Essure contraceptive device
The Essure® implant is an intrauterine device (IUD) permanent contraceptive that has been used in women since 1999. The Essure® device was removed from the market in 2017 following reports of adverse reactions in some women.
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, 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
Following concerns being raised, the supplier removed the Essure® device from the worldwide market in 2018. Since then, the Food and Drug Administration in America has continued to document reportable events. Most of these events are directly related to placement complications at the time of surgery. Some women have experienced a reaction to the Essure® itself, but this is uncommon.
Side effects from the Essure® device may occur at any time following insertion. Most Essure® side effects are mild and last only a few days following insertion. However, some patients have experienced and/or reported significant side effects or complications long-term.
What are the reported Essure® device complications?
Despite the risk of developing side effects or complications due to the implantation of the Essure® device being low, some women have experienced the following complications:
- unsuccessful placement of the Essure® including perforation into the wall of the uterus, fallopian tubes, bladder or bowel.
- the device migrating to other locations in the abdomen or pelvis
- the possibility of developing a metal allergy, namely nickel
- device fragmentation at the time of implantation or removal
- unintended pregnancy, including ectopic pregnancy (pregnancy that occurs outside the uterus).
- a moderate increase in pelvic pain lasting longer than 3 months.
- changes in period frequency and blood loss.
When compared to laparoscopic tubal ligation, rates of lower abdominal/pelvic pain and abnormal uterine bleeding is slightly increased.
What symptoms might I notice after having the Essure® device implanted?
Some Essure® symptoms are mild and last only a few days following insertion, but some symptoms may persist and may require further medical assessment.
- mild-moderate abdominal or pelvic pain
- abnormal periods
- uncontrolled abdominal bloating
- weight gain
- pain during sex, that had never existed before
- hypersensitivity to metal products
- itching, swelling, rash, hives
- memory lapses, dizziness and fainting
You should see your GP if any symptoms persist or concern you.
What should I do if I think an Essure® implant is affecting my health?
Visit your GP to determine if your symptoms are directly associated with your Essure® implant.
A physical examination of your abdomen, pelvis and vagina will determine any possible complications and assist in the development of a clinical management plan.
Your GP can refer you for a pelvic x-ray or ultrasound to confirm the location and integrity of the device. You should always disclose that you have an Essure® device prior to any medical imaging, especially Magnetic Resonance Imaging (MRI).
Can the Essure® implants be reversed or removed?
The Essure® device is recognised as a permanent contraceptive device and it was not designed for removal. If the device needs to be removed due to significant symptoms, 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 device along with the fallopian tubes, to a hysterectomy. A hysterectomy is the preferred surgical option, as indicated by the manufacturer, to ensure the device remains intact and to minimise the risk of fragmentation during extraction. Sometimes, women may require more than one surgery.
Experiencing adverse effects (symptoms), does not necessarily mean surgical management is required. Your GP can refer you to a gynaecologist who can discuss your options with you and give suggestions to manage any symptoms.
I think I might be pregnant. What should I do?
Data shows that after 5 years from successful insertion, there is less than a 1% chance of becoming pregnant. Essure® is as effective at preventing pregnancy as other contraceptive procedures or devices.
If you think you may be pregnant after having Essure® implanted you should be seen by a doctor as early in the pregnancy as possible, (preferably before 6 weeks) as the risk of ectopic pregnancy (pregnancy occurring outside the uterus) is higher. An ectopic pregnancy can be a medical emergency.
In the case of an emergency, please call 000 for an ambulance or attend the nearest hospital emergency department.
How do I know if I have the Essure® device?
It should be easy for your doctor to confirm whether you have had an Essure® procedure as it should be clearly documented in your medical records. If there is any doubt they are easily seen on an abdominal x-ray or ultrasound scan.
Can I get access to my medical records?
The healthcare service provider where you had your Essure® device implanted generally owns your medical record. You do have the right to access your record, because ownership and access rights are separate.
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)M.
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 support you with 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.
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.
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