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Australia Issues Update on AERs Attributed to Bayer’s Essure Device

August 24, 2018

Australia’s Therapeutic Goods Administration released an update on Bayers’s Essure contraceptive device, saying the agency received 59 adverse event reports relating to women implanted with the device since it was supplied in Australia in 1999 until Aug. 6.

TGA removed the device from the Australian Register of Therapeutic Goods on Feb. 9.

The AERs included changes in menstrual bleeding, unintended pregnancy, chronic pain, perforation, migration of the device, and allergy/hypersensitivity or immune-type reactions. Surgery was required in some instances to remove the device, the TGA said.

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