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.
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Showing posts with label Stephen Tower. Show all posts
Showing posts with label Stephen Tower. Show all posts

Sunday, May 4, 2014

They recall cars: but not failed hips?





by BYRON HARRIS

WFAA   FiDA Highlight
Posted on May 1, 2014 at 10:00 PM
Updated today at 7:30 PM


Your car may be a lemon. But is your artificial hip?
So many Americans have artificial hips that we could be called the hip generation. But, Americans may know more about their automobiles than what’s inside their bodies and as many as a million may be suffering damage they don't know about.
Generally, a hip replacement is very effective, but the process remains costly, unregulated and, some say, potentially harmful.
Right after her total hip replacement, Rebecca Thompson said she felt a “clicking” in her new joint. But, her DePuy hip had been on the market for years — tried and true, the company said.
Not until several years after Thompson, who lives in Burleson, got her hip did DePuy publicly admit it had a problem and recalled the device.
“It was like, ‘They recall cars, they don’t recall body parts. What’s going on?’” she recalled.
A total hip replacement consists of a cup and a ball. From the early 2000s until 2010, those components were often made of chromium cobalt metal in what's called metal-on-metal hips. As the parts grind against each other, they can produce particles of chromium cobalt that can cause a dangerous condition called metallosis in which metal debris builds up in the soft tissues of the body.
It’s a condition Dr. Stephen Tower of Anchorage Alaska knows firsthand.
As an orthopedic surgeon, he has replaced more than a thousand hips. An active outdoorsman, when his own real hip started bothering him, he had a new one installed in himself.
But soon the artificial hip was as painful as the real hip it replaced.
“The toxic effect of the cobalt destroyed all the ligaments around the hip,” he said. It also produced “pseudo tumors,” or non-cancerous fleshy growths.
He began studying the chromium cobalt levels in his own blood, as well as his patients.
“They were clearly experiencing neurologic toxicity or psychological toxicity or cardiac toxicity from that hip,” he said.
He said that in the last decade, up to “90 percent of the hips that have been replaced in the United States are potentially at risk for problems.”
Artificial hips are increasingly sold as products, with advertisements appearing in, among other things, national newscasts. And for most Americans, their new joints work very well.
“In the United States we perform about 400,000 hip replacements each and every year,” said Dr. Jay Mabrey, chief of the Department of Orthopedic Surgery at Baylor University Medical Center and a Professor of Orthopaedic Surgery at the Texas A&M School of Medicine.  He’s also former chairman of the FDA’s Orthopaedic Device Panel.
“Total hip replacement is one of the most successful orthopedic procedures,” he said.
That said, Mabrey added, “metallosis is a huge problem for certain types of implants.”
“I have a lot of patients with these metal on metal hips,” Mabrey said, and “when they move after sitting for a while, they get that click… That’s metal on metal. Just like your car engine, you really don’t want metal rubbing up against metal.”
Science is starting to view the amount of chromium cobalt in the bloodstream with more concern than in the past. The threshold for concentration in the bloodstream, Mabrey says, used to be 7 parts per billion of chromium cobalt. “Some people think you should be concerned at 2 to 3 parts per billion.”
On April 19, Texas Rangers fans got a firsthand look at what a successful hip operation can do.
Pitcher Colby Lewis got his first win on the mound since 2012. It was his second major league start since having his hip resurfaced, an operation similar to a total hip replacement. And it has, so far, helped turn around his career.
The price for miracles like this hard to determine – even for doctors.
“A lot of this is confusing to surgeons,” said Dr. Stephen Tower in Alaska. “A lot of this is funny money. People get these incredibly high bills and what actually gets paid is a percentage of that.”
A hip can easily cost more than a car.
Scott Abram has had three total hip replacements. One has been problem free; the other, a source of constant paint that ultimately had to be replaced.
Hospital records show his insurance company was billed more than $20,000 for his most recent hip. The total bill for that one was $60,000. He doesn't know how much was finally paid by his insurance company.
The price pales in comparison to the agony he’s endured for eight years.
“I'm in pain every minute of every day and all night long,” he said.
He’s an airline pilot, but the pain has kept him from working for nearly a decade. . 
“There wasn’t a great deal that was explained to me ahead of time,” he said. 
What he didn’t know was that his hip was never rigorously tested. Like other devices, it was approved by the FDA in a shortcut process called 510 k. 
“If they were similar to other products on the market then you could release these other models onto the marketplace, without adequate testing or data,” said Dr. Shezad Malik, a Dallas physician who is also a lawyer. He is suing the company that made Scott Abram’s hip.
Hips are failing, he says, at a rate higher than the public realizes.
“In Australia and the UK, they’ve found actually double digit failures,” Dr. Malik said. “And the failure rate can be as high as 50 percent at five years.” 
In the last 10 years, there have been 578 different recalls of hip implants from six major manufacturers, according to the Safe Patient Project, which is affiliated with Consumers Union.
The problem is, most patients don’t even know what kind of hip is in their body.
“We don’t know how many of those patients have died. Others may not be mobile. Families don’t know what’s going on,” Dr. Malik said.
One manufacturer, DePuy, has already settled a class action lawsuit for $2.5 billion. It faces another class action lawsuit for another of its artificial hip models. Other manufacturers are being sued as well.
But lawsuits won't solve the problem for the 1 million people with chromium cobalt in their hips across the country. Like owners of recalled cars, they could be headed for a crash and don’t know it.

Tuesday, May 28, 2013

'Flawed from legislative foundation': FDA June 13, 2013


The purpose of the meeting is to discuss FDA’s past, present, and future policy on 510(k) Modifications with external stakeholders. FDA seeks comment from stakeholders on different options, both in the form of submissions to the docket for the Federal Register notice associated with this meeting and in discussion during the public meeting. FDA also seeks actual examples of device modifications that industry has made in order to help the Agency develop its policy. FDA expects to discuss the following options:
1.             Potential use of risk management in 510(k) device modifications decisions – can FDA incorporate risk management into its policy on how to determine whether device modifications require new 510(k) submissions in a way that ensures appropriate and consistent decisions by industry and FDA staff?
2.             Potential reliance on design controls activities – FDA seeks proposals for how industry and FDA could utilize design control activities such as design verification and validation to ensure that device modifications are appropriately evaluated prior to marketing.
3.             Potential use of critical specifications – FDA seeks proposals on whether it could incorporate the use of critical specifications in its policy on how to determine whether devices modifications require new 510(k) submissions in a way that ensures appropriate and consistent decisions by industry and FDA staff.
4.             Potential risk-based stratification of medical devices for 510(k) modification purposes – FDA seeks input on the practicality of stratifying devices that require 510(k)s by risk, where lower risk devices would not require 510(k)s for most modifications, if those modifications are part of periodic reports submitted to the Agency.
5.             Potential periodic reporting – FDA seeks comments on the possibility of requiring periodic reporting for legally marketed 510(k) devices.
6.             Potential other solutions – FDA seeks comments on combinations of the options above, or other options not mentioned here.

Date, Time and Location
This meeting will be held on June 13, 2013 beginning at 9 a.m at the following location:
FDA White Oak Campus10903 New Hampshire AvenueBldg. 31, Room 1503 (the Great Room), Silver Spring, MD, 20993
                FDA Campus Information
This public meeting will also be Webcast. Persons interested in viewing the Webcast must register online by 5 p.m. on May 30, 2013. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after May 31, 2013.  If you have never attended a Connect Pro event, test your connection.  A quick overview of the Connect Pro program is also available.
Preliminary Agenda (All times are tentative)
Time
Subject
9:00 AM
Introduction
9:15 AM
FDA Presentation
10:00 AM
External Stakeholder Presentations
11:00 AM
Break
11:15 AM
External Stakeholder Presentations, continued
12:15 PM
Lunch
1:15 PM
External Stakeholder Presentations, continued
2:15 PM
Break
2:30 PM
Panel Discussion
3:45 PM
Open Comment Period
4:15 PM
FDA Close-out
4:30 PM
Adjournment
Registration to Attend the Meeting
If you wish to attend this meeting, you must register by close of business on Thursday, May 30, 2013.  
There is no fee to register for the meeting and registration will be on a first-come, first-served basis.  Early registration is recommended because seating is limited.
Comment
In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the meeting topics.  FDA would like to receive these comments by May 30, 2013, so they can be discussed during the meeting, however, comments related to this meeting will be accepted until July 13, 2013.
Regardless of attendance at the meeting, interested persons may submit either written comments regarding this document to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852 or electronic comments to http://www.regulations.gov.
If you wish to make an oral presentation during any of the open comment sessions at the meeting you must indicate this at the time of registration. FDA requests that presentations focus on the topics defined in the Federal Register Notice. You should also identify which discussion topic you wish to address in your presentation. In order to keep each open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak. FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by June 3, 2013.  If selected for presentation, any presentation materials must be emailed to Michael Ryan, Michael.ryan@fda.hhs.gov no later than June 6, 2013. No commercial or promotional material will be permitted to be presented or distributed at the meeting.
Workshop Details
Food and Beverages will be available for purchase during the breaks.
If you require special accommodations due to a disability, or need additional information regarding registration,  please contact Joyce Raines,Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5709, FAX: 301-847-8142, joyce.raines@fda.hhs.gov.
Contact Us
For questions regarding meeting content please contact:
Michael J. Ryan
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 66, rm. 1615
Silver Spring, MD 20993-0002
Phone: 301-796-6283,
michael.ryan@fda.hhs.gov

My comment:  FDA-2013-N-0430-0001  May 29, 2013 at 6:45pm CT
510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device
Question D: Risk-Based Stratification of Medical Devices for 510(k) Modifications Purposes
The 510(k) process is not patient centered and this omission causes patient harm.  FDA perpetuates harm by allowing the public to believe that there is scientific research/clinical study performed prior to marketing and implantation of a device.  In addition, the public believes that if a device proves defective, unsafe or ineffective (as in a consumer product failure) the harmed patient will have rights to justice and be cared for medically and financially and any future preventable harm will be stopped.  In fact, the medical provider is not legally responsible for notifying FDA if there is an adverse event with an implant, unless there is a fatality.  In addition, the FDA is not charged with providing an independent investigation of the event.  The harmed patient is charged with finding a lawyer willing to file a lawsuit (often in federal court) and risk their careers on a lawsuit that will cost them more than it will return financially (tort reform limits settlements).  The 510(k) serves to perpetuate the bureaucracy of the FDA, profit the entitled medical device industry and imperil patient safety.  Joint replacement is now the #1 category of expenditure of Medicare yet UDI’s (unique device identifiers) and post market surveillance is lagging.  The U.S. public is paying for countless unproven implanted medical devices that fail and many patients require long-term rehabilitation, often at public expense.

On July 29, 2011 the Institute of Medicine returned a FDA commissioned study report to FDA/CDRH stating
The committee finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the committee concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”
Given that the FDA/CDRH rejected this advice via FDA/CDRH Director Dr. Jeffrey Shuren’s press release (that day) stating “FDA believes that the 510(k) process should not be eliminated . . .” 
According to Barry Meier of the New York Times  “As of October 2011, some 3,500 patients had filed a lawsuit involving that (J&J DePuy metal-on-metal hip) device.
There is no data on the number of all-metal hips that have failed prematurely in this country because the outcomes of orthopedic procedures are not formally tracked by the government or private companies.”
Jane Akre, on May 24, 2013 reports on Mesh Medical Device News Desk that “21,257 Cases Filed in Federal Transvaginal Mesh Litigation.”  These harmed women have implanted surgical mesh complications that prevent them from having sexual relations, may develop auto-immune disorders, experience extreme pain, may be prevented from returning to work and normal activities for a permanently implanted failed product that was cleared via 510(k).
Stop patient harm.  Follow the IOM instructions to design a system for scientific evaluation of patient harm/risk designed for protection from dangerous and unnecessary medical device implants. 
Steven Baker (MedWatch adverse event #5009052)
Joleen Chambers  (completed training workshop for FDA/CDRHPatient Representative, September 2010)