Essure Problems 

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Lucy Bustamante of ABC 13 has been following Essure Problems for over a year. Her recent update includes an interview with Bayer's Edio Zampaglione.

Here Dr. Edio Zampaglione states himself, that Essure IS a surgical procedure. "There is a surgical procedure associated with placing essure."

#Essure IS a surgical procedure. We DEMAND Bayer stop the false advertising!

Dr Zampaglione states that "This is not the same kind of nickel that is in jewelry, piercings, anything like that." This is a false statement. There is only one element on the periodic table for nickel. The nickel in an alloy for jewelry is the same nickel that is in an alloy for a medical device. Just because the alloy is different, does not mean the nickel is not the same. It is. Misleading words, Dr Zampaglione!

The full interview can be watched below. The reporters questions can not be heard during the video, but we have copied them below so that you can read them as you watch.

The reporters questions cannot be heard on the video, so we asked her to transcribe them for us...

---If in fact the data is incorrect in the study, then does Bayer have a situation on its hands? Aren't you a victim too?
---You also say that you provide training for your physicians on the removal of the device? when did that training start?
---Sure no problem - (he couldn't hear the question)
---When did training of your physicians on the removal of the device begin?
---There are thousands of women who are asking for this product to be removed until they can prove that it truly is safe and effective. in the group of social media it's about 16,000 women and they've documented about 450 of them who have gotten pregnant with Essure inside - even though it's supposed to be a permanent contraceptive. How do you feel about removing the product until you can prove it's efficacy?
---That brings me to my next question - how does it compare to other contraceptive products like yazmin, yaz and mirena?
--- I understand that you say the removal isn't something that you train your physicians in...but being that many women have requested the removal of it - do you foresee offering training in the future- that will help avoid hysterectomies?
---You offer the figure 750,000 kits sold, but are you guys tracking out of that number how many have reported adverse events? or is that only being trakced through maude?
---How many wo-....yes - go ahead.
-What number do you have, sir?
---Can you share the number you have given to the FDA?
---Last set of questions for you.
the nickel allergy situation: there was a time - august of 2011 where the FDA announced that it was going to allow you to remove the contraindication for nickel on the packaging.

but at some point in time - clearly if it was Conceptus or Bayer they thought they had to put a contraindication of nickel on it. so basic question - if you have a nickel allergy should you have Essure implanted?
---So why remove the contra-indication?
---And you feel like the physicans have actually been trained to understand that???
---Is there any other - go ahead - finish your statement.
---I'll let you punch some holes into our story that we did on monday- your PR person say you wanted to calirfy some things. please state what you wanted to clear up about the nickel. is there anything that you want to clarify?

---Anything else you want to add sir?

okay - thank you for your time and sharing bayer's side of the story.

It is disingenuous and continued misrepresentation to promote the safety of a device based on the number of kits sold rather than number actually inserted into patients. Further, data regarding safety MUST be collected and available for independent review. Bayer should be aware that only a fraction of complications are documented or available in the MAUDE data or to them because women are simply not aware that an avenue exists for the collection of data regarding complaints and safety. Since patients are not aware that they can document their complaints in the MAUDE data, complications are being under reported. Therefore, without confirming the number of insertions and the outcome of each insertion, the safety of a device cannot be determined.
Further, there comes a point when the defense of a product in a public forum with flawed data is more than just disingenuous, it becomes a blatant lie and deceptive business practice.
The public was notified this week of a fifth death associated with the Essure device. HOWEVER, how many deaths have occurred without being reported into the MAUDE data?
Regardless of the overall number, the death of a single patient regarding a device that is marketed as NON SURGICAL should be an immediate indication for a moratorium on the sale and use of the device until the FDA can again confirm its safety. At minimum, the FDA must put a BLACK BOX warning on the device and IMMEDIATELY stop allowing the promotion of the device as NON SURGICAL, when by its own admission, Bayer is saying that the Essure is ABSOLUTELY WITHOUT QUESTION a surgical procedure, and now we have confirmation that this NONSURGICAL procedure can lead to DEATH when attempting its insertion.

I posted this comment on the ABC15 website regarding this story. Feel free to copy and send to any newcast station.
Good morning. My name is Dr. Julio Novoa. I am the primary medical commentary for the Essure Problems Facebook forum representing 16,800 members. I appreciate the fact that one of my colleagues took the time to file an adverse event report with the FDA. Most people, however, don't realize that this is voluntarily. Although we know about more than 20,000 complaints regarding the Essure, we are still not sure how many serious complications or death have been related to the Essure device. I strongly disagree with the Bayer corporation regarding its explanation of this event. BAYER promotes and advertises the Essure as a NONSURGICAL procedure. This is false advertising and deceptive in nature since it is indeed a SURGICAL procedure. Although it appears that the patient died due to a perforation of her uterus, she did so when he doctor attempted and followed the necessary steps to place the Essure as the instructions indicated. Bayer cannot disassociate itself from responsibility when death occurs from the use of its product anymore than any other manufacturer or doctor can in association with any complication from the use of the its product. If a patient can die while trying to place this device, the patient should be aware of this risk before she signs off on having it placed. Sincerely, Dr Julio Novoa