Birth control is an important topic among women who are in their child-bearing years. While many women want a form of birth control that can be easily discontinued should they decide to have a child, some women may want a more permanent option. In the past, a more permanent form of birth control usually required a procedure called a hysterectomy, which required a hospital stay and downtime. Then came Essure, a less invasive form of permanent birth control. It was a solution that turned out to be problematic for thousands of women. Now, the Food and Drug Administration is cracking down on sales of the device, as the Baltimore Post Examiner reports.
As of December 2017, the FDA had received 26,773 adverse reaction reports regarding the Essure device.
Women who have had the device implanted and experienced complications say that they have had pain so bad that they have missed work. They have also reported heavy, painful periods. Many of these women end up undergoing the procedure that they had hoped to avoid by getting the Essure device implanted – a hysterectomy.
The device has experienced a 70% decline in sales and, in April, the FDA began requiring that doctors go over the risk factors with their patient. The patient then has to sign a form stating that they are aware of the potential risks.
The FDA has also required that Bayer perform additional studies as to the safety and the effectiveness of the Essure devices.
Bayer says that they take reports of problems and adverse side effects very seriously.
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