“Essure” Nickel Labeling, FDA & Issues of Consent

Seeing “RED FLAGS” with the Changes in the Standard of Care

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:

The Essure device is made of a nickel-titanium alloy. Originally, women were advised via product labeling instructions for use (IFU) that in vitro testing demonstrated that nickel is released from this device. Women were advised to test for nickel allergy prior to having the Essure implanted. Women found to be hypersensitive to nickel were advised not to have the product placed.

After the product was on the market for some time, Conceptus lobbied the FDA to remove the contraindication for patients with known hypersensitivity to nickel as confirmed by a skin test. This should have been a big red flag for the FDA, but instead of seeing the red flag, the FDA gave Conceptus the green light. In August 2011, Conceptus removed important information and warnings relating to Nickel from their IFU having gained the FDAs approval to do so.

How did this happen?

This was NOT an action of consumer safety or protection on the part of the FDA. This was an action of giving the green light to a manufacture and obgyns to withhold important information from women at the time of consent.

This information was removed and withheld with the intent to persuade women to make the decision that the manufacture and doctor wants them to make. Withholding information from women at the time of consent is an intentional fraud. Doctors/organizations/medical device manufactures who withhold information, or who state that pre-testing for nickel allergy is not important and not necessary prior to the use of the Essure product are committing intentional fraud and misrepresentation. Withholding information constitutes forced (fraudulent) consent.

Co$t and Profit$:

When comparing the cost of performing a skin test for nickel allergy compared to the cost of losing a sale/surgery, and compared to the cost of future medical care needed for women finding out after the fact they do have an allergy to nickel is NOT equal. The cost of loss of health to the woman far outweighs the other.

Nickel hypersensitivity can cause:

• pulmonary asthma
• eosinophilic pneumonitis
• conjunctivitis
• inflammatory reactions around the nickel-containing implants
• anaphylactoid reactions after parenteral injection of nickel-contaminated medications

NICKLE ALLERGIES ARE REAL:

It is time the FDA alerts America to the fact that allergies to materials used in the human body do exist. In 1995 I spoke before the FDA DEVICE COMMITTEE and gave evidence of the Human Leukocyte Antigen (HLA) being linked to allergies with silicone and its use in BREAST IMPLANTS. The fact that this data has not been made public for decades is another reason that powerful institutions took my voice. This is unethical and simply flat out wrong. For progress in medicine to take place we must know what is not working and not cover it up. I am adding to the Hippocratic Oath my own statement ”What you do not know can kill you”.

Physicians have a duty to not cover up and not be silent about the wrongs they witness. This includes also the things they do wrong. It is best to admit all mistakes and wrongdoings. As I reveal in Shadow of Medicine many lives would of been saved had others joined me in speaking out. But they saw me being burned at the stake and turned their eyes away .

I consider the addition of nickel into this product completely insane. Why would anyone put nickel into a woman’s body? I have stated, as have others, that nickel should NEVER be used in any type of gynecologic implant.

Nickel is NOT a metal that has been shown to have NO NEGATIVE effects on the human body. People can be sensitized to nickel and have allergic reactions. It is criminal that the requirement for pretesting for nickel allergen was removed from the Essure product labeling and many women have been injured by this action.

For the record, POLYESTER FIBERS (PET) ALLERGIES ARE ALSO REAL: (I will write more on this at a later time)

Past and Continuing FDA FAILURES…

As I stated earlier, the FDA has failed in the past to inform the public that silicone can cause allergies. Certain HLA types have reaction to silicone. The FDA has publicly stated that there is no reaction to silicone breast implants. However that is not actual truth, the NIH has studies showing that some HLA types do have allergic reactions to silicone. However, this has not been made a proper part of informed consent which is a major issue that needs to be corrected. Silicone is not 100% safe. I reported this in 1995 with surgical cases to the FDA. I did a series of surgical breast implant removals with 100% improvement in patient condition with all symptoms of allergy and pain removed but also no breast deformity. No new implants needed to be placed as I showed the committee for Female Reconstructive Surgery (FRS) for breast operations. Also I showed the FDA that all breast implants cause chest wall deformity. None of this has been made public. It is time to reveal this data.

It is not ethical to not provide the patient with ANY and ALL complications to any device. This is a need that the FDA is not providing.

ALL is they keyword.

The patient must have ALL the information to make their consent or not.

Do not confuse “consent” with informed consent. Batteries occur when information is withheld in order to coerce a women into signing a form and then she suffers bodily harm (of a known risk which was not disclosed). A form stating that the women was “informed” or told of the risks is not valid without details of what she was specifically told or informed of.

I advise all women who believe or know that they have been a victim of a battery to file a police report. The fact that the battery took place in a medical setting has no bearing and does not change that a crime of battery has been committed. It is not for the police to decide if they should or should not take your report. If you are reporting a battery their job is to take your report.

The FDA allowed Conceptus and doctors to alter and with-hold important information about nickel allergy pretesting. This fact paints the picture that the FDA is working more-so for the device manufacture and their profits instead of protecting the public. This goes against all ethics.

Pretesting for nickel allergy is a legal and ethic requirement before use with of this product. Women also need to be informed in writing (via an informed consent document which she signs) that with use of this product she will be at higher risk for hysterectomy, and of all the risks associated with hysterectomy… and MORE.

The marketing pressure to not give 100% complete consent needs to end immediately for all products, devices and procedures.

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)
Phone 323–210–3371

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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

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