Women across America are furious with the FDA [and Bayer], and nowhere is this sentiment louder than on Twitter, where patients are posting daily about the devastating effects on their lives of a permanent, non-hormonal contraceptive called Essure.
Approved by the FDA in 2002, Essure is a non-hormonal birth control device consisting of two metal coils that are implanted in the fallopian tubes to prevent sperm from reaching the eggs. It’s supposed to be a less invasive alternative to tubal ligation (“getting your tubes tied”). The procedure is performed in a doctor’s office and, assuming everything goes as planned, does not require any recovery time.
Despite being advertised as relatively painless, for thousands of women Essure has been anything but. Over the last decade and change, the FDA has received nearly 10,000 reports of adverse events related to Essure. According to the FDA’s website, the most commonly reported side effects are pain (mostly abdominal), heavy and/or irregular periods, headaches, and fatigue. There have also been more than 600 reports of pregnancies. Of these pregnancies, nearly half resulted in miscarriages.
While these numbers are concerning in and of themselves, they pale in comparison to the individual stories of physical and mental anguish caused by an Essure implantation gone wrong. Earlier this month Refinery29 published a thorough investigation of the Essure saga. The article profiles several members of Essure Problems, a Facebook group started in 2011 to spread awareness about the dangers of the device and offer support to women affected.
The women interviewed by Refinery29 were among those who testified before a panel of FDA representatives at a special meeting held last September. Supported by a group of medical experts, they presented their stories as evidence that the hundreds of thousands of women who have been implanted with Essure were not adequately warned of the health risks posed by the device. Given their traumatic experiences, as well as the countless others that had not been officially documented, they were calling for an outright ban on the device.
Instead, the FDA announced in February that it would be adding a “black box” warning to Essure (the most severe warning), and would require Bayer, the maker of the device, to conduct additional trials. The response on Twitter was swift and vicious. According to an analysis by Treato of more than 6,000 Essure-rated tweets, patients and activists felt betrayed by the FDA, which they assumed had their best interests in mind. While they were used to unscrupulous behavior from “Big Pharma," they expected more from the industry's main watchdog. Notably, commenters placed more blame on the FDA, to whom they often referred as "you," than Bayer. If the FDA won't protect them, women seemed to wonder, then who will?