Essure contraceptive device
Hazard alert - labelling update relating to potential risks
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.
Information for health professionals
AMSL has written to health professionals who have performed the Essure procedure to provide further information about this issue and to advise them to review the updated IFU and new Patient Information Brochure. The brochure is intended to be reviewed by the patient with their doctor face-to–face, which may assist in identifying any device related issues.
If you have any questions or concerns regarding this issue, contact AMSL on 02 9882 3666.
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.