Essure, the FDA orders Bayer to block the sale

Essure, the FDA orders Bayer to block the sale

After theEurope, the United States also suspends the distribution and sale of Essure, Bayer's contraceptive which has come under fire for the large number of adverse reactions reported by the women who use it. There Food and drug administration In fact, he asked the pharmaceutical company to stop sales, still considering the warnings that Bayer has placed on the packaging insufficient. "We have closely evaluated the new information on the use of Essure and, based on our review of an increasing number of tests, we believe that this product requires additional and significant safeguards to ensure that women are able to make informed decisions. about the risks when considering this option, "said FDA Commissioner Scott Gottlieb who added:" We take the concerns of all women affected by Essure very seriously. I personally had the opportunity to meet several women and to listen to their important concerns about this product. Despite previous efforts to alert women about Essure's potential complications, we know that some patients are still not receiving this important information. This is simply unacceptable. Every single woman who receives this device should fully understand the associated risks. "

Bayer's contraceptive - also used in Italy but not as much as beyond the Alps - ended up targeting the French agency last year when it increased exponentially. number of reports of adverse reactions. Abdominal pain, nausea, vomiting, depression have been the contraindications that have reached the Agency in recent years. Before France, where the first class action took place in July with the participation of 400 women, had been there Food and drug administration elBrazilian National Health Surveillance Agency to "Attention" Essure



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