Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: JjrkCh

Tuesday, January 28, 2014

Costs vary wildly for knee replacements! Patients and doctors are in the dark.



Jim Landers

Published: 27 January 2014 09:37 PM
Dallas Morning News

WASHINGTON — I often write about the cost of health care, guided by the perception that Americans pay too much and get too little in return.
On Wednesday, it gets personal.
I am about to have knee replacement surgery at a hospital in Alexandria, Va., just across the Potomac River.
Both knees are shot. I played too much football, had two surgeries for torn cartilage and ran for too many years on unforgiving concrete sidewalks. An orthopedist told me in 2004 that I could keep on running and soon face knee replacements or quit running and postpone the inevitable.
Nine years later, it’s hard to dance or even walk the supermarket aisles with my wife. Running is out of the question. At my last physical, I explained this to Dr. Bilal Desai, my physician. She gave me a referral to an orthopedic group.
“You need total knee replacements — both knees,” said Dr. Daniel Weingold, the surgeon who explained my X-rays to me.
We discussed alternatives — Ibuprofen, weight loss, intense exercise — but none of those would repair the damage. Weingold said he could do the surgery at Inova Alexandria Hospital.

More expensive
Inova owns several hospitals in Northern Virginia, as well as the outpatient clinic where Dr. Desai practices.
I remembered reading that a knee replacement at Inova Alexandria Hospital would cost as much as $5,000 more than at Inova Mount Vernon Hospital, a few miles away.
I asked Weingold. He doubted there could be such a difference between two Inova hospitals. Well, what are the charges, I asked. He did not know. None of the surgeons in his group practices at Mount Vernon, he said, but if I wanted to go there, we could stop now and I could go to another orthopedic group.
I said I wanted to talk with my insurance company.
I emailed BlueCross BlueShield of Texas, which administers our health plan here at The Dallas Morning News. I asked: Do you have any information about which hospital does a better job? What the costs are? Does it make a difference to you if one is cheaper than the other?

High-deductible plan
I was told that both hospitals are in our health plan’s PPO, or preferred provider network, as is Dr. Weingold. Since the hospitals are in Virginia rather than Dallas, I was told, BlueCross Blue-Shield of Texas doesn’t have much information to go on in terms of a recommendation.
Like a lot of people working for Dallas companies, we have a high-deductible health plan designed to make employees better health care shoppers. My deductible is $1,500, and my out-of-pocket maximum is $3,000. I knew I would blow through that, regardless of which hospital I chose.
I’m not eligible for Medicare, but I looked at the Medicare charge information for 3,000-plus hospitals in the country. In 2011, Inova Alexandria Hospital charged $32,051 for a total knee replacement. Inova Mount Vernon Hospital charged $27,549.
I looked at the charges for Dallas hospitals. Medical City Dallas charged $117,616. Baylor University Medical Center charged $43,852. Texas Health Presbyterian charged $58,854.
None of the hospitals in Dallas charged less than $32,938, which was nearly $900 more than the Alexandria hospital.
‘Medicine in America’
I went back to Dr. Desai and told her she’d referred me to an orthopedic practice and hospital where the charges were $5,000 more.
“That’s a lot of money,” she said. “Go to Mount Vernon.”
“But I don’t know a surgeon at Mount Vernon. I went where you referred me,” I said.
“I can write you a blank referral and you can find a surgeon and fill it in,” she suggested.
“Well, why don’t you know about the difference in these hospital charges?” I asked.
“We don’t know about that,” she said. “That’s just medicine in America.”

I’m having the surgery on my right knee at Inova Alexandria. I’ll see how it goes but expect Mount Vernon Hospital will get my left knee.

Saturday, January 25, 2014

Bayer Essure harms young mothers: Erin Brockovich fights for their civil rights!



By Marisa Kabas
January 22, 2014 at 10:40 am

When it comes to choosing a method to make sure you don’t accidentally get pregnant, there are a host of options. And for women looking to avoid pregnancy for a sustained period of time, there are more permanent solutions, one of which is called Essure. You probably haven’t heard of this method, but it’s causing a whole slew of problems, and Erin Brockovich (the real one, not the Julia Roberts one) has stepped in.
On the surface, Essure sounds great. It’s a procedure that involves the placement of small, metal coils in the fallopian tubes which cause the body to form scar tissue and, in turn, blocks the tubes and prevents fertilization. The coils are inserted via catheter through the uterus, and it does not require surgery, anesthesia or a hospital stay. Easy peasy.
But it turns out that this miracle birth control, often prescribed to healthy, young mothers not looking to have any more children, could have nightmarish side effects. Cosmopolitan spoke to a number of women who have used Essure, including Mari Hall who was 21 and had just had her second child when she gave it a go.
“I had never heard of it, but my doctor was extremely adamant that it was the safest, quickest and most pain-free route for me,” says Hall, who lives in Tucson, Ariz. “She presented it as my only option.”
She had Essure placed 11 weeks after her daughter was born. Three months later, Hall’s health began to deteriorate. She felt sharp pains in her cervix, fatigue overwhelmed her, and migraines made her black out. And there was the bleeding.
Until recently, Hall thought she would need a hysterectomy. She is now seeking a second opinion.
Apparently the bleeding — along with depression and suicidal thoughts — caused by Essure can be so awful that a woman can literally feel like she is on the brink of death. “At least once a month, I have someone tell me they want to kill themselves,” says Desa, a founder of one of the Essure Problems Facebook Group
The problem here is that women experiencing these horrific side effects have no legal recourse, and that’s why Brockovich stepped in.
According to the Facebook page:
Currently, we CANNOT sue to the manufacturer because Essure is classified as a class three device by the FDA and qualifies for preemption which bars law suits being brought against the manufacturer. Until we change the law, no one can sue. With the help and support of Erin Brockovich, yes THAT Erin Brockovich, we are determined to fix this. Our goals are to have Essure pulled of the market, have the classification of class 3 rescinded by the FDA and get the federal preemption laws changed. These will not be easy tasks, but the membership is committed to making this happen!
Brockovich is using her gumption and know-how to unite the women suffering as a result of Essure, even though the FDA insists there is no link between the procedure and their symptoms.
Brockovich is leaning on members of Congress to investigate not just the Essure device, but also the preemption law that protects it. And she has created a petition to urge Essure’s manufacturer, Bayer HealthCare, to pull the product from the market, an outcome she admits is unlikely.
“We’re probably going to die trying,” she says. “If something does happen, it will happen in years to come. My way to help those who have been harmed is to get them unified, help them use their voices to get somebody’s attention, and to wake up the other consumers to make more informed choices.”
Desa and another administrator have been invited to testify at the shareholder’s meeting for Bayer, the producer of Essure. The meeting is in April in Germany, and they’re currently raising funds to make the trip.
While there are still some doctors who believe Essure is a viable option, the link must be made between the procedure and the devastating side effects. The most important thing when it comes to drugs and procedures is education, and hopefully Brockovich and other leaders will be able to at least educate prospective Essure users so that when they possibly need to have a hysterectomy at 30, it won’t be a total surprise.


Friday, January 24, 2014

Patient outcome research needed for heart implant devices!



Published: Jan 22, 2014


By Todd Neale, Senior Staff Writer, MedPage Today
Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania


Action Points
         Many cardiac implantable electronic device models currently used by clinicians were approved via the pre-market approval supplement process, not as original pre-market approvals.
         Most new device models are deemed safe and effective without requiring new clinical data, indicating the importance of post-approval surveillance.

Many of the high-risk implantable cardiac devices in use today were approved through a supplement pathway that does not require new clinical data on the safety and effectiveness of changes made to the products since their original approval, a review of an agency database showed.
From 1979 through 2012, 77 original pre-market approval (PMA) applications -- which required the manufacturers to provide clinical data on the safety and effectiveness of the devices -- were cleared by the FDA, according to Aaron Kesselheim, MD, JD, MPH, of Brigham and Women's Hospital in Boston, and colleagues.
During that same time, however, those original PMAs were subject to 5,829 approved supplement applications, which covered everything from relatively minor changes to labeling, materials, or packaging to substantial design changes, often without the need for additional clinical data, they reported in the Jan. 22/29 issue of the Journal of the American Medical Association.
"It behooves physicians and patients when they're considering a device to understand not only that the device has been FDA approved but to understand the process through which the device was FDA approved and any data that exist about the device," Kesselheim said in an interview.
The FDA uses the PMA process to evaluate new high-risk medical devices, which include pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. But changes to previously approved devices can be introduced using the supplements.
"The benefits [of the supplement pathway] are the more rapid approval and clinical use of new technology," commented Michael Rinaldi, MD, director of clinical research at Carolinas HealthCare System's Sanger Heart & Vascular Institute in Charlotte, N.C., who was not involved in the study. "Requiring a large randomized trial for every proposed iterative device improvement would slow and potentially stop needed improvements in technology."
But it also means that many of the devices clinicians are implanting into patients currently -- which may be substantially different from the device included in the original PMA after numerous small changes -- have not been subject to rigorous clinical testing.
Kesselheim and colleagues noted that the Medtronic Sprint Fidelis and St. Jude Medical Riata ICD leads -- which were recalled in 2007 and 2011, respectively -- were both approved through the supplemental process and were never tested in clinical studies before entering the market.
"The pitfalls [of the supplement pathway] are that it is difficult to know the impact of even seemingly small changes in actual use without clinical data. And as there are usually multiple supplements, many small changes add up," Rita Redberg, MD, of the University of California San Francisco, who co-authored an accompanying editorial, told MedPage Today. "As we learned from the Fidelis and Riata leads, what seems like a good idea may not turn out that way when implanted in patients."
The Study
During the study period, there were original PMAs for 46 pacemakers, 19 ICDs, and 12 CRT devices, according to the FDA's PMA database. But each device was subject to a median of 50 supplements (ranging from 0 to 306) by the end of 2012.
The median period of activity for a PMA -- the time from the original approval of the device to the most recent approved supplement -- was 15 years. And more than three-quarters (79%) of the original PMAs approved during the study had at least one supplement approved in the most recent year of the study period.
"The long active life of ... PMA approvals suggests that minor design changes may accumulate over time and in some cases may add up to substantial changes from the device approved in the original PMA application," the authors wrote.
"To guard against this outcome, the FDA could mandate an expert panel review of each PMA every 5 to 7 years in which it is active to evaluate the extent to which clinical data from older models still apply to newer ones," they suggested. "Another possibility would be more widespread implementation of rigorous post-market studies to evaluate device performance once approved for clinical use."
Risk-Benefit Balance of Supplements
The fact that most supplements are approved without additional clinical testing is not necessarily a bad thing, Kesselheim and colleagues wrote, because preclinical testing can be superior in some cases.
"For example, mechanical testing of ICD leads can simulate years of clinical conditions relatively quickly, and animal studies may allow for repeated induction of arrhythmias that would be impossible in a human model," they wrote. "Thus, our results should not be interpreted to indicate that the FDA is failing to review PMA supplement applications to determine safety and effectiveness."
But, preclinical testing may not uncover all of the problems that will occur when the implants are placed in the human body, Redberg and co-author Steven Goodman, MD, PhD, of Stanford University in Stanford, Calif., noted in their editorial.
"The tricky part is that it is hard to know in advance when changes approved by supplements without clinical data will turn out to be dangerous or even life-threatening in clinical use," Redberg told MedPage Today. "This is a particular issue for implanted devices, as they can be risky to remove. One cannot recall implanted medical devices when they are defective, as one does for a car."
The current study does not provide a way to assess the relative risks and benefits of using the supplement pathway to get modified devices approved for use, according to Rinaldi.
"There are risks in over-regulation by slowing useful and clinically beneficial innovation. There are also risks in under-regulation by not detecting well-intended but ultimately harmful innovation," he said. "While the ICD lead recalls were highly visible and clearly harmful to patients, the real question is: how often did rapid approval lead to harm and how often did it lead to benefit and what was the overall magnitude of the harm and benefit?"
He said that FDA is in a difficult position regarding device approvals.
"If they are too conservative, they will slow the pace of improved care and put the U.S. even farther behind other industrialized countries in terms of access to new technology, and they will be criticized by advocates for rapid innovation," he said. "If they are too liberal, then they are at risk for missing problems and will be pilloried by patient safety advocacy groups."
Rinaldi said he thinks the agency does a reasonable job, pointing out that "for all the device changes reported in the article, very few of them have resulted in harm. While the ICD lead problems are used to illustrate the downside of less strict regulation, no examples are provided of how patients were helped by iterative advances through this process or harmed by lack of access to improvements."
Kesselheim is supported by a Robert Wood Johnson Foundation Investigator Award in Health Policy Research, a Greenwall Faculty Scholarship in Bioethics, and a career development award from the Agency for Healthcare Research and Quality. One of his co-authors was supported by a Harvard Medical School fellowship. Another is the Lois Green Scholar at the Hebrew SeniorLife Institute for Aging Research and is supported by a career development award from the Harvard Catalyst Clinical and Translational Research Center and a Paul B. Beeson career development award in aging.
Kesselheim and one of his co-authors reported previously publishing research funded by the FDA on comparative medical device regulation. That co-author reported serving as a consultant to the FDA's Circulatory Systems Advisory Panel.
Redberg reported being a member of the FDA's Circulatory System Devices Panel and a member of the California Technology Assessment Forum. She is the editor of JAMA Internal Medicine. Goodman did not report any conflicts of interest.

From the American Heart Association:


Additional source: Journal of the American Medical Association
Source reference:Goodman S, Redberg R "Opening the FDA black box" JAMA 2014; 311: 361-363.


http://bit.ly/KMAGKH

Thursday, January 23, 2014

Health Activists Push Medical Device Accountability

Has Your Hip Been Recalled?


The Women's Health Activist
January/February 2014
By Kate Ryan
When cars, baby cribs, or even microwaves are recalled because there’s a safety problem or the product doesn’t work, you can check the unique serial number on your car, crib, or microwave to immediately discover if the one you own has been recalled, or if there’s no need for you to worry. Having systems that facilitate the quick and accurate identification of unsafe and ineffective devices is just common sense — so most people would be surprised to learn that, until six months ago, the system for tracking problems with medical devices was so ineffective that many people never even found out about recalls of defective products — which has the potential to put their health at risk.1
If, like me, you watch cop shows such as CSI or Bones, you probably think that implanted medical devices can be traced back to the medical record of the person whose body they’re implanted in. Shows like that have plenty of episodes where the murder victim is speedily and accurately identified because she has a hip replacement or pacemaker that can be tracked by its unique identification number. Unfortunately, until now that’s been fiction! In reality, the lack of a basic, commonsense system that allows someone to find out if she has a recalled device has left U.S. women and health care providers struggling to get their questions about specific products answered -- even basic information like whether the product a woman is using has been recalled.
That’s the scary news. The good news is that health advocates have finally persuaded Congress and the Food and Drug Administration (FDA) to establish a unique device identification (UDI) system and the National Women’s Health Network (NWHN) is working with the FDA to develop that system.
This is an important advance for women. The NWHN has advocated for a medical device UDI system for many, many years. This system is key to the FDA’s ability to protect millions of people from the harm caused by flawed and dangerous products.
The new protections will begin this summer, starting with the highest-risk devices like certain pacemakers, heart valves and joint replacements. Over the next seven years, the FDA will roll out requirements for medical device manufacturers to include a unique number and bar-code on the label of certain medical devices so patients, consumers, health care providers, and hospitals can track and identify these devices.2 The new UDI system will provide women who use medical devices with better information and prevent the unnecessary harm that results when recalled devices remain inside the body. The system also has the potential to improve how device problems are reported to the government, so the FDA can more quickly identify dangerous devices and remove them from the market — which will help all of us.
How much do you know about your device?
Currently, women do not have enough information about the specific devices they use or have had implanted to be able to tell if they’re affected by a specific device recall. Many patients leave surgery without knowing what company made their new hip, let alone what brand of hip they have — and it can be very difficult to track down those details later. The general information you get from scary lawsuit ads that warn of safety problems with surgical mesh or from news reports about a recall of hip implants do not provide enough detailed information about the recall, or the specific hip or mesh, for anyone to be able to tell if the product they have is affected.
You could try going to the FDA’s website to get more information about the recall, but you will only find the brand name and description of the device being recalled….which still won’t tell you if you have the specific recalled hip. The most likely place to find the relevant information is from the health care provider who either provided or implanted your device. The best-case scenario is that your provider documented which manufacturer and what specific brand or model of device you received. Unfortunately, labels for implanted devices are usually on the packaging, which is often thrown away during surgery, and the information doesn’t always make it into a patient’s medical records. Even if your provider did keep good records, it can be next to impossible to find that information if your provider has retired, moved, or gotten rid of her old patient files. The lack of a system has — until now — created enormous barriers to patient’s access to vital information.
Women are safer with more information
Once the new UDI system is fully implemented, women will be able to ask for their device’s specific UDI number when they get the device. That way, a woman will have all of the information she needs when she hears about an FDA device recall, and that may minimize both unnecessary worry and unnecessary harm. If her device hasn’t been recalled, she can stop worrying about the potential harm immediately – no need to make an unnecessary trip to her provider because she kept a record of what device she has and hopefully so has her provider. If her device has been recalled, she can promptly schedule an appointment with her health care provider and talk about whether she needs to stop using the device — or, if it's an implanted device, if she should get it removed and replaced.
The new UDI system will also improve the device recall system and decrease the amount of harm caused by slow or incomplete device recalls. With UDIs, it will be easier for hospitals and providers to stay current on the latest safety information and list of recalled devices. They will have the information that will allow them to check medical records for affected UDI numbers so they can contact patients directly with the recalled device, rather than waiting for patients to learn about the recall and seek information themselves.
Making it easier to for hospitals to identify and track recalled devices will also prevent unsafe devices from being given to patients in the first place. Without UDIs, recalled devices are, unfortunately, likely to remain in use, and a patient could have surgery and receive a device that has already been identified as flawed and potentially dangerous. While we’d all like to believe this is extremely rare, right now there’s no way to know how often it occurs. Of the approximately 700 medical device recalls that happen each year, about half of the faulty devices (53 percent) stay on the market, because manufacturers currently have no way to track their devices electronically. The UDI system will allow hospitals and providers to scan the bar-codes of all the medical devices in their supplies and assess the safety of the devices they intend to use. When a hospital or other health care provider is notified of a recall, the new UDI system will allow them to quickly find and remove any recalled devices from their storerooms.
Tracking devices will improve public health
The UDI system will have broader benefits for everyone, including people who do not have a medical device. That’s because it will also increase the accuracy of the information about all of the devices on the market.
Currently, when someone experiences a problem with a medical device, she or he can report it to the FDA, which maintains lists of what are called “adverse events.” But, these reports often lack detail, and may only state that a patient had a problem related to surgical mesh, or a hip, in general. While reports from health care providers sometimes include more information about the problematic brand or manufacturer, it still isn’t usually enough information to help the FDA estimate the extent of the problem. Is there just one faulty device out there? Do the adverse event reports indicate there’s a problem with one batch of a device stemming from a manufacturing problem? Or, do the reports signal that there is a larger issue with the design for a particular device model?
Under the new system, patients and providers will be able to include a UDI number in their adverse event reports, and the FDA will gain access to better information to help answer those questions and more quickly flag bigger problems.
Making the UDI system work for you!
Once the UDI system is fully in place, when you hear about a device recall, you’ll be able to find out whether the recall affects your specific device by checking the UDI number on the label against the FDA recall alerts and safety notifications. To do this, you’ll need to keep the label of any device you purchase or are given at a health care facility (like an insulin pump) and/or have surgically implanted (like an artificial hip). If you have a medical device implanted through surgery, make sure that the UDI number is included in your medical record and ask for a copy of the number to keep on hand. That way you can check the FDA’s safety notifications and recall alerts to see if your UDI number is on the recall list.
At the NWHN, we will continue to watchdog the roll-out of the UDI system to ensure that it meets women’s needs. We will advocate for the FDA to raise awareness about the new UDI system and to clearly communicate to patients and other consumers any recalled UDI numbers. We will also continue to push for more devices to be directly marked with the UDI number so people won’t need the label to keep track of their UDI number.
We want to ensure that you have the information you need as quickly and easily as possible. Knowing your UDI number will empower you to take action to protect your health when you hear about a possible safety problem or recall.
Kate Ryan is the NWHN Senior Program Coordinator
Additional resources
                NWHN’s article about device regulations: http://nwhn.org/blog/medical-mishaps-what-you-need-know
                NWHN’s article about Metal-on-Metal (MoM) hip replacement devices: (http://nwhn.org/newsletter/node/1369).

1. The Food and Drug Administration’s definition of a “medical device” is available here: http://www.fda.gov/aboutfda/transparency/basics/ucm211822.htm

2. Read more about the new rules on the FDA’s website: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDevi...

Wednesday, January 22, 2014

BBC Radio exposes the lack of regulation of implanted medical devices!

Face the Facts!: Tried and Tested?


New drugs undergo strict testing. New medical devices often don't have to. But with thousands of women damaged by vaginal surgery, surgeons and patients are calling for tougher safety rules. It's the latest in a series of controversies around new medical devices stretching back years - including metal-on-metal artificial hip joints and PIP breast implants.
Concerned surgeons say a compulsory register for all devices is long overdue, so we can track success and failure. But might insisting on too rigorous a testing regime have the unintended consequence of stifling medical innovation and making it too expensive for all but the biggest companies?
Presenter: John Waite Producer: Paul Waters Editor: Andrew Smith.
  • Broadcast onBBC Radio 4, 12:30PM Wed, 22 Jan 2014
  • Available until12:00AM Thu, 1 Jan 2099
  • First broadcastBBC Radio 4, 12:30PM Wed, 22 Jan 2014
    http://www.bbc.co.uk/iplayer/episode/b03q9dc8/Face_the_Facts_Tried_and_Tested/

Tuesday, January 14, 2014

Consumer Reports Survey/Study on Hip and Knee Replacement


consumerreports
We're looking for #hip & #knee surgery patients/caregivers for a study. Help us improve #healthcare !!! http://t.co/JU6kWPCa6f
1/14/14 11:22 AM
 (Twitter notice.)


 Go to this link to complete and submit your information and selected participants receive a complimentary ConsumerReports.org subscription!*



(Example Only)  User Questionnaire
Hello,
Thanks for your interest in our Hip & Knee Surgery study. This short questionnaire verifies your eligibility for an upcoming customer interview. The interview will help us better understand your needs in order to incorporate them into a new product we're developing.
Interviews will be held over a Google Hangout or telephone. If you’re interested in participating, please complete the questionnaire below. If you're selected, we’ll be in touch directly to discuss details and set your appointment time.
Details of the study:
- The duration of the interview is 30 minutes
- Participants will receive a complimentary ConsumerReports.org subscription*
To participate you will need to:
- Be at least 18 years old
- Allow us to video or audio record the session
* Please note that you will receive the complimentary subscription only if you are selected as a participant and attend the interview.
Thank you for your time.
Sincerely,
Patricia Ju, Shane Shelley, and Chris Baily
Technology Innovation Center
Consumer Reports
 * Required
1.             Availability *Mark ALL time slots for which we could schedule an appointment with you.
         Weekdays Morning
         Weekdays Afternoon
         Weekdays Evening
         Saturdays Morning
         Saturdays Afternoon
         Saturdays Evening
         Other:
2.             


First and last name: *


Best email address to reach you: *


Best phone number to reach you: *


What state do you currently reside in? 



Gender: *
         Male
         Female
         Prefer not to say
3.             


Age: *
         Under 18
         18-21
         22-28
         29-34
         35-44
         45-65
         66-75
         76 Plus
         Prefer not to say
4.             


What experience do you have with Hip or Knee Surgery? *Caregiver is an individual, such as a parent or child, who attends to the needs of a child or dependent adult
         Currently considering Hip or Knee Surgery
         Currently a caregiver for a candidate for Hip or Knee Surgery 
         Recently had Hip or Knee Surgery
         Curious about information on Hip or Knee Surgery