For women who seek sterilization, usually, surgery is the main option. Bayer tried creating a permanent form of birth control through the Essure device. The device, called Essure, is manufactured by Bayer and is a permanent and non-reversible form of birth control. But it has dangerous health risks that the FDA now recognizing.
In early March, the Food and Drug Administration (FDA), announced that the device would have to be packaged with a stronger warning about possible complications. The announcement came after some 5,000 reports of complications, including chronic pain, bleeding, and allergic reactions.
The birth control method is to be used by women who no longer want any children. The FDA reports that when inserted correctly, the device has less than a 1% chance of becoming pregnant. The device requires no surgery – a woman’s doctor can insert the device into a woman’s vagina, through her cervix, and up into her fallopian tubes. Once there, scar tissue begins building up around the device and after time, the sperm can no longer pass through to fertilize the egg.
The FDA states that it still considers Essure an appropriate method of birth control for women who no longer wish to have children. However, serious problems and side-effects have been reported by women who have had the device implanted. These included persistent pain, abnormal bleeding, allergic reactions. Some other complications included perforation of the uterus or the fallopian tubes.
The FDA is requiring that a stronger warning must be placed on the packaging for the device. They are also requiring that doctors go over a checklist with their patients to determine risk factors. Women will have to undergo testing three months after Essure is implanted, making sure that the device is placed correctly. In addition to these actions, the FDA is also requiring that Bayer conducts additional studies looking into the risks of unplanned pregnancy and other complications.
If you have suffered an injury or another adverse health event due to the implantation of an Essure device, you may be entitled to compensation. Contact the law offices of John Foy & Associates. The “Strong Arm” attorneys will help you get the compensation you deserve. Contact us today.