“Transvaginal Ultrasound” (TVU) replacing “Hysterosalpingogram” (HSG) as the 3 Month Essure Confirmation Test
First of all, with Essure, some perforations will take place during the insertion procedure. This is because there is no A-Assessment. No lab studies for contraindication have been done. No RISK ASSESSMENT has been done. No view into the pelvis. No STD work up! This is not the practice of medicine… this is the sales of a “magic pill” to women who are not educated and are always looking for that magic pill. This is true for most of the American population. The quick fix seekers. Hysterosalpingogram (HSG) shows only if the tube is open (or closed) and some of the internal tube condition. Transvaginal Ultrasound (TVU) shows where the NICKEL is. And where are the studies on nickel and ultrasound (US)? Without contrast the tube being open or not is not able to be determined. Again, I need to remind the medical community that by 1980 I was a published expert and researcher in ultrasound (US) for OB/GYN. I have never been attacked for my lack of skills or training. I am attacked because I tell the truth.
The current standard of care with Essure until recently was for all women to undergo a hysterosalpingogram (HSG) as a confirmation test three (3) months after the device is implanted to determine if the fallopian tubes are blocked by tissue in-growth around the coil inserts. What this means is that SEVERE INFLAMMATION AND SCAR TISSUE had resulted from the ESSURE. That the function of creating factors and co-factors needed for the female system have been destroyed by this action. This is an issue of informed consent women are not told… that they may have a higher risk of rheumatoid problems or have chronic pelvic pain with hydrosalphinx.
It was announced on July 1, 2015, that the FDA approved transvaginal ultrasound (TVU) to be the NEW primary confirmation test to be performed 3 months after Essure placement to check if the device had been “placed properly” (3 months after it was placed). In my science world this is malpractice. At the time of the insertion placement should be documented.
The 3 month TVU is to be done NOT in addition to a HSG test but as the primary confirmation test. As explained by Bayer, the TVU will be performed by the physician (after training) and only if the physician is unable to confirm correct placement with TVU, an HSG will have to be performed (by a radiologist).
This plan shows those behind it lack medical science knowledge. How is Bayer going to train a MD in an entire field of medicine that takes years of learning? Answer is: They are not. It also shows that the technology of intraoperative US is not known to the ACOG, FDA or Bayer and I could go on about what should be done… but that is INSANE since this entire “ESSURE” project is one I ETHICALLY CONDEMN.
While HSG tests confirms with dye and x-ray if the tubes are occluded or blocked (and alternative birth control is no longer needed) the TVU only checks for “placement”. This is also vague since the device could be in the correct plane but already have perforated out the tube.
This new rule did not just come on its own by the FDA. Bayer and obgyns had to make the request for this new protocol to be approved and had to lobby the FDA for its approval. The request from the manufacturer, the ACOG, and OBGYNs to forgo the HSG and replace it with a TVU 3 months after placement should have been another “Red Flag” for the FDA.
I challenge Bayer and the so called OBGYNS. Who the hell are these people? 1/ Hired guns for the project 2/ Stock holders 3/the devil?
The reality is only laparoscopy is a way of visualization and diagnosis for the many complications that women have reported.
The problems with this new protocol:
- TVUs are often fuzzy and hard to read.
- The TVU will NOT confirm that the tubes are occluded.
- TVUs do not detail as an x-ray HSG does as to how many coils are present or if they are bent/broken.
- Tissue pathology is not determined.
- The physicians who promote, sell (profit), and place the Essure device are proposed and anticipated to be the ones who will be trained/certified to do the Essure TVU “confirmation of placement” test. (This means MORE money for the e-doctors as they will be able to charge $$$ for performing the TVU) (Currently obgyns do not perform or profit from the HSG as TVU are performed by radiologists). As the doctors inserting the device already highly profit by charging “surgical fee” rate$ for inserting the device (which causes a conflict of interest over suggesting/offering other forms of birth control… ) the fact that they will further profit by performing the TVU only compounds this conflict.
- When doctors insert the Essure it is done so visually (using a hysteroscope) so it should be known at the time of insertion if the devise was properly placed. X-ray should be done at the time of insertion to confirm the device did not break while being inserted and for future reference.
- Checking for “proper” placement via TVU 3 months later is NOT done to see IF it was properly placed. It is done to see if it is still properly placed or has it migrated. How can this be determined if there are not before images to compare them to? Proper placement does not mean that the tubes are occluded, it just means the device is where the doctor wants it to be (which with TVU could be subjective).
- In the news article Bayer describes the Essure® insert as “soft and flexible”. The metal coil is not soft and it is not micro as they have described in the past. The insert can be seen with the naked eye and the coil is made of metal. Calling the coil micro, soft and flexible is marketing fraud done to mislead women and the public.
- The proper placement of Essure is for it not to be placed to begin with based on all the complications that have occurred and the lack of ethics and science in the development of this device.
My belief is that Bayer and OBGYNs would prefer the TVU over the HSG as they are visually less dramatic (as women are posting copies of their misplaced and migrated HSGs on the internet), and they give less information (which goes along with withholding information from women as is done with the nickel information).
I am the gyn who created intraoperative ultrasound in the early 1980’s. I presented this at the ACOG annual meeting. Thus I can speak to this issue as a world expert. The gyn community is not trained in intraoperative ultrasound nor in TVU. Thus adding ultrasound to Essure either at the time of insertion or 3 months after it is placed will NOT have any change in how it is placed, its migration, or in the iatrogenic sequel caused by the device.
The ACOG failed to create a program to advance this technology when I created intraoperative GYN US in 1981. I sent a teaching program to the ACOG who responded by stating that gynecologists should not learn this technology and it should stay in the radiologists control. I disagreed with the ACOG’s decision. Thus the addition of US for insertion or confirmation of device placement by a physician will not be able to take place. The public is unaware that meetings take place in which it is decided who is in power over technology in the medical industry. In this issue I was pushing for the establishment of GYN intraoperative ultrasound. The ACOG sat down with the heads of the American College of Radiologists and split how things would be done for economic reasons and to prevent territory fights.
The reason we do not have virtual colonoscopy today and much needed technology to reduce colon cancer is the fact that a territory fight has been going on for decades. Thus, virtual colonoscopy has not advanced as it should have for decades. This is a territory fight issue. It is based on money. The FDA is aware of these issues as well.
It takes time to find out the money issues that are behind this crime against women. I currently do not have the time to do this. However I can oversee a group of women who would volunteer to get to the bottom of these issues. I have found that the victims are not logical and in fear and are acting out as a result of these crimes. This is an area in medicine and finance that is not discussed. Victims cannot be true advocates for themselves because there is NO SUPPORT SYSTEM for them. The actions they take are emotional and often not logical. This is a true psychological condition taking place. There is no current therapy available and no experts working on this condition. I am first to describe this in the medical literature. I have seen the lack of focus and disorganization when these crimes take place. I am working on the psychological issues of the female victims of Bill Cosby. There are direct similarities in these cases. Women expect to have help. The medical community (those who make, sell, insert, and approve the use of Essure) take action to cover-up. Then they find out no one (family and friends) believes them. Then they become labeled by society as doing wrong or being mentally ill. This is a very difficult situation. Why have the women not gone after the patent holders of Essure? Why are they not filing police reports because with the lack of consent they all have been victims of a battery? They are not logical and are emotionally not able to separate so they can take action. They are totally overwhelmed (due to their negative iatrogenic condition, caring for young children, work, etc…). And in trying to work with them is difficult because they find comfort in “fun events” such as Facebook posting and rallies (as opposed to writing Congress, marching and protesting). The concept of hard work on these issues is not on the table for them. Some women have shame because they consented to the implantation of Essure. They know they were buying the magical pill and should have been more of an advocate for themselves. These women have not even come forth.
CONCEPT OF REVIEW:
It appears that the FDA needs to reevaluate its process. If a device has complications the etiology of these needs to be examined. The current PATCH policy is not scientific. The FDA current suggestion, for example, is to add Ultrasound. This is a patch bandage you are adding which is not logical and not science. In science one does not outline problems then put bandages on them. In science one goes back to the start and reviews the entire process. This is the scientific process which the FDA needs to work on as its protocol type. Currently the process used is a business review not a science review. I do not have the time to review the entire April hearing this year. I believe it was great because it is bringing transparency to the FDA. But in all the talks the foundation was in a business model review. The FDA attempts to support the device and the company to make the device work. This is done through business model concepts. This is not science or ethics and is a business position which is not what is needed. A complete scientific and ethics review is needed. A protocol needs development and I suggest that the FDA ask NASA for assistance in this process. I continue to study Aerospace Medicine because it is grounded in science and protocols. Use of ultrasound may in fact, with Essure, have complications with the nickel element.
I offer my services to corporations and to FDA and other government authority because of my skills and experience. I am not the enemy and never have been. But I am not silent and I do have a very different point of view. This point of view caused me and my family great harm but it also created new operations that I hope to document for the future to save lives. Follow the Hippocratic Oath and do good. Thank you for this act of transparency in allowing me to speak on these issues.
~ BE OF VALOR
Dr. Vikki Hufnagel MD
Hufnagel Bioethics Institute (HBI) — Founder
Director prior Institute for Reproductive Health (IRH)
The above is a segment from a position paper by ~Dr.Vikki Hufnagel. To read the article in full see: “Crimes of Essure and the FDA”