Essure Problems 

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The Battle Over Essure

                      On July 26, 2017, The Washinton Post printed an article by Jennifer Block

 titled "The Battle Over Essure"

It also ran in their magazine under the title "Pain and Protest"

This is my respons to Bayer's Op-Ed:

The July 30 Washington Post Magazine article “Pain and protest” did not present a balanced portrayal of Essure, the only Food and Drug Administration-approved, non-incisional option for women seeking permanent birth control. The article was intended to demonstrate the severe harm the device is causing hundreds of thousands of women worldwide. The focus of this article was to raise awareness and warn women about the true risk Essure carries.

On its website, the FDA states that it “continues to believe that the benefits of the device outweigh its risks, and that Essure’s updated labeling helps to assure that women are appropriately informed of the risks.” The FDA has failed the women it is supposed to protect when it comes to the Essure device. In the YEARS that it took the FDA to listen, the solution they came up with fell gravely short of helping these women. The FDA issued a “guidance” instead of a mandate, which means that they “suggested” doctors share the new safety warnings with their patients, however we have the proof that this is NOT happening.The article featured only women who reported problems with Essure; most do not. Bayer cannot state with legitimate confirmation that “most do not”. Yes, this article is about the women who have been harmed, that is the purpose of the article. The story relied on biased sources, including Madris Tomes, who was hired by plaintiffs’ lawyers involved in litigation against Bayer, and obstetrician/gynecologist Paul MacKoul, who advertises his Essure-removal services. Madris Tomes has been hired by attorneys to be an expert witness in Essure cases because she has built a software system called Device Events that can easily track adverse event patterns from the FDA’s own MAUDE database. Her data is based on facts and numbers directly from the FDA, there can be no bias. His advocacy for hysterectomy as the “right procedure” for Essure removal is inconsistent with the FDA’s instructions and could endanger women’s health. First of all, the FDA does NOT and DID not create proper Essure removal instructions, that is not something the FDA does, and if you look at the past track record of Bayer’s own instructions for essure removal, you will see a regularly changing set of instructions. The truth is, each woman’s Essure situation is different, and depending on location of the devices, only the surgeon can determine which surgery will ensure total device removal. I can say that from watching six years of women having Essure removal surgery within the Essure Problems FB group, the majority of women have had to get a hysterectomy, or if they didn't the first time, they most likely will end up needing one sometime down the road either due to continuing problems, or fragments of the device left behind. The article promoted randomized clinical trials for Essure, ignoring the ethical problems with creating a comparison group subjected to invasive surgery. Ethical? Women were signing up for an experimental form of female sterilization with no idea what could possibly happen to them. To also include a group of women who would randomly be chosen for tubal ligation ( with decades of research and real world use) does not sound unethical.

Bayer is committed to ensuring that women have birth-control options. Patient safety and proper use of our products are our greatest priorities ."Proper use of our products", lol, trying to throw the doctors under the bus as usual. A full review of the record shows that Essure’s safety and efficacy are supported by more than a decade of science and real-world clinical experience. Bayer stands behind Essure’s positive benefit-risk profile. The bottom line is that Bayer and the FDA continue to say that the benefits outweigh the risks with this device. The sad truth about that is, they are blatantly saying one woman’s convenience outweighs another woman’s safety. Actually, the real sad truth is, it's all about the money...