Friday, September 16, 2011

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!

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
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.


Joleen Chambers said...

Lana - you are a warrior! Thank you for standing up for the harmed patients and all of us who were unaware that implanted surgical mesh has been so poorly regulated and implanted even after data and patients have highlighted the tragic aftermath of this failed medical device.

Cathie K said...

Lana, I had the TVT (Gynecare Mesh) implanted in 2003 and unknowingly all my issues have been from that. After 2 yrs and several Dr's I am now scheduled to have "some" of it removed.The bleeding, pain and overall not feeling well now has a cause! I just don't know where to go for litigation. All the numbers on the internet and TV are out of state. How do we choose the right person for representation?

Anonymous said...

Thank-you Lana....your information came just in time for me. It sealed my decision totally against having synthetic mesh placed in my body. I am on the computer now because I couldn't sleep contemplating having surgery for a prolapsed bladder and still needing more information.....I clicked on your site and I am thankful to my Heavenly Father that I did. In my search since the prolapse two weeks ago, I discovered information alerting me to the dangers of mesh. My husband had it put into him about four years ago for a hernia operation and he has not been the same since. He is constantly searching for an answer to this bearable but chronic pain. I wonder.....Thank-you for sharing.