The FDA has received reports of more than 9,000 eliminations of the device given that 2009 due to issues including bleeding, discomfort, miscarriages, hysterectomies, fetal deaths and unwanted pregnancies..
” Bayer sympathizes with all ladies who have experienced negative health conditions, regardless of the cause, however the company continues to stand by the science supporting the security and effectiveness of Essure,” Bayer stated..
Maia Anderson –
Friday, August 21st, 2020
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In 2016, the FDA positioned a box caution on the gadget, and in 2017 patient advocacy groups contacted the FDA to do something about it versus the gadget as more women reported being damaged by it. In 2018, the FDA limited the sale of the gadget to only doctor that would provide info about the devices benefits and risks to patients..
Check out Bayers complete press release here..
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Essure is an irreversible contraception device approved by the FDA in 2002 that is implanted into the fallopian tubes to avoid pregnancy..
Bayer pulled the device from the U.S. market in 2018, however said its choice was since of a decline in sales rather than due to adverse occasion reports from ladies with the device..
Bayer stated Aug. 20 that it will pay $1.6 billion to fix most of claims versus its long-term contraception gadget, Essure, which thousands of ladies have actually claimed caused unfavorable results including bleeding, discomfort, miscarriages and fetal deaths..
About 39,000 claims have actually been submitted against the gadget, and Bayers $1.6 billion settlement deals with roughly 90 percent of them, the business said. Bayer remains in discussions to deal with the remaining claims, and other terms of the settlement are personal..
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The settlement includes no admission of wrongdoing or liability by Bayer, and the company stated it still stands by the gadget..