News

15-08-2018

The Essure contraceptive device was removed from the Australian Register of Therapeutic Goods in early February 2018. The device began supply in 1999 and was  recalled in August 2017 and no new devices supplied after this recall. There have been a number of news articles regarding the Essure this month in response to a class action being launched against the manufacturer of the device, Bayer.

The flexible coil implant made of nickel and polyester fibre was inserted into each of the fallopian tubes, causing scar tissue to build up and prevent conception. The device was marketed as fast, effective, minimally invasive and possible to insert in the doctor's surgery. The TGA has received 59 adverse event reports relating to women who have had the device implanted, the reports include changes to menstrual bleeding, unintended pregnancy, chronic pain perforation, migration of the device and allergy/hypersensitivity or immune-type reactions such as rashes and hair loss. Surgery, including hysterectomy  has been required in some instances to remove the device. The main problem with the device has been the corrosion of the stainless steel exterior, exposing the woman to the nickel inside the device, perforation of the uterus and migration of the device within the pelvis.

Women with severe complications are launching a class action against the manufacturer of the device, Bayer. There are no official figure on the number of Australian women with an Essure, but estimates are between 3000 and 5000.

The Royal Australian and New Zealand College of Gynaecologists and Obstetricians ( RANZCOG) have advised women to contact their GP or Specialist if they have any concerns about symptoms they may have. The spokeswoman's advice was that should the woman have no symptoms, she does not have grounds for concern.

The RANZCOG have also lent their support to calls for a unified, appropriately funded and independently run national register of implants. There is currently no way of determining which Australian women have had the Essure devices placed ( the same issues made followup with transvaginal mesh so difficult ).

Your GP is well placed to investigate any concerns regarding troublesome bleeding, pelvic pain and possible allergy/hypersensitivity and immune-type reactions and provide appropriate referrals if required

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