Friday, September 16, 2011

Let's Get The Mesh Out!

Good morning. My name is Lana Keeton. I am the President and Founder of Truth in Medicine, a patient advocacy organization. I am a medical device expert, with over 5000 hours of research into synthetic surgical mesh used for hernia repair, bladder suspension and pelvic organ prolapse. My experience as a steel broker for over 30 years fueled my research into the physical and chemical properties of polymers used for synthetic mesh and I have a unique perspective.

It’s really hard for me to stand here today in front of a room where many are hell bent on implanting garbage into humans. While the rest of the world is going green, doctors and device makers are going dark. Doctors and Device Makers should follow the example of the well known company, Waste Management, and dump Synthetic Surgical Mesh, a petroleum waste by product, a recycled garbage into the city dump.

Medical advisors & consultants, very well compensated, rally around surgical mesh like they are saving mankind. Mesh is not a polio vaccine. Mesh is not a cure for whooping cough. Mesh does not cure anything. It is a petroleum based waste by product from the gasoline refining process. I ask you, if they won’t put it in a car, why are surgeons implanting it into humans? I ask the FDA, the CDRH, this panel to make a wise decision.

There is group of pelvic organ prolapse surgeons, who are outraged their “toolkit” has been raided. They submitted a paper to the FDA, calling for the FDA to involve itself in practice of medicine issues only they, the surgeons themselves, have the power to change. These surgeons now take the position their “unskilled” counterparts do not properly implant synthetic mesh, causing the large number of complications. I strongly feel these surgeons should take a closer look at the bad tool. Have they taken in to consideration perhaps the usability of the design is flawed? Guess not since they are defending the tools in their toolkit as opposed to the thousands and thousands of injured patients…and let’s not forget the dead ones, either.

We probably would not be having this meeting today if doctors who implant mesh actually researched polymers themselves, instead of depending on the company who makes it and the sales rep. Or if they actually had mesh implanted in them.

Doctors look at the inflammatory reaction of the body to synthetic meshes and the ensuing disease process based on their medical training. They do not look at the chemicals causing the disease process.

So instead of better patient selection, better physician training or better informed consent recommended by this group of surgeons, let’s stop placing ticking time bombs of petroleum waste byproducts into women for POP and SUI and into men and women for hernias.

Respectfully, the FDA’s Ob-Gyn Advisory Panel Meeting scheduled to make recommendations here at this meeting on the use of synthetic surgical meshes is unqualified for its intended purpose, much like the synthetic meshes widely implanted in humans. Without a chemical textile engineer, a microbiologist, a human tissue engineer and other experts on synthetic polymers [polypropylene, polyethylene terephathlate, etc….] used in the manufacture of medical textiles, no valid conclusions will be drawn.

I am calling for all synthetic meshes to become controlled substances requiring the surgeon to write a prescription. Implanting surgeons should manage and/or pay for all mesh complications such as surgical mesh removal, pain management or other therapies necessary to manage the complications for at least 5 years. All synthetic meshes should be considered a drug under the FDA’s Pre-Market Approval Process. The chemical reaction of these drugs in concert with the chemical make-up of synthetic mesh implanted in the body is a biological disaster.

Synthetic Meshes have to be recalled, reclassified and tested as a drug for all chemical additives used in the textile manufacturing process, including antimicrobials, surfactants, dyes and other chemicals hazardous to human health. Thank you!

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