The Essure device was used in thousands of patients in Australia from about 2000 until it was withdrawn from sale by Bayer in mid-2018, and over this period has been linked with a range of serious conditions and complications, including: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.
The first stages of the case will involve issues concerning the identification of other parties who may be defendants to the claim. After this is completed, for the balance of 2019 it is likely that the case will involve finalizing the documents that detail parties’ claims and defences, and then attention will turn to the parties exchanging evidence concerning the allegations in the claim. 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’.