August 30, 2017 — Australia has recalled Essure and issued a hazard alert regarding serious safety risks.
The Therapeutic Goods Administration (TGA) said the manufacturers of Essure decided to discontinue sales in Australia for “business reasons.” There will be no further implantations of Essure in Australia.
The TGA was also concerned that women were not being adequately warned about the risks of Essure. In the United States, the FDA has expressed similar concerns about inadequate side effect information.
Many women in Australia have been injured by Essure, including some reports described as “serious” that required abdominal surgery to remove Essure. Furthermore, the TGA warned:
“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 previously recalled or stopped selling Essure in Canada and Brazil. Essure remains on the market in the United States, despite the largest grassroots campaign to ban a medical device since the silicone breast implant scandal in the 1980s.
Women who were injured by Essure have filed around 1,000 lawsuits against Bayer for failing to warn them about the risk of side effects.