Important Notice: Representative Proceeding Regarding the Essure Contraceptive Device
This is an update about a recent court order made in the Essure class action. You can find further general information about the class action below.
On 27 September 2021, the Supreme Court of Victoria made Orders that the ‘Important Notice: Representative Proceeding Regarding the Essure Contraceptive Device’ be published and sent to group members of the Essure class action. This is known as an ‘Opt-Out Notice’.
You can read the Notice here.
What is opt-out?
The Essure class action is brought on behalf of all people who received an implant of the permanent contraceptive medical device in Australia known as a ‘STOP’ device or an ‘Essure’ device at any time prior to 31 December 2018 and suffered harm as a result of that device.
If you meet this definition, then you are a ‘group member’ in the class action, meaning that the class action has been brought on behalf of you, as well as other group members. This means that you will be bound by the outcome of the class action, even if you do not register your details with us. If the class action is successful, you may be entitled to share in the benefit of any order, judgment, or settlement obtained. If a group member does not want to be a part of the class action, they can ‘opt out’ of participating in it by following the process set out in the Opt-Out Notice.
What should I do?
A. If you think you meet the definition and wish to remain a group member and make a claim for harm that you say you have suffered as a result of the Essure Device, there is nothing you need to do. If you think you may be a group member and wish to remain one, we encourage you to register your details with us below so that we can collect important details about your experience with the Essure device and provide you with regular updates about the case.
B. If you think you meet this definition, but you do not wish to remain a group member, then you should ‘opt out’ of the proceeding by reading the Notice carefully and completing and submitting the form at the end of the document before 4pm on 14 January 2022. By opting out, you will not be bound by or entitled to share in the benefit of any order, judgment or settlement obtained in the class action. You may be able to preserve your right to bring your own claim against the Defendants in relation to harm you suffered as a result of the Essure device, subject to time limits. If you wish to opt out, you should seek your own legal advice about your claim and the applicable time limit before doing so.
If you have any queries or wish to discuss this further, please email firstname.lastname@example.org or call 1800 568 723 at any time.
Introduction for group members
The Essure device was used in thousands of patients in Australia from about 2000 until it was withdrawn from sale by Bayer in mid-2018, and over this period has been linked with a range of serious conditions and complications, including:
- chronic pelvic and abdominal pain and inflammation;
- irregular menstrual bleeding and cramping;
- the device migrating through the fallopian tubes;
- perforation of the fallopian tubes and other organs; and
- corrosion of the device.
As a result of these complications, many of the women who we have spoken to have required hysterectomies or similar significant and invasive surgery to remove the device and relieve their symptoms.
Slater and Gordon has commenced a class action in the Supreme Court of Victoria against the manufacturers and distributors of Essure. This claim alleges that the defendants breached Australia’s consumer protection laws and their duty of care to consumers, in producing a device that has serious risks of harm of this nature, and also in failing to warn consumers about these risks so that women could make an informed choice about their contraceptive options. This is particularly important considering there were other permanent contraceptive procedures available that were equally as effective but considerably safer, and which did not involve these kinds of risks.
The claim covers all individuals who had one or more Essure devices implanted or inserted between 1999 and 2018, and who subsequently suffered injuries in relation to the device.
Register your details
We encourage all persons who have had an Essure device implanted in Australia to contact us to register your details with Slater and Gordon’s class actions team. By doing so, you can ensure you will receive updates and documents about the case directly (including documents that will be ordered to be sent by the Court concerning rights to opt out of the proceeding), and can find out more about your rights in the class action and how the claim will affect you.
Register your details
If you have been affected by Essure, we encourage you to ¬register your details with us, so that we can provide you with updates about the case as it develops.
Timeline of key events
23 July 2010:
Essure placed on the Australian Register of Therapeutic Goods.
26 August 2015:
The Therapeutic Goods Administration (TGA) imposes additional requirements on the manufacturer, including regular reporting to monitor the rate and pattern of adverse events associated with the device.
24 September 2015:
The Obstetrics and Gynaecology Devices Advisory Panel Center for Devices and Radiological Health (CDRH) of the United States Food and Drug Administration (FDA) holds a meeting to review Essure due to large numbers of adverse event notifications.
8 October 2015:
An article published in the New England Journal of Medicine alleged the product underwent inadequate pre-marketing and post-marketing studies, unregistered clinical trials, and providedincomplete and delayed dissemination of results.
29 February 2016:
As an outcome of the September 2015 meeting, the FDA requires Bayer to change Essure’s product labeling to include a boxed warning and a Patient Decision Checklist to help women understand the benefits and risks of the product.
31 May 2017:
Bayer withdraws Essure from the Australian market for ‘commercial reasons’.
30 August 2017:
The TGA issues a Hazard Alert for the Essure device. It notes the risk information and labeling of the product is being updated and indicates some patients may not have been fully informed of the risks associated with the product.
20 July 2018:
Bayer announces it is withdrawing Essure from the US market for ‘commercial reasons’.
Essure Statement of Claim (PDF 493KB)
Essure Class Action Summary Statement (PDF 94KB)
Opt-out notice (PDF 326KB)