Federal health experts today questioned the maker of Essure, a popular birth control implant that many women say caused long-term pain, bleeding, and fatigue. Since 2013, the FDA has received thousands of complaints about the device, often pitched as the only non-surgical option for permanent birth control, from women and doctors. While Essure's label warns about pelvic pain, bleeding, and allergic reactions shortly after the implant procedure, many women say these problems persisted and were so severe they required invasive surgery to remove the device. "Pain became my norm every day," one woman who used Essure says. "This negatively impacted my marriage, and I could not be the mother my children deserved."
Thousands of women have attributed severe problems to the implant, including chronic pain, headaches, mood disorders, hair loss, and irregular bleeding. Many of those complaints have been shared through social media, including a Facebook page called Essure Problems, which has more than 20,000 members. Bayer, the manufacturer of Essure, estimates 750,000 women have received the implant since 2002. The FDA convened the meeting today to have its outside experts review Essure's safety and effectiveness. The panel's recommendations are not binding. (Read more FDA stories.)