FDA and FTC issues
6-27-01: SJB -
The UAE device (PVA foam) is currently NOT approved by the FDA for use for uterine fibroid treatment. The FDA is just now starting clinical trails. Once approved, (if approved) the PVA foam manufactures can then label the product, "for use of treatment for uterine fibroids", but until then PVA foam is NOT a product/device approved by the FDA for this use. This was explained to me on 6-27-01 by the CEO of Surgica Corporation, Mr. Louis Matson, whose company is seeking the FDA's approval to market the product as a device treatment for fibroids.
Mr. Matson explained that the experimentation of using PVA/UAE as a treatment for fibroids started about 10 years ago. PVA has been used for the past 30 years for treatment of neurovascular (cancer) tumors (in the brain), and for nasal packing for nose surgery as a replacement for gauze which is used to control the bleeding. The material is not left in (the nose) but removed.
Currently there are three companies manufacturing PVA Foam in the United State. All three manufactures are seeking the approval of this product by the FDA to be used as an UAE device. Some of the clinical studies proposed/in the making will be conducted by Surgica Corporation.
Mr. Matson stated that everyone (to date) who has received the PVA product/devise for the treatment of fibroids (UAE procedure) has been in a clinical trial/study. I was a bit surprised at this because I personally have spoken to many women who have stated that they were never told or informed that they were in a clinical trial. When I asked Mr. Matson to explain he stated that there are physicians (radiologists) who are performing UAE and have used (are using) PVA in their practice for the treatment of fibroids. He told me that physicians are allowed to do this although the device is not approved by the FDA as long as they have proper consent. He summed this up by stating that the FDA does not regulate (or govern) the practice of physicians, physicians are allowed to use the product with the consent of the patient, and that physicians are allowed to do this.
Is this an oxymoron? The FDA does not govern the physician, but they do govern the products that doctors use, and doctors are currently using a product which is NOT approved by the FDA for use for the treatment of uterine fibroids. Since this product is not yet approved by the FDA for use in treating fibroids I again call to the the FDA to halt all federal funding, halt all clinical studies, demand that physicians and radiologists halt the practice of UAE and the distribution of this device/product until the estimated 15, 000 women who have received the UAE treatment can be located and given proper follow-up care and treatment. More then enough women have had this procedure done to date to gather adequate data. We have herd of numerous negative outcomes, including PE and death following UAE. Were all these women just practice guinea pigs for the clinical trials?
I asked Mr. Matson if the PVA material was toxic, could women have an allergic reaction or side effect to the PVA? He told me that the material was not toxic, and that there were no bad outcomes to the PVA material but there could be negative outcomes to the procedure its self. He stated that (pelvic) pain after the procedure was common.
I asked if the material could travel to other parts of the body, or does it stay in one place. His reply was the it "usually" does not travel. I asked if it did travel could it affect other organs? I was told that it would only affect/shrink the fibroids, and that no other organs would be affected. Mr. Matson summed up our conversation with stating that UAE is a great procedure, and will save many women from having to have an unnecessary hysterectomy for the condition of fibroids.
When an adverse effect does manifest does the woman return to the radiologist who did the procedure? Do they notify the manufactures of the device? NO! Manufacturers must report deaths and serious injuries to the FDA if the device caused or contributed to the event. When serious injuries/side effects happen they seek out the attention an obgyn or other doctor. Not that of the radiologist or company who manufactured of the PVA.
We know that suits have been already been filed due to bad outcomes of the UAE procedure. I suspect that these suits will be quietly settled out of court until such time a class action begins. In the mean while radiologists are jumping on this cash cow band wagon. What I've been witnessing is an iatroepidemic in the making.
FTC reports are also forthcoming. This product/device is currently being marketed by physicians, radiologists, hospitals, medical centers, and by organizations as having no restrictions, as not being experimental, as being tried and true, and as being a safe non-surgical alternative to hysterectomy. Major ad campaigns and slick web sites are promising a safe and non-surgical cure.
One example of the inside workings of marketing this procedure is the proposed name change by bias members of the FDA Panel. The name of the procedure, Uterine Artery Embolization (UAE), has been changed to Uterine Fibroid Embolization.(UFE). The fact is, fibroids are not embolized, arteries are. The motive to change the name is to promote the procedure as a treatment for fibroids, and to removed the negativity of the fact that arteries are what is embolized.
The risks of UAE should not be downplayed. The UAE procedure, while it may be medically considered a non-surgical treatment, is a very invasive procedure with known, potential, and variable risks which when added up far exceed the risks of advanced conservative surgery such as Female Reconstructive Surgery (FRS), and even hysterectomy.
Some examples of UAE ad campaigns include the phrases:
"Over 10,000 women have chosen this procedure and are now symptom free."
"No surgery. No scar. No more suffering."
Women being sold UAE are NOT being informed of all known/possible risks such as the material can travel to other locations, the treatment can affect other tissue, that the PVA can break down over time, and that there is a risk of receiving severe radiation burns. These burns can range from appearing as a skin rash to large, deep ulcerations.
Granted, receiving a radiation burn may be a small risk, but it is a risk non the less, and the FDA seems to believe that it's enough of a risk of the fluoroscopy procedure that they are currently preparing guidelines that would serve as amendments to the existing Federal Performance Standards. The document is in its final stages of review and is expected to be finalized by 2002.
Thomas B. Shope, Ph.D., of the FDA stated, "Patients may go for some time with undiagnosed injuries (radiation burns), as symptoms of skin injury can take weeks to appear, and skin breakdown from progressive necrosis can continue over a period of months...many cases (probably) have gone unreported."
There is also the issue of the Stark Law being broken. Once such example is shown below. This is a real ultrasound report which was presented to a woman who had a pelvic ultrasound done in May of 2001 to determine her condition. On the medical record, the radiologist "self refers" which is unlawful to do. As radiologists are routinely the first to diagnose women with having fibroids, and because radiologists are also those who are doing the UAE procedures, this abuse will become more apparent as time goes on. Women will be reinforced with the notion starting with the radiologist that their only option to save their uterus or to forgo hysterectomy is to have the UAE procedure.
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Read Dr. Hufnagel's 2016:
Whistle Blower Cover-up Case Study:
How medical device companies and the ACOG work with public relation firms specializing in “crisis management” suppress the truth, silence whistle blowers, work to erase history, and “sabotage” medical malpractice cases to protect their $tock.
Silencing Whistle-Blowers & Erasing History…
Issues of Tubal Ligation/female sterilization, Essure, Morcellation, Hysterectomy, uterine fibroid artery embolization (UFE)/(UAE) & Dr. Vikki Hufnagel, MD.
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Dr. Vikki does NOT advocate Uterine Fibriod Embolization - Learn why....
FDA Issues: On 5-22-2001 the FDA held a hearing regarding
Highlights of this and coming hearings are reported here.
The following was presented to the FDA on 5/22/2001:
THE DESTRUCTION OF THE FEMALE UTERUS
Vikki Hufnagel MD 5/22/2001 For FDA Panel on UAE (UFE)
The general destruction of normal uterine tissue as a result of UAE has not been given significant status in the evaluation of this procedure. I believe this stems directly from the culturalization that the uterus is an organ which we can eliminate with surgical easy (hysterectomy). And the value of the uterus is not held other than for childbearing in the majority belief system.
If you suspend your socialized concepts about the uterus and hold a position that the uterus has intrinsic physiological functions including but not limited to:
This concept of the human female uterus significantly impacts on the evaluation of said organ and its role in female anatomy and physiology.
I was and continue to be maliciously attacked by the American College of Obstetrics an Gynecology (ACOG), the CMB and by an appointed Judge for stating the uterus was a "sexual organ". The manner in which my own career has been affected by stating my beliefs reflects the need of such institutions’ to protect their existing belief systems.
How you view this organ imports on who you treat it.
Also how you view women is impacted on how you treat them. To often entrepreneurial medicine focuses on the fears of women and begins its sales campaign based on fear and ignorance. Ignorance then is then feed with quick fixes and so called noninvasive treatments offering safe and effortless cures.
In the case of uterine fibroids I am able to say after more than 15 years of surgical experience that there are many approaches that are successful that are advanced over traditional myomectomy that remove uterine fibroids. The standard surgical approach in general has not advanced in the world of gynecological surgery. Rather than focus on learning new ways to remove uterine fibroids the gynecological community has elected to support entrepreneurial medicine such as UAE. This is a political social reality that needs to be exposed.
POINT OF VIEW
Perhaps some analogy needs to be imposed within this discussion to try and demonstrate the absurdity of the approach that we are discussing here today.
A simple neoplasia ( non cancerous tumor ) of the testes can be treated with this UAE approach. Why are you not discussing here the occlusion of the vessels to the testes? Cutting of the blood supply to the neoplasia will cause it to shrink , to necrosis. Why is this not a topic here today?
These are all social issues in which we need to reevaluate our value system.
I find it appalling that the medical community has accepted the belief system that we can shut of the blood supply to uterus. We can shrink fibroids but leave them in the uterus enlarged, scarred and inflamed and call this a cure. It is my opinion that we are doing more harm when we destroy the anatomy and make surgical intervention more difficult in the future which is what occurs with all UAE cases.
The resulting necrosis of lieomyomata causes the capsule of the fibroid to bind and adhere to the normal myometrial tissue. In normal conditions the hard fibroid is distinctive from myometrial tissue and separated my a dense capsule.
The very thing that allows a surgeon to detect and remove uterine fibroid from the uterus ...is eliminated through the UAE process. UAE by the ischemia reaction causes significant loss of normal anatomical distinction. The myomertrial tissue is severely affected by UAE. The normal myometrial tissue becomes inflamed and damaged.
We are not dealing with an AV malformation in the cerebrum that is not accessible for surgery. We are dealing with benign tumors that can be easily extracted from the uterus. However the giant cell reaction, fibrosis, myometrial necrosis, histiocytic clumping, micro abscess formation within the normal myometrium make the surgical detection and removal of uterine fibroids extremely difficult even for the most skilled surgeon .
LACK OF SURGICAL EXPERTISE
The lack of training in the removal of uterine fibroids is an issue with in this nation. Many surgeons will be forced to perform hysterectomies on post UAE patients because of the anatomical changes that take place throughout the uterus.
Separation between the necrotic degenerating fibroids and the myometrium which has become inflamed and reactive to the necrosis is not easily delineated. The capsules of the fibroids become like super glue to the normal myometrial tissue.
I wonder how many women with a single fibroid tumor that was not symptomatic have undergone UAE. These women are excellent surgical candidates for tumor removal. The reality with new surgical approaches the number of tumors or size of tumors are not issues with reconstructive processes.
Women are not being fully informed that the likely hood of complete necrosis of their tumors in many cases is not possible. They are then further not told that they are at higher risk for a hysterectomy or a very difficult myomectomy. Many of the small seed fibroids will not be detected at surgery and re-growth is likely.
I asked Acheing Wamabo to describe her UAE in one word. She looked up at me and said "FAST". She was given no time to ask questions. She was not given adequate consent which seems to be a consistent complaint with this procedure.
Women are not been adequately informed of the negative affects . I have reviewed this case and it is present as a typical UAE. This patient was given Lupron to shrink her tumors before the UAE. She had a pulmonary emboli shower from the Lupron. This negative out come with Lupron was never reported. Many woman with negative Lupron experiences have no idea this can be reported. Worse, their physicians are not reporting these events.
I will be attacked for reporting this case and issue. No good deed goes unpunished has been the hallmark of my career. The physicians involved in Ms. Wambos case are leaders in the UAE movement ( Roxborgouh Hospital Penn.).
Her PE was in 1998. It is not referred to in any of her UAE records. The radiologist denied being told about it. The Achieng states she discussed this repeatedly because she nearly died. She has two official UAE operative reports in her file. One that states both right and left arteries where blocked . One that states on the left side was blocked. She had no follow up at all. No one performed a follow up ultrasound. No one dealt with the fact that she was still walking around with a massive size uterus with severe pressure and reoccurring right sided pains. She was living in fear of having any surgery told it could not be done because of her prior pulmonary emboli. The lack of evaluation and follow up in this patient needs to be seen as the trend in the FAST MILL sales development of UAE that has become the standard of care.
There was also an attempt to have Achieng seen by a surgeon who would remove her uterus and not report any of these findings. The physician involved with her LUPRON PE refused this woman her own records.This physician refused her records to myself. The records showed that there was no ultrasound follow up for two years. Trying to care for this woman was difficult to say the least. Her referring gyn had no files and no memory of her. She will be filing a FDA Device report and a report on Lupron.
I have had more than ten women this year tell me similar stories about their UAE. None of them had the negative outcomes reported. None of them knew about reporting. The data being report is very none representative . follow up has vanished . I see this as another abusive technology .
IS THIS ANOTHER OVA BLOC ...silence
What happened to the thousands of women injected under FDA studies with silicone in their fallopian tubes with the OVA BLOC fiasco. A conspiracy of silence develops around these issues.
Radiation exposure to the female for a non life threatening condition I feel is to great. I am concerned about the long term affects of radiation on the ovaries.
I am aware that we have technology to avoid this today. Visualization does not require radiation.
The Polyvinyl family is linked with toxic exposure and complications. These agents are linked with hormonal changes that may be related to development of female cancer.
LACK of FULL DISCLOSURE
The surrent documents and oral discussions with potential patents do not fully explain the unknowns of UAE and the known complications that have been witnessed. This area is lacking in adequate disclosure
The rush to get these women into UAE is part of the extensive marketing program that’s taken place. However, the follow up care is lacking .
Vikki Hufnagel MD
Notice to the FDA: Call to Halt All UAE
To the UAE Panel and the FDA
I am formally requesting that UAE be stopped until such time that a complete retrospective study is done looking at outcome:
Under the Freedom of Information act , I and others will begin a national retrospective study since it appears that the concerns of women are not being listened to.
Note: The following below is archived from Dr. Hufnagels website from 2001. Some of the links are broken or have been removed.