Essure Research Altered to Gain FDA Approval

Holy Hormones Journal: Well, I am not surprised – are you? Hiding severe reactions to drugs to gain government approval happens all the time. I have been blogging about the Gardasil 10.21.15 katie-orensteinvaccine for years because the same thing happened in that case. And now there are potentially hundreds of thousands girls who have been adversely affected.  In the initial clinical trial girls who experienced an adverse reaction were removed along with those with a family history of autoimmune disease and allergies. Are you aware that there are about 75 million people with autoimmune disorders in the U.S.? And the number is increasing? But no one is screened for that when pressure into getting the vaccine.

Gardasil clinical trials for adolescent boys were conducted in the same manner. Only “healthy” boys were chosen for the study. “Unhealthy boys” were eliminated – but they are not eliminated for getting the vaccine.

Before the first birth control pill went on the market in the 1960’s – it was being trialed in Puerto Rico. A different biochemical ethnicity. Why wasn’t the pill trialed on American women? (Actually we are the trial but you have heard me rant about that before). The adverse reactions could be hidden – “whitewashed” if in another country. Not today – word spreads like fire with the Internet and social media – but back then? Who heard the women in Puerto Rico say the pill caused too many adverse reactions? And the pill back then had a larger dose of estradiol – which really upset hormone imbalance.  But the women were ignored – the pill went on the market and in 1970 a Congressional hearing was held on the numerous complaints about adverse reactions. No women were allowed to testify at the hearing.

Do you see the common theme? Women’s voices were not heard in Puerto Rico – at the 1970 congressional hearing, and our voices were quashed when we reported adverse reactions to Essure. Whitewashed. And of course, the families of the adolescents injured by the HPV vaccine – from all around the world are ignored – Period.  And of course, now I have to mention the millions of families around the world with autistic and chronically ill children whose voices are not heard when they saw their child regress right before their eyes post-vaccination.

This issue is larger than birth control or a vaccine – it is about women’s voices being heard over the corrupt and unethical relationship between the pharmaceutical industry and our government.  Voices vs. Profit. That is the bottom line.

How can women even buy into an abortifacient that is being used for birth control? Then again, the IUD falls into the same category. And look how that is being pushed. We need to be informed so we can make informed choices.

And it is a real kick in the stomach when the pharmaceutical companies use a female “spokesperson” to deny concerned women’s allegations.

Women claim researchers altered severe reactions to Essure IUD to gain FDA approval

WASHINGTON, D.C., October 5, 2015 (LifeSiteNews) – Last week, in a day-long public hearing, women who participated in clinic trials for the Essure IUD contraceptive device say 10.05.15 essurereports about side-effects of the abortifacient “contraceptive” were falsified so as to make the device look safer than it was, in order for the manufacturer to gain approval from the Food and Drug Administration (FDA) to sell the device.

The FDA is investigating the testimonies of a number of women, who allege that researchers in clinic trials buried or altered their severely painful reactions to Essure. Since the FDA approved Essure for consumer use in 2002, 5,000 women have reported harsh pelvic pain, dangerous IUD coil migration, serious allergic reaction causing autoimmune problems, and internal injuries from the product.

Women at the FDA hearing said Essure should be taken off the market. One Arizona woman testified that her answers on surveys reporting “aching” and “unusual” and “severe” pelvic pain from Essure were changed to “comfort level: excellent.” Another woman’s “sharp” pelvic pain was changed to “comfort level: very good.” An Ohio trial participant said her answers were altered as well. Others said researchers “coached” their answers.

Conceptus, the original manufacturer of Essure, was in charge of distributing and gathering surveys of women in its clinical testing phase. NBC New York reports that in at least one California participant’s case, when she developed complications, Conceptus dropped her from the trials and stopped sending her follow-up surveys altogether. She initially became a spokeswoman for Essure, but after she was diagnosed with four autoimmune diseases, “They ‘lost’ my medical records,” she said. “They’re all of the sudden missing.”

She and other investigators have failed to find any record of her participation. “They were supposed to follow up with me for five years,” she said. But instead, “I had [only] one physical.”

Essure’s coils became embedded in another New York woman’s endometrial cavity. “It felt like this constant either dragging or shooting, stabbing pains,” she said. “Almost like someone literally had a knife – sitting inside of you with a knife like poking downward.”

The FDA approved Essure in part on the basis of the trials and did not verify the survey reports, which were provided by Essure’s manufacturer, Conceptus. In fact, the FDA agreed to remove an FDA requirement of testing for nickel sensitivity before implantation – despite the National Institutes of Health’s statistic that up to 17 percent of women are allergic to nickel – at Conceptus’s request.

Two years ago, after Essure had been approved and was selling well, Germany-based Bayer bought Conceptus for over one billion dollars.

Bayer spokeswoman Tara DiFlumeri denied the women’s allegations, emailing NBC New York to say, “Bayer strongly disagrees with any suggestion or allegation that the Essure clinical trial data collection was fraudulent or inappropriately altered.”

 

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.