Holy Hormones Journal: 750,000 units of Essure have been sold – since the product came on the market in 2002. 303 deaths link to the device. But if the FDA’s reporting is anything like the VAERS – site – Vaccine Adverse Reaction Reporting System (which many doctors and consumers are not aware of) it is likely that many adverse injuries and fetal deaths are not being reported. Only 1 to 10% of vaccine injuries are reported – and one would think that if a woman got pregnant while on Essure and lost the child, that she or her doctor would directly link the fetal death to the birth control device.
And there is a major discrepancy between the FDA’s data and the actual reports. FDA says 5 fetal deaths when in fact, a congressman from PA has revealed over 300 deaths.
On February 17, an article and video (which I am not privy to re-publish) was aired by aired by 23ABC news affiliate in Bakersfield, CA reporting that Congressman Mike Fitzpatrick (R-Pa.) alleges hundreds of fetal deaths and kickbacks from Essure.
The congressman stated that in addition to the fetal deaths more than 25,000 women have reported severe symptoms, and 10,000 women have filed formal complaints with the FDA.
He has introduced legislation called the “E-Free Act.” If this vital piece of legislation passes, the FDA will be forced to take Essure off the market.
Also in the article which can be read here – there is a copy of Bayer’s response to Congressman Fitzpatrick.
Are we waking up yet to the objectification and manipulation of our body? Who in their right mind would think that substituting natural reproductive hormones with synthetic hormones would be good for our mental/emotional health? Why would we think that these hormones that come in implants, injections and insertions of objects into our body would be healthy?
Just look at the picture of those coils. Who would want them in their body anyway? They look barbaric.
We are just beginning to see the epigenetic effects of synthetic hormone use and it is not pretty. There is a huge spike in the number of kids being born who are confused about their gender. In August, I wrote a blog post titled: Are Gender-Bending Chemicals Causing Gender-Bending Confusion?
Essure is marketed as an alternative to a tubal ligation. What is wrong with a tubal? Opting out of that simple procedure for insertion of metal coils in the fallopian tubes? And women bought into it? And dudes – what is wrong with a vasectomy? Both of these procedures require a snip and that is it. Done.
FDA likely underestimated fetal deaths from Essure: analyst
Feb 18, 2015
By Ransdell Pierson
(Reuters) – The U.S. Food and Drug Administration may have greatly underestimated the number of fetal deaths among women who became pregnant after using Bayer AG’s Essure contraceptive device, according to a private analyst who combed through the agency’s public database.
The FDA has cited five fetal deaths in women who became pregnant after using Essure, two metal coils inserted into the fallopian tubes.
“Irrespective of the type of birth control a woman uses, when pregnancies do occur, there can be complications,” a spokeswoman for Bayer said.
“It would be irresponsible to suggest that Essure causes fetal deaths when, after an unsuccessful Essure procedure, an undesired pregnancy cannot be carried to term,” she added.
Madris Tomes, founder and chief executive officer of Device Events, said her analysis of thousands of adverse events from the agency’s website shows 303 fetal deaths were linked to Essure.
The agency is expected this month to decide whether to restrict use of the device, change the product’s label or recommend additional clinical trials. The FDA also cited four adult deaths for reasons such as infection and uterine perforation.
The disparity on fetal deaths between the FDA count and her own was because the agency searches broad headings of adverse event reports that are submitted to the agency by patients and doctors rather than searching the detailed texts of such complaints, Tomes said.
“When adverse events go to the FDA, ‘death’, ‘injury’ or ‘malfunction’ are the boxes you check,” Tomes said. “My system searches the (fuller) narrative,” she said, using keywords such as ‘fetal death’, ‘stillbirth’, ‘stillborn’ and ‘miscarriage’.
Tomes worked as a consultant or data analyst employee of the FDA for four years before setting up her own company last summer to analyze the agency’s public data, she said.
U.S. Representative Mike Fitzpatrick, a Pennsylvania Republican who has introduced a bill to remove Essure from the market, on Wednesday sent the FDA a copy of Tomes’ report and urged the agency to review the “immense discrepancy” in numbers.
FDA spokeswoman Deborah Kotz on Wednesday declined to comment on Tomes’ analysis, but said the FDA would review it and respond to Fitzpatrick.