The manufacturer of Essure decided to stop selling it in Australia for “business reasons.” There will be no further implantations of Essure in Australia, according to a hazard alert issued on August 30 by the Therapeutic Goods Administration (TGA).
The TGA warned that some patients who received Essure may not have been fully informed of the possible device and procedure-related risks before choosing to have Essure implanted. There have also been numerous reports of injuries.
Some of the reports were serious and required removal of Essure with abdominal surgery, according to the TGA.
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.”
Bayer has also pulled Essure off the market in Canada and Brazil, but not in the United States.
Essure continues to be implanted in women in the U.S., despite a massive grassroots campaign to ban Essure — including advocacy by Erin Brockovich, thousands of “E-sisters” on Facebook, and around 1,000 injury lawsuits.
The U.S. Food and Drug Administration (FDA) has issued similar safety warnings, but no recalls. Instead, the FDA said it received 9,900 side effect reports from women, including 26 deaths and hundreds of pregnancy losses, between 2002 and 2015.
The FDA was also concerned that women were not adequately warned about the risks of Essure, so it created a “Patient Decision Checklist” to outline some of the serious risks.