OOOPS! Study: One third of all total knee replacements are 'inappropriate'.

One third of total knee replacements in US are'inappropriate'

Monday 30 June 2014 - 12am PST

One third of total knee replacements in the US are "inappropriate" when applied to a Spanish patient classification system, according to a study published in Arthritis & Rheumatology, a journal of the American College of Rheumatology.

Figures from the Agency for Healthcare Research and Quality show that more than 600,000 knee replacements are performed each year in the US. This surgery has become increasingly more common over the past 15 years, with studies showing a 162% annual volume increase in Medicare-covered knee replacement surgeries during 1991-2010.

Experts are divided on the reasons for this growth, with some maintaining it demonstrates that the procedure is effective, while others argue the surgery is being overused. One concern of the critics who believe total knee arthroplasties (TKA) are being overused is that the procedure "is highly reliant on subjective criteria."

For the new study, researchers from Virginia Commonwealth University in Richmond examined the criteria that is used to determine appropriateness for TKA.

The authors point out that the investigated criteria have not been studied in the US and have been developed in other countries.

"To my knowledge, ours is the first US study to compare validated appropriateness criteria with actual cases of knee replacement surgery," says lead author Dr. Daniel Riddle from the Department of Physical Therapy at Virginia Commonwealth University.

Dr. Riddle examined a modified version of an appropriateness classification system developed in Spain and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain and Physical Function scale.

In the study, Riddle and colleagues note that the Spanish criteria are considered by many experts in the field to be "among the most powerful tools for improving quality of care and controlling costs."

The classification systems were used to assess participants enrolled in the Osteoarthritis Initiative - a 5-year study of 4,796 people partly funded by the National Institutes of Health.

Looking at a sub-set of 175 people who underwent TKA surgery, Dr. Riddle's analysis found that 44% of surgeries were classified as "appropriate," 22% were "inconclusive," and 34% were "inappropriate."

The mean age of knee replacement patients in the study was 67 years old, and 60% of them were female.

"Our finding that one third of knee replacements were inappropriate was higher than expected and linked to variation in knee pain [osteoarthritis] severity and functional loss," says Dr. Riddle. "These data highlight the need to develop patient selection criteria in the US."

"I agree with Riddle and colleagues," writes Dr. Jeffery Katz - from the Orthopedic and Arthritis Center for Outcomes Research at Brigham and Women's Hospital in Boston, MA - in a linked editorial.

"We should be concerned about offering total knee replacements to subjects who endorse 'none' or 'mild' on all items of the WOMAC pain and function scales."

The new study also highlights that there are many variables involved in the decision to undergo TKA surgery. Severity of symptoms and the psychological readiness of the patient are two important factors, but in addition to the variables examined in the study, there are a wide range of variables specific to the patient that a surgeon will consider when making the decision for or against TKA surgery.

Written by David McNamee  @MNT_David

FDA Regulators and Gynecologists Duped by Medical Device Manufacturer?: Essure Patient Harm Mounts

Essure:Failure to communicate risks

Posted by Zuzanna Fimińska [1] on May 28, 2014

The permanent method of contraception for women continues to cause controversy, but evidence seems lost amidst the heated debate. Personal stories dominate the discourse, and while the medical community appears divided, the media demand a response from Bayer, which hides behind a generic statement.

Since 4^th November 2002, Essure’s approval date, through 25^th October 2013, the FDA received 943 reports of adverse events related to the product. The most frequently reported adverse events were pain (606), hemorrhage (140), migration of the device or device component (116), patient device incompatibility (113),and device breakage (37), among others¹. Only three of those adverse events were featured in the information booklet that accompanied the procedure, and, according to the women we spoke with, doctors who performed the procedure weren’t informed about possible side effects either.

The original pamphlet contained incomplete and misleading information

“I was absolutely not well-informed about the risk-benefit profile before undergoing the procedure,” said Angie Firmalino, who founded the Facebook group called Essure Problems [2] in 2011, two years after undergoing the procedure. The group now has 7,635 members, and adds 25-50 new members each week. “I received a pamphlet that looked like a vacation brochure. Perforations, migrations, and other side effects were not listed in it,” she said, adding that her OBGYN also failed to provide adequate information concerning possible side effects.

The pamphlet has since been updated. It now features possible side effects as well as a disclaimer that it is “not intended to be comprehensive as all women have individual needs and concerns.” Among the listed adverse reactions are unsatisfactory placement of the inserts in 8% of women in clinical trials (during a three month follow-up, incorrect placement was identified in an additional 4.5% of women). “Unsatisfactory placement” includes perforations that result from the device, and migrations of the coils. Other problems listed in the new booklet include breakage, nausea, sweating, pain, cramping, vaginal bleeding, heavy periods, and ectopic pregnancy, among others. 

There are three potential reasons the list of side effects was incomplete in the original booklet. One, Bayer hid trial results from the FDA. Two, the side effects are the result of long-term usage of the device, so they were not present in clinical trials, which are not designed to check long-term safety of a device. Or three, the trials conducted by the manufacturers were less than perfect. Firmalino believes the last possibility, calling Bayer’s trials “faulty and biased,” but she’s unwilling to speak about the details.

“Many women, including myself, have retained a law firm preparing to file suit against Bayer. The administrators of the Essure Problems page and I have been working closely behind the scenes with the firm, and we have collected much evidence and proof. It will all come out when the legal trials begin,” she said.

Essure is not an effective form of contraception

Despite a warning about possible ectopic pregnancies, according to the new information pamphlet, Essure is 99.83% effective although another form of contraception should be used for the first three months following implantation. According to Firmalino, the assurance that a woman would never again have to worry about pregnancy is very misleading.

“In our group, we have seen numerous pregnancies, some resulting in a miscarriage (on average, 55% of women pregnant with Essure will miscarry). We have seen some full term live births, some pre-term, and a handful of stillbirths. Bayer’s pregnancy rates are far from accurate,” Firmalino said.

Indeed, a new study coming out of Yale University seems to be supporting Firmalino’s observations. According to their estimate, 9.6% of women could become pregnant within 10 years of undergoing hysteroscopic sterilization, or Essure. This is nearly four times the estimated risk after a laparoscopic tubal ligation, the more traditional method.

The study, published in the journal Contraception, is the first to compare the effectiveness of the two main choices offered to women who seek a permanent form of birth control. According to the Chicago Tribune, about 345,000 American women undergo sterilization procedures each year, with Essure an increasingly popular choice because it does not require a surgical incision.

Crucially, if a woman does become pregnant after Essure, the risks to the mother and the fetus are unknown.

Doctors disagree on the safety of the procedure

The safety of the procedure has divided the medical community. Although some doctors extended their support to Essure Problems Facebook page, admitting that there is a problem with the device, others have no doubt the procedure is the right choice for women. For example, Steve Parsons, an OBGYN and the main provider of the Essure procedure in the Netherlands, makes a bold statement that he "believes in Essure because he believes in women". He compares Essure to other metallic devices implanted in the body, e.g. clips and coils used to open blood vessels around the heart when patients have suffered a heart attack. Furthermore, he suggests that there are two logical explanations regarding pelvic pain and other symptoms that occur after Essure. One, he admits that the symptoms might be due to the device. Two, he suggests that the might be caused by other conditions such as PMS or perimenopause. In his conclusion, he addressed the Essure Problems community saying that “it is sad that this group, some of whom may have valid gynaecological problems, are scaring a lot of women out of a safe procedure, forcing them into a riskier option.” He then requested to be removed from the group.

We, as doctors, have accepted the manufacturer’s word for the safety of the device without anything to confirm it".

In a rebuttal of Parson’s statement, doctor Julio Novoa writes that the comparison between Essure and devices used in heart surgery is invalid because those devices, unlike Essure, aren’t designed to cause a chronic inflammatory response. He also asserts that there are no peer-reviewed, double-blind studies addressing the safety or the incidence of complications regarding Essure compared to the general population regarding chronic pelvic pain, abnormal vaginal bleeding, etc. “We, as doctors, have accepted the manufacturer’s word for the safety of the device without anything to confirm it,” he writes.

Faulty device, or failure to communicate risks?

Whether or not Essure is a faulty device remains unclear. The FDA was unwilling to speculate on whether or not the device might be pulled from the market, but they don’t seem to be concerned about the safety of the product. “The FDA has not found a causal connection between the use of Essure and certain adverse events reports,” said Jennifer Rodriquez, a spokesperson for the FDA in charge of the Essure case. Nevertheless, she also stressed that the Agency continues to take reports of problems with Essure very seriously and will continue to review them carefully. “We will continue to monitor the safety of Essure to make certain that it does not pose an increased risk to public health and safety and that its benefits of providing women with a non-surgical sterilization choice continue to outweigh the risks,” the statement read.

Firmalino was disappointed with the FDA’s stance, and said that she’d expected the Agency to “protect the population, as is their job". She added: “However, we are finding that they, too, are regurgitating the same answers, relying on faulty clinical trials. There seems to be a lot of conflict of interest that lies within the FDA and pharmaceutical companies and device manufacturers”.

Bayer failed to respond to our request for comment about the long-term safety of the device.

The heated debate around Essure continues and is likely to only be settled in court. Sympathetic plaintiffs, big pharma manufacturer as defendant, and a device with a questionable safety profile will certainly attract broad media attention. But perhaps concerns over product safety are not the only problem here. Bayer is obviously in need of some damage control if they want to retain any public trust that is already fragile. Hopefully this high profile class action law suit will not be necessary to elicit some response from the manufacturer.

1. I was referred to this data by the FDA spokesperson, Jennifer Rodriguez in an email exchange. According to other sources, the numer has skyrocketed to 2,049 as of March 2014.  

Links:
[1] http://social.eyeforpharma.com/users/zuzanna-fimi%C5%84ska
[2] https://www.facebook.com/pages/Essure-problems/178631888835781

Mounting Patient Harm and FDA history of medical device disasters!

ArtifactsTell the Story of Our Culture and FDA’s History

Posted on May 13, 2014 by FDA Voice  FiDA highlight

By: John Swann, Ph.D.

Looming sentry-like over the collection of artifacts that document FDA’s  history, the products  we regulate, and our interactions with the public is a rather large and curious figure. It is a green velvet head with bulbous, languid eyes and two upper teeth in an otherwise large and empty mouth. It doesn’t have ears or hair, but is marked by a few bright green pustules.  This is part of a life-size costume, an element of a public education campaign called Fight Bac! in which FDA was a major participant. It began in the 1990s to alert the public, young and adult alike, to the dangers of food-borne diseases and how to avoid them.

Countless objects in our collection tell the decades-long tale of FDA’s educational activities. For example, the agency still has a cabinet and some of its contents from the “Chamber of Horrors” exhibit that traveled around the country in the early 1930s to alert citizens, legislators, the press and others of the need for a stronger consumer protection law, drawn from egregious examples of how the law then in place fell short.  FDA officials also communicated through a variety of other displays for Congressional testimony and other purposes.

Much of the collection captures the problems that gave rise to the laws and regulations we have today, a regulatory arc often originating with a problem product—sometimes of disastrous proportions. Thus one can find specimens of:

▪                Elixir Sulfanilamide, a poisonous preparation of a wonder drug in 1937;

▪                thalidomide,  the globally marketed sedative that caused thousands of grave birth defects in the 1950s and 1960s;

▪                Bon Vivant vichyssoise, a botulism threat in the early 1970s;

▪                the ill-designed Dalkon Shield intrauterine device that caused thousands of pelvic infections; and

▪                ephedra-containing dietary supplements from the 1990s that killed several users.

These are among the objects that eerily illustrate why we have the laws and regulations we do.

Decision-making in the agency depends to a considerable extent on investigations and analyses, some of the tools of which are documented here. These artifacts of the growth of regulatory science include:

▪                balances and early calculating devices used in the laboratories of the Bureau of Chemistry from the 1900s to 1920s to analyze questionable foods and drugs;

▪                triers, tools used for routine sampling of various foods to ensure compliance with the law, from the mid-20th century; and

▪                advanced analytical devices from the 2000s to detect sophisticated counterfeiting of medicinal products.

Treatments of dubious value for both serious and non-serious diseases make up a significant part of the collection as well. There are hundreds of fraudulent medications, primarily up to about World War II, as well as hundreds of medical devices from the 1950s and 1960s that offered hope with no scientific underpinning.

In addition, how the public came to engage FDA and its work, especially from the 1970s forward, can be seen in a number of objects, including protest buttons and placards from the past two decades.

Artifacts like these tell the story of how our many laws and regulations came to be, how FDA has carried them out, and how the public and FDA have engaged each other in the interest of the public health.

John Swann, Ph.D., is an Historian at FDA

- See more at: http://blogs.fda.gov/fdavoice/index.php/2014/05/artifacts-tell-the-story-of-our-culture-and-fdas-history/#sthash.XEiRd40Z.dpuf

If my knees were a car, my mechanic would choose my next automobile!

Landers: Knee replacements make for strange healthcare economics

Jim Landers

jlanders@dallasnews.com

Published: 12 May 2014 09:15 PM

Updated: 12 May 2014 09:44 PM  FiDA highlight

WASHINGTON — This winter, I had my knees replaced. I used a surgeon and a hospital in my neighborhood of Alexandria, Va., not far from where I work. The surgery and rehab are going fine. The lessons in health care economics are becoming strange.

For each knee, the bills (hospital, surgeon, anesthesiologist) came to roughly $32,000. Michael Toomey, president of Compass Care Engineering in Dallas, says the average in the Dallas area is between $42,000 and $43,000.

My new mechanical knees were the most expensive items in the bills. The hospital wanted $16,097.05 for each of them. My insurance agreed to pay $10,982.72 apiece.

These are Sigma System knees, size 5, made by DePuy Orthopaedics of Warsaw, Ind. DePuy is part of Johnson & Johnson.

The knees are made of cobalt, chrome and polyethylene. There’s a buckle-like piece that fits over the knee tip of my thigh bone. There’s a piece that looks like a peg with a circle on it drilled into my shin bone. Between them is a plastic disc. On the back of the knee cap, there’s a metal dome.

My surgeon chose these knees. The hospital bought them. Insurance (and my out-of-pocket max of $3,000) paid for them.

So, let’s see, if my knees were a car, my mechanic would choose my next automobile. A garage would buy it, and add its own markup. My employer (which is where I get health insurance) would pay for most of it, using an insurance administrator to bargain over the price.

Survey of surgeons

This is standard practice in the medical world. Device manufacturers will pitch their products to surgeons, but the surgeons are often in the dark or heedless of the cost. A survey cited in the January issue of Health Affairs found that 81 percent of orthopedic surgeons could not accurately guess the cost of these devices. And American surgeons replace about 720,000 knees a year.

Baylor Scott & White Health is using a different approach. The surgeons and the supply people meet to talk openly about prices and quality. They agree on a price the hospital system will pay. Medical device makers are then invited to meet or beat that price.

“Everybody can play, but you have to meet this capitated [maximum] price,” said Pam Bryant, Baylor Scott & White’s senior vice president for supply chain services.

Surgeons can choose among four or five key types, Bryant said.

Texas Health Resources also negotiates as a chain for its joint replacements. But here, the surgeons can choose what they like.

“While there is a great deal of similarity between devices, surgeons have definite preferences based upon training and their individual style of surgery — as well as the individual patient needs, including age, activity and other factors,” said John Gaida, THR’s senior vice president for supply chain management.

“Texas Health strives to make virtually all brands of hip and knee implants available to our surgeons so that the patient needs are always the primary consideration,” he said.

Across the country, surgeons are not clued in on the cost of medical devices often because the hospital can’t share that information. They typically sign a contract with the medical device company that forbids disclosure.

Doctors order

I know little about mechanical knees. My surgeon implants them all the time, so it makes sense to follow his guidance on what would suit me best and last longest.

But we didn’t go over a list of knees and manufacturers. My surgeon asked about my lifestyle, looked at my age and weight, and chose for me.

The hospital did the negotiating with DePuy. Did they get a good deal?

A 2012 Government Accountability Office report covering a small sample of hospitals found that one paid $5,200 for a knee replacement while another paid $9,500 for the same device.

There are several types of knees on the market. There’s a standard, fixed-bearing knee; a rotational knee that can handle more twists and turns; and a rotational/full flexion knee that allows for deep squats.

Prices seem to run between $2,000 and $16,000 for the device. So it turns out that my new knees (rotational) are pretty high-end. I hope they last a long time.

Follow Jim Landers on Twitter at @landersjim.