POSITION PAPER(s):

MedWatch FDA Failures — Essure, Ovabloc, Morcellation, Mesh, Colonoscopy, Breast Operations and Silicone

May 19, 2015 Provided to FDA

HUFNAGEL BIOETHICS INSTITUTE:

Founder/Director DR. V. Georges Hufnagel
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POSITION PAPER: MedWatch FDA Failures

MedWatch is an important program that is not functioning according to its design and purpose. I investigated this in depth several years ago. A woman contacted me as an inpatient at Columbia Medical Center in New York. I have assisted patients without the practice of medicine as a bioethics expert. I will contact the woman, who consented to have her story written about, to write to the FDA directly.

She had undergone UAE, uterine artery embolization (aka uterine fibroid embolization or UFE). She was having severe pain in her fingers and toes. These areas were turning blue at the tips. Blood was not circulating and not reaching these areas; she was at risk to lose the skin in these areas. I interviewed all those involved in her care including: a medical student, an intern, a resident, the chief resident, her attending physician, the chief of the department, and the ER admitting physician.

This entire team knew that she had UAE for a large fibroid tumor. She did not have a full work up, which I believe needs to be done on all women with fibroids. Again the key word is ALL, including: cervical culture and pap smear, uterine samples and irrigation sample, pelvic scan, biopsy of pelvic masses with seal and irrigation, full informed consent of UAE (e.g. informing patients that tumor size is an issue and may restrict the possibility of embolization, pulmonary emboli is a common complication, and that major issue that the FDA allows the use of silicone beads which are not radiologically opaque).

I notified the head of devices at the FDA so this could be corrected: one cannot use a device that cannot be found — such as non-radiologically opaque beads. The director thanked me for informing him of this major error. I would of liked to have him inform me that it was corrected but never received any follow up. The FDA needs to work on having better communications. It is a major issue that a protocol for devices does not exist. It should have been in the news. The device director should have met with the committee and worked on establishing protocols and rectifying what is wrong with MedWatch.

UAE is a destructive procedure that does not have proper informed consent. I was at the ACOG annual meeting where a hands-off policy with radiologists was made. This was a political move made. UAE has no place in health care of women. If they have tumors, remove them. MedWatch is a total failure; no data is published and no one knows what it is. I had a large group of women with complications from Essure whom I told, “you must file with MedWatch.” They saw that the FDA did nothing regarding this device so they felt filing would be a waste of their time. Women also routinely kept saying, “what is MedWatch?” The public is not educated at all on how to organize and bring about change in the medical world. It is frustrating to witness this daily. I had to tell them it’s a program that has failed in protecting and evaluation of devices and formulas.

None of the providers for the young woman at CPH in NYC reported her case to MedWatch and only the chief and ER admitting physician knew what MedWatch was. They stated they had never reported any case to MedWatch.
I had to educate the patient to file her own Med Watch complaint. I submitted one additionally. I never got a notice that the complaint was received or that any research was going on. She informed me no one contacted her.

The Chief of the Department thought someone under him would have reported the case and that this was not his job. The ER doctor told me he was only the ER doc and the GYN staff needed to report the case. Everyone else had no idea what MedWatch was.

For that year I asked at every medical meeting I attended if the attendees knew what MedWatch was. All military physicians knew about MedWatch and the CDC. Most private physicians did not know about MedWatch. At university hospitals, those in training had no idea and only the administrative physicians knew. Nevertheless, those in positions of authority were not educating those under them. Protocol is not in place in medicine as it should be.

This is how the system fails. There is no public education to teach patients how to report to MedWatch themselves. My Bioethics Institute is starting a new website ¬¬for the public to file complaints and get an education on how to report to appropriate agencies.

I have tried to teach patients that reporting complications is extremely important. Because they never heard about MedWatch, they cannot believe it is a real government program.

An actual campaign is needed for the nation to know about MedWatch and use it. I believe far too many have died or been injured by medications and devices that were not reported on. I am asking the FDA to have as standard protocol that the informed consent for any medication or device during trials includes full information on MedWatch. This needs to be provided during all trial testing for patients to know about, have the form, and learn how to file. In this way the education on MedWatch can be designed to provide actual full informed consent.

We need complete informed consent with full information on MedWatch as law in every state.

UAE is regretted by many women who subsequently after the procedure become bitter and depressed. The reality of the politics of UAE is more disturbing. You are not selective in causing tissue death to individual fibroids. You are putting silicone beads that cannot be detected into a major artery, potentially causing pulmonary embolism and death. One patient reported two episodes of pulmonary embolism. She never had a response from the FDA to her MedWatch complaint. Some women get uterine necrosis and need a hysterectomy. Destructive medicine needs to end in routine care. It is insane that women today would elect to take these risks. They do it because they are not being given full informed consent.

My investigation into my patients’ issues with UAE led me to uncover much more. It has not been made public, but a major error took place in the research and release of UAE for use. This took place because a routine pre-evaluation of each research project does not exist. One basic question is where is the device? This is simple and relevant: you want to know where the device is. My patient had the small silicone beads blocking her blood vessels. She was never tested for HLA status. I found, as did NIH researchers, that HLA type is related to antibody development in patients. No one is given this in UAE consent. No one is told, “we cannot find your beads in your body after we insert them.” No one is told that femoral artery damage can take place and you may lose leg function or bleed out and die. In speaking with the FDA and asking the questions that seem routine to me, I found the FDA let UAE be produced and used with silicone that was not detected by x-ray. Silicone beads may travel in the body and one cannot look for the beads by radiological techniques. These are mistakes that can be limited by creating a review process to apply to each device and or procedure. I have seen toes and fingers fall of by emboli occurring in extremities. It is not rational that in all these years we have not given the MedWatch evaluation to every trial subject.

MedWatch is a failure. It needs a new life and position that every person needs to know about before any surgery or procedure. Time and money need to be spent to make this work. Data from MedWatch needs to be posted and public. I will offer my time to any issue that I am writing you on. Things need to change. The isolation policy has not worked for the health of the nation.

VGH

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POSITION PAPER: To Recall Essure and Gather Data For A Proper and Full Investigation

Essure is another product created without proper protocols and without proper informed consent. The FDA lacks an ethics section to review submissions and the physicians on its committees are standard physicians who respond as your local doctor would. These people are not trained to be dedicated to the protection of patients. These are people doing their best with limited training.

The first issue the public is unaware of which needs to became a national issue is the change in law which has created a license to kill by taking away the right to for patients to sue for failures of medical devices. This is a critical issue which the press and media wore blinders on as human rights have been profoundly intentionally destroyed. Law currently exists to prevent patients from bring suit against manufacturers for products and devices.

First one needs to know that the FDA so called protection and reporting system is a complete failure. It is held out that MedWatch is a system to protect patients so that all patients can report any and all complications with products, procedures, and devices. In a study I did with the medical staff at Columbia Presbyterian Hospital in New York, where one of my patients was in the hospital with severe complication from Uterine Artery Embolization, I spoke with the emergency room physicians, the attending, the residents and the medical students in the department of gynecology. No one knew of MedWatch. The patient was not informed about MedWatch when she had her UAE consent. This is the reality of our world today.

The FDA actually has no real idea of how many women have had problems or what the problems are with Essure because we do not have a proper reporting system. The company that makes Essure does not want to know about problems. Their business is about sales. Success for corporations is measured by income, not patient outcome. This product causes harm to the fallopian tubes and cannot be easily removed. Proper evaluation did not take place in patients, including genetic evaluations to look at risk of infection or disorder — such as risk for diabetes. Additionally, full evaluation for conditions that would increase complications has not taken place. Full studies for STD and inflammatory conditions were not obtained prior to use of Essure. How many women had mycoplasma or ureaplasma in their fallopian tubes? How many women had endometriosis? Informed consent as to the risks that could all take place was not and is not provided to these women.

Essure makes the claim that they are the only non-surgical permanent form of sterilization. This is not true. I filed and took enforcement action in the past on a device called Ovabloc with the FDA. Susan Bucher, in one of our global research projects, found many forms of hysteroscopic tubal occlusion (HTO) for permanent contraception which have been considered, tested, or currently practiced in the United States and elsewhere in the world. They include, among other things, the use of methyl cyanoacrylate (MCA aka “super glue”), the use of liquid nitrogen to freeze the cornua which creates scar tissue blocking the fallopian tubes, the Adiana system, Ovalastic (off shoot of Ovabloc), and the practice of placing chemical pellets into the fallopian tubes such as Atabrine or Mepacrine (also called Quinacrine) to scar the fallopian tubes shut. Quinacrine sterilization is currently practiced in the United States today as the FDA allows doctors to use medications in anyway they see fit “off label”. It is interesting to note that in 1998, India banned the import or use of Quinacrine for female sterilization use as it can cause cancer and yet it’s allowed to be used in the U.S. for female sterilization. Today there are numerous designs and patents on “removable fallopian tube plugs” and “intrauterine fallopian tube occlusion devices,” which will be following in the path of Essure.

Essure also claims they are using micro coils. This is a made up terminology to make women believe the device is microscopic. It is an intentional fraud to mislead patients as to device construction. The coils are not microscopic and can be seen easily with the eye. The coils produce inflammatory processes, and may perforate the fallopian tissue and migrate through the body. The actions of the coils can produce sepsis, rupture of organs, necrosis of tissue, obstruction of the bowels, hemorrhage and other complications.

All of the complications could be predicted without any studies being performed based on the history of other products such as Ovabloc. The lack of a proper protocol appears to be an ongoing act of negligence in gynecology.

I am asking for an immediate stop in the use of the Essure device and a full investigation by the FDA take place to evaluate every case of insertion and gather proper statistical data. The law that prevents litigation against devices and products must be removed. This will take years of hard work. How such a law got passed is in need of a full exposé. How did this injustice evolve?

MedWatch needs to be totally revised and have proper funding to do what it has never done. It needs to collect every case of problems with devices and products, such as drugs and procedures. It is a failed system and we need it to be working to protect the public.

“Reverence for life requires action. One must stand up alone against all odds and speak out as to the issues and events that are corrupted and cause human suffering. Knowing at all times that the fact they are seeking change is the very reason they will face attack. The more vocal, the more vicious the attack”.

— V. Georges Hufnagel 1985

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POSITION PAPER: Evaluation of Ovabloc

I am old fashioned in my beliefs based on experience: when one sticks to the Oath of Hippocrates, the physician, the institution of medicine, the patient and the society are protected.

I heard one of the physician owners of Ovabloc speak and he lied as to the safety of the product at every ACOG meeting I attended. He was not shunned for his actions. It was as if nothing negative had happened. The physicians behind Ovabloc are making money today in Europe, where there are fewer regulations on devices and prescription items. I believe that the recall of devices that are not licensed is an essential step in gathering important data that can benefit research and development in the field. I am focusing on this issue because of my vast experience in women’s healthcare and understanding that complications from devices and medications occur both in the short term and in the long-term.
A review of the medical literature notes that Ovabloc is in Mexico, France, the Netherlands, and the Czech Republic. Not recalling the product here in the USA allowed the company to close its doors in the U.S. and simply continue pumping hot silicone into women in Europe.

When I first began my ethics work it was on the abuse of hysterectomies in America. A female Japanese writer contacted me for help. She found that one hospital in Japan did hysterectomies on every woman who walked in. Hysterectomy is sold there as the cure for every problem a woman may face. This one hospital in Japan used hysterectomy to cure depression, anxiety, and “hysteria.” The doctor and surgical team had set up a system that allowed them to treat hysterectomy as an assembly-line operation.

She and I worked to get the story out and found that no one could sue hospitals in Japan. Patients do not have this right. She also learned that Japan had a large outbreak of AIDS at the same time. We found that tainted blood was coming from the USA. Again, there was no means for a patient to sue. Blood was being sold to Japan during the time in which we knew that a disease was spreading and we had no methodology for determining the disease at the time. Thus we were selling blood that we knew could be contaminated without giving warning.

Today, new women are victims of Ovabloc in part because there was no recall. I asked and begged the FDA for recall status. When a device is recalled there is some level of public awareness made because a press release is made by the FDA. But no license being issued is not national news. How many women had damage undetected by their gynecologists telling them everything was fine? Telling them that some pain is normal. Women are routinely told that the side effect of a device for birth control will cause increased pain and that this is normal. Physicians often fail to look for any other cause of pain. Many women suffer from severe pelvic infection that goes undetected for months. The difference between US care and UK care was markedly different, with earlier intervention in the UK and smaller death rates. It is my belief that there is valid data that should still be collected on all women who participated in these medical trials with Ovabloc. Informed consent is still necessary even though years have passed. A true informed consent must have in it all negative possibilities that could occur to a woman undergoing any procedure or device insertion or medication use. The general consensus that is used in most of these trials is far too weak and does not provide adequate information to the patient; I believe this is a human rights issue and have been fighting for it for many years.

The business model that was shown repeatedly during the April 21 conference is an important element in evaluation of a product or device. However there are the ethical issues, the psychological issues, and the financial issues that need to be evaluated. The FDA has this responsibility and has always had this responsibility. As we attempt to come out of our economic crisis, at some point we’re going to have to realize that we have to change the business model; when an individual takes actions with malicious intent, they will be subject to criminal proceedings. Below I have listed some of the areas for review and made suggestions:

WHO: Who are the team? What is their history? Has there been any intentional misrepresentation of a product or device in the past? Has there been any documentation or publication of medical articles that were found to be untrue? The FDA needs to meet and have in-depth discussions and input because they have the experience in this area.

WHY: Why the product? Why is the team promoting it? Is the developer of the device the president of the company? Does a member of the corporation have holdings in a partner corporation? Is the development of the product based on improvement of devices or a medication, or is the motivation purely economic?

WHERE: What is the plan of expansion? Is this product for limited use in the USA? Is it for a specific population?

WHAT: What is the desired outcome for the corporation? Is it part of a large conglomerate? Is it a desire for a patent to continue to monopolize an area of medical care question? What is the corporation’s vision for the future?
I am aware that Ovabloc is still being marketed and performed in Europe. I am still upset knowing this is ongoing, when it is clearly evident that making money is more important than the lives of women is at issue.

The FDA and the public are subject to our cultural beliefs. When looking at a product or device, analysis needs to include psychological review. It is very difficult for the average American to self-reflect on their own consciousness and review society’s influence on their own behavior. In our society today the majority of individuals revere physicians and see them as being immune to such things as acts of evil intention, disregard for human life, or putting money ahead of patient outcome. Part of my work in bioethics is to see how authority and large organizations conduct their actions. In this area, I have found that the ACOG does anything to protect its territory. The reporting that we get from health reporters is very superficial and basically only covers press releases. There are only a handful of healthcare reporters to actually provide investigative reporting. The April 21 conference is reflective of a conscious action to create more transparency by the FDA and my desire and hope is that the FDA will continue along this path no matter the pressures that will be placed on it by powerful organizations such as the ACOG and AMA.

I believe that the FDA would benefit from an in-service on corporate disinformation. Medical associations such as the American College of OB/GYN hire companies such as Abelson Taylor, a marketing company located in Chicago, to target individuals which they desire to have made silent. The marketing aspect of a product or device is extremely important and the FDA cannot be naïve as to the extent that a corporation will go to.

As reporter I covered a story on overcharging by two of the major hospitals in San Diego. I was working on the story of a Hispanic woman who died of breast cancer and was billed for chemotherapy she never received. I found a class action lawsuit was filed against Scripps and Sharp Hospitals. The lawsuit was based on unfair billing. There were other hospitals, including a group of Catholic Hospitals in Northern California in the lawsuit. The press and media in San Diego never provided proper reporting on this story. I was shocked to see no series in print, on the radio, or on television. It was a great story: one man stood up against these hospitals who were attempting to collect excessive monies from him that exceeded the billings of patients who had medical insurance. In reality the practice was that the hospitals were offering a discount price to cash paying patients. This was a potentially Pulitzer prize-winning story, yet those in power of the media and press red lined it. The end result is that the population of poor, people of color, and immigrants all were at risk for being victims to this practice, which had not been publicized. In the case I worked on, I found multiple billings for the same item and overcharges — a Band-Aid was being charged for $8-$10. This woman had been billed for chemotherapy and believed she was getting chemotherapy through her IV, but she never had any chemotherapy at all.

The firm handling the Class action case was Cabraser Lieff. I learned a great deal about device law from Wendy Fleishman an attorney for the firm out of their east coast office. Most Americans have no idea that device law has changed so that the concept of justice is not what one may think.

VGH

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POSITION PAPER: Virtual Colonoscopy

I have written the FDA on endoscopy and colonoscopy. My grandmother died from colon cancer. She was in a time when colonoscopy was not practiced. GI physicians did not have a surgical area to earn money in then. When surgery was needed, they called a general surgeon in.

I found that virtual colonoscopy existed but was not practiced after my own diagnosis of colon cancer.

One of the originators of this technology is Dr. Bill Glen. I met him and he was very caring to me. He was worried that I would die from my tumor growing and left unfound in my body after my colonoscopy. He was genuine and kind. He also was a Harvard graduate. He worked hard to computerize a way of visualizing the colon. He created a computerized program that unzipped the colon to open it up so one could see inside the colon.

The virtual colonoscopy can give excellent data. One can scan the colon and get very good data. I have lost multiple teeth to traditional colonoscopy with rough handling and failure to protect my teeth. This has taken place despite my demands and pleas. The surgeons and anesthesiologists often ignore history. They are not educated on the problem and the pain and suffering a patient goes through with this. Many people cannot afford dental care. They act like ‘Cowboys.” This is a term I have used to describe very aggressive behavior that fails to see that less is best: less destruction, less force, and less action. I did not need or have a condition that caused fracture of my teeth. It was the rough ride I had in the operation by a heavy hand that broke my teeth. I was not a wild bronco that needed to be broke. I have suffered from losing my teeth and not being able to be in public with lost teeth. No one will listen to a toothless person. Looks do matter.

Many years have passed while this technology waited and progress was prevented by the fear and jealousy of the GI empire. Part of this is the psychology as well. Imagine a field of medicine that only saw patients, gave them medications, and did no surgical intervention. Then they got scopes and increased their skills, helped patients more and earned far more money. They were happy with their role. Now radiology comes in and has a means to avoid colonoscopy, which is the standard of care today. War takes place, and the GI doctors have numbers and money to put on a fight to keep virtual colonoscopy out of the game. There is Dr. Glenn and he has no army and no war chest. As a bioethics student here is my point of view:

How many have died who feared a colonoscopy? If we began using the virtual colonoscopy years ago the cost would have reduced with increased use. We could have created a massive scan program to get cancer before it was cancer and save lives. GI docs would have a source of patients to keep them busy by starting a national screening program. This technology could also potentially be used to investigate other disease processes and disorders. The ethics of this situation are very clear and what took place was not ethical.

This is one of the many stories I sent the FDA. The point here again is that the business model does not work. You need to look at history, psychology, and politics. The work is all about humanity.

I stopped counting the years this went on for after 12 years of action by the GI doctor community to stop this added tool to reduce colon cancer. The FDA can see the time line. The politics of this example needs in depth analysis by the FDA. The GI group used its money and influence to stop the licensure of virtual colonoscopy by the FDA. Your records will reveal these events. Meanwhile, many who would have benefited from this technology have died of colon cancer. The GI doctors did not want to lose income. They saw new technology as taking away their income. The colonoscopy was their bread and butter. They did everything to stop virtual colonoscopy and people died as a result.

I would not have lost my teeth had this been approved. Also the science of virtual colonoscopy would of evolved and improved during the prolonged process of licensure. The radiologists and GI docs could have made a deal to help each other early on and save more lives. If GI docs had helped the radiologists ,we would have advanced this science, reduced the cost, and increased screening so that more patients could be screened. This is an example in looking at the politics of technology to add this to the review. Mediation between the two groups would have benefited patients. Mediation is a concept that needs to be part of licensure because politics can play a huge role in the review process. Science needs to advance over territory control of the health care market.

People do lose teeth during this routine exam, in which there is no mention of the complications that can take place. I got to a top UC medical center and was not given informed consent before my colonoscopy. Teeth replacement costs over $2,000 each tooth, plus the pain and suffering involved.

You do not have anesthesia with a virtual process. You do not lose teeth and the risks associated with anesthesia. I will have to fight to get a virtual study because it is not common and seen still as experimental. I am in a difficult place because I do not want to die from colon cancer. The years of fighting to get the process approved would have established the study so it could be covered by insurance.

The issue of ethics needs to be on the FDA list. None of the doctors who scheduled me for a colonoscopy ever gave me proper informed consent. We need in all areas of medicine proper documents that cover everything that can go wrong. When you license an instrument and procedure it needs to have proper consent. This needs to be regulated. Consent that is given is not adequate and a review needs to exist for this process. Having cancer, one tends to do whatever they are told out of fear and extreme anxiety. When I created informed consent for female operations it was a 30-page document. Learning all of the complications, I realized, was part of a patient’s needed education. With proper education, the patient before and after a procedure can better care of themselves and avoid complications. 30-pages allowed me to perform the most difficult and complicated operations and have the lowest complication rate in my area in Los Angeles. Education before an operation is not at the standard it needs to be. Pre-operative protocol needs to be created and revised constantly as we learn more and continually gather data. How we view things over time needs to be flexible.

Everyone having a colonoscopy has the risk of tooth loss. In my last colonoscopy, I wrote on my face and pointed to the teeth I lost. I spent 10 minutes with the GI doctor on every visit before my scope complaining about my tooth loss. And yet, no care was taken to prevent tooth loss. The medical records of my office visit did not contain any notes of prior tooth loss. When I went in, I wrote a page about my tooth loss and gave it to the staff for the GI doc and anesthesiologist to read and have it put in my chart. When I finally got my medical records, that document was not in my chart. I am a physician and this is how I was treated. No one in the GI world even mentions the virtual colonoscopy to patients. Technology needs to be applied and used for the best outcome for the patient. This is not occurring because it is an economic turf war that is ongoing.

In cases like this mediations with reason and compassion need to take place so that patients benefit and medical science can advance. Currently others are losing their teeth and believe that it is an accident, when it is not. This loss comes from poor preoperative evaluations of candidates and the heavy hand of anesthesia. A study needs to be completed on this. No one told me ever in my informed consent process I could lose a tooth.

The complexity of authority and control in the medical sciences needs in depth analysis. Everyone needs to be on the couch, taking the time to think and feel what is taking place. Self-reflection is needed by those in authority and it is lacking in our current systems.

VGH

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POSITION PAPER: Breast Operations, Silicone and Morcellation

In 1995, I asked to meet with the device committee at the FDA to discuss several issues. I took Susan Wine and producer Mark Popp with me to the FDA, where the meeting was filmed. I had learned that RICO activity took place in medicine to control power and authority and would not do anything without witnesses. The meeting in 1995 covered several topics:

1. I asked for Ovabloc to be recalled and explained why: to prevent its use in Europe, and to gather needed data of harm caused. I provided operative and pathology reports. I provided Sara Woods’ case files; the silicone had covered her colon and it required resection. I explained all the cases I had worked on and the findings were provided to the FDA. Sara Woods, who had extreme complications from Ovabloc, filed a MedWatch report and was never contacted by the FDA.
2. I explained I had asked Storz to make diagnostic equipment for uterine mass and for mycobacterium in the use of the morcellator. I was told this was not needed that the fibroids just needed to be morcellated; no pre-op diagnosis was needed. I explained that the morcellator had to be isolated given that particles would seed disease, infections, and cancer. I stated that the morcellator should not be tested. I explained that a protocol and new closed system design needed to be made to prevent the spread of sarcoma. I stated that the unit would be used to remove ovaries, fallopian tubes, and uteri without protocol and without consideration of reparative operations. It was a destructive mode only. Misinformation was taking place through marketing that told women laparotomy was not better for them. This was not true. Laparotomy would reduce spread of sarcoma by total removal of mass. Storz was not giving proper informed consent on morcellation by not providing information on the spread of cancer, infection, adenomyosis, endometriosis, and fibroids that would be seeded by its use. This was a crisis. Additionally, there was a lack of proper protocol for follow-up.
3. I showed pathology reports from the US Army resulting from silicone breast implants, including: silicone migration into tissue in saline implant patients, the relationship between HLA and the inflammatory response seen in these women, and chest wall deformation in all cases of implant, resulting in pain and deformation of the ribs. I additionally proved that with Female Reconstructive Surgery (FRS), breasts could regain their normal shape within 2-months post implant removal — body fat would fill the space left my implants.

I had removed implants from multiple women with saline implants. I found that silicone migrated from the silicone envelop into the chest wall tissue, and provided these pathology reports to the FDA. The concept that silicone is 100% safe is not true. The capsule formed also has silicone fragments in it. The idea that there is no silicone in the body is not truth and not factual.

I provided pathology reports and also went to the US Army Pathology Department to record these findings. I received no written response from the FDA.

At the time NIH had research showing that certain a HLA group type had allergic reactions to silicone. In all the women from whom I removed implants, they had their immune status reversed after removing the implants and capsule scars. I provided patient contact information to the FDA of the women and filed MedWatch reports. Rh factor, lupus status, and sed rate elevation were noted before removal and then returned to normal 3 months after removal of the implants.

Every woman seen with implants had concave chest walls. The implants deformed the chest wall and this was even seen via x-ray. Why were radiologists not reporting this? Silicone is dense and has more weight than human fat so these implants actually deform the chest wall. This is one cause of chest pain in women with implants.

I used the new technology of FRS to expand the area and allow normal patient fat to fill the area without a need to put implants in. I had no deformed breasts and never put implants in a patient after removing them. That was big news then and today. Women can have normal appearing breasts after FRS removal of implants. Women do not need an implant to look normal after removing implants.

A list of patients was given to the FDA to contact. This is old science now for myself and my patients at the time. The FDA did nothing with this information.

The major complication I had was from plastic surgeons seeing a patient with fluid coming from their breast and never reading the operative report. They never called me and instead would drain the expanders. I would then have to replace the expanders.

No action was taken on the requests I made to the FDA. However, notification of what was to take place with morcellation and problems with breast implants was given in 1995.

VGH

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POSITION PAPER: Mesh

Dallas Jury Awards Woman Largest Amount So Far in Vaginal Mesh Lawsuit

I was contacted by Dr. Jennifer Berman. She wanted to meet with me to discuss how she could learn my surgical techniques of Female Reconstructive Surgery (FRS). I came with a non-involved engineer scientist to witness the discussions.

Dr. Berman explained to me that she had not learned any new operations or technology in her residency program in urology. She had read and heard about the multiple operations that I created within FRS to deal with bladder problems in the female. I had a zero complication rate and no failures when patients adhered to post-operative care. The only complication was with one woman who went home and had vaginal sex through she was told not to. You have to wait about nine weeks with a full Hufnagel Reconstruction.

I explained that I did not use a destructive theme in FRS and spent a long time in research in creating the technology first. In doing this work, I worked with Masters and Johnson for many years on the female sexual response and also the psychological aspects of belief systems and their role in surgical intervention. It was clear that Berman had not been taught any thing of much interest. She was not able to offer me anything and she assumed that because she was on television and wrote a book that I would simply tell her everything. I confirmed that I had created a multiple new operations and I was available for any offer of having me on staff for clinical work or teaching, and that I was not available to tell her everything I knew and then let her go often think that she could do the operation without any training.

She was receiving a great deal of money from UCLA to create a urological center and they counted on her press from being on television and writing books. During the time period that she was at UCLA, I received multiple calls with complaints by patients who were suing her and UCLA for botched surgeries, which had been influenced by a mesh salesman who had been in the operating room. All the women who called me stated that a salesman was in the operating room at UCLA.

When we had the meeting I was clear that under no circumstances would I use any of the current available matches in any operation. I was also quite clear that the mesh itself caused adhesion formation, which would cause chronic pain in women. I’ve seen immune changes in women and elevated sed rates that remained elevated after the installation of mass. The longer the mesh is left in, the more difficult it is to remove and the more complications that can occur. The body is supple and the body soft. Mesh is hard and firm and with time becomes harder.

I only used soft materials, many of which were biodegradable and those that were permanent were completely flexible. I advised all my patients to avoid mesh. I explained what it felt like — I would have example in my office so that they could feel how hard and inflexible it was. All the operations I designed were designed to not place this type of hard material into the body at any time, and to reconstruct the anatomy appropriately using soft, flexible materials. The operations were all designed to correct female anatomy where it had been stretched by tumor weight or had been cut in an operation previously requiring reattachment and resuspension. The suspension was performed successfully on hundreds of women without complication and with correction of the prolapsed bladder.

Several women approach me for correction of the prolapsed bladder. Physicians who had used mesh or suture told their patients that there was no way to correct this due to the fact that the mesh had contact with normal tissue and could not be separated from it without blood loss and loss of peritoneal surface. This was all true using traditional surgical equipment.
At this point I had created a plasma state process, which reduced tissue loss and controlled bleeding significantly. Many women have gone from surgeon to surgeon having multiple operations without relief.

The story of Dr. Berman, who was the star at UCLA until the number of lawsuits filed against her was too significant to allow her to continue there, is an important lesson. She left UCLA silently after they stopped funding her. I do not believe that salespeople should ever teach surgeons how to operate; yet this is an ongoing problem. The choices that one makes should be based on ethical considerations rather than finance.

VGH