Essure Problems 

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If anyone is interested in emailing the new FDA commissioner, here is his info. I just sent one.
New FDA commissioners email [email protected]

Hello Mr. Ostroff,
I am writing to you to make sure you are aware of the issues going on with a medical device called Essure. I help administer a Facebook page of almost 17,000 women harmed by the device. A few of us admins along with a couple of doctors met with members of the FDA on April 2, 2015. Abiy Desta is gathering information that we provide and is keeping it in a shared folder for the members who attended the meeting. I would like to make sure that you have access to that folder. Recently I sent Abiy an interview that one of our news reporters did with Dr Edio Zampaglione of Bayer, the manufacturer of Essure. In that interview the doctor makes some statements that need your attention. The first statement that concerns us, is he refers to the Essure Procedure as surgical. Bayer advertises Essure as a non-surgical form of sterilization, when in actuality, it IS a form of hysteroscopic surgery. It is coded as a surgery and billed as a surgery. Many women have it done under anesthesia. The false advertising needs to stop immediately. We have brought this to the attention of the FDA and the FTC. Second, he states that the nickel in Essure is not the same as the nickel in costume jewelry. OK, I have to pull out my metal smithing card here as I have a BFA in metal smithing from Syracuse University. There is only ONE nickel, period. The ALLOYS of medical devices and jewelry are certainly not the same, but the nickel in each of them certainly is. That is like telling a woman who is allergic to gluten that the wheat in bread is not the same as the wheat in cereal. It's just plain false information. If you are allergic to something, such as nickel, and it is in an alloy, no matter what the other metals are, you are going to react to it. Plain and simple. Bayer cannot be allowed to make such false claims!
Thank you for your time, I hope that you reach out to Abiy for more information.
Angie Firmalino

Dear Mr. Ostroff,

I am one of the many thousands of women who have been adversely affected by the Essure permanent sterilization device, a device manufactured by the Bayer Corporation. I am reaching out to you to let you know that there
are REAL women suffering REAL problems because of Essure, and yet Bayer not only continues to deny reality, but also continues to make false claims in its advertising of Essure.

Bayer claims the Essure is a non-surgical procedure. This is false. In fact, I, personally, had the procedure done in a hospital under general anesthesia. (My device was implanted in June 2005.) The implantation of the Essure device IS a SURGICAL procedure -- it is coded & billed this way for insurance purposes.

Bayer claims that 750,000+ women have been implanted with Essure. This is FALSE! The 750,000+ represents number of kits sold, NOT number of women implanted. Please keep in mind that most women are implanted with TWO coils, one in each tube.

Bayer claims the nickel in the Essure device is not the same as the nickel in costume jewelry. This is FALSE!! My husband works in the metal industry (he's been a welder/fabricator for over 15 years), and he assures me there is only ONE type of nickel. While it may be alloyed differently, nickel is nickel, and if a women is allergic to nickel, she will react to the Essure device. (This is my case, personally. I'm not only allergic to nickel, but even more so to gold -- another metal in the Essure device. My implanting doctor NEVER asked me about any sensitivities to metals, nor did any testing.) Metal allergies are SERIOUS and need to be taken seriously by the FDA. There are all kinds of peer-reviewed studies that show toxicity & debilitating health issues from exposure to various metals, especially nickel! (Many women, myself included, are now having to have a hysterectomy to remove the Essure device from our bodies because we have been adversely affected by the metals used in Essure.)

Bayer claims the Essure device is 98-99% effective in preventing pregnancy. This is FALSE! There has been no peer-reviewed, long-term study done to prove the effectiveness of Essure. Bayer cannot possibly know with any accuracy the effectiveness of the Essure device in preventing pregnancy.

At least one of the fibers in the Essure device, the Polyethylene Terephthalate ("PET") fibers, has an MSDS which specifically states, "CAUTION: Do not use in medical applications involving permanent implantation in the human body." How could the FDA have approved of the Essure device when it contains a fiber that should not be implanted in the human body????

The FDA approved the Essure device without any long-term studies being done. Shame on the FDA! Now, because the FDA failed in its oversight in the case of Essure, thousands of women are suffering a variety of symptoms due not only to reactions to the materials in Essure, but also due to migration of the coils.

It is my hope that your office will follow through on its promise to launch an investigation into the Essure device and all of the adverse events it has caused to thousands of women. Additionally, it is my hope that the FDA will pull Essure off the market.

Anne Tess
Green Bay, WI