Consumers and health professionals are advised that Australasian Medical and Science Ltd (AMSL), in consultation with the TGA, has issued a hazard alert for Essure. AMSL is also recalling unused stock and withdrawing the device from the Australian market.
Essure is an implanted device that provides permanent contraception for women. A 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.
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.
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. Some of these reports were considered serious and resulted in removal of the device, which involved abdominal surgery.
The labelling for the product is being updated. The update includes revised Instructions for Use (IFU) and the introduction of a Patient Information Brochure with a patient-doctor discussion checklist. The updated labelling provides warnings about potential adverse events and situations where device removal may be necessary. The IFU is being updated with additional information, including a new section on patient counselling, as well as changes to sections about safety, clinical studies, directions for use and patient management.
On 31 May 2017, the TGA was informed about the manufacturer’s decision to discontinue the distribution of Essure in Australia for business reasons. The Australian Register of Therapeutic Goods entry will be cancelled and there will be no further implantations of Essure in Australia.
Information for consumers
If you have an Essure implant, please be aware of this issue. You may wish to request from your doctor a copy of the Patient Information Brochure, which provides an overview of the procedure, possible side effects and other potential immediate and long-term risks (including pregnancy risk), from your doctor.
If you have any questions or concerns about this issue, or if you have experienced any suspected side effects, talk to your doctor.
