MAJOR VICTORY FOR WOMEN AND WOMEN'S HEALTHCARE...PELVIC ORGAN PROLAPSE MESH KITS BITE THE DUST!

Breaking News…..Major Victory for Women!


And for Women’s Health Care!

Dateline: Miami, November 28, 2012

By Lana C. Keeton (copyright protected)

The Center for Devices and Radiological Health (CDRH) will be up classifying all Synthetic Surgical Mesh for Pelvic Organ Prolapse repair from Class II to Class III within one year.

Even better, in the very near future, all but one of the most popular prolapse kits, will no longer be sold.

The CDRH will be announcing important new regulations in December. Companies will have to pay an upfront fee of $250,000.00 to be part of a registry along with conducting 3 year clinical trials to prove safety and effectiveness of these “kits” which is not possible and will cost them millions.

And there will be major new requirements for surgeons implanting surgical mesh in the pelvis. No longer will surgeons be able to take a weekend course taught by an industry paid “medical advisor/consultant” to start implanting a filthy petroleum waste by product into women.

Medical mercenaries will now think twice before they mutilate women internally with a foreign body polymer that shrinks, hardens and moves at will within their pelvis mercilessly destroying their lives.

Doctors on the prolapse kit bandwagon who have ignored what they earned in med school about foreign bodies, checked their medical training at the door when they walked into the operating theatre and spouted the ridiculous mantra that foreign body polymers are biocompatible and inert will now be held accountable for their actions. Praise the Lord!!

Just as I was quoted in Bloomberg News in January when the FDA mandated 522 studies of 99 synthetic surgical mesh products used for prolapse and incontinence, industry knows it will not be able to prove these “medical devices” safe or effective and it will cost them millions they are unwilling to spend.

And there it is. It was never about health. It was always about the money, no matter how many millions of people were harmed or put at risk for serious harm or even death.

Now we are seeing the death of insanity in women’s health. Another “Dalkon Shield” bites the dust.

Patients and patient advocates have won a very long and significant battle for the safety of patients who will not be harmed in the future!!

ABDOMINAL SACRAL COLPOPEXY with MESH....NOT BETTER, NOT SAFER!

Open Letter from Lana Keeton, patient advocate and medical device expert....

[this letter and any and all content on this blog is copyright protected]

Dear Transvaginal MDL Litigators,


For those of you who don’t know me, my patient advocacy organization, Truth in Medicine, and I were instrumental in getting the FDA warnings on synthetic surgical mesh issued in 2008 and 2011. Based on that work, I appeared as a speaker on the Transvaginal Mesh Panel at Mass Torts Made Perfect April 20, 2012 in Las Vegas.

It’s important to understand, this is a bigger fight than a lawsuit and a product. Use of synthetic surgical mesh is a fatally flawed concept which remains unchallenged. Hernias, incontinence and pelvic organ prolapse are conditions caused by torn or weakened tissue. These are not diseases, only conditions. Implanting a foreign body polymer, synthetic surgical mesh, does not treat causation.

Treating the symptoms with synthetic mesh is a confounding factor in these conditions. The complications are complicated. The cause is not. It’s the device, not the doctor, not the procedure, not the patient.

ABDOMINAL SACRAL COLPOPEXY

Abdominal sacral colpopexy is not a better, safer alternative than mesh kits for pelvic organ prolapse. It has a high complication rate and a long recovery. In addition, a significant complication is stress urinary incontinence (SUI) leading to further surgery and the use of synthetic mesh slings, which is the subject of current litigation.

Recurrent prolapse: 8% - 24%

Repeat surgery: 5% - 9%

Stress Urinary Incontinence: 10%

TVT/Ob-Tape: 3% - 13%
(recommended postoperatively for SUI)

The severity of this procedure and its complications are well documented in long standing literature. It is a very intrusive procedure drastically cutting the internal pelvic organs with a long recovery period.

There are significantly better, safer surgical and non-surgical alternatives.

Please do not use this procedure in the Transvaginal Mesh Cases as a better, safer alternative! It Is Not!

BOSTON SCIENTIFIC "SHOW ME THE MONEY" STILL HARMING WOMEN 15 YEARS.....AND COUNTING

Copyrighted by Lana C. Keeton November 9, 2012
*all rights reserved

Boston Scientific brought its’ first bladder suspension sling, the Protegen Sling, to market based on a 90-day rat study, and the wide use of its Hemashield fabric for cardiovascular grafts. Nov. 15, 1996, the FDA granted clearance for the Protegen Sling but 56 serious adverse events were reported in the first 9 months on the market. 57 were reported in the next 6 months.


During a June 1998 inspection of the company’s manufacturing plant, the FDA found the company was not reporting a large percentage of adverse events. Internal company documents showed at least 233 other reports never given to the FDA. Boston Scientific had selectively reported cases of surgical removal of the mesh and omitted other equally dangerous medical complications.

So what has changed at Boston Scientific since 1998? Based on the current investigation of BSX by California Attorney General Kamala Harris and other states attorneys, not much. Boston Scientific continues to market deadly synthetic surgical mesh for pelvic organ prolapse and bladder suspension through its Urology/Women’s Health division.

Promotion of dangerous medical devices to unsuspecting patients is the norm because of lax regulatory authority, the snails pace of FDA actions and the device industry’s strangle hold over doctors, professional medical societies and billions of dollars spent on direct to consumer advertising and lobbying in Congress.

But we as patients and patient advocates have made a difference and here’s why!

We have influenced the national conversation on the regulatory process with our testimony about the failures of the 510 (k) at the Institute of Medicine in 2010 and we decreased their sales because of the FDA’s July 2011 Transvaginal Mesh Warning! Read and enjoy….

From Boston Scientifics’ 3rd Quarter 2012 Form 10Q SEC filing:

Under “Women’s Health/Urology” they say:

However, our Women's Health business declined 11 percent primarily due to continued pressures on elective procedures and lower sales levels following the FDA release of a Public Health Notice update in July 2011 regarding complications related to the use of urogynecologic surgical mesh for pelvic organ prolapse.

Under “Litigation and regulatory compliance” they state:

Our ability to minimize or avoid future field actions or FDA warning letters relating to our products and the on-going inherent risk of potential physician advisories or field actions related to medical devices;

Legislative or regulatory efforts to modify the product approval or reimbursement process, including a trend toward demonstrating clinical outcomes, comparative effectiveness and cost efficiency, as well as other healthcare reform legislation.

And we are hitting their bottom line!!

“Our accrual for legal matters that are probable and estimable was $411 million as of September 30, 2012 and $299 million as of December 31, 2011…”.

And for the early 2000’s even before the current investigations, “the total incremental tax liability now asserted by the IRS for the applicable periods is $1.162 billion plus interest.”

MOST MESH INJURED PATIENTS HAVE BEEN HORRIBLY INJURED BUT AT LEAST THERE IS HOPE OTHERS WILL NOT BE HARMED IN THE FUTURE!

DAVID DID NOT THINK GOLIATH WAS TOO BIG TO HIT. DAVID THOUGHT GOLIATH WAS TOO BIG TO MISS.

From John Riley Bible Study Atlanta, GA early 1990’s


MUELLER NEEDS TO BE HELD ACCOUNTABLE FOR FALSE, MISLEADING ADVERTISING IN OCTOBER 2012 ISSUES OF TEXAS MONTHLY AND SUPER LAWYER MAGAZINE  ( see red type below)

“M... Mueller, M... Thompson, MD.,* and Wi..ard Bear, along with friend and Georgia lawyer Henry Garrard, have developed much of the science and liability supporting transvaginal mesh litigation, leading to recalls, FDA changes and bellwether trials. “

Mueller makes a mockery of hundreds of thousands of mesh injured patients worldwide.


- and Wi..ard Bear:It is an affront to men and women everywhere that Mueller includes a stuffed bear on the “legal team”. It belittles his clients and makes a mockery of a serious medical disaster.

And publishes false, misleading advertising:

- have developed much of the science and liability supporting transvaginal mesh litigation,

I worked as a paid legal consultant and research analyst to M... Mueller starting in the summer of 2010. He sought me out and contacted me because of the work I had done starting in 2005 when I sued Johnson & Johnson/Ethicon/Gynecare Worldwide for their defective Gynecare TVT Prolene (polypropylene) Bladder Suspension System as a pro se plaintiff.

Mueller and M Thompson and W...d B..ear did not develop the science or all of the litigation strategy. Myself and other experts benefitted him with our expertise and knowledge. He may have paid for access to some of the science and liability we experts developed long before he was ever involved in transvaginal mesh litigation.

- leading to recalls,
Mueller did not become involved in synthetic surgical mesh at all until mid-2010. To say, his work led to recalls is a ridiculous assertion. The work leading to the recalls began at least as early as 2005.

- FDA changes
Again, Mueller did not become involved in synthetic surgical mesh until mid-2010, long after the 1st FDA Public Health Notification warning of the serious risks and complications associated with transvaginal mesh was issued October, 2008. So exactly how did his work and that of M.... Thompson, W...rd Bear and Henry Garrard lead to FDA changes?

- and bellwether trials:
The bellwether trials were precipitated by thousands of adverse event reports filed by patients and their healthcare providers, persistent long term patient advocacy and the FDA’s Public Health Notifications, not M... Mueller.

“R... Kleinman* and J... Larrimore* add unique skills. Mueller terms the pelvic mesh fiasco ‘medieval treatment of women’.”

- “medieval treatment of women.”

Mueller himself demeans women. His office staff turnover would be envied if it was a manufacturer’s inventory. However, how does he maintain continuity for his mesh injured clients when a huge percentage of his staff turns over every 6 -12 months, starting with the loss of his long time partner, Hunter Hillin, in 2010 and key litigator, Kay McCartan in 2011? Why is he dropping women's mesh cases with abdominal sacral colpopexy and not taking any more of their cases?

Mueller needs to lose the bear and take the plight of mesh injured patients seriously. 


Mueller needs to be held accountable for false, misleading advertising.

MESH "EROSION": NOT A MINOR COMPLICATION!

Doctor Disconnect:
Synthetic Surgical Mesh Myths and Lies
By Lana C. Keeton
My Views as a Synthetic Surgical Mesh Patient Survivor
lanamiami@bellsouth.net
January 31, 2012

If you went to your barber for a haircut and he cut out a chunk of your scalp, along with your hair, you would find another barber. Yet it is accepted practice, and even recommended by prominent surgeons…and paid for by insurance companies…to remove “chunks” of a woman’s vagina or bladder, or other tissue or organ, to remove pieces of “eroding” surgical mesh – without anesthesia, I might add. The latest position of a group of surgeons says it’s a “minor” complication easily dealt with in the office. From a patient’s perspective, this is a barbaric practice which doesn’t stop mesh erosion from recurring year after year. Let me tell you, I have had many of those “haircuts” by Dr. G. Willy Davila at the Cleveland Clinic in Weston, FL and it is excruciating pain, not to mention demeaning and expensive.

You have to ask yourself, “Why would any doctor recommend such a procedure?” It’s quite simple. “Erosion” of synthetic surgical mesh, implanted during pelvic organ prolapse repair and/or bladder suspension surgeries, occurs repeatedly in an alarmingly high percentage of women. To tamp down the vast legal liability created by the widespread use of synthetic surgical mesh for these procedures in major institutions such as Cleveland Clinic, Mayo Clinic, Vanderbilt University and the University of Michigan over at least the last decade, surgeons, institutions, major medical professional societies and industry are purposely diminishing the severity of the mesh complication so benignly called “erosion”. They even created a completely new lexicon of terms to describe mesh. “Exposure” is one of the new terms du’ jour. Marketing, marketing, marketing!

Writing major protest letters to the FDA, and testifying before the FDA’s Ob-Gyn Advisory Committee Panel Meeting in September 2011, surgeons, numerous professional medical societies, institutions and industry spoke out on behalf of foreign body polymers, petroleum waste by-products, and against the authority of the FDA’s warning of the serious complications, with no apparent benefit to women, of trans-vaginal mesh. “Pharmageddon”, as Paul Hilton wrote years ago, has arrived.

As a patient advocate, thousands of men and women have written to me for help. Now I am sure you are asking yourself, Why would mesh injured patients write me, another patient and not a medical professional? Why not just go to the original surgeon who implanted the mesh and get those complications straightened out? They write me because the medical profession and industry are not addressing the vast array of debilitating complications of synthetic surgical mesh. Patients are routinely abandoned or discarded by their physicians. So why is this? For one, the complications are frequently permanent and irreversible.

Other scenarios I am aware of….
- The surgeon is a paid medical consultant/advisor to a mesh manufacturer who is protecting his/her job, the clinic or hospital he/she works for and the mesh manufacturer. He/she does not want to validate what he/she knows to be truth about the dangers of mesh.
- The surgeon is not a paid medical consultant/advisor but paid minions of industry have been less than honest in informing the doctor about the nature, severity and real percentage of complications. The surgeon is unprepared to deal with the unexpected complications.
- The use of the body’s natural inflammatory response prevents the surgeon from explanting what he/she has implanted because, as intended by the manufacturer, the patients tissues have scarred into the interstices of the mesh.
- The surgeon knows the dangers of mesh and fears the loss of his/her career, reputation and financial security if he fails in his attempts to help the patient.



DOCTOR DISCONNECT

So what do these surgeons typically do? Most patients tell me the response is, what I term, the classic mesh lie: “It’s not the mesh.” They deny it is the mesh. Deny the association between the complications and the mesh. Say it is the patients fault. Say the pain does not exist. Say it is a pre-existing condition. Tell the woman she has back problems. Tell her the pain is in her mind and does not really exist. Prescribe an anti-depressant. Tell her the autoimmune disease she suffers is not related to the mesh. Send her for physical therapy (a highly invasive treatment where another person puts their hands into a woman’s vagina to manipulate it). Send her for trigger point therapy. But then, how is it a doctor identifies which injured nerves to inject in a woman’s pelvis for the trigger point therapy to succeed? Or send her for pain management. Or maybe they give her one of those in-office “haircuts”.

In other words, despite multiple physical manifestations to the contrary, doctors disconnect from the reality the pelvis is connected to the rest of a woman’s body and the mesh a surgeon has implanted IS the cause of the complications. In my opinion, the highly touted benefits of synthetic surgical mesh are a lie and the complications are a life sentence for anyone, and I do mean anyone man or woman, implanted with it.

I have to emphasize these myths and lies are the same for men and women implanted with surgical mesh for hernia repair. Mesh hernia repair surgeries just have a different, but very similar, set of dangerous complications. The horror of the majority of mesh complications is that they are permanent and irreversible. Even complete mesh removal does not mean major nerve damage will not result in severe chronic pain and/or permanent disability.

In my very informed opinion, the unnecessary use of synthetic surgical mesh for hernia repair, bladder suspension and pelvic organ prolapse is a disgrace to the medical profession, major hospitals and clinics, educational institutions and medical device makers. Synthetic surgical mesh does not self-implant. Surgeons should protect their patients by putting down the scalpel which only they control. Surgeons must STOP implanting surgical mesh, except in the rare cases where there is no human tissue available.

Based on my near death experience more than 10 years ago following the implantation of Ethicon’s Gynecare TVT mesh bladder sling, I can promise you “erosion” is a debilitating complication, not an in-office “haircut”! 17 procedures and/or surgeries attempting to remove it, chronic debilitating pain, autoimmune disease, bankruptcy and homelessness directly related to “erosion” are not minor complications. Surgery #18 is planned for later this year. Who knows when it will stop? For me, maybe never.

Changing the lexicon from “Erosion” to the word “Exposure” is not the answer. NEVER having had an untested, unsafe petroleum based medical device implanted in me would have been the best option. Surgeons must take a stand for their patients to stop this major medical scandal!

TO THE HONORABLE FDA OBGYN ADVISORY PANEL
GAITHERSBURG, MD
SEPTEMBER 9, 2011

Synthetic Surgical Mesh is a flawed concept. It depends on a misuse of the body’s inflammatory process. The purpose of inflammation is to protect the body. Purposely creating inflammation with the flawed “tension free” synthetic surgical mesh concept starts an irreversible disease process. The body is in a constant state of heightened immune response.

The primary focus of yesterday’s meeting was a doctor’s ability, or lack of ability, to implant synthetic surgical mesh. Does a doctor’s skill change the chemical and physical properties of synthetic mesh? No. Does a doctor’s skill stop the inherent degradation and decomposition of polymers? No. Do doctors prevent shrinking and hardening of mesh? No. The conversation has to change to the cause of the problem, the device itself.

In the last 10 years, I personally have treated with over 20 of the best doctors across America, literally, from South Florida to California. I have had 17 surgeries and/or procedures to “manage” erosion. Dr. G. Willy Davila at the Cleveland Clinic Weston treated me for 7 years and did not stop the chronic pain. Finally in 2010 Dr. Philippe Zimmern at UTSW in Dallas, removed 4 “ of mesh in a 3 hour surgery. Finally the pain stopped. Women do not want their complications to be managed. They do not want the complications associated with mesh. Thank God, I will not suffer anymore in-office trimmings, a barbaric practice which hides the real number of adverse events.

Surgical mesh does not treat causation. Hernia, incontinence and pelvic organ prolapse are symptoms of a condition, torn or weakened tissue. Rather than address the weakened tissue, doctors are treating symptoms of the condition. These are not life threatening conditions. Treatment with the medical device, synthetic surgical mesh, is life threatening.

If, as presented here by so many medical doctors, the cause of the complications is due to limited surgical skills, the design is bad. This is not a practice of medicine issue. This is medical device safety issue. It is not usable because the design is flawed. It is a petroleum waste byproduct, in effect garbage. It should recalled by the FDA, except in rare cases, for all uses including hernia repair, bladder suspension and pelvic organ prolapse.

Here are a few key points.
1. The literature is rife with publications that mesh is not inert. There are too many variables for mesh to be used in a human. It is impossible to standardize.

2. Based on my understanding of mesh, as a medical device expert with 30 years experience and thousands of hours of research, load transfer is impossible to achieve. The biomechanical properties of living tissue are measured by strain. Human tissue is not measured in same context as textiles which are measured by tensile.

3. Textile manufacturing process
The use of chemical additives for the processing itself, along with antimicrobials, adhesion preventatives, physical mishandling by humans, surfactants like nonylphenol which are known endocrine disruptors, cross contamination by bacteria in the manufacturing facilities, uncontrolled chemical reactions between the polymer, the various additi ves and the human body is impossible to quantify. The in vivo degradation process sets up chronic inflammation and a cascade of autoimmune diseases.

The Alternatives
1. Treat the cause of the condition; strengthen all the tissue, not just bridge or scaffold with mesh
2. Base treatment on quality of life and the needs of the individual patient, not on the one size fits all mentality created by commercialized mesh kits
3. Use incontinence products
4. Implant non-cross linked biological meshes which constructively remodel inside the body
5. Prescribe pessaries and other non-surgical removable inserts.
6. Diet, exercise and a wellness mentality to protect and strengthen weakened tissue.

All of this is well documented. All of this is in the known literature. Please stop considering the flawed medical device, synthetic surgical mesh, through the solitary lens of doctor skills. This is a very complex issue and there is no magic button. Stop the use of synthetic surgical mesh except in the rare cases where there is no tissue available. Thank you!

Lana C. Keeton
President & Founder
Truth in Medicine Incorporated
1521 Alton Road, #198 Miami Beach, FL 33139
305.671.9332 phone 800.509.9917 fax 786.566.7780 cell

INSTITUTE OF MEDICINE - PUBLIC MEETING - TESTIMONY
by LANA C. KEETON, PRESIDENT & FOUNDER
TRUTH IN MEDICINE INCORPORATED
SEPTEMBER 16, 2011
My name is Lana Keeton. I am the President and Founder of Truth in Medicine Incorporated, a patient advocacy organization. I personally wish I never heard of the 510(k) but it came slamming into my life back in December 2001. I woke up from surgery with a flesh eating bacteria and spent the next 3 months struggling to survive as the giant abscess on my stomach very slowly closed.
Based on my personal experience, the FDA’s 510 (k) clearance process just doesn’t work. The system is seriously failing the American public.
It has to be replaced. Meant as a bridge when the FDA first started regulating devices in 1976, it has long since become obsolete.
My near death from implantation of synthetic surgical mesh brings me here today. What happened to me should happen to no one. Following surgery for hysterectomy and mesh bladder suspension, I was in the hospital for almost 3 weeks, in bed for 3 months and did not work for 6 months. I lost my health, my home, my business and wound up in bankruptcy. Despite being a long time highly successful steel broker, I was at one time homeless and hungry from a highly touted “minimally invasive” outpatient procedure. I have been to over 20 doctors since 2001 trying to get well and have had multiple mesh removal surgeries. I still require one more surgery.
My bladder became a cottage industry for doctors, hospitals, attorneys and the court system and by now probably has a value of over a million dollars. The cost has been paid by me, my health insurance carrier, when I had health insurance, and the American taxpayer. This is in stark contrast to the original cost of the small piece of implanted Prolene mesh, $1,320.00. $1,320.00 billed to my health insurance company and over a million dollars to deal with the consequences is ludicrous.

Very, very sadly, I am not the only one with a million dollar bladder from the FDA’s 510 (k) 974098 for the Gynecare TVT System. It has been implanted in hundreds of thousands of women with staggering personal and financial costs….permanently disabled patients, broken families and relationships, millions of dollars in cost to the insurance companies, increased premiums to all Americans and court systems overburdened with mass torts where the tab is picked up by the American taxpayer.

My experience and thousands of others is a glaring example of the flawed 510(k) clearance process. The Protegen Sling, was taken off the market as misbranded and adulterated, only 3 months after the Gynecare TVT sling was cleared for sale by the FDA’s 510(k) in October 1998.

Ethicon’s Gynecare TVT sling was cleared by the FDA as being “substantially equivalent” to the recalled predicate device, the Protegen Sling. The TVT sling remains on the market almost 13 years later. Based on Medical Device Reports from Ethicon, at least 10 women have died from the Gynecare TVT sling.

Synthetic Surgical Mesh, a Class II medical device is responsible overall for the deaths of at least 17 women and who knows how many men. Over 6,000 adverse events have been reported to the FDA’s MAUDE database for mesh used for hernia repair, bladder suspension and pelvic organ prolapse since 2005.

But the FDA does not have the regulatory power to recall these 510(k) cleared dangerous devices.

Last week there was a meeting of the FDA’s ObGyn Advisory Panel which recommended re-classifying surgical mesh for pelvic organ prolapse to Class III. Re-classification will take up to 3 years and will only apply to new applications for new mesh devices.

Does anything change for patients? Yes, hundreds of attorney ads warn them of the dangers of mesh and validate them if they are already harmed.

Are the real issues recognized? No. Real experts on the mesh polymers themselves are not consulted.

The panel discussion at the meeting never turned to the real cause of the problem, the medical device itself, a petroleum based waste by product purported to be bio-compatible. Doctors on the panel and in the audience blamed other doctors lack of surgical skills for the high rate of complications caused by a bad medical device. ACOG and AUGS and industry and others called for better doctor training, better patient selection and better informed consent.

If mesh were a baby stroller that had killed 17 babies and injured over 6,000 b, it would be off the market. The manufacturer would never suggest better training of moms on how to push the stroller. But that is exactly what happened last week at the FDA Ob-Gyn panel meeting. This process is fundamentally flawed.

Does a doctor’s skill change the chemical and physical properties of synthetic mesh? No. Does a doctor’s skill stop the inherent degradation and decomposition of polymers? No. Do doctors prevent shrinking and hardening of mesh? No.

Even with the panel recommendation, all synthetic meshes for all uses currently cleared for sale by the FDA’s 510(k) will remain on the market. Patients continue to be harmed.

Today, this morning, patients across America are being put at risk by life-threatening

medical devices implanted for a non-life threatening condition, weakened or torn tissue. You don’t usually hear of someone dying of a hernia or incontinence or pelvic organ prolapse. But patients do die at alarming rates from the 510 (k) cleared medical device, synthetic surgical mesh.
The FDA has the duty and the obligation to protect the public health and to put patient safety first, before all other stakeholders. Please stop the great concern voiced by doctors, the FDA and industry about the burden placed on industry. Those who profit mightily should shoulder all the associated costs.
Please end the practice of patients paying the price of bad medical devices forcing them to live the consequences of decisions beyond their control and without their knowledge.

Safe and effective devices tested and proven by a different and better FDA regulatory framework will change the medical ecosystem, taking the grievous burden off individual patients, lawsuits out of American courts and significantly reduce the cost of healthcare to all Americans. The FDA’s 510(k) simply does not work anymore! Please replace it with a better regulatory process that truly protects patients!

Respectfully,
Lana C. Keeton
Founder and President
Truth in Medicine Incorporated
1521 Alton Road, #198
Miami Beach, FL 33139

phone: 305-671-9332 cell phone: 786-566-7780
e-mail: lanakeeton@truthinmedicine.us.com
website: www.truthinmedicine.us.com
Regardless of the decisions relating to the 510(k), please implement the following now.
1) Educate the American public about the difference between Pre Market Approval and Pre Market Notification Clearance Process.
2) Make patient labeling mandatory for all medical devices.
3) Make reporting mandatory with clear consequences for silence by doctors, hospitals and medical device makers.
4) Create a very specific guide for the FDA/CDRH to make better use of their regulatory authority. The decision making process for when and how to use FDA’s regulatory authority should not be left to the discretion of FDA/CDRH employees.
5) Include a mechanism which stops medical device makers from paying doctors to misuse their legal authority to sell products off label to increase the sales of their products.