson's weight-loss device had to be removed after it cut into her stomach.
Photo by: Inti St. Clair               
In 2009, after many unsuccessful diets, Lisa Wilson, then 46, a pharmacy technician from Seattle, received the Lap-Band adjustable gastric band.
The implanted band constricts the size of the stomach to make it difficult to eat large quantities of food. In fact, the opening left to Wilson’s stomach was so small that she had difficulty eating even small amounts of food. It also caused her to throw up almost every day.
But she stuck with it, losing 70 pounds, until a routine endoscopy in December 2010 revealed that the band had cut into her stomach lining and would have to be removed immediately. She developed a post-surgical infection that resulted in a partially collapsed lung and an eight-day hospital stay. Wilson says she has regained half of the weight she lost.
More than 650,000 Lap-Bands have been sold worldwide, according to the 2010 annual report from its manufacturer, Allergan. It’s among the minority of devices so novel that manufacturers can’t find an older product for grandfathering.
Those products usually have to undergo advance testing for safety and effectiveness to get the FDA’s approval for marketing. But the tests aren’t nearly as rigorous as those required for prescription drugs, even though, as Redberg notes, “if you have a problem with a drug, you can just stop taking it, but you can’t do that for a device implanted in your body.”

And the FDA charges device manufacturers only $220,050 to review a new device, compared with the $1.84 million it charges to review a new drug application.
If Lisa Wilson had seen the lone study on which the approval was based, she might not have been surprised by her problems. Of the 299 people in the study, 51 percent reported nausea, vomiting, or both, and 25 percent had their bands removed before the end of the three-year study because of complications or failure to lose enough weight.
Imagine if a car had a recall rate that high,” says John Santa, M.D., director of the Consumer Reports Health Ratings Center. “Consumers and regulators would be up in arms. But in the world of medical devices, these things often stay hidden.”
The Lap-Band clinical trial was fairly typical of such pre-marketing studies. Redberg and colleagues looked at 123 studies done on high-risk cardiovascular devices that received FDA approval between 2000 and 2007. Only 27 percent met the gold standard of being randomized clinical trials, according to the report, published in December 2009 in the Journal of the American Medical Association.

Metal hips: Missed alarms


Stephen Tower, M.D., was injured by the same artificial hip he implanted in patients.
Photo by: Clark James Mishler               
If any patient should have gone into a hip replacement fully informed, it was Stephen Tower, M.D., 55, an orthopedic surgeon from Anchorage, Alaska. Instead, he became the victim of another device that was grandfathered onto the market without clinical testing.
In this case, it was an artificial hip introduced in 2005 by DePuy, the orthopedic division of Johnson & Johnson. Called the ASR XL (shown at the top of this page), it was distinctive because both components—the ball at the top of the femur and the socket liner inside the pelvis—were made of chrome-cobalt metal.
The FDA cleared it without clinical testing based on “substantial equivalence” to earlier devices, though such metal-on-metal hips had long been on the agency’s high-priority list for requiring advance clinical trials.
The all-metal hips were supposedly a great advance over hips with the traditional plastic socket liner, Tower recalls. “The main reason hips traditionally failed was because of plastic wear,” he says. “The metal-on-metal hip was being promoted not only commercially but in the medical literature as being a solution for patients like me, who wanted to return to no-holds-barred physical activity.”
By 2006, Tower’s arthritic hip had forced him to give up practically all the outdoor pursuits he had moved to Alaska to enjoy. He had a DePuy ASR XL implanted in May of that year, and “within six weeks I did a double century bike race,” he says. He was so enthusiastic that within 10 months he had put various models of metal-on-metal hips in six of his patients.
But by the time a year had passed, it became clear that something was wrong. His hip was “pretty much constantly painful” and the chromium and cobalt levels in his blood “were notably high,” he says.Then he started noticing other problems, such as disturbed sleep, mood swings and anxiety, hearing loss, visual problems, and tinnitus.
Throughout that period, he says, he repeatedly questioned DePuy engineers, design surgeons, and sales representatives, “and they’d say, ‘Geez, Steve, we haven’t heard of this.’
Tower’s symptoms became so severe at times that he was unable to work. Meanwhile, his research, some of which he has since published in medical journals, was uncovering evidence that metal debris from joint implants can cause what he describes as “profound poisoning.”
After having the hip removed in 2009 and replaced with a new one made of ceramic and plastic, his symptoms have markedly improved.
In August of 2010, DePuy recalled all 93,000 ASR XL hips worldwide after it became clear that the device was failing far more often than average and producing serious injuries. While it’s unclear how many people actually have had to have their artificial hip removed, an article in the British Medical Journal called it “one of the biggest disasters in orthopaedic history.”
Although the hip was invented and manufactured by an American company, the recall occurred because as early as three years previously—even as DePuy’s engineers were assuring Tower that the hip had no problems—regulators in Australia, England, and Wales were noticing serious problems.
They were able to do so because they have national joint registries—a list of every joint implanted—and the ability to track how patients fare with various models. There is no such national registry in the U.S., although Kaiser Permanente has a large private one.
The FDA has a voluntary system whereby doctors, manufacturers, and patients can report problems with medical devices. And though experts estimate that only a fraction of device problems ever get reported, from 2009 through 2011, the agency received 20,518 reports of injuries from metal-on-metal total hip replacements. Of those, 15,137 concerned the now recalled DePuy hip. Many of the remaining complaints concerned several other brands and models that are still on the market in the U.S.
The 2011 Institute of Medicine panel concluded that the FDA’s ability to spot problems is so inadequate that it’s “impossible to confidently draw broad conclusions about the safety and effectiveness of products that are on the market.”

How to fix the system

Consumers Union, the advocacy arm of Consumer Reports, agrees with the Institute of Medicine that the current system of medical-device regulation doesn’t protect patients from harm. Consumers Union recommends that the FDA:
  •  Require that implants and other “life-sustaining” devices be tested at least as rigorously as drugs.
  • End the practice of “grandfathering” high-risk new implants and life-sustaining devices.
  • Create a “unique identifier system,” or IDs for implants, so that patients can be quickly notified about recalls and safety problems.
  • Create national registries so that problems can be spotted quickly and patients notified.
  • Increase the user fees paid by manufacturers for regulatory review so that the FDA has enough money to do its job.
Have you had a problem? Tell us about it now. If you’ve had a problem with an implant or a medical device, please tell Consumer Reports about your experience. Your information is kept confidential (unless you indicate otherwise) and your story helps us monitor medical problems, research future articles, and push for reform.
To help, go to SafePatientProject.org and click on “Share Your Story” or click on “Act Now” to help us work for change.

Protect yourself against risks

Here are a few steps you can take to guard against the risks posed by dangerous medical devices.
Consider alternatives. Ask your doctor what will happen if you don’t get the implant. Many women who received transvaginal mesh for prolapse repair, for example, probably never even needed surgery.
“Pelvic organ prolapse is almost never a life-threatening condition. It’s a quality-of- life issue,” explains Daniel S. Elliott, M.D., assistant professor of urology at the Mayo Clinic College of Medicine. “The overwhelming majority of women do not need to have surgery. If you’re not bothered by it, then don’t do anything. I think many patients weren’t adequately informed about that.”
You may also have non-mesh alternatives. Elliott says he and other well-trained pelvic surgeons routinely repair prolapses with techniques that don’t require any mesh at all. On the other hand, people ill enough to need an implantable defibrillator for their heart may not have another choice.

Research the device. The Food and Drug Administration’s website, FDA.gov, has a wealth of information about device safety warnings, complaints, and recalls, easily accessible by typing the name of the device into the site’s search box. It’s also worth searching Google. If the results include a lot of law firms looking for clients injured by the device, that’s a sign to ask your doctor some hard questions.
For an optional device like a Lap-Band or breast implant, look around the Internet for patient forums. Though the information there isn’t validated, you’ll get a sense of whether patients are reporting trouble with the device.
Write down what you got. If your doctor doesn’t give you information about the brand name, model, and serial number (if it exists) of your device, ask for it. If you learn of a warning or safety recall, from the FDA or elsewhere, you’ll know whether yours is one of the problem models.
Stay alert—but don’t panic. If you learn that there are problems with your device, contact your doctor and ask what warning signs to watch for. Also go to the FDA website to read up on official warnings and find out whether it’s safe to keep the device in your body.
For example, if you have a metal-on-metal hip, call your doctor if you have pain or other unusual new symptoms, such as heart, vision, hearing, emotional, or neurological problems, because all of those might be signs of a reaction to the device. You might also want to get your blood tested for high cobalt levels, a sign that the hip is deteriorating.
But don’t assume that all problematic devices have to be removed. For example, pelvic surgeons say they often get calls from worried women who have had mesh repairs. “If the mesh is not causing any problem, don’t do anything because getting mesh out is very difficult and dangerous,” Elliott says.

Cardiac devices are risky, too


Automatic external defibrillators have been recalled 90 times in seven years.
Cardiac devices dominate the list of reports to the Food and Drug Administration of deaths and injuries. Here are three devices that have had significant problems in recent years:
Implantable cardioverter-defibrillators. Since 2009, the FDA has received reports of close to 29,000 deaths or injuries from these devices, by far the most for any device type, according to our analysis of the FDA’s database of adverse events. Implanted in more than a half-million Americans with serious heart disorders, the defibrillators detect abnormal rhythms and administer shocks to correct them.
The most troublesome aspect of the devices are the leads—wires that connect them to the heart. There have been two major recalls, in 2007 and 2011, of defective leads, the Medtronic Sprint Fidelis and the St. Jude Riata, after they had already been implanted in almost 350,000 patients. Patients with the device leads require close monitoring and face the prospect of having to have them surgically removed.
In congressional testimony in 2009, Boston cardiologist William Maisel, M.D., described what happened to a patient of his: “The simple act of removing his shirt over his head caused his … lead to fracture. [He] suffered a cardiac arrest in front of his wife.” The patient survived but never fully recovered.
Vena cava filters. These devices are placed in the vessel that returns blood from the lower body to the heart to prevent pulmonary embolism, a life-threatening condition caused by blood clots breaking loose from the leg and traveling to the lungs. Some 200,000 people get such filters each year.
Many should be removed once the danger of clots has passed, but often aren’t. In a November 2010 study in the Archives of Internal Medicine, Pennsylvania researchers found that pieces of the Bard Recovery filter had broken off and migrated elsewhere in the body in one of four study patients. One patient needed open-heart surgery.
“Remarkably,” wrote cardiologist Rita Redberg, M.D., of the University of California, San Francisco, in an editorial accompanying the report, these filters “were considered Class II by the FDA—the same risk category of mercury thermometers—and received approval without any clinical data of safety and effectiveness.”
“The devices were being used inconsistent with their FDA clearance,” says Jeffrey Shuren, M.D., director of the agency’s Center for Devices and Radiological Health. “We don’t have authority to do something about that.” If you’ve received the device, ask your doctor whether it has been removed.
Automated external defibrillators. Found in airports and other public buildings, these devices are designed so that bystanders can operate them. AEDs automatically diagnose abnormal heart rhythms and deliver shocks to people in cardiac arrest.
The problem is, they don’t always work. The industry has conducted about 90 recalls over the past several years, affecting hundreds of thousands of devices. Between 2009 and 2011, the FDA received reports of 72 injuries, 686 deaths, and 20,667 malfunctions connected with the devices. Arizona researchers found that in most cases the machines weren’t able to diagnose the abnormal rhythms properly or failed to deliver the recommended shock.
The FDA is considering whether to downgrade AEDs from the highest-risk category to moderate-risk. recalled Defibrillators have been recalled 90 times in seven years.
Editor's Note: A version of this article appeared in the May 2012 issue of Consumer Reports magazine with the headline "Dangerous Devices."

Thursday, March 29, 2012

Discrediting the counterpoint?

Two nites ago, I published the only counterpoint I could find to the Brits recomendation of discontinuing the use of  large head metal on metal implants.  I thought the  publication was  odd because it came out the same time the Lancet article was published recommending that they not be used any more. Further, I noted one of the authors was a surgeon who published and worked  for Depuy before.  Sure enough, he may have been  paid in 2011 to pull those articles together or at least it looks that way.  http://www.mydepuyhiprecall.com/2012/03/counter-point-to-recent-metal-on-metal.html  (one of our readers pointed this out to me.)

I think there is nothing wrong with being paid to perform work.  We all get paid to perform work but if you are publishing in a journal with the presumption of objectivity, I would want to know who paid you to do the work.  With respect to Dr. Kindsfetter, I would like to know what percentage of his patients recieve metal on metal implants at this point.

I  think that all journal articles should have a clear indication of what money funded the publication.  A source of funds statement would be in order. Medical companies are a huge source of research dollars to science.  I just think there should be full disclosure of the source of funds for medical studies.  We do that in Finance now.  If someone is advocating the purchase of stock and their institution has an interest in pushing it, it must be disclosed via the safe harbor provisions which require the disclosure.  Surely medicine is no different.

From the Depuy web site: http://www.depuy.com/about-depuy/depuy-divisions/depuy-orthopaedics/find-surgeon/104

Dr. Kirk Kindsfater specializes in joint replacement and reconstruction. He received his undergraduate degree in Mechanical Engineering from Colorado State University and his medical degree from the University of Colorado School of Medicine. Dr. Kindsfater did his orthopaedic residency at the University of Colorado Health Sciences Center in Denver, Colorado and followed this with a fellowship in adult reconstructive surgery at the Brigham and Women's Hospital, Harvard School of Medicine in Boston. He is board certified by the American Academy of Orthopaedic Surgeons and is a member of the American Association of Hip and Knee Surgeons and is a past president of the Colorado Orthopaedic Society. Dr. Kindsfater has practiced in Fort Collins, CO since 1995. Dr. Kindsfater has extensive clinical experience, having performed over 7,000 hip and knee replacement procedures since beginning practice in 1995.

2010 Jan-Dec 2011
Consulting Income for Professional Services $46,699 $153,842
Clinical Research $0 $9,132
Commercial Air $2,868 $7,688
Corporate Air $1,973 $741
Direct Expense Reimbursement $4,834 $1,007
Lodging $977 $1,372
Meals $1,233 $2,163
Transportation $491 $370

Wednesday, March 28, 2012

Who said there were no suspicions surrounding these metal-on metal hips until late? Not so.

I think you will find this article interesting because of the date of publication of it: 1973!!!  39 YEARS AGO!


Br Med J. 1973 Mar 3;1(5852):527-9.

Concentration of wear products in hair, blood, and urine after total hip replacement.



Abstract


Raised levels of cobalt and chromium are found in the blood and urine of patients with metallic total hip replacements. When one of the hip components is made of polyethylene much less metal seems to be released from the joint. The long-term effects of the accumulation of chromium in the body need to be studied further.

Now fast forward to 1998


J Bone Joint Surg Am. 1998 Oct;80(10):1447-58.




Metal release in patients who have had a primary total hip arthroplasty. A prospective, controlled, longitudinal study.



Source


Department of Orthopedic Surgery, Rush Arthritis and Orthopedics Institute, Rush Medical College, Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois 60612, USA. jacobs@ortho4.pro.rpslmc.edu

Abstract


There is an increasing recognition that, in the long term, total joint replacement may be associated with adverse local and remote tissue responses that are mediated by the degradation products of prosthetic materials. Particular interest has centered on the metal-degradation products of total joint replacements because of the known toxicities of the metal elements that make up the alloys used in the implants. We measured the concentrations of titanium, aluminum, cobalt, and chromium in the serum and the concentration of chromium in the urine of seventy-five patients during a three-year prospective, longitudinal study. Twenty patients had had a so-called hybrid total hip replacement (insertion of a modular cobalt-alloy femoral stem and head with cement and a titanium acetabular cup without cement), fifteen had had insertion of an extensively porous-coated cobalt-alloy stem with a cobalt-alloy head and a titanium-alloy socket without cement, and twenty had had insertion of a proximally porous-coated titanium-alloy stem with a cobalt-alloy head and a titanium socket without cement. The remaining twenty patients did not have an implant and served as controls. The results of our study showed that, thirty-six months postoperatively, patients who have a well functioning prosthesis with components containing titanium have as much as a threefold increase in the concentration of titanium in the serum and those who have a well functioning prosthesis with cobalt-alloy components have as much as a fivefold and an eightfold increase in the concentrations of chromium in the serum and urine, respectively. The predominant source of the disseminated chromium-degradation products is probably the modular head-neck junction and may be a function of the geometry of the coupling. Passive dissolution of extensively porous-coated cobalt-alloy stems was not found to be a dominant mode of metal release. CLINICAL RELEVANCE: Increased concentrations of circulating metal-degradation products derived from orthopaedic implants may have deleterious biological effects over the long term that warrant investigation. This is a particularly timely concern because of recent clinical trends, including the reintroduction of metal-on-metal bearing surfaces and the increasing popularity of extensively porous-coated devices with large surface areas of exposed metal. Accurate monitoring of the concentrations of metal in the serum and urine after total hip replacement also can provide insights into the mechanisms of metal release. Our findings suggest that fretting corrosion at the head-neck coupling is an important source of metal release that can lead to increased concentrations of chromium in the serum. Determinations of the concentrations of metal in the serum and urine may be useful in the diagnosis of patients who are symptomatic after a total joint replacement as increased levels are indicative of at least one mode of mechanical dysfunction (for example, fretting corrosion) of the device.

Tuesday, March 27, 2012

A counter point to the recent metal on metal warnings for large diameter hips>: Do they result in low or high revision rates? Should they be used or shouldn't they?

I am printing this journal article because it seems to be completely leaning in the opposite direction of the British medical advise which is to stay away from the large diameter hips.  It was curious until I looked at the authors.  I noticed this fellow Dr. Kindsfeter.  I knew I had seen his name previously.  Turns out that he did a study on these hips which Depuy printed in all of their sales literature re the safety of these large MoM hips:

*Reference:
Kindsfater K, Barrett WP, Dowd JE, Southworth CB and Cassell MJ. "99.9% Midterm Survival of the Pinnacle Multi-Liner Acetabular Cup in a Prospective Multi-Center Study." Poster Presentation #P077, AAOS, San Diego, CA. February 14-18, 2007.

Notice this reference  was to the  Depuy Pinnacle multi-liner acetabular cup. Unfortunately, no one can produce this study as it was just a poster at the American Orthopedic Association conference in 2007.  I presume it was NOT peer reviewed?

"Pinnacle Hip Solutions were designed to help provide a more fluid range of natural motion. DePuy Orthopaedics remains the leader in metal-on-metal technology, offering several advantages, including larger diameter bearings that can improve hip range of motion and stability. In fact, one study conducted since the device was approved in 2002 observed that an estimated 99.9 percent* of Pinnacle Hip components remain in use. Only Pinnacle Hip Solutions feature TrueGlide™ technology, allowing the body to create a thin film of lubrication between surfaces. The result is a smooth, more fluid range of natural motion."

Gee, its interesting because multi district litigation has begun with the Pinnacle metal on metal hip.  While they haven't been recalled, the law suits are piling up.

I just don't know what to make of this study in light of what seems to be some very strong ties with Depuy.  I don't know for sure of course but do you know of any other medical professional publishing new data on the great performance of metal on metal hips?  Well, here is one!  This would have had to be peer reviewed to get into this journal.  If I find other studies promoting the use of these hips, I will let you know.

Also note the dates of both sides of this argument:

The Kindsfeter article appeared before print on `14 March 2012
The British Lancet article appeared before print on 12 March 2012.

Is this just a mere coincidence?

Kindsfeter's compiled findings of other studies are quite positive vs the Lancet findings which are completely negative.

J Arthroplasty. 2012 Mar 14. [Epub ahead of print]

Large-Diameter Modular Metal-on-Metal Total Hip Arthroplasty: Incidence of Revision for Adverse Reaction to Metallic Debris.

Source

Valley Orthopedic Associates, Proliance Surgeons, Joint Center at Valley Medical Center, Renton, Washington.

Abstract

Large-diameter modular metal-on-metal (MOM) total hip arthroplasty (THA) may offer reduction in wear debris and improved stability. Four studies are summarized here that used a large-diameter modular MOM system. A total of 1076 THAs were performed. This article presents data from 779 of these THAs with minimum 2-year follow-up (mean, 4.2 years) or revision since index THA (21 hips, with 1 more pending). Overall survivorship at 2 years was 98.6%; at 5 years, it was 97.0%. Seven revisions for an adverse reaction to metallic debris (ARMED), and 1 additional pending revision for ARMED, showed marked variability in presenting symptoms and intraoperative and postoperative findings. Data show good clinical performance of the modular MOM system, but suggest that surgeons must be diligent in monitoring MOM THA patients and aggressive in diagnosing and revising patients with a potential ARMED

xxxx

How do we reconcile these studies with the new recommendations comming out from the British folks recently?  Fodder for the lawyers?  see the following posts:

At last week's British Hip Society Annual Conference, in Manchester England: "... large diameter MoM primary hip replacements should no longer be performed.... http://www.mydepuyhiprecall.com/2012/03/at-last-weeks-british-hip-society.html

Recent Data from the Hip registries in England and Wales: Metal-on-metal stemmed articulations give poor implant survival compared with other options and should not be implanted

http://www.mydepuyhiprecall.com/2012/03/recent-data-from-hip-registries-in.html


Lancet. 2012 Mar 12. [Epub ahead of print]

Failure rates of stemmed metal-on-metal hip replacements: analysis of data from the National Joint Registry of England and Wales.


Monday, March 26, 2012

Top FDA Regulator Calls For End of Medical Device Loophole

reprinted from Drug Watch

The top medical-devices regulator at the U.S. Food and Drug Administration (FDA) says the agency needs more power to block unsafe products and prevent repeats of faulty hip implants and vaginal mesh that sparked thousands of patient lawsuits, Bloomberg News reports.

Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, is speaking against the backdrop of legislation introduced in February that would allow the FDA to reject medical devices that are based on recalled products.

“It’s good for patients and it’s good for companies and it assures that if there’s a problem with the new device, it gets addressed before it goes to market,” Shuren said. “The challenge now is if there’s a problem, it can get replicated.”

Shuren did not endorse the bill but does support a legislative fix.

Rep. Edward Markey (D-Mass.), who sponsored the bill in the U.S. House of Representatives, asserts that loopholes in the FDA’s 510(k) approval process that bypass clinical trials must be closed.
“If an automobile is recalled for a major safety problem, we wouldn’t allow future models to repeat this same flaw, and the same should be true for the medical devices used in our bodies,” Markey said in a statement. The bill ensures “that devices do not mimic the mistakes made by other products.”
By law, the FDA has to OK devices that claim an approved predicate unless the older device has been taken off the market by the agency, Shuren said. Because most companies choose voluntary recalls, the devices can continue to serve as models for future products, he said.

Numerous and dangerous complications of transvaginal surgical mesh implants used to correct Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), which have been marketed without human testing, prompted the bill. Many of the implants were approved based on a mesh product from Boston Scientific that was voluntarily recalled in 1999.

Shuren said that even though an average of only 28 of 3,000 devices approved annually can be traced to the loophole, some, such as vaginal mesh, have created dangerous health situations and undermined the public’s trust in the FDA.

The bill would need to pass the House and the Senate before President Barack Obama could sign it into law.

If the bill passes, it would also affect another large class of medical devices – hip replacement systems. More than 93,000 DePuy ASR hip implants were recalled in August 2010 because the metal-on-metal parts created excessive friction, releasing metal fragments into patients’ blood. The Johnson & Johnson subsidiary introduced the ASR model after its Pinnacle hip replacement system, which had a similar defective design. A new law would help prevent such successive faulty products in the future.

Sunday, March 25, 2012

Did Depuy unload inventory of ASRs after problems were known?

Excerpts from the Injury Board article

1.  The 2009 data from the Australian Registry showed high failure rates of the ASR

2.  In 2009, the FDA confidentially notified Depuy that they would not be approving a new ASR resurfacing system that had been in use in the UK.

3.  A letter from the FDA expressed concerns about the high levels of metal in traditional hip implants

4.  A depuy employee discussed selling out the inventories  in 2009 and 2010, until the inventories were almost depleted.

5.  products were recalled in 2010.

See article source for these claims for the actual New York Times article published on Thursday last week:  Hip Device Phaseout Followed F.D.A. Data Request

Friday, March 23, 2012

Hip Device Phaseout Followed F.D.A. Data Request

Officials also wrote that reports from countries where the implant was then being used showed it was performing “somewhat more poorly” than data submitted by the company’s DePuy Orthopaedics unit indicated. By mid-2009, for example, data from Australia showed that the device was failing at high rates just a few years after implantation, rather than lasting 15 years as expected.

The Food and Drug Administration’s statements were contained in a so-called nonapprovable letter in which the agency confidentially notified DePuy in 2009 that it was turning down the company’s application to sell the device in the United States. The bulk of the letter focused on problems that agency reviewers found with study data submitted by DePuy to support its claim that the artificial hip was safe and effective.

In its letter, the agency also asked DePuy for added safety data if it wanted to pursue its application.
DePuy did not recall the device at issue, or a companion model that was used in this country, until August 2010, a year after it got the administration’s letter. But in September 2009, just weeks after the letter arrived, company executives started a strategy to phase out the devices while selling their remaining stocks for use in patients both here and abroad, company records show.

It is not known how many patients got the hip model, known as an articular surface replacement and sold under the trademarked name ASR, during that year. In an eight-year period, some 93,000 patients worldwide received the model, about one-third of them in this country.

In addition to dealing with a high rate of premature failure, hundreds of patients who got an ASR have suffered crippling injuries caused by particles of metallic debris generated as the all-metal implant wears.

“We are almost out of ASR, and the few doctors still using ASR are threatening to leave DePuy anyhow,” a company executive wrote in an e-mail in May 2010, nine months after the Food and Drug Administration’s letter. Thousands of patient lawsuits are proceeding against DePuy in connection with the ASR, and the e-mail is among thousands of company documents gathered by lawyers.
       
DePuy executives have insisted that they acted appropriately in recalling the implant model when they did, saying that before August 2010 internal company data showed that the model was performing as well as competing implants. They have also repeatedly said that their decision to phase out the model was based on slowing product sales, rather than any factors related to the device’s safety or the Food and Drug Administration’s decision not to approve the device.

Last month, after an article in The New York Times disclosed DePuy’s receipt of the administration’s letter, the company’s chief executive, Andrew Ekdahl, defended DePuy’s 2009 decision not to disclose the letter to doctors or patients. Mr. Ekdahl said any suggestion that the administration had concluded that the ASR had safety issues was “simply untrue.”

A DePuy spokeswoman, Mindy Tinsley, said the only conclusion the administration reached in its letter was that the data submitted by DePuy “was inadequate to evaluate the safety and effectiveness” of the device.

She also said comments made by company executives about selling the device’s inventories were simply part of a program to phase out the device and were not connected to safety issues.
The version of the device that the administration declined to approve for the United States was used abroad only in an alternative hip replacement procedure known as resurfacing. A sister version of the device was used both here and abroad in traditional hip replacement. Both models were based on the same component, a metal cup replacing a patient’s hip socket, which experts say was flawed in design.
       
Unlike the model used in resurfacing, the version used in traditional surgery was cleared by the Food and Drug Administration in 2005 through a regulatory pathway that did not require it to undergo clinical studies. Today, that device is failing prematurely at even higher rates than the one the administration would not approve, data from patient registries in Britain indicates.

In another article published last month, The Times reported that a top DePuy executive, Pamela Plouhar, had told her colleagues in a 2009 internal e-mail that the resurfacing version of the implant was not approved for sale here because of its high rate of early failure, or “revision,” during clinical trials.

To phase out the device, DePuy executives started a so-called rationalization, essentially a strategy to end the model’s production and to sell off its existing stocks while persuading orthopedic surgeons to switch to other implants from the company.

DePuy publicly announced that plan in November 2009, initially setting late 2010 as its completion date. But in the spring of 2010, a DePuy official wrote that the program would end not at a fixed date, but when all the ASR stocks “are depleted,” an internal e-mail indicates.

Thursday, March 22, 2012

The Most Profitable Orthopedic Device Companies in 2011

Featured:  Written by Laura Miller | March 21, 2012  (Becker's Spine Review)  Excerpts

Stryker ($8.3 billion). Stryker's net sales were up 13.5 percent in 2011 over 2010. United States sales rose 9.9 percent in 2011 to $5.2 billion, with international sales up 20.2 percent to reach $8.3 billion all together. Spine sales showed 48.5 percent growth in 2011, to $1.4 billion, while neurotechnology jumped 134.4 percent to $750 million. Hip sales were up 6.4 percent while knee sales remained flat. During the first half of 2011, Stryker acquired Orthovita and received FDA clearance for its MDM X2 Modular Dual Mobility Mobile Bearing Hip System. The company announced it would close two locations of its subsidiary, Gaymar Industries, during the fourth quarter. In early 2012, Stryker President and CEO Stephen MacMillan announced he would step down from his post for family reasons.

DePuy Orthopaedics ($5.8 billion).
Johnson & Johnson subsidiary DePuy Orthopaedics reported $5.8 billion in 2011, a 4 percent increase over 2010. The company's United States sales dropped 1.7 percent to $3 billion, but the company offset U.S. sales with a reported 11.3 percent international sales increase. Over the past year, Gary Fischetti was appointed company group chairman for the DePuy Family of Companies and Andrew Eckdahl was named the company's new president during the first half of the year. In 2011, Johnson & Johnson spent $521 million on the DePuy ASR Hip recall program, up from $280 million in 2010. The company launched six new devices recently at the American Academy of Orthopaedic Surgeons annual meeting in 2012.

Zimmer Holdings ($4.45 billion).
In 2011, Zimmer's net sales grew 5.5 percent over 2010. The company attributes its success to above-market performance in European, Middle Eastern, African and Asian Pacific markets. The American market remained flat, with reported net sales at $620 million. In the fourth quarter, the company completed the ExtraOrtho acquisition. It's knee business saw a 2 percent increase in net sales overall, but in the American market net sales declined by 4 percent. Hip sales were up 7 percent worldwide while spine sales dropped 4 percent to only $225 million. During 2011, the company received FDA clearance on several devices and introduced the new CLS Brevius Hip Stem with Kinectiv Technology to the United States in December. The company acquired XtraFix External Fixation systems in November and presented the results of clinical trials at national orthopedics meetings.

Smith & Nephew ($4.2 billion).
Smith & Nephew's revenue was up 8 percent in 2011 over 2010. Smith & Nephew's CEO Dave Illingworth announced his retirement early in the year and was succeeded by Oliver Bohuon. The company's orthopedics business rose 2 percent to $2.1 billion. Fourth quarter revenues were flat in the United States and dropped by 7 percent in Europe after the company decided to take back management of some supply lines in Spain, but these results were offset by 10 percent growth in the rest of the world. The company's sports medicine business grew 7 percent in 2011 while orthopedic trauma sales were up 3 percent. Smith & Nephew introduced several new devices to the market in 2011, including the VERSAJET II for advanced wound care.

Biomet ($2.8 billion). During 2011, Biomet reported $2.8 billion in net sales. During the second quarter of fiscal year 2012, the company reported a 4 percent increase in net sales, but spine sales were down 5 percent worldwide. The company celebrated the 35th anniversary of its Oxford Partial Knee replacement and launched the Signature Personalized System for the Oxford Partial Knee. The company received FDA clearance for the Active Articulation E1 Dual Mobility Hip System and worked with OMeGA Collaborative to support graduate medical education.


Wright Medical Group ($512.9 million). Wright Medical Group's net sales were slightly lower in 2011 than in 2010, when the company reported $518.9 million. Domestic sales dropped by 4.5 percent in 2011, which drove the 1.2 percent overall decrease in sales. International sales increased by 3.8 percent, but wasn't enough to offset poor U.S. sales. The company's extremities product sales grew by 8 percent, while its hip, knee and biologics product sales fell by 2 percent, 3.8 percent and 12.4 percent, respectively. The company will focus on its foot and ankle business over the next year, but still expects 2012 sales to fall below the 2011 numbers.


MAKO Surgical ($84.5 million). Full year revenue in 2011 experienced a 91 percent increase over 2010. In the fourth quarter alone, the company's revenue grew by 122 percent to $32.9 million, due in part to the addition of the MAKOplasty total hip arthroplasty applications during the second half of 2011. The company reported its THA application accounted for 44 percent of the domestic commercial installed base in 2011. There were 6,932 MAKOplasty procedures performed in 2011, a 99 percent increase over 2010. The company reported selling eight RIO systems during the fourth quarter, bringing the number of systems installed around the world to 133. In March 2011 the company signed a distribution agreement with Corin Group to use the Metafix Hip System and Trinity Acetabular Shell System with MAKO's RIO Robotic Arm Interactive Orthopedic System

Wednesday, March 21, 2012

Chromium and Cobalt levels 4 months post revision

I just had my chromium and cobalt levels re run.  The bottom line is the levels have dropped considerably.  While I had been told they would drop, I was skeptical.  It made me wonder if the tumor like growths/granulomas or whatever they are, have dropped significantly.

2011 levels of Chromium/cobalt...(I had repeated tests to verify the results.)


Chromium Blood ion test taken on 1/4/11
Cobalt blood ion test taken on 1/4/11
24 hour Urine chromium test taken on 1/30/11
Other Urine chromium test taken on 1/30/11
Cobalt Urine test taken on 1/30/11
2nd blood chromium test taken on 2/9
2nd blood cobalt test taken on 2/9
Actual result
28mcg/l
34 mcg/l
86
49
> 10.0 ug/l
21.6 ug/l
29.5 ug/l
Reported normal level
<2mcg/l
<1.8mcg/l
.6
.5
.1-.2
.5 ug/l
<1ug/l
Multiple over normal
14x
18.8x
143x
98x
5-100 x
43.2x
30x


4 months post revision levels

2012 results (3/8/12)


Chromium
Cobalt
Actual
7.5
2.5
normal
1.2mcg/l
1.8mcg/l
Multiple over normal
6x
1.3x

 While the levels are still considered high, at least there has been a significant drop in the levels.  I will have these levels done at the 7 month marker to see if they drop lower.
The real interest to me is, given this information, have the "tumor" like growths that have developed, shrunk?  It is a possibility that  these growths  might be granuloma formations as a result of the metals,   I will be repeating the cat scans on the abdomen tonite.  I will let you know how that turns out once I have the results.  The tumor growths have been discussed in a series of posts which can be found here 
Seeking information.......Granulomas, histiocytosis, type IV immune response.... (part 1 of x in this series)

So what is the cause of these pseudotumors after the second revision? (part 2 of x in this series)

Granulomas, necrotic pseudotumors post revision.....what is the story on this? (part 3 of x)

Background on Type IV Immune response (part 4 of x)

Background on Type IV Immune response (part 5 of x)

Background on Type IV Immune response (part 6 of x)