Posted on 13 Aug 2018
Leading class action firm Slater and Gordon today announced it will pursue a class action against Bayer, the manufacturer of contraceptive device Essure, after hundreds of women across Australia suffered severe complications.
Essure, recalled by Bayer in the US in July, is a permanent contraceptive implant comprised of a metal coil which expands to anchor the device in the fallopian tube.
The Essure device has been known to corrode, exposing women to nickel poisoning, as well as migration and perforation of the uterus and other organs.
It has also caused complications including irregular menstrual bleeding, pelvic or abdominal inflammation and pain, pain during intercourse, reduced libido, stiffness and muscle pain, and symptoms including fatigue, hair loss and rashes. Expert medical opinion suggests a complete hysterectomy is the only safe way to remove the product.
Slater and Gordon Associate Ebony Birchall said Slater and Gordon will consider whether the product was inherently defective.
“Essure was hailed as the new wave of contraceptive devices. Unlike traditional permanent contraceptive surgery, Essure was marketed as being fast, effective, and minimally invasive, it could be inserted in your doctor’s office,” Ms Birchall said.
“However for the women who have experienced complications it has been incredibly damaging. It has literally turned their lives upside down.
“For most women the only solution has been to have a complete hysterectomy,” she said.
Ms Birchall said a large number of women with serious complications from the Essure implant had contacted Slater and Gordon but that there were likely many more Australian women who were suffering in silence or who do not know their symptoms are related to the device.
One such person was Tanya Davidson. Tanya, whose husband was a FIFO worker and was a stay at home mother of four children under four, had the device inserted in 2010 and has battled with the severe effects for the past 8 years. She experienced symptoms such as hair loss, severe menstrual bleeding, chronic fatigue, gastric issues, stabbing ovarian pain and loss of cognitive function.
“The loss of cognitive function has been the scariest as it just feels like it continues to get worse,” Ms Davidson said.
“Every day I wake to the feeling of brain fog, have trouble remembering simple things like the names of everyday objects or get lost mid-sentence.
“I was terrified I was experiencing the onset of early Alzheimer’s Disease.”
Ms Davidson said when she first decided to have the device implanted it seemed like the best option.
“As a busy working mum I couldn’t afford to take time off, so the fact that the procedure was non-invasive and I didn’t have to take time off to recover from surgery was appealing. Instead it has been eight years of hell.”
Ms Davidson was eventually diagnosed with a Nickel allergy and in February 2016 had the device removed.
However during that procedure the device broke and she had to undergo a hysterectomy 6 months later as a result of the damage caused by the remaining fragments. She still suffers from side effects.
“Some days I just feel like I can’t get out of bed, but as a mum I don’t have a choice.
“For years doctors told me that the symptoms were in my head and that they couldn’t be related to the device.
“I know there must be other women out there who are in the same boat and I want them to know they are not alone,” she said.
Bayer has not provided details of how many of the device were sold in Australia or worldwide.
The class action is open to all women who have suffered complications as a result of having an Essure implant inserted in Australia. For more information go to the Essure Class action page
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’.