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Tag: essure
Judge rules Essure lawsuit can go forward
2016-03-24 00:36:51| Chemicals - Topix.net
A federal court has dismissed most of the counts in a lawsuit against Bayer in relation to the permanent contraceptive device Essure. In the ruling, the United State District Court for the Eastern District of Pennsylvania let stand only two counts in the suit against the pharmaceutical giant.
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New, stronger FDA warning for Essure birth control implant
2016-03-01 00:51:02| Chemicals - Topix.net
This Wednesday, May 13, 2015, file photo, shows the North American headquarters of Bayer Healthcare in Whippany, N.J. The Food and Drug Administration announced Monday, Feb. 29, 2016, it plans to warn consumers more strongly about Essure, a contraceptive implant that drew thousands of complaints from women reporting chronic pain, bleeding and other health problems. The FDA is requiring manufacturer Bayer to conduct studies of the device to further assess its risks in different groups of women.
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UPDATE 1-U.S. FDA likely underestimated fetal deaths from Essure -analyst
2016-02-18 08:39:07| Biotech - Topix.net
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.
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FDA likely underestimated fetal deaths from Essure: analyst
2016-02-18 02:14:00| Chemicals - Topix.net
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.
Tags: analyst
deaths
fetal
fda
Higher risk of surgery seen with Bayer Essure contraceptive: study
2015-10-15 00:20:08| Biotech - Topix.net
REUTERS: Women implanted with Bayer AG's Essure permanent contraception device were more than 10 times more likely to require post-procedure surgery than those who underwent laparoscopic sterilization, a study published on Tuesday found. The findings could cast additional doubt on the safety of the Bayer device, which was approved in 2002 as an alternative to surgical sterilization and acquired by Bayer in 2013.
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