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Washington D.C., Jul 20, 2018 / 05:30 pm (CNA).- The Essure sterilization device is being withdrawn from sale, the pharmaceutical company Bayer announced today. This comes after more than 10,000 women filed a lawsuit saying they were seriously harmed by the device, and about three months after the FDA restricted sales and required patients be given additional information about risks.
The FDA added a “black box” warning to Essure in November of 2016, after numerous patient complaints about complications, such as abdominal pain and uterine perforation.
Essure - Market - United - States - December
Essure will be taken off the market in the United States as of December 31, 2018. Sales in every other country ceased as of September of last year, due to poor sales figures. The device was first approved for use in 2002.
The device is described as a “non-surgical permanent birth control,” and consists of a pair of metal and polyester coils that are inserted into the fallopian tubes. These coils cause scarring in the tubes, blocking eggs from reaching the uterus. Bayer claims to have sold about 750,000 of these devices around the world. The device was preferred by some women as it purportedly had a much faster healing time than other sterilization techniques.
Statement - Bayer - Decision - Device - Decline
In a statement, Bayer said the decision to pull the device was was “based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable,” but that they “continue to stand behind the product’s safety and efficacy.”
The Food and Drug Administration has been monitoring Essure since September...
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