August 30, 2017 — Bayer’s permanent birth control implant Essure has been recalled and pulled off the market in Australia for “business reasons,” following numerous reports of women who were severely injured.
Australia’s Therapeutic Goods Administration (TGA) issued a hazard alert for Essure and said there will be no further implantations of Essure.
Like health officials in the United States, the TGA was concerned that women were not being adequately informed of the possible risks of choosing Essure instead of a tubal ligation (“having tubes tied”).
The U.S. Food and Drug Administration (FDA) has not recalled Essure, but re-classified it as “maximum risk” and reported 9,900 injuries, 36 deaths and hundreds of pregnancy losses by 2015.
Similar adverse events have been reported in Australia, including some that 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.”
Essure has already been pulled off the market or recalled in Canada and Brazil. Essure continues to be sold and implanted in women in the U.S., despite the largest grassroots campaign to get it off the market since the silicone breast implant scandal in the 1980s and 90s. There are now around 1,000 lawsuits from women who were injured by Essure.