TGA Statement Re: Essure Contraceptives
Thousands of women join a class action against the contraceptive manufacturer after suffering painful reactions.
A spokeswoman for the Therapeutic Goods Administration issued the following statement:
• Supply of the Essure device in Australia ceased in August 2017 when a product recall from the Australian market was undertaken, and concurrently a hazard alert was published on the TGA website.
• The Essure contraceptive device was cancelled from the Australian Register of Therapeutic Goods (ARTG), by the sponsor of the device, on 9 February 2018.
• The TGA has received 59 adverse event reports associated with the Essure medical device, dating back to 1999.
• The Essure device was approved for supply in Australia, for women who desire permanent birth control (female sterilisation) by bilateral occlusion of the fallopian tubes, prior to the implementation of the current medical devices regulatory framework in 2002.
• It obtained European notified body certification in 2001 which was used to continue supply in Australia after the transition to the current regulations, and was approved by the USFDA in 2002.