Patients, lawyers, and advocates recently met with FDA chief to discuss complications with Essure - maybe they should have also brought guns and money.
Washington, DC.Essure critics last week met with FDA chief Scott Gottlieb to discuss problems with the sterilization device, particularly Bayer's failure to warn of Essure's serious complications. But Gottlieb said they need to wait for Bayer to finish its safety study - in 2023! Perhaps those critics should have brought to the meeting lawyers, guns and money.
Gottlieb had a private meeting (no media allowed) with five women who run the Essure Problems Facebook group comprising over 36,000 people, a handful of lawyers and Device Events Founder and CEO, Madras Tomes.
Essure and the FDA
Tomes is a former employee of the FDA, where she worked on its adverse event reporting program. She created a system whereby she can search the entire FDA medical device adverse events data since 1996 and she discovered hundreds of fetal deaths linked to Essure that Bayer neglected to report to the agency. She told this reporter that "Some women had died but I was seeing fetal deaths - miscarriage, ectopic pregnancy and stillbirth - checked as injury, while some checked under death were fetal death." She went on, "The FDA held an advisory panel meeting last September that included a presentation showing 25 deaths, five of which were fetal deaths. But if they aren't counting injuries such as miscarriage as fetal death, they are missing a lot."
Still, Tomes' findings weren't enough evidence for the FDA to withdraw Essure. Every other country has enough evidence to ban Essure - the U.S. is the only place where Bayer is still selling its device. The group brought to this meeting six years of documentation showing complications from the device, including photographic evidence of broken coils implanted in uteruses, body rashes, stillbirths, dissolved fallopian tubes, and dental problems that they claim were caused by the device, according to Buzzfeed.com.
Bayer and the FDA
The FDA in 2016 did slap a black box warning on Essure. Since that time, however, of the 476 women who had joined the Facebook group, only eight said their doctors had informed them about the warning, and 442 said they never even heard of the warning (25 did not respond). Buzzfeed News reported Gottlieb telling the women that, not only does he need to wait for Bayer to finish its safety study five years from now, which will include 2,800 women, but as of October the drug company had only enrolled 136 patients. Further, FDA spokesperson Deborah Kotz told Buzzfeed that the agency encourages doctors and women's organizations to inform patients of Essure's possible risks and is "committed" to the Bayer study to "provide answers." This comment begs the question: what is the relationship with Bayer and the FDA? Stay tuned…
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