Essure Recalled In Australia After Health Officials Issue Hazard Alert
While thousands of women are pursuing Essure lawsuits in the United States over serious complications caused by the birth control implant, and American regulators have required the manufacturer to add stronger warnings in recent years, Australian health officials have declared that Essure will no longer be used in that country and an Essure recall has been announced by the manufacturers.
Essure is a medical device designed to provide permanent birth control or sterilization, which involves the placement of coils in the fallopian tubs that cause scar tissue to form and prevent pregnancy. However, severe and disabling Essure complications have been reported among women who have undergone the out-patient procedure in recent years.
In November 2016, after controversial hearings involving testimony from thousands of women, the FDA decided not to recall Essure in the United States, allowing the device to remain on the market with stronger warnings designed to ensure women are aware of the risk, and understand that if Essure needs to be removed, it must be done through a risky surgical procedure.
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Last week, the Australia Therapeutic Goods Administration (TGA) issued an Essure hazard alert, indicating that it the birth control implant will be recalled from the market in the country, following reports of bleeding, unintended pregnancy, chronic pain, perforation of organs, migration, hypersensitivity and immune system reactions.
“The Australian Register of Therapeutic Goods entry will be cancelled and there will be no further implantations of Essure in Australia,” the TGA announced in a statement posted August 30.
The manufacturers have said that Essure’s removal from the Australian market was a “business decision,” according to the TGA. However, in the United States Essure has not been recalled, but rather women are provided a checklist before undergoing the procedure, which is designed to ensure they are aware of the potential side effects linked to the birth control coils.
Approximately 750,000 women worldwide have been implanted with the device, and Bayer estimates that 70% of those have been implanted in women in the U.S.
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