Clinician information: Essure device
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 in use globally since 1999 until 2017.
Following reports of side effects and complications in some women, the Essure device was recalled around the world, and in Australia in August 2017. It is no longer being sold or implanted in Australia.
The device is a soft flexible metal coil insert that does not contain or release any hormones. The Essure inserts are made of materials that include polyester PET fibres, nickel, titanium, platinum, silver-tin and stainless steel.
The Essure implant has been reported to corrode and migrate inside some women, exposing them to nickel poisoning, inflammation and causing problems with their uterus and other organs.
Side effects from the Essure implant may occur at any time following insertion. Some Essure problems are mild and may last only a few days. However, some patients have experienced and/or reported significant adverse events.
The most common complication for women with the Essure device is pain.
Symptoms may include:
- Abdominal or pelvic pain
- Abnormal periods
- Allergic symptoms such as itching, swelling, rash or hives.
Other symptoms that have been reported:
- Severe bloating
- Weight gain
- Changed toilet habits
- Twinges in the implant location and aching joints
- Pain during sex, that had never existed before
- Autoimmune disease
- Hair loss
- Reduced libido
- Memory lapses, dizziness and fainting.
It is known that patients with hypersensitivity to polyester fibres, and metal allergies (including nickel) are more likely to present with an allergic reaction to the Essure device.
Every woman presenting with complications following Essure implants will require a physical examination of their abdomen, pelvis and vagina with detailed documentation of the symptoms.
It is important to assess for any clinical indications of migration of the device.
Given the frequent reported incidence of pain in women having had the Essure system implanted, it is suggested that a comprehensive pain assessment be undertaken at the earliest opportunity.
Although patients who have less complex symptoms do not necessarily require surgical management, it is suggested that a gynaecologist opinion is considered to ascertain if surgical management is required. Hysterectomy is the preferred surgical option; an extended salpingectomy may also be considered.
An ultrasound and/or CT scan are appropriate and useful diagnostic images to perform prior to gynaecology review.
An immunology assessment may be beneficial for women with suspected allergy/hypersensitivity or immune-type reactions.
Report any suspected Essure implant adverse event to the Therapeutic Goods Administration via the medical device incident reporting & investigation scheme (IRIS).
Therapeutic Goods Administration response
The Essure contraceptive device was cancelled from the Australian Register of Therapeutic Goods (ARTG) on 9 February 2018.
No new Essure devices were supplied to the Australian market after 31 May 2017. However, some Essure devices were already in the supply chain and were able to be used until they were recalled in August 2017. The Essure device was not supplied again in Australia following this recall.
Since the device began supply in Australia in 1999 until 6 August 2018 the TGA received 59 adverse event reports relating to women implanted with the Essure device. The reports have 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.
Further information is available on the TGA website.
Reporting adverse events
To assist in monitoring the safety of medical devices the Therapeutic Goods Administration (TGA) maintains a website where consumers (patients) and clinicians can report instances where a medical device has caused an adverse event (death, serious injury or serious deterioration). The TGA assesses each report submitted.
For more information on reporting adverse events from a medical device please read the TGA guide to the medical device incident reporting & investigation scheme (IRIS).