FDA Investigates

FDA Investigates Essure After Numerous Complaints

The Food and Drug Authority (FDA) has started their investigation regarding Essure, which is a permanent birth control device, after it received numerous complaints.

A user’s experience

Tess Schulman from Clayton decided that she would like some kind of permanent birth control and talked to her doctor regarding tubal ligation. Here, the doctors introduced to Tess a device called Essure. Since Tess wanted to avoid going for surgery, she decided to get the device inserted. An X-ray which took place after a few months as a follow-up proved that the device had worked. However, after two months of the follow-up, serious symptoms started to show up, the first one being gastrointestinal. She experienced abdominal pain which was only described as excruciating. During the next six years, symptoms increased. She became allergic to a number of things ranging from medications to foods, and to metals so much so that she could not even wear her wedding ring.

She had numerous tests. However, all the tests came out to be perfectly fine. The doctors could not figure out what the problem was. Then, Tess saw stories about all the other women that were facing numerous issues after using the faulty contraceptive device, and she wondered whether the permanent birth control system was the root cause of all her symptoms.

About Essure

Essure basically consists of two pieces of coil which are placed in the uterine tube. The procedure is non-surgical and can be performed in the doctor’s office. Once, the coils settle in, scar tissue starts to form around the coils, blocking the tubes and thus, preventing pregnancy.

What the manufacturer has to say

According to the website, 750,000 devices have been sold around the world. In a video that was posted on YouTube, the manufacturer, Bayer, did acknowledge that some users of the device did experience some issues. But it was stated that there was no relation between the problems and Essure which he could recognize. The company further stated that it believes majority of the users of the device were satisfied with the product. The company added that the device is completely safe and effective. Bayer added that it offers specialists that can answer questions on the phone.

FDA takes action

FDA ordered additional testing for the birth control device. FDA also announced that soon box warnings will be present on the device and the manufacturer should provide a patient checklist which the doctor must go through with women that are considering using Essure.

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