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Update on FDA post-approval study
14 July 2020
The U.S. Food and Drug Administration (FDA) have published an update with the interim results from the Essure Postmarket Surveillance ("522") Study. Although Essure is no longer being manufactured or distributed, the FDA had required the manufacturer undertake a post-market surveillance study.
Early results show that Essure patients tend to have higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding as compared to women who had laproscopic tubal ligation. The rate of additional gynecologic surgical procedures, which includes device removal, was higher for Essure patients than tubal ligation patients. The pregnancy rates are similar for patients with Essure and laparoscopic tubal ligation.
Further details on the interim report can be found at: FDA In Brief: FDA Posts Interim Results from Required Essure Postmarket Surveillance Study.
Details on how to report adverse events in Australia can be found below.
Update relating to current status
13 August 2018
The Essure contraceptive device was cancelled from the Australian Register of Therapeutic Goods (ARTG) on 9 February 2018. Prior to cancellation the manufacturer of the device changed sponsors from Australasian Medical and Scientific Limited (AMSL) to Bayer Australia Ltd.
No new Essure devices were supplied for the Australian market after 31 May 2017. However, some Essure devices were already in the supply chain and were able to be used until August 2017 when they were recalled. The Essure device was not supplied again in Australia following this recall.
In September 2017, Bayer advised the TGA, it would not be seeking European recertification for the Essure device.
The device began supply in Australia in 1999; up to 6 August 2018 the TGA received 59 adverse event reports relating to women implanted with the Essure device. The reports included changes in menstrual bleeding, unintended pregnancy, chronic pain, perforation, migration of the device, and allergy/hypersensitivity or immune-type reactions. Surgery, including hysterectomy, was required in some instances to remove the device.
Due to a sponsor change, if you have any questions or concerns regarding this issue, you are advised to contact Bayer on 1800 008 757.
Hazard alert - labelling update relating to potential risks
30 August 2017
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.
Reporting problems
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.