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By Darian Carrow, The Stream, March 13, 2019
Essure, a sterilization device for women, isn’t safe. At least that’s what the evidence suggests, with thousands of women reporting being harmed by the devices. Regardless, Bayer AG kept the device on the market until December 2018. America was the last country that sold the device.
Many women have filed lawsuits against Bayer because of the side effects caused by Essure. Some of the side effects include tears of the uterus or fallopian tubes and migrating devices. Essure was sold as an easier and safer alternative to surgery. Women could go back to their regular activities the same day.
Known Problems with Essure
Bayer knew about the side effects before Essure was approved for sale. Clinical trials had recorded problems with the device. It didn’t matter. The U.S. Food and Drug Administration (FDA) approved the device anyway. Dr. Katy Moncivais, a medical writer, said the FDA isn’t absolved of their actions. “Their decision panel discussed the risk associated with approving a permanent implant like this after following clinical study patients for only a year but ultimately approved the device anyway.”
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What’s more, the FDA likely rushed the process for Essure to go to market. The FDA usually requires new medical devices to go through a safety evaluation before it can be sold in the U.S. That process usually takes 180 days or more. Some records suggest Essure made it to the market before 180 days. In addition, the study may have been doctored. Some believe that several women in the trial had their records altered to reflect favorable data.
Alarmingly, the most major complications were not reported. They were covered up. Tens of thousands of complaints were not reported to the FDA. Other concerns came to light after an inspection of the facilities. The facility where the device was made had been unlicensed for three years.
It was only after thousands of adverse events had been reported by Essure patients that the FDA took steps to regulate the product. The first of which was to add a boxed warning. This warning explained possible risks associated with the device. Boxed warnings are the most serious warning the FDA issues. They indicate that the prescription has reports of serious adverse events.
The FDA also required Bayer to begin a three-year post-market study of the device. The study would look at the benefits and risks of the device compared to other sterilization methods. After Bayer voluntarily stopped the sales of Essure, the study was extended to five years.
In April 2018, the FDA began to require that all women complete a patient decision checklist before getting Essure. This checklist was used to inform patients of the benefits and risks of the device.
The device was either banned or pulled from the market by Bayer in many countries prior to December 2018. Bayer and the FDA should have acted quicker in pulling the device off the market. If they had, thousands of women might have been saved from the harm caused by Essure.
The president of the nonprofit National Center for Health Research, Diana Zuckerman, said Essure is among medical devices approved without “clear evidence of safety or effectiveness.”
“As a result, when thousands of women reported serious complications from Essure, there was no unbiased long-term research to refute or confirm those reports,” she said. “If patients had been listened to when the first clinical trials were conducted on Essure, better research would have been conducted to determine exactly how safe and effective Essure is.”