Conceptus

Apr 12, 2023

Karen SweeneyAAP Hundreds of thousands of women worldwide were implanted with the Essure device. Designed to permanently block the fallopian tubes, they were used in Australia for nearly two decades until 2017. Bayer, which bought Essure's creators, Conceptus, in 2013 is being sued in a class action in Victoria's Supreme Court along with other companies involved in the manufacture, distribution, marketing and sponsoring of the device. The action is focused on Patrice Turner, who underwent a hysterectomy at 32, five years after getting the devices and suffering severe chronic pain and abnormal bleeding. Fiona Forsyth KC, representing the women, said the companies presented studies which they claimed showed device defects could not be discovered, but she argued they showed the opposite. "There were red flags from an early point in time of precisely the sorts of issues we are now raising," she said. A 1999 Conceptus document showed one pathologist believed inflammation could be expected to last "the implantation life of the device". The device could only be removed with abdominal surgery, and likely removal of organs through a hysterectomy or removal of fallopian tubes. In a later document Conceptus claimed "we believe the worst case expectation resulting from the inflammatory response will be pain, tenderness, menstrual changes or discharge". "We already have a recognition in 1999 that the worst case expectation from the inflammatory response includes precisely the things that we're complaining about today," Ms Forsyth said. Those issues should have been front of mind she said, noting they also acknowledged the need for long-term studies. "Only two years later it's approved and it goes to market," she said. "It was already being put into women's bodies and at this point the device is permanent - and that's where we say there's a real issue." Essure worked by inserting tightly wound 4cm coils through the vagina and uterus into the fallopian tubes, and expanding them to cause inflammation and then scar tissue, resulting in a contraceptive effect. In a joint defence, the companies say there's no "signature" Essure injury that the women can point to as the cause of their symptoms. They're jointly represented by David Collins KC, who on Wednesday argued Ms Turner's symptoms were caused by adenomyosis. But Ms Forsyth previously told Justice Andrew Keogh that while that was an early suspected diagnosis given by her doctor, it was not confirmed by pathological studies post-surgery, which is the only way to diagnose the condition. Mr Collins said the device was the subject of numerous clinical trials and tests which established that the device was safe, and no studies over the 20 years it was available showed safety risks. "The device provided an important alternative means of permanent contraception and was used by many hundreds of thousands of women," he said. "Despite this extensive use over a long period, there is still no evidence to establish the critical safety risks that the plaintiff alleges." The trial is expected to run for 12 weeks.