A Bayer Corporation subsidiary has been having a lot problems with the medical device known as “Essure,” used for birth control or sterilization. Pieces of the device can migrate within the body, causing sometimes serious damage. See the full article here.
In October of 2013, the FDA finally acknowledged that since its initial approval of the Essure device, the regulatory agency had received a total of 943 reports of adverse events – in addition to as many as 1,000 complaints submitted through the FDA’s voluntary reporting system. As is far too often the case, growing evidence indicates that the manufacturer was aware of these dangers from the beginning – and yet, the Essure sterilization device was granted FDA approval in 2002. The selling point of Essure was, as always, based on cost analysis. Tubal ligation, the traditional method of sterilization, is a major surgical procedure that requires the patient to be anesthetized and to remain in the hospital. Implanting Essure is a relatively minor outpatient procedure that can be done in a physician’s office.