Essure contraceptive device

Background on the Essure Contraceptive Device

The Essure device was intended to be an alternative permanent contraceptive device, that did not contain or release any hormones. The device contains metals, such as nickel, titanium, silver-tin, stainless steel, and a polyester fibre and is implanted into a woman’s fallopian tubes, expanding to anchor itself. Over the three months following its insertion a barrier forms around the inserts that intend to prevent pregnancy. The device was available in Australia in public and private hospitals in various states from 1999 to 2017. This included Tasmanian hospitals at the Royal Hobart Hospital (RHH) and Launceston General Hospital (LGH).

Device recall

Supply of the Essure devices to the Australian market ceased on 31 May 2017. The Essure Contraceptive Device was recalled in August 2017 and removed from the Australian market. There have been reports of adverse symptoms and complications resulting from the implantation of the device. Although the risk of developing symptoms from an Essure device is low, if you have experienced any complications or are experiencing any of the following symptoms ongoing, please contact your GP or specialist.

Symptoms

Symptoms from the Essure device can be mild and last only a few days following insertion, but some symptoms may persist.

Common symptoms include: 

• increase in pelvic pain (can last longer than 3 months)
• abnormal periods (including changes in period frequency and blood loss)
• hypersensitivity to metal products (metal allergy resulting in itching, swelling, rashes and hives).

Other reported symptoms include:

• abdominal bloating
• fatigue
• migraines, memory lapses, dizziness, and fainting
• weight gain
• pain during sex, that had never existed before
• reduced libido

Complications

The risk of developing complications or side effects due to the Essure device is low. However, reported complications relating to the Essure device include:

• migration (the device moving to other locations within the abdomen or pelvis)
• device fragmentation (at the time of implantation or removal)
• perforation (cutting into the walls of the uterus, fallopian tubes, bladder, or bowel)
• development of metal allergy (symptoms include, itching, swelling, rash and hives) 
• infection
• unintended pregnancy, including ectopic pregnancy (pregnancy occurring outside the uterus)
• changes in period frequency and blood loss.

If you are experiencing or have experienced any of the complications listed above. If you believe you may be pregnant following the implantation of the device, please see your GP or specialist urgently. Your GP or specialist will be able to investigate and if necessary, refer you for an x-ray or ultrasound to determine any possible complications and assist in resolving any issues.

Treatment options

The risk of side effects from an Essure device is low. Anyone who thinks an Essure implant may be affecting their health should see their GP or specialist. Your GP or specialist may be able to offer suggestions to manage your symptoms or refer you to a gynaecologist who is able to discuss.

Surgical management is not always required, however in situations, where there are severe and ongoing complications, a person may need surgery. The type of surgery will depend on the specific symptoms or complications and will differ from patient to patient. It is important to consult your GP or specialist or receive a referral to a gynaecologist to discuss options. The manufacturer of the Essure Contraceptive Device recommends a hysterectomy as the preferred surgical option. This is to ensure the device remains intact and to reduce the risk of surgical complications, such as the device fragmenting. The type of surgery needed to remove the device will depend on the specific complications and reasons for the surgery. It is best to discuss options for surgery with your GP.

The Essure device was intended to be a permanent contraceptive device and was not designed for removal. Data shows five years after successful insertion the chances of falling pregnant are less than 1%, however, if you think you may be pregnant it is important to see your GP immediately as the chance of ectopic pregnancy (pregnancy occurring outside the uterus) is higher and can be a medical emergency.

Further information

There are several permanent contraceptive implants devices in use. Current concerns relate only to the Essure brand of device. The discharge summary you were given from the hospital where your procedure was performed should state Essure or hysteroscopic intratubal sterilization. If you do not have this discharge summary, your GP will have received a copy, or you may need to contact your hospital to if the device implanted was an Essure device.

It is important that you disclose that you have an Essure device implant when you are having any medical procedures, examinations, or Medical Resonance Imaging (MRIs). 

It is important to be aware that experiencing any of the symptoms mentioned does not mean surgery will be necessary. It is best to discuss your symptoms with your GP. 

In the case of a Medical Emergency please call 000. 

Links

Read more on the Essure® contraceptive device | Therapeutic Goods Administration (TGA)