Uncovering Swift Tactics Of
Tomes isn't the only one voicing concern about the FDA's database. Jeanne Lenzer, former physician's associate, medical journalist and author of The Danger Within Us, said in a recent interview with NPR.org that implanted medical devices are approved with far less scrutiny and testing than drugs, and as a result, some have caused harm and even death. She went on to say that medical devices are approved with far less scrutiny than drugs, and many high-risk devices go to market without clinical trials. And one study says that as few as one percent of adverse events reported wind up in MAUDE database. "It is important that the FDA has proper access to their own data so they can make informed decisions" Tomes' goal at February's Essure meeting was to get Gottlieb and the FDA to see their database through her eyes. "Since this meeting I have seen no plans for the FDA to change course," says Tomes, "even though Gottlieb asked us what the women want. They asked for the FDA to remove Essure from the market until after the post-market study conducted by Bayer". Gottlieb expressed that not only does he need to wait for Bayer to finish its safety study five years from now, which is supposed to include 2,800 women, but as of October 2017 the drug company had only enrolled 136 patients. The aim of this study is to compare Essure patients with tubal ligation patients to determine just what risks the coils presented to women. But why endanger another few thousand women when there are 30,000 women who were already implanted with Essure and are willing to provide their data to this post-market study?
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