Overnight, a controversial contraceptive implant has been recalled and removed from the Australian market after reports of chronic pain, unintended pregnancies and medical complications.
The Herald Sun reports a ‘hazard alert’ was issued on Wednesday night by the Therapeutic Goods Administration (TGA) and Australasian Medical Science Limited for the Essure device, designed to prevent pregnancy by permanently blocking the fallopian tubes.
The controversial device has been recalled after several years of women campaigning about its serious negative side effects.
The soft, flexible insert is placed into each of the patient’s fallopian tubes and, over the following three months, a barrier forms around the inserts, which is intended to prevent pregnancy.
However, the TGA says there have been reports of women who have the Essure device implanted experiencing changes in menstrual bleeding, unintended pregnancies, chronic pain, perforation and migration of the device, allergy/hypersensitivity, or immune-type reactions.
“Some of these reports were considered serious and resulted in removal of the device, which involved abdominal surgery.”
This decision comes after several years of women campaigning about the painful and frightening side effects of Essure.
“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,” said the TGA in a statement.
The statement advised doctors and consumers that unused devices were being recalled and no more would be implanted in Australia. The TGA said on May 31 it was advised by the manufacturer of its decision to discontinue the distribution of Essure in Australia for “business reasons.”
Women who are concerned about adverse effects from the implant should seek medical advice.
