"The Premarketing Approve of Essure was based on two nonrandomized, nonblinded, prospective studies that lacked a comparator group and enrolled a total of 926 women...."
"...In addition, the FDA required, as a condition of approval, a third study examining the outcomes achieved when 40 physicians, newly trained in Essure implantation, attempted the procedure in 20 patients each. Although this study was not registered and the only publication was based on a subgroup of the study cohort, FDA reports indicate that the trial was stopped early after physicians attempted implantations in a total of 476 patients. Despite 39 device malfunctions and 13 periprocedural adverse events — and no reported postimplantation follow-up — the device was deemed safe in women who had successful bilateral device placement." Read the attached article for more details. Revisiting Essure — Toward Safe and Effective Sterilization
“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
Those who withhold information about the known risks of “Essure” prior to its use are committing fraud. Withholding information constitutes forced (fraudulent) consent which can lead to battery. ~ Dr. VGH
Essure Nickel Labeling and Warning:
Seeing “RED FLAGS” with the Changes in the Standard of Care
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. ~ VGH
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). - read more
Video presented by Dr. Vikki Hufnagel to the FDA Obstetrics and Gynecology Devices Public Panel 09/24/2015
Topics covered in this video presentation and in the associated Position Paper includes information about; Human Rights, Womens Health rights, Ethics in Medicine, FDA governance, Essure, Ovabloc, Morcellation, NovaSure, Uterine Artery Embolization, breast implants, hormones, tubal ligation, post tubal sterilization syndrome, Transvaginal Ultrasound (TVU), Hysterosalpingogram (HSG), nickel, product labeling, informed consent, and serious issues of abuse, fraud, battery, mayhem and negligent homicide.
This document is formatted to provide the reader with existing laws that came to be because of the fact that women suffered and have died from the experiments performed on them without their consent or knowledge. This is America and we hold truth and justice for all as a primary foundation in our lives. It is self evident that the FDA must adhere to existing laws and protocols that honor the reverence for female life and being. After the reminder of these important laws and concepts, is comment on how the FDA has failed in meeting these national and international known accepted policy that the FDA has repeated failed at achieving.
Art imatates Life - Shown here is a handmade lampwork glass focal bead by Susan Bucher, founder of the Coalition for Post Tubal Women (CPTwomen).
The title of this e-Bead is "Perforation"
Bead pays tribute and homage to the victims of Essure. Inclusion in the glass bead is a spring wire, symbolic of the Essure permanent birth control device. The resilient yet fragile glass bead is symbolic of women. The inclusion of the wire into the bead causes the glass to react with bubbles which is symbolic of the inflammation that the device causes. The only way the wire could be removed from the bead would be to shatter and destroy the bead; symbolic of the hysterectomies, cycle of abuse, devastation and mayhem the Essure device has waged upon women.
A portion of the funds raised from this auction is being donated to ASHES Advocating Safety In Healthcare E-Sisters to support their activism work.
“Transvaginal Ultrasound” (TVU) replacing “Hysterosalpingogram” (HSG) as the 3 Month Essure Confirmation Test
