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."

"completely cured."

"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.