Implanon Contraceptive Failure

Implanon:

Contraceptive failure may lead to doctors’ liability for “wrongful conception”

The Irish Medicines Board (IMB) has confirmed that 33 reported unintended pregnancies have occurred to women using the contraceptive device Implanon since it was licensed in Ireland in 1999.
In the UK, where over the same period the device has been administered 1 million times, 584 unintended pregnancies have been reported.


What is Implanon?

Implanon is a contraceptive implant fitted under the skin which contains a synthetic progesterone. When fitted correctly, it provides 3 years contraceptive cover.


What went wrong?

Interestingly, the manufacturer Schering-Plough has stated they are:

  • ‘confident in the efficacy and safety of Implanon, a contraceptive medicine that has been prescribed to women since its initial approval in September 1999.The basis for successful use of Implanon is a correct and carefully performed subdermal insertion of the implant in accordance with the product instructions. If the implant is not inserted in accordance with the instructions and on the correct day, this may result in an unintended pregnancy. In addition, no contraceptive is 100% effective.'

Meanwhile the UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Safety Warning stating:

  • ‘Implanon must be correctly implanted to work effectively. When used correctly Implanon is a safe, effective and reliable contraceptive that prevents pregnancy for up to three years. However, it is important that Implanon is correctly implanted by someone who is trained to fit it. Healthcare professionals who wish to fit Implanon are strongly encouraged to undergo training.’

What are the legal issues?

Both Schering-Plough and MHRA would appear to be pointing the finger of blame at doctors for incorrectly implanting the device which is a 4cm long plastic tube. The device has been noted to be difficult to position correctly and a newer device named Nexplanon is now available which allows doctors to verify the correct positioning of the device by x-ray.

If the contraceptive has failed due to incorrect implanting by a doctor, it is likely that a case for professional negligence can be taken against that doctor seeking compensation for the damage caused.

How then does Irish law consider ‘damage’ arising from an unintended pregnancy and what are the limits to what can be claimed?

The case of Byrne v. Ryan, Irish High Court 2007 is the current leading case on the issue of unintended pregnancy or ‘wrongful conception’. Here a woman who had undergone a tubal ligation sterilisation procedure in 2000 but became pregnant shortly after and had a second subsequent pregnancy the following year. It transpired that the tubal ligation had been incorrectly performed. The High Court awarded her €90,000 for the pain and suffering of the two pregnancies and allowed €10,000 for a second tubal ligation procedure necessitated by the failure of the first procedure. The court was asked to consider awarding damages for the cost of rearing the children but refused to do so on the grounds that to do so would be against public policy.


Clearly the courts in Ireland and the UK are unwilling to allow a life and the costs associated with that life to be equated with an injury however in the UK, the courts have shown themselves willing to allow additional compensation where the child born of the wrongful conception was born with disability. Should a similar situation come before Irish courts, it is uncertain how the case would be dealt with.

Summary

Women who have become pregnant while using the contraceptive device Implanon may have a cause of action against the doctor who implanted the device.


Should they be successful in that case, they will be entitled to substantial damages for the pain and discomfort of the pregnancy and birth together with any expenses or losses arising from that.


They will not be entitled to claim damages for the cost of rearing or educating the child of that pregnancy under current law however the issue of special or additional costs associated with rearing a child with disabilities has not been considered by Irish courts but has been allowed in the UK.


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