Essure contraceptive device

  SA Health Pelvic Procedure Consumer Support Line — 1800 370 559

The Essure implant is an intrauterine device (IUD) permanent contraceptive that has been used in women since 1999. The Essure device has been recalled and is no longer being used in Australia following reports of adverse reactions in some women. Refer to the Frequently Asked Questions below for detailed information.

What support is available?

The SA Health Pelvic Procedure Consumer Support Line (1800 370 559) is operational between 9.00 am to 4.00 pm, Monday to Friday (excluding public holidays).

What is the Essure® contraceptive device?

Essure is an implanted device that provides permanent contraception for women.

The device, a soft flexible metal coil insert that does not contain or release any hormones, it is placed into the woman’s fallopian tubes and expands to anchor itself in the fallopian tube. Over the three months following its insertion a barrier forms around the inserts, which is intended to prevent pregnancy.

What are the Essure® inserts made of?

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

What is the concern with the Essure® device

Essure is an implanted device that provides permanent contraception for women.

The device, a soft flexible metal coil insert that does not contain or release any hormones, it is placed into the woman’s fallopian tubes and expands to anchor itself in the fallopian tube. Over the The Essure device has been recalled and is no longer being used in Australia following reports of adverse reactions in some women, both in Australia and worldwide since 2013.

The implant, also recalled from sale around the world, features a metal coil that expands to anchor the device in the fallopian tube. However, it has been reported to corrode inside some women, exposing them to nickel poisoning, and causing problems with their uterus and other organs.

Side effects from the Essure implants can occur during or after the procedure. Some Essure problems are mild and last only a few days. Some patients have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, persistent pain and migration into the abdominal or pelvic cavity.

If you are worried or have symptoms that may be related to an Essure® implant you are encouraged to call the SA Health Pelvic Procedure Consumer Support Line on  1800 370 559 between 9.00 am to 4.00 pm, Monday to Friday (excluding public holidays) or email EssureDeviceSupportService@sa.gov.au months following its insertion a barrier forms around the inserts, which is intended to prevent pregnancy.

What are some of the possible Essure® device complications?

The Essure metal coil implants can cause significant and severe complications for some women.

Complications with the Essure device can occur during or after the procedure.
For example, some Essure implants can fracture or migrate from the fallopian tubes causing significant and severe complications for some women, including:

  • punctures or lacerations requiring surgical repair of vessels, nerves, structures or organs, including the
    • bladder
    • urethra
    • bowel
  • implant migration, explosion or erosion into the vagina or other structures or organs
  • acute and/or chronic pain, or neuromuscular problems
  • metal allergy (itching, swelling, rash, hives)
  • autoimmune disorders (lupus, rheumatoid arthritis, chronic fatigue syndrome).
  • infection
  • ectopic pregnancy (life-threatening pregnancy that occurs outside the uterus).

What symptoms might I notice after having the Essure® device implanted?

Some Essure symptoms are mild and last only a few days but some symptoms may mean there is a more serious complication that may require immediate attention, symptoms include:

  • extreme pelvic pain
  • abnormal periods
  • memory lapses, dizziness and fainting
  • severe bloating
  • fatigue
  • migraines
  • weight gain
  • changed toilet habits
  • twinges in the implant location and aching joints.

You should see your GP if any symptoms persist.

What should I do if I think an Essure® implant is affecting my health?

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

Women who have symptoms associated with the Essure implants would benefit from an assessment by their GP. A physical examination of their abdomen, pelvis and vagina will assist in determining possible complications and the development of a clinical management plan.

Although, patients who have fewer complex symptoms do not necessarily require surgical management, it is suggested that a Gynaecologist opinion may be beneficial to ascertain if surgical management is required.

What can I do now?

If you are worried or have symptoms that may be related to your Essure® implant you are encouraged to call the SA Health Pelvic Procedure Consumer Support Line on 1800 370 559 between 9.00 am to 4.00 pm, Monday to Friday (except public holidays) to discuss your issues.

If you require help in accessing the SA Health Pelvic Procedure Consumer Support Line the following services are available.

For those who speak languages other than English:

Translation service, phone (08) 8226 1990, then ask for 1800 370 559.

For those who are deaf, hearing impaired or speech impaired:

  • TTY users — 133 677 then ask for 1800 370 559.
  • Speak and Listen users — 1300 555 727 then ask for 1800 370 559.
  • Internet relay users — connect to the National Relay Service, then ask for 1800 370 559.

What other support is available?

  • Health Consumers Alliance of SA Inc
  • Australian Essure support groups – Support groups are available on Facebook by searching ‘Essure support group’. A moderator may need to approve you joining the group

What is being done about this problem for women in South Australia?

SA Health is supporting women in South Australia who are experiencing complications from Essure® implants and has established the SA Health Pelvic Procedure Consumer Support Line (1800 370 559). This phone service is operational between 9.00 am to 4.00 pm, Monday to Friday (excluding public holidays).

Can the Essure® implants be reversed or removed?

The Essure device is recognised as a permanent contraceptive device and is not designed for removal. The Essure implants may break during removal, leaving metal and polyester fibres in the body, which can cause inflammation and pain.

Women who wish to have Essure devices removed may have limited surgical options. Surgery can range from a simple outpatient procedure to a hysterectomy. Sometimes, women may need to have more than one surgery. It is advised that you discuss your options with a Gynaecologist.

Who owns my medical records?

Generally, the health service provider who creates a medical record owns that record. This doesn't interfere with your right to access your record, because ownership and access rights are separate.

Can I get access to my medical records?

SA Health agencies

If your medical records are held by a South Australian public hospital you have a right to access those records.

SA Health is supporting women in South Australia who are experiencing complications from Essure® implants and will waive the Freedom of Information (FOI) application fee and the associated charges.

The South Australian Freedom of Information (FOI) Act 1991 gives members of the public a legally enforceable right to access information held by South Australian Government agencies, subject to certain conditions. For more information please refer to the
Pelvic Procedure: Request for Access to Health Records Fact Sheet (PDF 104KB).

Applications for access to documents must be made in writing and lodged with the agency that holds the document. To apply for access to your personal medical records you can complete the Pelvic Procedure: FOI Application Form (PDF 85KB), or access the relevant agencies (for example, hospital) website and complete their FOI Form.

The SA Health Pelvic Procedure Consumer Support Line (1800 370 559) can provide more information regarding accessing your medical records.

If you believe you have been unfairly denied access to your medical record by the agency, you have the right to seek an internal review by the Principal Officer/Chief Executive of the agency. If access is still not granted then further rights to request a review exists, either to the Ombudsman, or to the South Australian Civil and Administrative Tribunal.

Ombudsman SA has the power to investigate and conduct an external review of determinations by agencies under the FOI Act. They may confirm, vary or reverse the determination made by the agency. They may also review the fees and charges levied by agency for access to documents under the FOI Act.

Private health service

If your medical records are held by a private sector organisation, such as a doctor in private practice or by a private hospital, as a general rule, you have a right to gain access to all the information held about you as prescribed in the Commonwealth Privacy Act.

You may exercise this right in a number of ways (depending on, for example, the sort of information you have asked for, the type of organisation and the way the organisation holds its records) for example:

  • looking over the records
  • taking a copy of those records with you
  • having them explained to you.

In some cases you may need to reach an arrangement about access with the organisation holding the records. There are some limitations on your right of access. These may apply for example, to:

  • where giving access would pose a serious threat to the life and health of anyone
  • where refusing access is required by law.

If you believe you have been unfairly denied access to your medical record by the ‘private health service’, you can make a complaint to the Office of the Australian Information Commissioner.

Can my health service provider give my representative access to my medical records?

In some cases, an individual may need a representative to assist them in gaining access to their medical record. For instance, an individual may be unable to exercise their access rights because they lack the legal capacity to do so, but their guardian (if they have one) may seek access, if the guardian has the appropriate legal authority.

How can I make a request for access to my medical records?

When making an application for access to your medical records through the Freedom of Information process you will need to provide enough information to enable the correct documents to be identified.

How much time can an organisation take to meet my request for my medical records?

Health service providers should respond to a request for access to medical records within an appropriate time. What is appropriate will depend on a number of factors, which can include:

  • the amount of information requested
  • the complexity of the organisation's functions and activities
  • the way the access is to be provided.

A request for access will be dealt with as soon as practicable, or within 30 calendar days of it being received. In certain circumstances the agency may extend the timeframe for dealing with your application and should inform you if an extension is necessary, and why.