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article imageBayer's Essure trial is approved again after FDA re-evaluation

By Claudio Buttice     Sep 19, 2016 in Health
The U.S. Food and Drug Administration (FDA) concluded its investigation on Essure's pivotal trial. Bayer, the company that manufactures the controversial contraception method, has been, in fact, accused of manipulating data to inflate the device's safety.
Recently, Congressman Mike Fitzpatrick accused the German pharmaceutical giant of mishandling many patients reports in order to under-report the many side effects of the allegedly dangerous device. He formally requested a review to ensure that the company did not lie to the consumers and even alleged that the manufacturer paid illegal kickbacks in the form of referral lunches and free medical equipment to increase the use of Essure. The U.S. regulatory agency found that there's no evidence of real manipulation and, after reviewing all data provided, confirmed that no case report forms have been inappropriately modified.
According to the summary of findings published by the FDA, in fact, Bayer can now shrug off all accusations of “clinical trial misconduct” it received so far. Investigators found no discrepancies between the "comfort level" of the patients implanted, and the pain they reported in later times. Technically less than one percent of total reports included slight modifications, but even among those, less than 35 percent were actually in favor of the device's safety. Although the pharmaceutical company cooperatively provided all the documentation to the FDA, all the original lab records collected before the trial was over (i.e. prior to 2002) were not available.
Essure consists of two metal coils (micro-inserts) inserted in the fallopian tubes without the need of surgery nor anesthesia (hysteroscopic sterilization). After a few months, scar tissue blocks the tubes preventing sperm cells from reaching the egg, effectively stopping conception. In the United States, an impressive amount of lawsuits has been recently filed by women who claim they have been injured by the device. Since its original approval in 2002, a number of stories of patients who suffered all kind of side effects shortly after being implanted with Essure started appearing through the web. Many of them were collected in one of the most famous Facebook groups in history, the so-called Essure Problems. Led by the famous consumer's advocate Erin Brockovich, many of these alleged victims brought their cases to court, accusing Bayer of releasing a dangerous product to the market through the pre-market approval process (PMA). Over 10,000 adverse reaction reports have been filed in just a few years, mostly complaining about unexpected pregnancies, heavy bleedings, and chronic pain. However, some of the most gruesome Essure stories included horrific injuries caused by device breakage such as organ perforation and punctured uterus.
Due to these concerns, in February 2016 the FDA re-assessed Essure's safety and effectiveness after completing a new six-months-long real-world surveillance study. Eventually, the agency requested Bayer to conduct a new post-market evaluation of their product, and added a new black box warning to be added to the device's label. Worldwide, Essure is still seen as a relatively dangerous medical device. On May 30, Health Canada issued a warning about the risk of serious complications and is actively monitoring all patients implanted. In Italy instead, less than one percent of women chose Essure as a form of birth control method, compared to a much higher 23 percent in the United States.
More about essure, Bayer, Lawsuits, Contraception, Medical devices
 
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