elringtons health law update – hazard alert for Essure contraception implant device

On 30 August 2017 the Australian Therapeutic Goods Administration (TGA) issues a hazard alert about a permanent contraception implant called Essure.

According to the TGA:

“It has been identified that some patients who have received the device may not have been fully informed of the possible device and procedure-related risks before choosing to have Essure implanted.

There have been reports of changes in menstrual bleeding, unintended pregnancy, chronic pain, perforation and migration of the device, allergy/hypersensitivity, or immune-type reactions. Some of these reports were considered serious and resulted in removal of the device, which involved abdominal surgery.”

In May 2017 the manufacturer of Essure advised the TGA that it would cease importing the device and there is now a recall for all unused devices. Essure was first approved for use in Australia in July 2010. The TGA provided no indication about the scope of the device’s use or the number of people impacted. Simply because of the length of time it has been available it is possible that many Australian women have had an Essure device implanted.

If you think you may have had the device implanted you should follow up with your doctor to obtain information about it. If you are concerned about side effects, you should also discuss these with your doctor.

If you have experienced any side effects after having an Essure device implanted, you may be entitled to compensation for the further treatment expenses, pain and suffering and for other losses. There are questions about the safety of Essure’s design, it’s fitness for use and the warnings about side effects which were provided to doctors and patients.

Please feel free to contact Tom Maling to discuss your concerns or refer to our information on health law and medical negligence.

Further information: