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.
Twitter: JjrkCh

Wednesday, June 22, 2016

FDA/CDRH - Celebrates 40 year old (unsafe and ineffective) Medical Device Amendments


Posted on June 22, 2016 by FDA Voice

By: Jeffrey Shuren, M.D., J.D.
In 1976, Steve Jobs and Steve Wozniak founded Apple and a gallon of gas was $.59. And in another action that has had long term impact, President Ford signed the Medical Device Amendments that closed the dangerous gap between what he called FDA’s “horse and buggy authority” and “laser age problems.”

Jeffrey Shuren, M.D., J.D., FDA’s Director of the Center for Devices and Radiological Health, speaking at FDA’s Celebration of the 40th Anniversary of the Medical Device Amendments
Unlike the pharmaceutical industry, which was born from large chemical companies that discovered medical uses for the products they made, the device industry sprung to life as a scrappy sibling—mostly mom-and-pop businesses addressing the needs of individual patients and physicians through invention.
Although Congress had first given FDA explicit authority over medical devices in the 1938 Food, Drug, and Cosmetic Act, the focus was on fraudulent products. Efforts to extend FDA’s oversight on medical devices failed in 1962 and again in 1970.
Then in 1975, reports emerged that thousands of women had been harmed, some even died, from pelvic inflammatory disease, as the result of using the Dalkon Shield, an intrauterine device for contraception. Congress responded the following year by enacting the Medical Device Amendments, which authorized FDA to classify all medical devices based on risk into one of three classifications, to require premarket approval for Class III devices, and for devices to comply with reporting and GMP requirements.
The law ushered in a new era for medical technology innovation, patient access, and patient safety, but also created a tension, contributing to a political environment where the pendulum continues to swing between these objectives, defining and driving the medical device ecosystem ever since.
In signing the legislation, President Ford noted that, when “well designed and well-made and properly used” medical devices “support and lengthen life.” But when medical devices are “poorly designed, poorly made, and improperly used” they can “threaten and impair” life.” His words still ring true today.
The initial Medical Device Program started with about 180 people. Today, FDA’s Center for Devices and Radiological Health (CDRH) is 1,700 strong; a vibrant family of individuals with a wide range of scientific, clinical, engineering, legal, and other expertise, who hail from a variety of backgrounds, and who are ready to tackle the latest scientific advancement.
And the mom and pop industry has transformed into a world of sophisticated software algorithms, miniaturization, combination products, wearable sensors, non-invasive procedures and diagnostics, robotics, and artificial intelligence.
Along the way, CDRH has adapted its expertise and regulatory approaches to meet the needs of such rapidly evolving innovation. While we will continue to adapt, more importantly, we are focusing on proactively anticipating where we need to be so that regulatory innovation is out in front of medical device innovation. We’re doing this now in the digital health space, by designing regulatory frameworks around the type of technology and its unique evidence generation and innovation cycle rather than applying a one-size-fits-all approach.
We are implementing new models for evidence generation. They include the establishment of a National Evaluation System for health Technology, or NEST, that could transform the historical tension between device innovation, patient access and patient safety into an alignment of interests to drive the development and more timely access to life-saving, life-enhancing, and life-advancing devices. This is consistent with our vision: That patients in the U.S. have access to high-quality, safe and effective medical devices of public health importance first in the world.
And we are also going to new places with patients by establishing a foundation for engaging with them as our partners and routinely incorporating their perspectives in our decisions. And that’s fitting because improving the health and the quality of life of patients by assuring they have timely access to medical technologies that will benefit them is at the heart of who we are and what we do.
As we look ahead to the future, it is our work, our care and our dedication that will allow us to reach our vision.
Jeffrey Shuren, M.D., J.D., is FDA’s Director of the Center for Devices and Radiological Health
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http://www.fda.gov/NewsEvents/Speeches/ucm508146.htm
Remarks at FDA’s Celebration of the 40th Anniversary of the Medical Device Amendments


Remarks of Jeffrey Shuren, M.D., J.D.
Director of the Center for Devices and Radiological Health
U.S. Food and Drug Administration
June 22, 2016

1976.
Anyone thought about where they were or what they were doing in 1976?
I was in junior high school with no clue what the FDA was but very focused on a girl I had a crush on.
In 1976, Nadia Comaneci won 3 gold medals in gymnastics in Montreal.
The Steelers won the Super Bowl.
Steve Jobs and Steve Wozniak founded Apple.
The first “punk rock” single—by a group called The Damned—flopped horribly.
A gallon of gas was $.59 and the Dow Jones Industrial Average closed the year at 1004.
And, as we know and are here today to celebrate, President Ford signed the Medical Device Amendments that closed the dangerous gap between what he called FDA’s “horse and buggy authority” and “laser age problems.”
How we got here has been quite a journey. We’ve been using medical devices for thousands of years, including tools to punch holes in the skull to let out evil spirits and sticks to help the disabled walk. In 1850, a German scientist, Hermann von Helmholz, invented one of the first modern day medical devices, the ophthalmoscope, using a light source and lenses to view the interior of the eye.
At about the same time, Willhelm Roentgen, a professor of physics in Bavaria, discovered that radiation can penetrate solid objects of low density, which led to the invention of X-ray machines. In 1927, the respirator was introduced. In 1939, the first heart-lung bypass machine came on the market.
However, unlike the pharmaceutical industry, which was born from large chemical companies that discovered medical uses for the products they made, the device industry sprung to life as a scrappy sibling—mostly mom-and-pop businesses addressing the needs of individual patients and physicians through invention.
I’ll give you an example: Earl Bakken and his brother-in-law Palmer Hermundslie co-founded Medtronic in 1949 in a garage in Minneapolis. The company started as a repair service for hospital electrical equipment and a regional distributor for other manufacturers. They would build new equipment on order or customize standard instruments for laboratory or clinical researchers. They would install equipment, train personnel on their use, troubleshoot and repair it as necessary. At the time, they were barely getting by.
Enter Walton Lillehei. This world-renowned cardiac surgeon at the University of Minnesota pioneered techniques for the repair of congenital defects as part of the rapidly evolving field of open heart surgery.
Despite successful repair of the congenital defect, about 1 patient in 10 developed post-operative, complete heart block due to damage of the conducting system while the surgical repair was being performed. It was thought that temporary cardiac rhythm support via pacing would keep the patient alive until recovery of the conducting system occurred. However, the high voltage pacing stimuli delivered across the chest by the machine invented by Zoll was believed to be too traumatic on young children.
Dr. Lillehei and his co-workers developed the myocardial wire – a multi-stranded, braided stainless steel wire in a Teflon sleeve that could deliver low voltage pulses. One end of this wire was implanted directly into the heart muscle and the other end was connected outside the body to the physiology lab stimulator.
Early attempts to use the device were successful until October 31, 1957,  when a 3-hour municipal power failure resulted in the tragic death of a baby. The hospital had emergency power generation in its surgical suites and recovery area but not in its patient rooms.
The very next day, Lillehei asked Bakken to see if Medtronic could come up with something better.
Initial attempts at building a more reliable and portable pacemaker involved adding an automobile battery with an inverter to convert 6 volts direct current into 115 volts alternating current.
This didn’t work. So, Bakken found a back issue of Popular Electronics where he had seen a circuit for an electronic, transistorized metronome. He modified the two-transistor circuit and placed it, without the loudspeaker, into a four-inch-square and inch-and-a-half-thick aluminum box with terminals and switches on the outside. The circuit was run by a miniature 9.4 volt battery housed within the box.
From that determination and ingenuity sprung the field of “medical electronics.” Prior to 1957, there had never been a partly or completely implantable electrical device.
Every journey brings new inspiration and experience—and, inevitably, bumps, potholes, and dead ends.
Following Medtronic’s early success, the pace of innovation picked up dramatically. But, the transition from garage to manufacturing facility didn’t always include rigorous scientific and clinical evaluation. Instead, it continued to rely on bedside observation for benefit and risk determinations.
Which led to problems. And tragedy.
Congress first gave the FDA explicit authority over medical devices in the 1938 Food, Drug, and Cosmetic Act, with our focus primarily on fraudulent products. However, in 1962 when Congress passed a new regulatory framework for drugs, they dropped President Kennedy’s proposal to include medical devices.
Then in 1970, President Nixon established the Cooper Committee – chaired by Dr. Theodore Cooper, then director of the National Heart and Lung Institute – to study medical devices as part of the President’s endorsement of medical device legislation. The committee recommended that any new legislation be specifically targeted to the device industry, because devices presented entirely different issues from drugs. It also suggested that different classifications for medical devices be created, which would tailor the regulatory controls to the risks involved. But Congress couldn’t agree on a bill.
In 1975, reports emerged that thousands of women had been harmed, some even died, from pelvic inflammatory disease, as the result of using the Dalkon Shield, an intrauterine device for contraception. Congress responded by enacting the Medical Device Amendments, which authorized the FDA to classify all medical devices based on risk into one of three classifications, to require premarket approval for Class III devices, and for devices to comply with reporting and GMP requirements.
The law ushered in a new era for medical technology innovation, patient access, and patient safety, but also created a tension, contributing to a political environment where the pendulum continues to swing between these objectives, defining and driving the medical device ecosystem ever since.
“Today, devices are routinely implanted in our bodies. They replace limbs, bones, tissues, even entire organs. They permit treatment of forms of illness that can be accomplished in no other way. They magnify and speed 10 thousandfold the diagnostic power of the human eye and brain.
“Medical and diagnostic devices have produced a therapeutic revolution, but in doing so they have also become more complex and less easily understood by those who use them. When well designed, well made, and properly used they support and lengthen life. If poorly designed, poorly made, and improperly used they can threaten and impair it.”
While I’d like to take credit for those words—I can’t. While they sound suspiciously recent—they are not.
These are President Gerald Ford’s words—a succinctly accurate and descriptive summary of why, in 1976, America desperately needed the law he was signing to allow the FDA to regulate medical devices based on risk.
Medical devices can save and give us better lives. I know because my family has relied on them for years – from cardiac stents to implantable hips to the mammogram that picked up my wife’s cancer in time to get her the treatment she needed. But we can rely on these medical miracles because of the careful oversight we provide here at CDRH.
When my wife had to decide what course of treatment to pursue, she was given the results of a laboratory developed test. However, it wasn’t until she and I had the results from an FDA-approved test that we had the information and the confidence we needed to make fully informed decisions.
It is our work, our care, and our dedication that will allow us to reach our vision—that patients in the U.S. have access to high-quality, safe and effective medical devices of public health importance first in the world.
CDRH’s vision—our shared vision – intentionally begins with “patients” because improving the health and the quality of life of patients by assuring they have  timely access to medical technologies that will benefit them is at the  heart of who we are and  what we do.
After 40 years, we live in a world of sophisticated software algorithms, miniaturization, combination products, wearable sensors, non-invasive procedures and diagnostics, robotics, and artificial intelligence. And, all along the way, we at CDRH have had to adapt our expertise and regulatory approaches to meet the needs of rapidly evolving innovation. That has been our history.
Make no mistake:  We are as scrappy and as enterprising as the industry we regulate.
As we look to the future, however, we will continue to adapt, but, more importantly, we will and have already begun to focus on proactively anticipating where we need to be so that regulatory innovation can get out in front of medical device innovation. We’re doing this now in the digital health space, by designing regulatory frameworks around the type of technology and its unique evidence generation and innovation cycle needs rather than applying a one-size-fits-all approach.
 And we are implementing new models for evidence generation, such as through the establishment of a National Evaluation System for health Technology, or NEST, that could transform the historical tension between device innovation, patient access and patient safety into an alignment of interests to drive the development and more timely access to life-saving, life-enhancing, and life-advancing devices.
We are going to new places with the patients who drive our mission, by establishing a foundation for routinely incorporating their perspectives in our decisions. After all, they are our most important customer and should be our partner in best serving them.
Forty years ago, the initial Medical Device Program started with about 180 people, and our country was celebrating its 200th anniversary. That year, NASA unveiled its first space shuttle – The Enterprise – which, as a Star Trek fan, I thought was very, very cool. As a nation we were ready to soar.
Forty years later, CDRH is 1,700 strong; a vibrant family of individuals with a wide range of scientific, clinical, engineering, legal, and other expertise, who hail from a variety of backgrounds, and who are ready to tackle the latest scientific advancement, including what one day soon may be the first Star Trek-like tricorder. While our mission and vision guide us, and patients drive us—it is our people and their diverse personal and professional backgrounds, experiences, and expertise who are fundamental to our success as a public health agency.
If our mission and vision are our North Star, if patients are our compass, then our ship – our USS Enterprise – that will boldly go where no person has gone before – is CDRH, and you are its crew.
Captain James T. Kirk once said, “You know the greatest danger facing us is ourselves, an irrational fear of the unknown. But there’s no such thing as the unknown — only things temporarily hidden, temporarily not understood.”
I don’t know what new worlds we will discover or the new technologies we will encounter, but I look forward to traveling there with you wherever we may go.

Happy anniversary.

Tuesday, June 21, 2016

J&J relies on European registries for recall data: FDA fails to protect US citizens.



J&J’s Ethicon recalls Physiomesh flexible composite hernia mesh

JUNE 20, 2016 BY BRAD PERRIELLO   FiDA highlight
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon last month recalled 1 of its surgical mesh products after studies showed higher revision rates after a type of minimally invasive hernia repair using its Physiomesh flexible composite mesh.
In a May 25 letter to healthcare providers, Ethicon said it’s pulling the mesh after a review of unpublished data from a pair of European registries revealed the discrepancy between Physiomesh flexible composite and the other meshes in the registries after laparoscopic ventral hernia repair.
West Somerville, N.J.-based Ethicon said it believes the higher revision rates are due to a “multifactorial issue,” possibly including “product characteristics, operative and patient factors,” but hasn’t been able to pin down a cause.
“Consequently, Ethicon [has] not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and [has] decided to recall Ethicon Physiomesh composite mesh from the global market,” according to the letter. “Ethicon will not return theEthicon Physiomesh composite mesh product to the market worldwide.”
Patients already implanted with the product should be followed as usual, the company said. The recall does not involve any other Ethicon meshes, including the Physiomesh Open flexible composite mesh, it said.

“Ethicon recognizes the voluntary product recall of the Ethicon Physiomesh composite mesh may be disruptive to your facility and apologizes for any inconvenience this may cause,” the company wrote. A list of the affected product codes can be found here.

http://www.massdevice.com/jjs-ethicon-recalls-physiomesh-flexible-composite-hernia-mesh/

Tuesday, June 14, 2016

Zimmer Persona Knee Revision Surgery Prompts Recall



Zimmer Persona Knee: They Don’t Make ’em Like They Used To

June 13, 2016, 08:00:00AM. By Gordon Gibb  FiDA highlight

Warsaw, IN
It’s a common refrain in the modern age: things are not as they were. People don’t respect each other, or each other’s property like they used to. The politeness of old has vanished. “They don’t make ’em like they used to.” And for the most part, things aren’t built to last. One must forgive such a lament coming from the plaintiff behind a Zimmer Persona lawsuit alleging a failed Zimmer Persona Trabecular Metal Tibial plate.

Pundits find it remarkable that while the life expectancy of Americans continues to rise - thanks in part to ongoing advancements in modern medicine, disease prevention and more active lifestyles - the quality of the “parts” employed to make us whole again continues to decline, or so it appears.

A fast-track approval process employed by the US Food and Drug Administration (FDA) to bring new products to market more quickly without the traditional, years-long clinical trial process isn’t helping.

There is little doubt that for the majority of Americans, prosthetic knee devices work well and are on track to achieve the assumed service life expectancy of 15 years or more. However, when patients begin having problems with their medical devices - again, in the minority - even an apparent small number can have sufficient statistical impact to warrant a product recall.

That’s what happened last year with the Zimmer Persona Trabecular Metal Tibial plate. The latter is a plate that sits atop the tibia and serves as the surface area for the prosthetic knee device. According to various attorneys engaged in Zimmer lawsuits, a growing minority of patients reported loosening of the plates. This, in part, appears to be exacerbated by a lack of bone growth into the tibial plate, which would serve to anchor the plate. For a statistically large number of patients, this bone growth was either insufficient or not happening at all, leading to Zimmer Persona Knee pain and failure of the artificial knee.

Just referencing the failure of a medical device, implanted into a human body and failing soon after implantation, is serious enough without consideration of where a patient might be, or the activity involved at the point at which an artificial knee fails: driving a car; crossing a busy intersection; skiing; even walking across the kitchen with a steaming hot cup of tea from which a patient could suffer scalds or serious burns were a Zimmer knee to suddenly fail.

Thus, the Zimmer Persona Recall of 2015 when the Zimmer Persona Trabecular Metal Tibial plate was voluntarily recalled by the manufacturer - a recall endorsed by the FDA. Many patients experiencing Zimmer Persona Knee pain from a failed Zimmer Persona Trabecular Metal Tibial plate and requiring revision surgery to replace the failed component(s) are filing a Zimmer Persona Metal Plate lawsuit to seek compensation for pain, suffering and even loss of income. Revision procedures are often more complex than the initial procedure, with higher rates of complication. Having to go through a second surgery so soon after the first, followed by additional rounds of physiotherapy and rehabilitation, can eat into an individual’s income and livelihood given the additional time away from work.

The Zimmer Persona Trabecular Metal Tibial plate, it should be noted, was brought to market through an FDA 510(k) Clearance, the regulator’s fast-track program that allows design updates or new devices substantially similar to those already on the market and performing well to be brought to market without having to go through a clinical trial.

Clinical trials are long-term tests on volunteer patients, conducted to establish the safety and efficacy of a medical device before it is released to market and made available to the general population. If there are problems that surface in clinical trials, the device can be revised prior to a full market release.

Zimmer Biomet (Zimmer) is not the only manufacturer recalling medical devices. Other blue-chip medical devices firms are becoming saddled with recalls. Similarly, the FDA 510(k) Clearance is available to most large device manufacturers.


Speaking of Zimmer, US Official News (4/14/16) reports another Zimmer Persona Recall, but this one has to do with packaging. According to the FDA, the recall involved the Persona Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty (REF # 42-5114-008-18).

The recall stemmed from a complaint that there were two sets of information on the box containing the product: One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.

The products at issue were distributed to various states in the United States as well as globally (but not Canada).


The Zimmer Persona Recall was voluntary, issued by the manufacturer.
https://www.lawyersandsettlements.com/articles/zimmer-persona/zimmer-persona-lawsuit-recall-10-21533.html?opt=b&utm_expid=3607522-13.DLfjpNTnSeOVrAk1Ud2uNA.1&utm_referrer=https%3A%2F%2Fwww.facebook.com%2F

Friday, June 10, 2016

Please Support Ariel Grace's Law HR5403

June 10, 2016
The Honorable __________________
___________________ HOB
Washington, DC 20515

Dear ________________________, 


On June 8, 2016, Congressman Mike Fitzpatrick (R-PA) and Congresswoman Louise Slaughter (D-NY) introduced an important new bi-partisan bill.  This bill seeks to remove the preemption protection granted to Class III medical devices which receive initial premarket approval by the FDA.  Accordingly, manufacturers of medical devices, which  later may be shown to be defective and dangerous, will not be automatically shielded from liability.  Often the threat of civil litigation is the necessary force to ensure that manufacturers provide medical devices that are both effective and more importantly, safe. A similar bill had over 100 cosponsors several years ago, and we hope to drive similar bipartisan support.

The bill is aptly named, Ariel Grace’s Law, after Ariel Grace Burrell, whose stillborn birth was caused by a Class III medical device. Kristiana Burrell has given her blessing to have the bill named after her daughter and the bill was introduced on the one year anniversary of the birth/death.

This  bill is  applicable to all Class III medical devices. It is an amendment to an already existing statute and merely amends the statute to allow access to courts for those injured by defective medical devices and is states as follows:              

This Act may be cited as the “Ariel Grace’s Law

(a)  Amendment- Section 521 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360k) is amended by adding at the end the following:
(b)  NO EFFECT ON LIABILITY UNDER STATE LAW- Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the laws of any State.”
(c)  EFFECTIVE DATE; APPLICABILITY. - The amendment made by subsection (a) shall
(1) Take effect as if included in the enactments of the Medical Device Amendments of 1976 (Public Law 94-295): and
(2) Apply to any civil action pending or filed on or after the date of the Act.


As your constituent, I strongly urge your support of this bill. It is unconscionable and unjust that manufacturers who have a medical device approved by the FDA pursuant to a  premarket approval process can be forever shielded from liability and immune from suit even when the device later proves to be dangerous and/or defective and causes injury to device users. It was never the intent of the Federal Food, Drug and Cosmetics Act to provide blanket immunity for medical device manufacturers for defective devices placed into the stream of commerce.  Quite simply, there is no plausible reason nor rationale for the failure to support this amendment, which serves to protect your constituents.  Accordingly, I strongly urge you to join forces with Representatives  Fitzpatrick and Slaughter and make this bill into law as soon as possible.

My best,


Monday, June 6, 2016

USA Patient Network-Advanced Patient Training Workshop June 3-4, 2016


I (Joleen Chambers) attended this excellent workshop last weekend (photo above).  Every patient should have this information BEFORE taking any drug or being treated with any medical device!  Dr. Diana Zuckerman, President of the National Center for Health Research hosted the workshop and these are her presentation slides.  I also must thank PCORI (Patient Centered Outcomes Research Institute) for awarding partial financial support to the host organization of this workshop.  
PLEASE SHARE!!!!



































Friday, June 3, 2016

They Can Run, But They Can't Hide! J&J Halo Products Shielding Medical Device Failure


Johnson & Johnson Is Urged to Slim Down

By ROBERT CYRAN JUNE 2, 2016  @rob_cyran  The New York Times

Johnson & Johnson weighs heavy. The bulging health care conglomerate is swallowing the hair-care company Vogue International for $3.3 billion in defiance of calls to break up. Johnson & Johnson’s $312 billion market value makes it a hard target for activists. Yet its size has created ailments, including poor merger-and-acquisition activity and mediocre shareholder returns.
Over the last decade shareholders have largely come to the conclusion that pharmaceutical firms should focus on developing medicines. After all, there’s little in common between using science to discover a cure for Alzheimer’s and selling shampoo. That has led Abbott Laboratories to spin off the pharmaceutical division AbbVie; Pfizer and Merck each to sell their consumer-goods business;and GlaxoSmithKline to divest nutritional drinks. The results have been largely favorable to investors too, because the cash thrown off by consumer goods companies is coveted by yield-starved investors.
Johnson & Johnson has resisted the trend. About one-fifth of its revenue comes from selling consumer health and beauty products such as Band-Aids and Listerine. Over 40 percent comes from cutting-edge drugs, and the rest from medical devices. The diversity may produce relatively steady results, but investors aren’t terribly appreciative of the fish-fowl hybrid. The company is valued at about 11.5 times estimated earnings before interest, taxes, depreciation and amortization, or Ebitda, over the next 12 months. That’s lower than the multiples attached to the consumer goods maker Colgate and the drug maker Eli Lilly, which trade between 14 and 15 times Ebitda, and the medical device firm Medtronic, at 12.5 times.
This has not escaped investors. Artisan Partners tried to pressure Johnson & Johnson to split earlier this year. However, Artisan owned well under 1 percent of its stock; combined with Johnson and Johnson’s scattered investor base, the activist had almost no power to battle its giant target.

The company’s girth comes at a cost. The drug business is faring well, but the other divisions are not. The consumer-goods unit’s margins are below rivals’ and some of its factories still operate under regulatory oversight from the Food and Drug Administration after a wave of product recalls a few years ago. The medical device division’s profits have been essentially stagnant since 2010 despite buying a rival, Synthes, for around $20 billion five years ago. Slimming down, or even splitting into three, would serve Johnson & Johnson well.
http://www.nytimes.com/2016/06/03/business/dealbook/johnson-johnson-is-urged-to-slim-down.html?emc=edit_tnt_20160602&nlid=50639700&tntemail0=y&_r=0