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Stronger Warnings for Essure Not Enough

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The FDA has slapped a black box warning on Essure, but many critics and Essure victims say this strictest warning is not enough - they want the permanent birth control device permanently removed from the market.

Along with Essure’s heightened risk warning, the FDA is ordering Bayer to conduct a clinical study, or postmarket surveillance study, to measure the “real-world safety record” of the device. Many complaints to the agency regarding Essure safety have called for the device to be removed from the market until proper clinical trials have been conducted. A consumer petition claims that original Essure clinical trials weren’t conducted properly, and the device shouldn’t have been approved in the first place.

In a statement issued last month, the FDA explained that Essure is an “appropriate option for the majority of women,” but that “some women may be at risk for serious complications,” especially if the device shifts out of position and punctures the uterus or other organs.

And from Dr. William Maisel, chief scientist for the FDA’s device center:

“More rigorous research is needed to better understand if certain women are at heightened risk of complications.”

But how many women are “some” and “certain” women whose lives may be at risk?

Many Essure victims say they were unaware of any risks and didn’t even know that the device required surgery to remove it before having the implant.

One reason that this device is causing serious complications is due to the clinical trials, where specialists are experienced at implanting the coil. The average surgeon may not have experience or training. As well, complications with permanent devices (such as transvaginal mesh) can occur years later.

After Emily suffered many Essure side effects, she needed the Essure coil removed, but it wasn’t that easy.

“My current doctor said he wasn’t familiar with Essure and won’t risk removing it,” said Emily. “I told him that it has to come out because I can barely take care of my three boys with this constant pain. I can’t pick them up without doubling over. He gave me a choice: I could either get hormonal therapy or a hysterectomy. He could find a doctor to remove the coil but a piece of metal could be left behind. After all the research I have done, I tend to agree with him.”

The FDA has also ordered Bayer to conduct a three-year clinical study in which they will follow 2,000 women who have been implanted with Essure, and compare them to women who’ve had different sterilization procedures, according to CNN Reports. The FDA expects Bayer to submit a study protocol within 30 days and the company is required by law to begin the study within 15 months.

Meanwhile the Facebook page “Essure Problems” has over 27,000 members, increased from 14,000 last year. If these members are anything to go by, a conservative estimate of members after the three-year clinical trial could total about 60,000 women with Essure complications. The FDA, however, has received about 10,000 complaints of adverse effects since the device’s approval in 2002.


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Upon reflection of nickel leaching and labeling of Essure.
I would like to share some reflections concerning nickel leaching from Essure after implantation. As I have stated in my comments to the FDA, in my opinion the uniform nickel leaching from Essure nitinol coil as well as probable nickel release caused by the galvanic corrosion effect between nitinol outer coil and stainless steel inner coil of the device can be neglected.
on average 12% to 15% of women are allergic to nickel. A very small proportion of the nickel-allergic population are hyper-sensitive. Taking under consideration the percentage of nickel allergic women (12%-15%) with over three quarter of a million (750,000) women implanted with Essure device the amount of complaining women should be between 90,000 and 112.500. However this is not the case, the number of women complaining to FDA is much smaller (around 5,000). Even if the number of complaining women is on the lower side it is still not even close to 90,000-112,500.This calculation proves that uniform nickel leaching is not the culprit of all the complained suffering.
However the amount of nickel leaching from surface intermetallic inclusions or matrix surrounding them (in the case that they are present on surface of implanted nitinol coil of Essure device) is staggering, incomparable with uniformed nickel leaching from nitinol without surface inclusions in the same environment (body tissue). In my opinion this is a real culprit of suffering of unlucky women which were implanted with faulty unchecked nitinol coil with surface intermetallic inclusions. This is very sad taking under consideration that lot of this suffering and health complication could be avoided if the FDA had implemented a test for detection of surface intermetallic nitinol inclusion as proposed in Citizen Petition FDA-2009-P-0362 from 07/29/09. Another sad fact is that the FDA does not take into account even their own sponsored research performed by their own scientists. (At least two articles published in 2015 sponsored and coauthored by FDA scientists show the vital importance of cleanliness and final finish of medical devices made of nitinol (the material that outer coil of Essure-device is made of).
This shows how taxpayers’ money is wasted.
My second reflection concerns the label warning which in my opinion should be placed on presently produced Essure devices. Every implanted medical device including Essure is introduced to the very harsh environment of body fluids upon implantation. These fluids are composed of many organic and inorganic substances and elements, which interact with foreign material. One of them, especially harsh to metals, particularly to nickel, is the chloride ion Cl-, which is abundant in body fluids. The chloride ions react with nickel contained in nitinol surface inclusions or with the surrounding matrix enriched in nickel. The corrosion products of these reactions will contain ionized nickel compounds in the form of hydrated nickel chloride [NiCl2x6H 2O] and nickel hydroxide [NiOH2] or a mixture of. The above corrosion products will poison surrounding tissue and will migrate and harmfully interact with other tissue and organs in the human body. Most probably nickel can illicit an enhanced immune response resulting in tissue damage and immune mediated disease as psoriasis and lupus. That there has been no tissue study for nickel content in explanted tissue surrounding Essure device to date is simply unbelievable.
Both of those substances are toxic and when sold commercially or shipped they have to by law be marked accordingly by GHS (Global Harmonization System) pictograms. The GHS pictograms warn of the dangers associated with hazardous chemicals such as chronic health hazards like carcinogens, acute toxicity, target organ toxicity, mutagens etc.
The warning micrographs: GHS08, GHS07, GHS06, are required to be placed on chemicals such as: [NiCl2xH2O] and [Ni OH2].
Coincidentally these chemicals are also corrosion products of implanted nitinol medical devices if corroded in human body upon implantation.
Now somebody can ask how implantable devices with corrosion products that are the poisonous substances could be allowed by a government agency (FDA), which is responsible for protecting and promoting public health, to be implanted into the human body?
Another question is why such devices are not marked accordingly by the same pictograms?


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