How Did Essure Get Approved? Here’s One Opinion

“The FDA requires a Premarket Approval (PMA) to review and evaluate the safety and effectiveness of Class III medical devices like Essure. FDA regulations require that this takes 180 days, and normally longer, but there are records that show that this process was expedited and several trial candidate’s records were altered to obscure unfavorable data. Some patients were completely thrown out of the clinical trials when their data reflected poorly on the device. According to the citizen’s petition linked above, there were many adverse events that Essure manufacturers and PMA holders failed to report and/or covered up. Additionally, over 16,000 patient complaints were withheld from the FDA. When the manufacturing facilities were inspected, many unsettling thing came to light, starting with the facility’s lack of license. The manufacturer of Essure were operating without a license for three years.” (