Analyst Finds 'Immense Discrepancy' in FDA Data on Bayer's Essure

Feb. 19, 2016

A private analyst says the U.S. FDA may have greatly underestimated the number of fetal deaths among women who became pregnant after using Bayer's Essure contraceptive device.

While the FDA has cited five fetal deaths in women who became pregnant after using Essure, Madris Tomes, founder and CEO of Device Events, says the number is actually 303.

Tomes analyzed thousands of adverse events from the FDA's website, reading the detailed text of all complaints, and searching with a broader list of keywords than the FDA uses.

Approved in 2002, Essure was promoted as an alternative to tubal ligation. The FDA is expected to meet this month to make a decision that could involve restricting use of the device or additional clinical trials.

In 2013, famed consumer advocate Erin Brockovich launched a grassroots campaign against Essure, lobbying for the device to be taken off the market. Bayer maintains that the device is safe, claiming to have sold around 750,000 units.

Read the recent Reuters article