FDA investigation into Essure contraceptive device adverse events-Conceptus/BayerHealth Care

The FDA has acted on citizens petition requesting a recall of the Essure contraceptive device from Conceptus/Bayer HealthCare and allegations of fraudulent clinical trials.The FDA has referred the complaint to the Office of Compliance of the Centre for Devices and Radiological Health for investigation.

Comment: The Essure device has been controversial for several years with complaints from hundreds of women claiming that the device causes pain, organ perforation and device migration amongst other events An earlier FDA investigation found 934 reports of adverse events from 2002 to 2013 but found that the results of a five year post marketing study did not identify new safety problems and that the device was 99.8% effective in preventing births.