Elringtons Health Law Update: Adverse Effects of Contraceptive Implant Mirena

We recently wrote about some serious side effects from contraceptive implants, Mirena and Implanon, which had initially been reported by the ABC.

Since then, there has been a case of a woman in QLD who suffered severe blood loss and can no longer have children, due to an issue with the Mirena implant. It is said the Mirena was incorrectly fitted and that this particular woman had a retroverted uterus, which increases the chances of side effects for a woman who has such a contraceptive device implanted. The surgery found a massive tear to her uterus, which is aligned with the ABC’s report that other uterus perforations have resulted from the Mirena.

In this particular case, the woman has said she was not warned of the risks, particularly regarding different uteruses, by her GP prior to having the device implanted.  A doctor owes a duty of care to you when prescribing you the right treatment and when giving warnings about the side effects on a treatment. As we say in our article Medications and Medical Negligence:

A doctor’s duty to warn about side effects extends to a side effect which a reasonable person in the circumstances would think was significant.  This accounts for the severity of a side effect, how often it might occur, and a patient’s particular circumstances.

Take for example the drug sodium valproate (Epilim).  It is known to carry a risk of birth defects if taken by women who are pregnant.  A doctor should warn a woman trying to get pregnant, or who is pregnant and taking Epilim, of this risk.  It is a serious risk.  However, a doctor treating a female patient who chooses not to have children or is unable to have children, need not be warned of the risk, as that patient would attach no significance to it.

A person’s particular circumstances may require a doctor to warn about a side effect which they ordinarily would not be required to warn about. For example, a patient who only has vision in 1 eye would likely place more importance on a slight risk of harm to their vision than someone who has no sight impairment. Another example is where a person asks particular questions of their doctor about risks of harm and side effects.

The poor Queensland woman ought to have been warned about the potential side effects. While a doctor owes you a duty of care, one way to help prevent side effects from occurring is to inform yourself of the proposed treatment. We made recommendations in our article Hospital Complications and Negligence about the sort of questions you may ask:

In 2018 the Harvard University recommended 7 questions to ask a doctor when they prescribe a new medication. These are:

  • Why do I need this medication, and how does it work?
  • What are the risks and benefits?
  • Are there side effects?
  • How do I take this medication?
  • Do I need to avoid anything while taking this new medication?
  • How soon will the medication work, and how long will I be taking it?
  • When will you review how well this is working for me?

These types of questions can help you know about the treatment and the risks and benefits of the treatment.

If you have a contraceptive implant and have experiences any side effects, you should seek immediate medical advice. If your side effects have led to further medical treatment, time off work, or other pain and suffering, compensation may be available to you. A medical negligence claim can seek damages to help compensate for and suffering experienced.

We have further information available to help you understand your rights and any remedies available to you following medical negligence:

Please feel free to contact our medical negligence team for further information or to discuss your circumstances.

For similar, or further information, see:

Chemical Restraints in Nursing Homes

Nursing home abuse – Medications administered without consent are an assault

People with dementia are being administered medications to control their behaviour, but many may have been victim of an assault because consent was not first obtained.

A report by the Australian Aging Agenda on 21 March 2018 highlighted the issue of prescribing medications to people with dementia in order to control behavior. The dangers of prescribing antipsychotic medication have been known for numerous years. The Australian Aging Agenda report highlights that while rates of antipsychotic medication prescription have decreased, behaviours are still sought to be controlled by other medications.

Leaving aside whether or not the prescription is appropriate, the issue of prescribing medications to people with dementia in nursing homes to control their behaviour raises a fundamental issue: is there consent to administer the medication? If not, then an assault has occurred and this may attract criminal and civil consequences.

There have been no reported cases in this area, so it is difficult to anticipate how Courts and Tribunals will respond to claims on this serious issue. Contact us to speak with Matthew Bridger or Tom Maling to arrange a free initial appointment in order to identify get further information about what a claim may be worth.


Public interest litigation

Claims need to be brought to make nursing homes accountable for breaches of a fundamental right to bodily integrity. In addition to this, claims can raise the awareness of this issue which will hopefully lead to better laws to protect older Australians. The ABC Law Report program heard that a class action in Ventura County in the US was successfully brought by residents who were given antipsychotic medications without their consent. The ABC heard that this had a knock-on effect to nursing homes in the surrounding areas by causing an improvement their administration practices for antipsychotic medications.

Elringtons sent two solicitors to the 2018 National Elder Abuse Conference in Sydney. We are specialists in health and medical law. We know that we have an important role in protecting the rights of older Australians. Contact Matthew Bridger or Tom Maling to discuss your circumstances to see how we can help.

Further elringtons resources

Further resources

e: info@elringtons.com.au | p: +61 2 6206 1300

TGA warnings on sleeping tablet Belsomra

On 20 March 2018 the Therapeutic Goods Administration (TGA) released a warning about prescribing practices of Belsomra (also known as Suvorexant). The TGA stated:

Since registration, the TGA has received a number of reports of adverse events, including sleep paralysis, gait disturbance, hallucination, headache and paraesthesia.

These potential side effects, including next day residual effects, are well communicated in the Product Information, but it is important for patients to be warned of these potential adverse events before they are prescribed suvorexant.

The concern is not the action of the drug, but the warnings (or lack of) given by doctors to patients. As we discuss in our article Medications and Medical Negligence  doctors have a duty to warn you about side effects. Only after receiving warnings about side effects can a person make an informed decision about whether or not to take a medication.

The risks the TGA reported on can be very severe, particularly if they occur while someone is driving or at work. This latest TGA warning highlights the importance of asking your doctor about risks and side-effects of medications. Our advice in our article Hospital Complications and Negligence rings true with prescriptions of Belsomra, or any other medications. In that article we stated:

In 2018 the Harvard University recommended 7 questions to ask a doctor when they prescribe a new medication. These are:

  1. Why do I need this medication, and how does it work?
  2. What are the risks and benefits?
  3. Are there side effects?
  4. How do I take this medication?
  5. Do I need to avoid anything while taking this new medication?
  6. How soon will the medication work, and how long will I be taking it?
  7. When will you review how well this is working for me?

These are good questions for patients to ask doctors and other health practitioners who administer treatment in hospital. Be an informed patient. It is your body and you have a right to ask about your treatment. In doing so, you may prevent a hospital complication, like being administered the wrong medication, from happening.

If you have taken Belsomra, or any other medication, and experienced a side effect or adverse reaction that you were not warned about, you may have a medical negligence claim. For more information see our Medical Negligence homepage or contact us to talk to Matthew Bridger or Tom Maling.

Further resource

elringtons health law update – adverse effects from Implanon and Mirena

By Tom Maling

A 12 December 2017 ABC investigation report has exposed that Australian women are experiencing serious side effects from the long-acting contraceptive devices Implanon and Mirena.

The ABC report detailed that Australian women have experienced chronic pain, pelvic inflammatory disease, scarring, unintended pregnancies and depression following insertion of these devices.

The report is the latest to put a spotlight on a medical device for women that has been found to cause serious side effects. Another well-known example is the pelvic mesh device. Another, perhaps lesser known, is the Essure device. Earlier in 2017 elringtons lawyers wrote about the side effects that some women experienced after insertion of the Essure permanent contraception implant device (see elringtons health law update – hazard alert for Essure contraception implant device).

It goes without saying, if you think you have experienced a side effect from an Implanon or Mirena advice, you should seek medical help immediately. For those who have experienced additional costs as a result of a side effect such payment for extra treatment, time off work or even pain and suffering, compensation may be available. A medical negligence claim can help put you back to where you would have been without the side effect (as much as money can).

We have put together a range of articles to help health consumers understand their rights and remedies following negligent treatment. We hope the following help you understand more about your rights:

Please feel free to contact Tom Maling for further information or to discuss your circumstances.

Further information:

p: +61 2 6206 1300 | e: Info@elringtons.com.au

Nursing home abuse by residents on other residents

On 13 November 2017 a journal article was published which detailed the high rates of abuse by nursing home residents on other residents . The researchers found:

  • Over a 14 year period 28 people had died as a result of resident-on-resident violence
  • There is likely under-reporting by nursing homes about resident-on-resident violence
  • US research had found at least 20% of nursing home residents had experienced resident-on-resident violence

This is just further evidence detailing the dire experiences some Australians are having in some nursing homes. Nursing home care is undoubtedly very complex, and resident-on-resident abuse is no exception, with perpetrators generally having dementia or another form of cognitive impairment. Despite this, all nursing home residents have the right to be safe and free from harm in their nursing home.

elringtons has particular concerns about the emerging evidence of mistreatment. We have previously published on preventable deaths  and nursing home abuse Nursing homes owe their residents a duty of care. This is established at common law and by the Aged Care Act.

Resident-on-resident violence raises questions about:

  • How has a nursing home assessed the perpetrator’s and the victim’s needs?
  • Has the nursing home provided appropriate care to the perpetrator?
  • What sort of risk assessment has the nursing home conducted?

Nursing home residents are at particular risk of harm and are extremely vulnerable as they are, very often, unable to remove themselves from the sense of danger. elringtons has a particular interest in protecting the rights of nursing home residents. We can provide assistance with a range of issues such as:

  • Putting in a complaint to the Aged Care Commissioner
  • Advocating to nursing homes to resolve complaints and issues
  • Obtaining compensation for extra treatment and care following nursing home negligence or misconduct

Please feel free to contact Tom Maling to tell us your story and to see how we can help.

Further resources

For more information please do not hesitate to contact Matt Bridger or Tom Maling:

p: +61 2 6206 1300 | e:  Info@elringtons.com.au