Essure Problems 

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Organizations Oppose Black Box Warning
on Essure 

In the article FDA Finalizes Guidance on Boxed Warning, Patient Decision Checklist for Essure Devices by Michael Mezher posted on RAPS Oct. 31, 2016, two organizations were pointed out as opposing the black box warning on Essure.


“FDA also received comments from two healthcare practitioner groups that opposed the boxed warning and patient decision checklist—the Association of Reproductive Health Professionals (ARHP) and the American College of Obstetricians and Gynecologists (ACOG). Both groups argued that the information presented in both the warning and checklist are based on anecdotal evidence, rather than clinical data.

"ACOG strongly recommends that the proposed black box warning language for hysteroscopic sterilization devices be revised to reflect only supported clinical data, or eliminated from the labeling requirements. We also strongly recommend that the Patient Decision Checklist be abandoned as a patient informed decision making tool for hysteroscopic sterilization devices," ACOG said in its comments.”


- See more at: http://www.raps.org/Regulatory-Focus/News/2016/10/31/26102/FDA-Finalizes-Guidance-on-Boxed-Warning-Patient-Decision-Checklist-for-Essure-Devices/#sthash.1LY8pDr7.dpuf


While we are not surprised at their opposition, we do have a few words to say. Lets start with a comment posted by Dr. Julio Novoa:


ACOG, the American Congress of Obstetricians and Gynecologists, is the largest national representative of OBGYN doctors in the United States. Its membership exceeds 50,000.

ACOG has strongly objected to the wording of the Black Box Warning and Patient Checklist for the Essure that came out this week.

Their main objection is their claim that the FDA is basing it's recommendations on anecdotal information rather than on clinical data.

So what does anecdotal mean?

(of an account) not necessarily true or reliable, because based on personal accounts rather than facts or research.

For example,

"while there was much anecdotal evidence there was little hard fact"

As both a clinician and researcher, just how much information is necessary for an organization to take a position on complications effecting close to 30% of women with the Essure device???

Even the original clinical and pivotal data used to defend and approve the Essure demonstrated an exceedingly high risk of complications.

Where was ACOG with its research when the MAUDE data of complications jumped from 700 over a 10 years period to over 10,000 in a 4 year period of time???

Where was ACOG when international OBGYN societies, such as in the Netherlands, were organizing meetings to warn doctors and address their concerns about the complication rates????

Where is ACOG when literally dozens of its Board certified members are performing hundreds of salpingectomies and hysterectomies ever month due to the complications of the Essure device???

Just how many so called "anecdotal" cases does it take to prove that there is a problem and rather then support a ban on the Essure, the ACOG takes a position that potentially endangers women by not encouraging its members to proceed with caution when recommending and managing the Essure device???

Where is ACOG, when the complications of the Essure is so dramatic and widespread that a Congressional bill has been proposed to ban the Essure???

Clinical data is being collected but it will take years to compare multiple studies before ACOG will act.

Years which literally hundreds of thousands women simply don't have and should not be forced to endure for the purity of research science.

Anecdotal data is not unreliable. Very often it is the first sign that shows researchers that a problem exists.

ACOG has 10,000 MAUDE data cases that they can review.

They have the power and obligation to make a committed effort to protect their fellows and patients by acknowledging that a serious problem exists with the Essure device.

It should not only support the BBW but the Patient Checklist because nothing on the checklist impedes doctors from advising doctors regarding potential problems with hysteroscopic procedures. On the contrary, it serves as an absolute minimum as a guidelines for a nationally recognized template for Informed Consent regarding the Essure.

ACOG needs to call a national meeting to discuss the Essure and should invite those members with clinical experience in Essure removal to give a formal position on exactly what is happening regarding the Essure .

Sincerely,

Dr Julio Novoa




Now let me share this with you all.

http://www.acog.org/About-ACOG/ACOG-Departments/Annual-Meeting-2016/Exhibitors

Here is ACOG's website showing their sponsors. You only have to scroll down a short ways to see that Bayer, of course, is listed as a sponsor, along with all of the other industry sponsors.



Here you can see the comments submitted to the FDA by ACOG regarding their thoughts on Essure. As you can see at the end, the list of references are all major stakeholders in the company and product. This is why ACOG continues to push for the FDA to ONLY base decisions on the “clinical evidence”, because the clinical evidence is all information that was presented by manufacturer and is biased towards the device.

http://www.acog.org/About-ACOG/Announcements/ACOG-Comments-to-FDA-on-Essure









Congressman Fitzpatrick speaks about the FDAs final guidance on #Essure.


http://fitzpatrick.house.gov/press-release/fda-issues-final-guidance-essure

The latest recommendations from the FDA do not go far enough. A boxed warning and patient checklist highlight the severe risks of Essure—but they’re not legally enforceable requirements. Tens of thousands of women have been harmed by this unsafe medical device, including hundreds of fetal deaths.

A year ago, I introduced the E-Free Act to revoke FDA approval of Essure and prevent government agencies from purchasing this device considered to be unsafe. Since then, hundreds of women affected by Essure have shared their stories with my office. And I believe now, as I believed then, if the FDA will not act to protect these women, then Congress must act now.”