“Women need to be informed that with the use of “ESSURE” they will be at higher risk for hysterectomy, and of all the risks associated with hysterectomy.” ~Dr. Vikki Hufnagel
Since the 80’s I have lobbied and advocated for baseline hormone testing not only for post tubal ligation and sterilized women but for ALL women as a standard of care to promote hormone health. This has been a major focus of my work. I have had NO support since my mentors died. No one in the OBGYN community has assisted me in this issue. I have been attacked repeatedly for my opinion which in this area is based on science and proven to be correct over the decades.
My protocol directs baseline hormone testing for ALL women starting at age twenty-five as a standard screening test in the same way that mammograms are for women at age forty. This was based on hundreds of patients I studied and presented showing that hormone levels are necessary for the standard of care for ALL women. In some cases of disease hormone studies are needed before age 25.
Loss of hormone production, hormone imbalance, and hormone shock (sudden loss or abrupt change of hormones triggering physical shock and manifesting with shock related symptoms) can affect both a woman’s physical and mental health (a few examples include bone health, cardiac health, memory, REM sleep and libido).
In the United States, a woman’s odds are more then one in four of one day having a tubal ligation (female sterilization) or hysterectomy. A woman’s chance of one day having a surgery that could affect her hormone production or possibly castrate her is much higher (1 in 4) then getting breast cancer (1 in 8), yet women are not routinely offered hormone testing as they are with mammograms.
The ACOG et al have repeatedly refused to inform women about hormone testing and about hormones being sold to them. The ACOG knows that many hormones are the cause of breast cancer by the formulas being used and the manner in which the hormones are given. My work was intentionally suppressed by the ACOG in collusion with the CA division of the AMA, and the CMB. The GYN community has told lies to women patients for decades. These lies have caused morbidity and mortality. One lie is that a woman only needs one ovary to function. This story is not based in science. The GYNS failed to study these women for decades. Also GYNS have failed to study women with appendectomies. I studied women with lost ovarian function after an appendectomy. The loss of one ovary is common.
My neighbor is a typical female patient. She was put on manufactured hormones. She never had hormone studies. She now has ductal carcinoma. She never had a ductal cell study. She never had a risk assessment for breast cancer. This is the condition in the standard of care in the upper class in Beverly Hills Ca. You can imagine the care the poor are getting.
Women are not informed about or offered hormone testing. A woman having this information about what her levels are when she is in the prime of life and feeling her best is essential information to have in her medical files. A base line is needed for all women should she need NCH tm NATURAL CYCLIC HORMONES then it can be provided to fit her personal hormone state.
The Hormone Profile Protocol I created in the 80’s (for which the CMB stated I was a criminal and women did not need hormone testing) directs for the following plan of care:
All women (including women younger then age 25) should be hormone tested before all surgical procedures or medical treatments which could affect her hormone levels short term or long term: This would include being tested before a hysterectomy, tubal ligation/female sterilization (“ESSURE”), uterine fibroid embolization, prior to donating eggs, Lupron shots, prior to starting hormone replacement therapy or taking the birth control pill, etc…
In any operation blood supply to organs can be lost causing loss to the organ. Thus a cesarean section can cause loss of ovarian function. Thus any disease, device, procedure or operation can stop hormone production. Testing before and after is a scientific fact that needs to be a standard of care and I am sorry that the ACOG and CMB have caused so much harm to so many. The FDA needs to be science based. Tests need to be done before an action and then after. The fact this is not done is medical negligence and medical malpractice. In 1995 I discussed this issue at the medical device committee meeting. The failure to test female hormones is a crime by anyone who practices medicine.
Women who are experiencing irregular periods or cycles (regardless of age). This would include missing cycles (in the absence of pregnancy), experiencing long periods (longer then 10 days of bleeding) long or short cycles (having two periods in a month, going 45 days between cycles). Any cycle that has new symptoms associated with it also needs investigation.
All women who have undergone any form of female sterilization/tubal ligation (Essure), tubal reversal, Essure removal, hysterectomy, uterine fibroid embolization, one or both ovaries removed, one or both fallopian tubes removed, or any type of surgical or medical treatment that could have affected her hormone production (regardless of age).
It is not scientific to allow a device to be used without hormone studies. This is a continuation of a business protocol to sell a device and not be thinking at all times of the welfare of women. Again, the FDA needs to use a science and ethics protocol. A business protocol can be used after you have created a safe product. It is clear that this ESSURE, Morcellation which kills women, UAE (UFE), Mesh Implants and Breast Implants all are not as they should be. I will prove that Morcellation was allowed and is now allowed and that any reasonable person would condemn this device and condemn how it came into use. If the FDA does not evolve into using a science and ethics protocol in time the public will take action. It takes time and hard work to uncover wrongs. It took me 30 years to expose Bill Cosby. Do not believe that the FDA is more powerful than truth. No one is more powerful than truth.
Women are not offered hormone studies because the ACOG has lied to women for decades about hormones. It has lied about the fact only one ovary is needed for normal function. There is no science behind their statements. As women evolve and become educated they will learn they cannot trust those who lie and fail to teach. The ACOG failed to educate women or offer hormone studies in a proper way for too long of a time for anyone to trust them. They have made public statements which inform the public that the tests for hormones are unreliable and not necessary. This is not true.
There is a cost to run hormone tests. However had this been done for decades the cost would of decreased. I went to China in 1996 to create hormones that would be safe. That same year the ACOG and CMB attacked me to stop my work. My neighbor who has breast cancer was never given risk assessment, never has any hormones studies. She is like millions of women she trusted her GYN. Women are not having baseline hormone studies which is negligence in the provision of hormones to women. Yet, across America women are get hormones from physicians without proper testing.
The other side of this issue is women are in fear of hormones and refuse them. Many of the women refusing hormones will also suffer. This is an area in women’s medicine that is corrupt. The manufacturers of patent drugs run this. The ACOG has not done any education of women to learn about hormones and has fought me for decades on routine testing. However I will not give up. Routine testing of hormones is the same as having routine testing of your blood pressure or a pap smear. It is basic and essential. Thus any action that can change hormones needs to be studied. And this refers to all the medications, devices and procedures being reviewed by the FDA.
Hormone studies need to be done in depth. I can tell you that most GYN’s do not even know all the hormones the female body creates. For example getting a FSH follicle stimulating hormone test is not enough information. When ESSURE came to the FDA they should have been concerned about the co-factors and chemicals created within the fallopian tube. Why were they not? This is the question I ask and the reality was they were not working with a scientific model. I offer to provide an educational program on female hormones to the FDA.
Thus, in evaluating ESSURE one cannot offer safety because the studies on hormone effects has not taken place. This is another issue of lack of informed consent and failure of FDA protocol. Patients should not have this research after the fact. It should have been done during the testing phase.
I will be sending a FOIA on the files of several issues I wish to investigate. On this section I want to see all of the studies done before insertion of ESSURE and after: toxicology, allergy, immunological, general blood chemistry, rheumatoid studies, hormone studies, nickel studies and inflammatory studies.
As a Bioethics Surgeon and Physician I am asking to see the toxicology studies for ESSURE. All those for ESSURE would needed to have had an allergy and immunological baseline studies prior to insertion of Essure. Then follow up studies for changes.
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)
For a visual of peristaltic waves see: https://www.youtube.com/watch?v=1LKpQ0pybZE
(video — Fallopian peristaltic waves shown in this video starts at 3:15)