Essure® came onto the American market in 2002 promoting itself as a safe, minimally invasive, half hour, in-office procedure that provided women with an effective, permanent birth control solution. Because this new device seemed so promising and held FDA approval, many doctors recommended it to their patients. Sadly, many of the women implanted with Essure® feel as if they did not make a fully informed decision because they were not warned about the serious side effects that caused devastating harm to their overall health.
In fact, the FDA itself has begun to hold Bayer accountable for its questionable testing procedures and dubious reporting of the results of those tests. They now require Bayer to label this device with what is commonly called a Black Box Warning. This warning is designed to plainly inform patients and doctors of the serious risks associated with the use of this device and is the FDA’s strongest warning, reserved for serious or life-threatening risks. The FDA also mandated a Patient Checklist to better inform women of the possible adverse events associated with Essure®. Bayer will further be required to submit ongoing reports on new, improved studies and the data and analysis of the results of those tests.
The FDA hopes these actions will increase awareness of the risks associated with Essure. These new warnings come too late for the thousands of women already implanted with this device. Women deserve better. Women who take their reproductive health and choices seriously enough to consider such a device have an absolute right to all of the necessary data, information, and risks as well as benefits of any device they choose to have permanently inserted into their bodies.