Doctor testifies against Essure at FDA headquarters
EL PASO, Texas - A local gynecologist testified before the Federal Drug Administration in Maryland Thursday regarding the dangers of the birth control implant, Essure.
Although the FDA maintains there's no evidence linking these claims to the permanent birth control device, the public outcry from thousands of women sparked a review of the device along with Thursday's hearing.
Nearly 50 people testified at the open FDA hearing, including El Paso Doctor Julio Novoa. A few people had good things to say about the device while the majority slammed the FDA and pharmaceutical company Bayer for the debilitating side-effects they say Essure caused.
Each person was given three minutes to speak. Novoa is the main commentator on the Essure Problems Facebook forum that has more than 21,000 members.
Novoa cited data from a survey done within that forum.
"Data collection found over 500 unintended pregnancies with ectopic pregnancies and Essure induced abortions rates as high as 40 percent," Novoa said.
His main message to the FDA was Bayer should not be allowed to market Essure as a non-surgical device.
"Advertising it as nonsurgical is not only misleading but unethical and potentially criminally deceptive allowing this to continue compromising the trust and welfare of the US consumer and must stop immediately," Novoa said.
Before he left for Maryland, Novoa said it's difficult to get a product like this off the market, so he pleaded for the FDA to order Bayer to stop advertising this as a 'non-surgical' device.
The FDA committee will discuss the testimonies heard Thursday and vote to either make changes or keep everything the same.