Friday, June 25, 2010

Institute of Medicine Public Health Effectiveness of the FDA 510 (k) Clearance Process

The Institute of Medicine has a Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process. The Committee held a public workshop on June 14-15, 2010 in Washington, DC. The purpose of the workshop was for the committee to gather information related to the statement of task.

I attended the workshop and testified along with 5 members of the organization I founded, Truth in Medicine Incorporated. My written testimony follows. If you go to the following link, you will be able to see my actual testimony on video. When you get to the web page, scroll down to Public Comment Section and go to the timeline 11:00 minutes:

My name is Lana Keeton. I am the President and Founder of Truth in Medicine Incorporated, a patient advocacy organization. I am here despite my near death from the implantation of a medical device, Synthetic Surgical Mesh, in December 2001. 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. I have been homeless and hungry in the last 8 years and I live in chronic pain. I have been to over 20 doctors since 2001 trying to get well and have had multiple mesh removal surgeries. In fact, I have another surgery scheduled for next Tuesday.

My bladder has become a cottage industry for doctors, hospitals, attorneys and the court system and by now probably has a value of over a million dollars. That 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 this small piece of Prolene mesh about $1,200.00. $1,200.00 to create it and over a million dollars to deal with the consequences is insane. Johnson & Johnson may have made a $1,000.00 profit and myself and the American public is still paying for it 8 years later.

Clearance of the Gynecare TVT Prolene Mesh System sold by Ethicon & its parent company Johnson & Johnson was a medical marketing decision. I was not included in the decision made by Gynecare, by Ethicon, by Johnson & Johnson to put an unproven, unsafe dangerous petroleum based permanently placed medical device into the stream of commerce. The FDA cleared the device for sale through the 510(k). No patient should ever, ever, ever have to travel the journey I have traveled because of an unproven medical device.

The 510(k) clearance process is the Fox guarding the Hen House. It does not protect patients. The choice to make an informed decision of whether to take the risk of serious harm or death vs. the benefits is not an option for patients. Medical Marketing trumps patient safety.

The FDA does not educate the public, or even its own employees, medical devices are cleared through a process not requiring proof of safety or efficacy for Class I or Class II devices. An uninformed, unaware public is daily endangered by unsafe, unproven medical devices.

The battle cry of industry is innovation. They say innovation will be thwarted without this fast, easy money access to selling products. My question is: what innovation? How long has it been since polio was cured? When was the small pox vaccine created? A very long time ago. Is there a cure for cancer? No. Has AIDS been eradicated? No.

What pharmaceutical company is leading the charge to find these cures? Who knows? Do pharmaceutical companies sell sickness to the worried well? Yes. Is there an epidemic of disease mongering in the U.S.? Yes.

The 510 (k) clearance process is highly flawed. You as a committee have the duty and the obligation to put patient safety first and foremost for any and all clearance/approval processes at the FDA/CDRH.

Please stop the Conspiracy of Silence leaving patients in the dark. I recommend you make the following changes to the 510(k) clearance process:

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.

I am not the only one with a million dollar bladder. 510 (k) #974098 for the Gynecare TVT system alone has astounding financial costs associated with it….disabled patients who are no longer functioning members of society, broken families and relationships, millions of dollars in cost to the insurance companies for the multiple surgeries each disabled patient requires, increased premiums to all Americans as the insurance companies pass along these costs, the court systems became overburdened with thousands of lawsuits, the cost of which is again passed along to all Americans through the taxes they pay to support the court systems.

And the result…catastrophic devastation to unsuspecting Americans who believed any product used in a hospital had been proven safe and effective by the FDA. That is simply not the truth. You can change it so none of you or your loved ones becomes one of those unsuspecting Americans.

Please end the practice of patients paying the price of bad medical devices forcing them to live the consequences of industry’s decisions without their knowledge.

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

phone: 305-671-9332

Saturday, June 5, 2010

Lana Keeton Wins Medical Negligence Verdict Against Dr. Bernard Cantor

Dateline: Miami, Florida Patients Advocate Lana Keeton, Founder and President of Truth in Medicine, scored a victory in court. Ms. Keeton won a verdict against defendant, Dr. Bernard Cantor, a Miami doctor, for medical negligence. The victory is a first in a lawsuit involving the Johnson & Johnson Gynecare TVT Prolene synthetic surgical mesh. Ms. Keeton underwent a hysterectomy and bladder suspension in December 2001 that almost ended her life.

Successfully treated for a necrotizing soft tissue infection at Jackson Memorial Hospital, following the initial surgery performed at Mt Sinai Medical Center on Miami Beach by Dr. Bernard Cantor, Ms. Keeton spent several months recuperating. Her experience has made her a formidable force in advocating for other injured patients.

Testifying at trial, Ms. Keeton stated she was not given proper informed consent for the implantation of the mesh. Dr. Cantor’s description to Ms. Keeton of the Prolene synthetic surgical mesh was simply “It’s a new tape. You will really like it.” No mention was made of the fact that the “tape” was a permanently placed medical device which cannot be removed without significant damage to tissue once implanted in the body. Nor did Dr. Cantor tell Ms. Keeton the product could be improperly implanted during the procedure or could erode (move by itself within the body) to cause permanent irreversible complications which she suffers. Dr. Cantor also omitted his lack of experience in the performing the procedure and complications in patients he had operated on prior to Ms. Keeton which required re-operation of the patient.

Ms. Keeton and Mr. James Shull, the Vice President of Truth in Medicine, were instrumental in getting the FDA to issue a Public Health Notification warning doctors and patients of the serious risks and complications of trans-vaginal placement of synthetic surgical mesh in October 2008. Based on their work, many law firms began filing lawsuits on behalf of other patients permanently harmed by synthetic mesh.

In an e-mail to a Truth in Medicine member in September 2009, Dr. Bobby Shull, Professor of Obstetrics and Gynecology, Dept Obstetrics and Gynecology, Texas A&M’s Scott & White Clinic in Temple, Texas says:

“Personally, I am pleased there is a patient advocacy group who is involved in helping us learn more about these products. My feeling is we will look back on this time with a sense of ‘why did anyone ever convince women to be subjected to these treatments?’ when little real information existed on the risks to be assumed.

There are other examples in gynecology; the Dalkon Shield for example or earlier sub-urethral slings…Protegen is one. Other products have been removed from the market only after a number of women were found to have been harmed.

It is unfortunate that women are and have been harmed. Perhaps with your group's influence the current situation can be changed for the sake of all the other women who are yet to be treated.”

Truth in Medicine’s primary initiative to achieve its’ mission is an Informed Consent Project with the University of Miami’s Bioethics Department headed by Kenneth W. Goodman, PhD. The focus is to create a comprehensive Informed Consent Tool Kit website for medical devices, the first being for synthetic surgical mesh. This would significantly lower the cost and increase the quality of healthcare.

Ms. Keeton notes the proliferation of synthetic surgical mesh “kits” have emboldened surgeons lacking the requisite surgical skills to do operations that have bad outcomes for the patients because, among other things, they do not know how to deal with the complications.

Ms. Keeton says, “The victory over Dr. Bernard Cantor signifies a big step forward in stopping future harm of other patients.”