GYNECARE TVT COMPLICATIONS & DEATHS CONTINUE TO RISE! ETHICON'S PROLENE POLYPROPYLENE SYNTHETIC SURGICAL MESH USED IN GYNECARE TVT DEVICE INTERNALLY MUTILATES HUMAN BEINGS!
EVERY DAY MORE & MORE PEOPLE WITH MESH COMPLICATIONS FROM HERNIA REPAIR, PELVIC FLOOR DISORDER AND BLADDER SUSPENSION, BOTH MALE AND FEMALE, CONTACT ME SEARCHING FOR HELP!
Every morning the FDA, the CDRH and the Pharmaceutical Companies have blood on their hands. Every day new victims of synthetic surgical mesh complications are internally mutilated and begin a slow horrifying death…of their life as they knew it, of their hopes and dreams, of their physical abilities.
Americans go to doctors, whom they trust, who perform surgery on them in accredited hospitals using FDA approved products. They believe in the system. Americans don’t ask questions. They trust a system that actually betrays them.
The FDA facilitates the pharmaceutical industry’s betrayal of Americans and the health system because of the flawed 510 (k) Premarket Notification Approval Process.
There is greater interest in profitability for industry than in assuring patient safety. Speed of approval is more important than safety. As for the efficacy of thousands of medical devices implanted in Americans, that is an unknown.
The FDA’s 510 (k) Pre-market Notification submission process only establishes that medical devices are “substantially equivalent” to a product already approved for sale. There is no proof of the safety and efficacy of these medical devices. No human clinical trials are required.
All Americans need to be well advised of the difference between the FDA’s Pre-Market Approval and the FDA’s 510 (k) Pre-Market Notification submission processes.
Pre-Market Approval means that there have been human clinical trials. Safety and efficacy of the medical device has been established. Risks and complications of the device are relatively well known.
Pre-Market Notification means that the pharmaceutical companies have followed the FDA’s criteria for establishing “substantial equivalence”. The medical device is approved for sale. No human clinical trials are necessary.
For Pre-Market Notification, the safety and efficacy[that it actually works] of the device does not have to be established. Risks and complications will be learned as physicians perform surgery on the general public. Each and every surgical patient is unknowingly a part of a human clinical trial, a guinea pig.
Steps to educate the American public about these very important differences have to be enacted by Congress. The following actions would enable all Americans to make informed decisions about their healthcare.
a. Provide a written statement to every patient entering the hospital for implantation of a medical device clearly explaining the difference between Pre-Market Approval and Pre-Market Notification. The patient should be notified at that time what the approval process was with the FDA for the medical device and/or foreign body being implanted in them.
b. Provide an Adverse Event Report to each and every patient with his/her discharge papers following any procedure involving any foreign body that is implanted in them.
The Adverse Event Report should include the name of the manufacturer, name of the product, model/catalog #, FDA approval number whether Pre-Market Approval or 510 (k) Pre-Market Notification, name of doctor performing implantation, user facility, date of surgery, original diagnosis for procedure, surgical procedure followed for the implantation of the foreign body, traceability label, etc.
For future medical care, patients will be able to fully advise their doctors of anything and everything that is in their bodies
Inadequate, substandard physician training in the implantation of synthetic surgical mesh significantly increases the percentage of complications.
Each new mesh product and/or delivery method has a learning curve for each doctor. There is a much greater incidence of complications in the first 20 implantation procedures of medical devices that any doctor performs.
If there are 20,000 doctors performing procedures on their first 20 patients using only one medical device through one method of implantation, that would be 400,000 patients that are at greater risk for complications from that one product alone.
As there are over 10,000 new medical devices approved by the FDA each year used by 20,000 doctors on 20 patients, the figure would be in the multi millions.
This learning curve is devastating to the American public. This does not factor in bad doctors and bad medical care, only the normal percentages of a new procedure with a good doctor.
Human tissue is powerless against implanted synthetic surgical mesh. The mesh moves at will within the human body.
Movement of the mesh within the body, erosion, as it is so benignly described, is an irreversible complication. Removing the mesh from the human body when it causes complications is an Irreversible Complication. It is like removing gum from hair. No package insert for mesh from any pharmaceutical company states this.
Once the complication occurs, physicians do not know how to remove the mesh. Or it is physically impossible to remove because of where it is within the body. Explantation of surgical mesh has not been addressed on the package inserts or in the limited training of doctors who implant surgical mesh.
Very frequently mesh victims are substantially more harmed during the removal of the mesh, the explantation process, than from the irreversible complications of erosion. Daily torment from the complications of surgical mesh becomes a way of life for its victims.
The long term impact of these Synthetic Surgical Meshes on the lives of the victims, the load placed on the health care system, the load placed on the court system and on all Americans through increased premiums to major medical insurance companies who pay for the continuing care of Surgical Mesh Victims is staggering. This is a major medical catastrophe. The use of surgical meshes has to be completely stopped.
The FDA, the CDRH and HHS depend on an extremely flawed system to make determinations about recalling these dangerous medical devices and drugs. Who knows about the MAUDE database?
Certainly not me, until I nearly died from the surgical implantation of the Gynecare TVT System and its TVT device, Prolene polypropylene mesh.
Most people don’t unless they become seriously injured by a defective medical device or a dangerous medication.
Please do your part to remove Petroleum Based Synthetic Surgical Mesh from the marketplace completely.
Go to www.truthinmedicine.us.com and fill out the Worldwide Registry of Complications of Surgical Mesh.
The information will be compiled and given to Congress to force the FDA/CDRH to recall all Synthetic Surgical Mesh from the marketplace.
The site is secure and encrypted. No one will have your name or identifying information. The only one to see all the information will be me.
Your privacy will be protected by assigning a number to your submission to the Registry when used in the presentation to Congress.
Take the steps to stop this from happening to one more human being. Go to www.truthinmedicine.us.com right now. You can not change what happened to you. You can stop it from happening to another human being!!
God bless, Lana Keeton
Americans go to doctors, whom they trust, who perform surgery on them in accredited hospitals using FDA approved products. They believe in the system. Americans don’t ask questions. They trust a system that actually betrays them.
The FDA facilitates the pharmaceutical industry’s betrayal of Americans and the health system because of the flawed 510 (k) Premarket Notification Approval Process.
There is greater interest in profitability for industry than in assuring patient safety. Speed of approval is more important than safety. As for the efficacy of thousands of medical devices implanted in Americans, that is an unknown.
The FDA’s 510 (k) Pre-market Notification submission process only establishes that medical devices are “substantially equivalent” to a product already approved for sale. There is no proof of the safety and efficacy of these medical devices. No human clinical trials are required.
All Americans need to be well advised of the difference between the FDA’s Pre-Market Approval and the FDA’s 510 (k) Pre-Market Notification submission processes.
Pre-Market Approval means that there have been human clinical trials. Safety and efficacy of the medical device has been established. Risks and complications of the device are relatively well known.
Pre-Market Notification means that the pharmaceutical companies have followed the FDA’s criteria for establishing “substantial equivalence”. The medical device is approved for sale. No human clinical trials are necessary.
For Pre-Market Notification, the safety and efficacy[that it actually works] of the device does not have to be established. Risks and complications will be learned as physicians perform surgery on the general public. Each and every surgical patient is unknowingly a part of a human clinical trial, a guinea pig.
Steps to educate the American public about these very important differences have to be enacted by Congress. The following actions would enable all Americans to make informed decisions about their healthcare.
a. Provide a written statement to every patient entering the hospital for implantation of a medical device clearly explaining the difference between Pre-Market Approval and Pre-Market Notification. The patient should be notified at that time what the approval process was with the FDA for the medical device and/or foreign body being implanted in them.
b. Provide an Adverse Event Report to each and every patient with his/her discharge papers following any procedure involving any foreign body that is implanted in them.
The Adverse Event Report should include the name of the manufacturer, name of the product, model/catalog #, FDA approval number whether Pre-Market Approval or 510 (k) Pre-Market Notification, name of doctor performing implantation, user facility, date of surgery, original diagnosis for procedure, surgical procedure followed for the implantation of the foreign body, traceability label, etc.
For future medical care, patients will be able to fully advise their doctors of anything and everything that is in their bodies
Inadequate, substandard physician training in the implantation of synthetic surgical mesh significantly increases the percentage of complications.
Each new mesh product and/or delivery method has a learning curve for each doctor. There is a much greater incidence of complications in the first 20 implantation procedures of medical devices that any doctor performs.
If there are 20,000 doctors performing procedures on their first 20 patients using only one medical device through one method of implantation, that would be 400,000 patients that are at greater risk for complications from that one product alone.
As there are over 10,000 new medical devices approved by the FDA each year used by 20,000 doctors on 20 patients, the figure would be in the multi millions.
This learning curve is devastating to the American public. This does not factor in bad doctors and bad medical care, only the normal percentages of a new procedure with a good doctor.
Human tissue is powerless against implanted synthetic surgical mesh. The mesh moves at will within the human body.
Movement of the mesh within the body, erosion, as it is so benignly described, is an irreversible complication. Removing the mesh from the human body when it causes complications is an Irreversible Complication. It is like removing gum from hair. No package insert for mesh from any pharmaceutical company states this.
Once the complication occurs, physicians do not know how to remove the mesh. Or it is physically impossible to remove because of where it is within the body. Explantation of surgical mesh has not been addressed on the package inserts or in the limited training of doctors who implant surgical mesh.
Very frequently mesh victims are substantially more harmed during the removal of the mesh, the explantation process, than from the irreversible complications of erosion. Daily torment from the complications of surgical mesh becomes a way of life for its victims.
The long term impact of these Synthetic Surgical Meshes on the lives of the victims, the load placed on the health care system, the load placed on the court system and on all Americans through increased premiums to major medical insurance companies who pay for the continuing care of Surgical Mesh Victims is staggering. This is a major medical catastrophe. The use of surgical meshes has to be completely stopped.
The FDA, the CDRH and HHS depend on an extremely flawed system to make determinations about recalling these dangerous medical devices and drugs. Who knows about the MAUDE database?
Certainly not me, until I nearly died from the surgical implantation of the Gynecare TVT System and its TVT device, Prolene polypropylene mesh.
Most people don’t unless they become seriously injured by a defective medical device or a dangerous medication.
Please do your part to remove Petroleum Based Synthetic Surgical Mesh from the marketplace completely.
Go to www.truthinmedicine.us.com and fill out the Worldwide Registry of Complications of Surgical Mesh.
The information will be compiled and given to Congress to force the FDA/CDRH to recall all Synthetic Surgical Mesh from the marketplace.
The site is secure and encrypted. No one will have your name or identifying information. The only one to see all the information will be me.
Your privacy will be protected by assigning a number to your submission to the Registry when used in the presentation to Congress.
Take the steps to stop this from happening to one more human being. Go to www.truthinmedicine.us.com right now. You can not change what happened to you. You can stop it from happening to another human being!!
God bless, Lana Keeton
