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Australian women claiming to have been injured by Bayer’s Essure permanent birth control implant are joining together to file a class-action lawsuit. Bayer already faces thousands of Essure lawsuits by women who allege that they were injured by the birth control implant. The women assert that Essure has caused side effects like chronic pain, migration of the device, perforations, and more.

Bayer Stops Selling Essure in Australia, but Continues in the U.S.

Essure appeared on the Australian market in 1999. It is a spring-like device that doctors place inside a woman’s fallopian tubes. There, it encourages the formation of scar tissue, eventually sealing off the tubes and preventing pregnancy.

The Australian Register of Therapeutic Goods (ARTG) issued a hazard alert for Essure on August 30, 2017, and recalled the device from the Australian market. The move was in response to reports of problems with the product.

Between 1999 and August 2018, the Therapeutic Goods Administration (TGA) received 59 adverse event reports from women using the device, with women complaining of changes in menstrual bleeding, unintended pregnancy, chronic pain, hypersensitivity, migration, and perforation. Some of the issues were serious and resulted in the removal of the device through surgery, including hysterectomies.

Prior to this recall, On May 31, 2017, Bayer had decided to discontinue the distribution of Essure in Australia, for alleged business reasons. Devices already in the supply chain, however, were still allowed to be implanted until the recall in August. After that, no new Essure implants were allowed in Australia.

Bayer continued to sell the product in the U.S., however.

FDA Limits Use of Essure in U.S.

One of the plaintiffs in the proposed class-action lawsuit is a mother of four who had the device implanted in 2010. She claims to have then experienced side effects for years, including bleeding, hair loss, and loss of cognitive function. She and the other plaintiffs claim that Bayer failed to provide adequate warnings about the risks associated with Essure. The case is expected to be filed before the end of 2018.

Australia was the first country to recall Essure. A month after that recall, Bayer pulled the device from all other markets where it was being sold, except the U.S. But then in April 2018, after learning that women were not properly informed about Essure risks before implantation, the FDA announced it was restricting sales of the device. From that point on, only doctors and healthcare facilities who agreed to use a safety discussion checklist with their patients were allowed to continue offering Essure as a birth control option.

The checklist was approved by the FDA, and gave doctors and patients a way to go over all the potential risks associated with the device. Each patient and her doctor were supposed to sign the checklist before the women could have the Essure implanted.

In July 2018, again citing business reasons, Bayer announced that it would stop selling Essure in the U.S. by the end of 2018.

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