Essure permanent contraceptive device side effects

The Essure implant is a medical device that provides permanent contraception for women. It has been in use globally since 1999, and up until 2017.

Following reports of side effects and complications in some women with Essure devices both in Australia and worldwide, hospitals in Australia received advice from the Therapeutic Goods Administration in August 2017 requiring that the Essure device not be used in any further procedures. It is no longer being sold or implanted in Australia.

The Essure device has been reported to corrode and migrate inside some women, exposing them to nickel hypersensitivity, inflammation and causing problems with their uterus and other organs.

The device is a soft flexible metal coil insert that does not contain or release any hormones. It is placed into the woman's fallopian tubes and causes scar tissue to form. Over the three months following its insertion a barrier forms around the inserts, which is intended to prevent pregnancy.

The Essure device inserts are made of materials that include polyester PET fibres, nickel, titanium, platinum, silver-tin and stainless steel.

Side effects from the Essure device may occur at any time following insertion. Some Essure side effects are mild and last only a few days. However, some patients have experienced and/or reported significant side effects or complications.

Find out if you have had an Essure device implanted

Essure insertion is typically performed by a gynaecologist under general anesthesia, however in some cases local anaesthesia may have been used. The device is introduced into the fallopian tubes through the uterine cavity so no cuts in the abdomen are made. The device can be seen on an x-ray (e.g. abdominal or pelvic x-ray) or ultrasound.

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 general practitioner will have received a copy.

There are several permanent contraceptive implants devices in use, the current concerns relate only to the Essure brand of device. You may need to contact your hospital to seek further information as to whether the sterilization device implanted was an Essure if not clearly stated in the discharge summary.

Complications

The risk of developing side effects or complications due to the implantation of the Essure device is low. However some women with Essure have experienced side effects and complications.These include:

• cutting into the wall of the uterus, fallopian tubes, bladder or bowel (perforation)
• the device moving to other locations in the abdomen or pelvis (migration)
• the possibility of metal allergy (itching, swelling, rash, hives)
• infection
• unintended pregnancy, including ectopic pregnancy (pregnancy that occurs outside the uterus).

In some instances, the device may require surgical removal via a hysterectomy.

Symptoms

Some Essure symptoms are mild and may only last a few days, with others being more persistent and women experiencing longer term symptoms. Symptoms may be exacerbated due to the length of time women are exposed to the Essure device.

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
• Fatigue
• Migraines
• Weight gain
• Changed toilet habits
• Twinges in the implant location and aching joints
• Pain during sex, that had never existed before
• Depression
• Autoimmune disease
• Hair loss
• Reduced libido
• Memory lapses, dizziness and fainting.

You should see your GP if any symptoms persist.

Where to report your symptoms

Visit your GP to determine if the symptoms are associated with your Essure implant.

There is no need to take additional action if you are satisfied with your Essure implant and are not having side effects or complications.

Treatment options

The Essure device is recognised as a permanent contraceptive device, it was not designed for removal. If the device needs to be removed, surgery will be required. The type of surgery needed will depend on the positioning of the Essure device, your prior medical history and symptoms.

Surgery can range from removal of the fallopian tubes to a hysterectomy, depending on the location of the Essure device and the amount of inflammation in the area. Hysterectomy is the preferred and safe surgical option (as indicated by the manufacturer); the Essure device needs to remain intact so that fragmentation of the device does not occur. Women who wish to have the Essure device removed may have limited surgical options. Sometimes, women may need to have more than one surgery. It is advised that the options are discussed with a Gynaecologist.

Although women who have fewer symptoms do not necessarily require surgical management, it is suggested that a Gynaecologist opinion be considered to ascertain if surgery is required.

Alternatives to Essure for long-term contraception

There are alternatives that health care providers can recommend for women and their partners who desire long term contraception. These alternatives include tubal ligation, vasectomy, levonorgestrel intrauterine device (IUD) or copper IUD.

Regulation of medical devices

The Commonwealth Government's Therapeutic Goods Administration (TGA) is responsible for the regulation of medical devices in Australia. 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 could be used until they were recalled in August 2017. The Essure device was not supplied again in Australia following this recall.

Further information is available on the TGA website.

Reporting your symptoms (adverse events)

To assist in monitoring the safety of medical devices the Therapeutic Goods Administration (TGA) has established 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).

Accessing medical records

Every Hospital and Health Service (HHS) has a contact point for enquiries about personal information, health records, privacy and Right to Information (RTI) advice. If you want to access your records contact the Hospital and Health Service where you think the information is located.

See the Hospital contacts for health records.

If you are unsure where you should go, ask the Privacy and Right to Information Unit within the Department of Health for advice on

Phone: (07) 3082 0546
Email: RTI-Privacy@health.qld.gov.au