MDUFA III FDA PATIENT STAKEHOLDER PANEL (photo on right)
LANA KEETON, PRESIDENT & FOUNDER, TRUTH IN MEDICINE (left) PAUL BROWN, GOVERNMENTAL RELATIONS, NRC (center) KATE RYAN, PROGRAM COORDINATOR, NWHN (right)
PUBLIC TESTIMONY LANA C. KEETON
FDA PATIENT STAKEHOLDER PANEL
Hello, my name is Lana Keeton. I am the President and Founder of Truth in Medicine. My comments today are first to thank Dr. Jeffrey Shuren for his leadership as the Director of the CDRH in tough political and economic times. I want to thank Dr. William Maisel for taking a leadership position at the CDRH to continue his fight for medical device safety. I want to thank the team members of the Synthetic Surgical Mesh Investigative team who do their very best every day to keep patient safety first. They have done an exemplary job within the current framework at the FDA.
All the well deserved compliments aside, the FDA regulatory framework they must work under is completely inadequate. Americans are not safe. Industry is here to preserve and protect the profit of their companies for their stockholders. It is their day job. I am here to speak for patient stakeholders who do not have a voice, who are sick and injured and disabled, some who are already dead and some who would welcome death not to be in pain anymore. Patients don’t sign up for the greater good. They go to their doctors to be well. What happens to them is despicable.
The FDA does not have the resources or the manpower or the regulatory authority to protect the public health. $595,000,000.00 is a ridiculously small amount of money for one of the most important institutions in the American government. While we as Americans spend countless billions around the world in lives and treasure and aid to disaster victims, the House of Representatives, the Senate and the President of this country fund the FDA with only a few hundred million per year.
There never really should have been a MDUFA I. The FDA and the CDRH should be a wholly funded government entity, not the hybrid government/private sector funded entity it is today.
Much has been made of late that the FDA is stifling jobs and innovation. I have to ask, what is innovative about a copycat piece of mesh that has been used for over 50 years? As for the FDA being a job creator, the jobs are not moving overseas because of the FDA’s speed, or lack thereof, in the approval process. These are international companies producing products overseas. These medical devices are, and have been, overseas for years now by choice. The laws are less stringent overseas. Device companies produce the products in the most favorable legislative climate in other countries and then ask the FDA for U.S. approval touting their approval in other countries. It’s a shell game. A well played shell game.
Not only does the medical device industry produce products internationally, it produces harm internationally. Lorraine Evans, U.K. Director of Truth in Medicine and founder of TVT Mum Charity in Bristol, UK recently received a response from the Department of Health after raising concerns to David Cameron, Prime Minister of England, and Andrew Lansley, the Secretary of State for Health, of the severe ongoing harm from synthetic surgical mesh.
In a letter to Dr. Shuren and Dr. Hamburg in May 2011, Gayle Graham of South Africa, wrote: “The reason for this letter is to educate and plea to the FDA on their decisions, the repercussions of those decisions, and procrastination to action in rectifying those decisions, and how this effects individuals beyond U.S. borders even as far as South Africa.” South Africa has no public health agency.
Robyn Ribarits and other women have traveled from Australia to Los Angeles to have surgical mesh removal by Dr. Shlomo Raz at UCLA in Los Angeles because they were unable to find a surgeon in Australia to help them.
What we need are stronger laws here in the U.S. so the innovation would become SAFE AND EFFECTIVE MEDICAL DEVICES, not we tried this in animals and we think it might work in humans. As Janet Holt, Regulatory Affairs Director of Truth in Medicine says, “We must mandate patient labeling and clinical trials for implanted medical devices and no wait for MDUFA IV before patient registries are created.”
Instead industry will pay $595,000,000.00 over the next 5 years to the FDA, a drop in the bucket to what device companies spend every single year to get their products to market knowing they will injure patients who they will only compensate through product liability litigation.
They spend money influencing medical students at university level. They pay money to support professional medical associations. They pay money to individual doctors and surgeons designated as key thought leaders. They pay money to medical consultants, medical advisors and speakers. They pay money to foundations. They sometimes pay ghost writers. They pay money to lobbyists. They pay millions of dollars to defense attorneys. They pay millions of dollars in settlements to device injured plaintiffs.
They even pay money to the Department of Justice. Pharmaceutical and device companies have paid over $19.2 billion dollars since 1992 in criminal fines. And still they have multi-billions of dollars of profit almost every year from the medical devices that continue to harm unknowing, innocent people who simply wanted to be well.
Here’s the big picture. The International medical device industry has sales of approximately $350 billion dollars per year. You only need look at the annual reports from these medical device companies to see their worldwide structure. These companies are not shipping jobs overseas because of the FDA’s performance as a regulatory authority. These companies already have major worldwide holdings.
For Instance, in approximately 2000, Johnson & Johnson bought Medscand AB, a Swedish company, producing the metal hooks used to implant their trademark Prolene mesh. The Gynecare TVT Prolene mesh is then assembled in Switzerland, shipped to Scotland for sterilization, returned to Switzerland for distribution through a Johnson & Johnson plant there. Ethicon U.S. just distributes the product here in the U.S. This is not a USA manufactured product.
Then there is the Bard Avaulta, originally designed and produced in France where the CEO of the company, Dr. Michel Therin is a veterinarian. A pilot study on the product by Dr. Jim W. Ross here in the U.S. was on 4 sheep for 45 days which referred to studies on mice and rabbits and pigs. Was it ever studied in humans? Who knows? But it is implanted in thousands of women, hundreds of whom are now suing Davol Bard.
When I was fighting for my life following emergency surgery to remove a flesh eating bacteria on Christmas morning 2001, I had no idea I had a piece of polypropylene implanted in me a few days before by my doctor, a piece of petroleum waste byproduct they won’t put in a gas tank, an untested, unsafe medical device cleared by the FDA.
The next 4 days in the hospital with a million units of a cocktail of antibiotics dripping into my body every 2 hours, I was terrified. What had happened to me? Was I going to live? A small card given to me upon discharge, patient labeling, from the initial surgery would have told the surgeons who removed the 3” diameter portion of the skin of my stomach there was a foreign body inside me that was potentiating the infection.
It was almost 4 years after the first surgery when the tenth doctor I had seen for complications told me Ethicon, a division of Johnson & Johnson, was being sued for a bad product. Until that moment, I believed all of my health issues were caused by the initial surgery, a bad doctor and a life threatening infection. Until then, there was no way to deal with the complications because I did not know the cause of them.
From that day in August 2005 until today, I have been trying to get a ½ “ by about 8” piece of Prolene mesh out of me. I have had repeated surgical procedures and am now waiting till June when I will be eligible for Medicare to hopefully have the last surgery to remove the last 4 inches of petroleum waste byproduct that has ruled my life for over 10 years.
Here are two tiny pieces of the mesh, one the size of a flea and the other the size of a tick, that required a cystoscopy, without anesthesia, and $1,200.00 to remove it. Erosion, they call it, a minor in office procedure. Of course, they don’t have mesh inside of them or they would never call it a minor problem. I won’t bore you with the details but my bladder is now worth about a million dollars from medical treatment and lawsuits. A stark contrast to the approximate $1,200.00 the hospital paid to purchase the device from Ethicon in 2001.
The sad results of the flawed 510(k) system is hundreds of thousands of permanently disabled patients, millions of recalled devices, thousands of lawsuits and billions of wasted taxpayer dollars. The remedy for this: SAFE MEDICAL DEVICES.
To make Americans safe, we must properly fund and properly man and give the best regulatory authority possible to one of the most important institutions in the American government, the FDA. The House of Representatives and the Senate and the President of the United States have to stop using the FDA as a political football. They have to come together in unity to do their most important job: protect the public health!
Footnote on Johnson & Johnson - 38% of its sales are from medical devices and 43% of its profit is from medical devices:
“Worldwide Medical Devices and Diagnostics sales of $6.4 billion for the first quarter (2011) represented an increase of 3.3% versus the prior year consisting of an operational increase of 1.3% and a positive currency impact of 2.0%. Domestic sales decreased 0.5%; international sales increased 6.6%, which reflected an operational increase of 3.0% and a positive currency impact of 3.6%. http://www.jnj.com/connect/news/all/johnson-and-johnson-reports-2011-first-quarter-results”
MDUFA III WRITTEN COMMENT by JANET HOLT
REGULATORY AFFAIRS DIRECTOR, TRUTH IN MEDICINE
The MDUFA 111 negotiations have shown to be government at its worst. It is thru these negotiations that I have come to realize that patients and patient advocates were really not allowed to have a seat at the table. My name is Janet Holt. I am a patient advocate with Truth in Medicine. I am an American citizen.
In the negotiations patients were not heard. Here is the short list. We asked that clinical trials for all permanently placed medical devices be done before implanted into patients. We asked for patient labeling for all medical devices. We asked for a patient registry for all permanently implanted medical devices. These requests were needed to inform patients so they could make an informed decision and track complications sooner rather than later.
You have to ask yourself why the medical device companies would object. We only have to take a look at the political battle that took place just this past week to understand we have a group of players who some have lost their moral compass if they ever had one to begin with. We had Representative Markey (D) from Massachusetts ask that a “loop hole” be closed within the 510(k) clearance process that allowed companies to clear their medical devices based on a device that may have been recalled due to death or permanent injury to patients. You would actually have to pass a law to give the FDA the power to reject medical devices similar to ones already cleared even though the FDA knew the devices were not safe.
Let me pause here while I wrap my head with duct tape. We have to pass a law to stop a medical device company from killing or permanently injury an American Citizen. In any other venue, we would call this pre meditated murder or intent to do bodily harm to another. This should be criminal. Rep Markey is trying to legislate that a medical device company have a moral compass.
Rep Markey I thank you for taking on this battle. On the other side we have Rep Gingrey from Georgia ( R) with HR-5 who wants to rein in tort reform by limiting the liability for a patient who has been harmed by a medical device that the device companies knew when they put the product on the market would kill or permanently harm the patient.
Call me simple minded but if we did clinical trials before permanently implanting a medical device and we provided the patient with brochures that showed more than just a happy face and all the miracles that would happen in their life if they had the medical device. If they gave the patient a card that had the name of the product, who made it, and the lot number so that any complications that occurred could pull the medical device into a different class and stop the need for a law suit in the first place. Just call me simple minded here.
Have you ever actually looked at a pamphlet on a medical device in a doctor’s office. You have a happy patient, smiling, maybe riding a bike oozing with “it’s a wonderful life” if only you would have this FDA cleared medical device permanently implanted inside your body. What I want to see is some truth in advertising here. I want to see the person in a wheel chair with a listing of the complications this wonder device did for them. Now that would be an honest brochure on a medical device with the current 510(k) clearance. A brochure should list all the facts known on a medical device. The good, the bad, and the ugly.
Medical devices are ruining patients lives here people. The FDA should reopen the MDUFA talks with the medical device companies and demand more from them. Patient advocates should have a seat at the head of the table. Patients are the reason we are having this conversation. This is a balance between patient safety and innovation.
TVT MUM SUPPORT GROUP
WRITTEN COMMENT BY LORRAINE EVANS, FOUNDER
30 Briar Way · Fishponds · Bristol · BS16 4EB · United Kingdom
Since 2009 I have received thousands of enquiries and helped hundreds of women suffering severe health problems from the TVTs/Mesh implants. Our health situation is critical and at this present time there are very few surgeons in the UK to help us.
I am in regular contact with the MHRA, Department Health and with some Medical Experts to help try and bring changes to the following items:
Our campaign is to bring awareness on the following:-
1. Reclassification of TVT/Meshes medical devices from class 11 to class 111
2. To achieve a National TVT/Mesh register (the MHRA)
3. Increase awareness on reporting adverse events from the clinicians and members of the public
4. For the MHRA to issue a Public Health Notice similar to the FDA
5. Concerns with the manufacturers control bringing onto the market the medical devices without Randomized controlled trials (RCT’s) no human trial studies were done first for TVT/Meshes
6. To have multi-disciplinary teams possibly in 5 regions across the UK
7. Informed consent - the MHRA are currently raising this issue with clinicians through workshops
8. Patient safety with continued research on how the TVT’s/Meshes have affected patients health
9. Keeping up to date on current World-wide investigations.
10 To keep the much needed and valued TVT Mum campaign and support group active
. Surgeons need to be honest and give a fully informed consent
. 100% removal is only in the first week after this it will entail severe tissue damage and for those who have had in for years the complications are more severe, nerve, organs, etc.
. We desperately need experienced surgeons around the UK people are travelling hundreds of miles and paying thousands of pounds to private practise
. Surgeons referring patients s onto other surgeons (not reporting adverse reports)
. More help needed from the NHS – Multi-disciplinary teams urgently required
What we want to see done within the Medical World
. Urgent need to have a National TVT/Mesh Register and for regional multi-disciplinary teams
. Compulsory adverse reporting both from surgeons and patients, and the need to give more awareness to the public. The need to make this easier as the present system is too confusing and also some people are not internet savvy. Public Health Notice similar to the FDA to show on the MHRA website and in the press
. Medical Device regulations to change vaginal mesh medical devices from class 11 to CLASS 111 - the meshes can cause death. 510k process predicate devices every decade plus the use of clearance instead of approval!
Multiple manufacturers are bringing numerous products onto the market and overtaking medical science. They have not done any long term randomised controlled human trials (RCT’s) only rat studies we were used as the guinea pigs without our consent.
How I set up the Charity
Lorraine put her personal life on hold to get the workload done, it has increased over the years and we provide a voluntary support help-line. We are hoping experts will come on board and help us as it’s difficult to keep the support group going whilst we are all so ill most charities have healthy people working for them!
Campaign work in the Pipeline
I recently sent a full 13 page document to the Rt Hon David Cameron MP, Prime Minister and to Andrew Lansley, CBE MP Secretary of State for Health. I have received a four page letter from the Department of Health and they answered all raised concerns. I am sending another letter next week.
I’m going to have a meeting with the MHRA very soon to raise our concerns and to see if they can point us in the right direction to receive more expert help and to achieve the goals as above.
The charity has a petition active at this time since January 2011 and I am hoping to present it end of this year although we might feel it necessary to extend the term.
. A future prospect: A POSSIBLE CONFERENCE? Later in the year for us to attend with medical experts and the patients the way forward to help each
. Request the need to have experienced sonographers to give the 2D and 3D trans-labial ultrasound for all women! This is not currently offered as the correct imaging test, surgeons are wasting NHS money on MRI, CT Scans and Ultra-scans.
. At a later date: ADVERT FOR MESH INURED MESH PATIENTS
. Important: Independent testing facility for the extracted mesh
I have an extensive database with peer articles collated over the years and many of the articles have been taken down from the internet, there is only a fraction of these articles uploaded to the TVT Mum website as I really want to keep this private until the right person comes along who shows an interest and genuinely wants to help resolve our critical health situation and to change ‘Medical Marketing overtaking Medical Science’
I have had to cope with a tremendous amount of work whilst in ill health and as you can imagine there have been some days I nearly threw in the towel! Besides producing the website I have had to set-up a full charity and achieved it through sheer determination, caring and constantly thinking about the poor ladies needing somewhere for support and help. There have been many times I have gone to bed crying my eyes out but the thought of people having somewhere to turn too kept me going.
The sheer volume of emails, letters and telephone calls has been absolutely unbelievable and difficult for me to cope with on my own, although I do have a few ladies who are kind enough to give the help, support and advice to many women.
Through listening to my heart with dignity and constantly working during difficult times and with sheer determination one day someone will come along and give us the help we all deserve is how I achieved the charity, website and support group today.
Many people who have had the TVT/Mesh surgery will tell you it hasn’t only affected their health but also their quality of life - the truth is harrowing and very disturbing.
May 27, 2011
Re: Gynecare TVT mesh device manufactured by Ethicon Johnson & Johnson & FDA
Dear Dr. Shuren & Dr. Hamburg
My name is Gayle Graham, I reside in South Africa. The reason for my email is to educate and plea to the FDA on their decisions, the repercussions of those decisions, procrastination to action in rectifying those decisions, and how this effects individuals beyond US borders even as far as South Africa.
From what I gather the FDA seems to have the necessary expertise on board to determine whether a product is causing incidents and problems in the market from the response and complaints received to determine if that product is possibly defective or not.
In 2006 at the age of 36 years old I was advised by my urologist to have the Gynaecare TVT Mesh inserted for urinary incontinence. I will not go into the detail due to lack of time. 10 days later I was in agony and presented with a high fever, inability to urinate, extreme pain etc. after being rushed into the emergency room at the local hospital I was diagnosed with Septicaemia, an abscess 12 x 15 cm in the Pouch of Douglas, micro abscess in the liver and Jaundice and a 30 % chance of survival. I was immediately operated on, spent 9 days in ICU with 5 pints of blood and 15 operations under my belt to repair the damage that the TVT mesh created. It eroded through my vagina, abdominal wall and created nerve damage which resulted in excruciating pain down the one side of my body, with which I still live with today and effects my life of a daily basis . I have been operated on 3 times out of those 16 in an attempt to remove the mesh.
After having approached an attorney to begin litigation I was exposed to numerous woman who have had similar and worse conditions in South Africa as a direct result of the Gynaecare TVT mesh device. The excuse given by the medical industry and specifically Johnston & Johnston is that the device is approved by the FDA and they are not responsible for the mentioned problems.
On going to my investigation I have only but found in excess of 1000 woman that I am aware of who have been crying out in your country, the US for the FDA to help and stop the use of this device, or to re-consider the approval process. Let alone the thousands of woman internationally that the FDA approval has effected and ruined lives.
While all of you in the US are debating this issue, we in other parts of the world are being affected by your approval process and are not exposed to your warnings you issue (neither are our doctors being informed by the pharmaceutical companies as surely Africa is a great place to make tons of money on the ignorance of the public and after all who is going to question these big multi-nationals when they have FDA approved products). But, the problem does not just stop in SA there are numerous complaints in the UK and throughout Europe, this would be just the beginning!
The FDA’s credibility as a body which is supposed to protect the US public, needs to understand that your approval is not just for the US public but the world as a whole. The decisions you make in the FDA has an impact that perhaps the FDA are not aware of worldwide. The pharmaceutical companies are using this FDA approval as a marketing tool to give a false sense of safety and security to their products and intern exploiting the various markets, who trust and believe that the FDA and US would have a tamper proof process of testing and approving a product before allowing pharmaceutical companies to launch into the market and derive millions in revenue.
Please could you advise me of what the FDA intends to do about the Gynecare TVT mesh device by Ethicon? Whether you will be loyal to your credibility not just in the US but understand your responsibility to the rest of the world when you put your stamp of approval on a product and, your duty as the FDA to respond when the general public complain in numbers both in the US and internationally. Please could an individual within your organisation take the time to “Google” complications associated to the Gynaecare TVT device to find out what is really happing out there in the “cold face” of reality, thousands of woman cannot be wrong no matter which way you look at the situation.
What concerns me is that I am one of thousands of woman, who are desperately wanting to prevent and educate other woman from experiencing the same trauma that I have been through.
Due to the FDA’s approval which is being utilised internationally as a benchmark in safety, I urge you to listen to the complaints, action them, and re-consider the Gynecare TVT device complications and product safety in the market, change your approval process which seems to be fundamentally flawed. The FDA like it or not, when approves a product puts their credibility as an organisation behind that product and that credibility filters and effects millions beyond USA borders.
Please could you respond to me providing me with information on what the FDA is doing with regards to the TVT mesh device by Ethicon, if anything? As well as whether Johnston & Johnston have done the necessary clinical trials to warrant the FDA approval if so, please could you advise me on what trial were conducted? Could you also inform me on your process that a multi-national like Johnston & Johnston needs to go through to obtain FDA approval?
Your assistance and co-operation in this matter will assist thousands worldwide to understand and help with the damage the FDA has done by approving products through an obviously flawed process, in particular the TVT mesh product by Ethicon.
Your speedy response would be appreciated.
Kind Regards, Gayle Graham, South Africa
...and the Sword of the Spirit which is the Word of God. Ephesians 6:17
All Rights Reserved. [2008 - 2016] All information on this site copyrighted to Truth in Medicine Incorporated and/or its contributors.