Earlier this year, an independent researcher working for a New Orleans-based law firm discovered some discrepancies between the number of unwanted pregnancies in women using Essure and the number that manufacturer Bayer actually reported to the Food and Drug Administration. The researchers claim that Bayer's own internal reports counted over 2,000 cases in which the device failed to prevent pregnancy – yet the FDA received reports on only 631 of them. Yet Bayer continues to insist that their Essure device is “more than 99% effective,” and has sent a letter to the firm requesting that the press release be taken down, calling it “plainly inaccurate.”
That is not the only adverse event associated with the faulty birth control device that has allegedly been under reported. For example, in February, the FDA reported a total of five fetal deaths in women who conceived despite having the Essure device. However, Madris Torres, founder and head of Device Events, closely examined the FDA public database, and found that number to be over 300.
What is the explanation for these discrepancies? According to Torres, it has to do with the method the FDA uses when searching for information on adverse events. These reports are submitted by patients who have been affected as well as physicians. However, when the FDA searches these reports, it looks at the broad headings, not the actual details contained in the text. Torres points out that adverse event reports to the FDA have check boxes for issues such as “malfunction,” “injury” or “death.” She says, “My system searches the [complete] narrative, using keywords such as 'fetal death', 'stillbirth', 'stillborn' and 'miscarriage'.” A former data analyst for the federal regulatory agency, Torres started Device Events in the summer of 2015 in order to conduct more in-depth analyses of FDA public information.
The disparities in this information also caught the attention of GOP legislator Mike Fitzpatrick of Pennsylvania, who introduced a bill last year to have Essure taken off the market, calling on the FDA to withdraw its “pre-market approval” of the Essure device. According to Fitzpatrick, the discrepancies between the FDA data and the information discovered by Torres indicates serious problems with the way the agency conducts its post-market surveillance. He told the Regulatory Affairs Professional Society that “It's pretty clear [the] FDA either has data they're not paying attention to or they've got defective systems in place to analyze the data.”
Fitzpatrick is correct. The FDA's 2002 pre-market approval of Essure was based on a limited study in which only about 750 women took part. Furthermore, only 25% of those patients were followed up over the subsequent two-year period. In the meantime, Bayer continues to insist that the device is safe, stating that it is “irresponsible to suggest that Essure causes fetal deaths when, after an unsuccessful Essure procedure, an undesired pregnancy cannot be carried to term.”