The Essure implant – designed to prevent pregnancy by permanently blocking the fallopian tubes – has made headlines around the world thanks to a growing number of complaints from former users.
“It has been identified that some patients who have received the device may not have been fully informed of the possible device and procedure-related risks before choosing to have Essure implanted,” the TGA’s statement read.
There has been a long campaign by some Australian women to have the device banned after many suffered from a range of health complications.
“There have been reports of changes in menstrual bleeding, unintended pregnancy, chronic pain, perforation and migration of the device, allergy/hypersensitivity, or immune-type reactions,” the TGA statement continued.
“Some of these reports were considered serious and resulted in removal of the device, which involved abdominal surgery.”
The sale of the implants in the EU was temporarily suspended this month due to similar complaints, with its manufacturer Bayer asking UK hospital to cease use of the device during this time.
One British woman – who later had to undergo a hysterectomy – said she was left suicidal due to the “unbearable” pain cause by the contraceptive.
In the US, more than 15,000 women have reported problems to the US Food and Drug Administration (FDA), including pain, allergic reactions and "migration of device".
If you're concerned about complications from the implant, speak to a medical professional.