The Federal Drug Administration is currently conducting hearings into the safety and effectiveness of the Essure permanent sterilization implants, as marketed by Bayer. This comes as tens of thousands of complaints have poured in, and lawsuits are filed.
Essure is marketed by Bayer as a safe and effective alternative to surgical sterilization, in that the device is implanted in women through the vagina in a doctor’s office. Two coils are implanted in a woman’s Fallopian tubes. Scar tissue forming around the implants then blocks the tubes, preventing conception. The FDA fast-tracked Essure onto the market because it offered the first seemingly viable alternative to surgical sterilization, with a promised quick recovery.
That’s not the way it’s worked for over 15,000 women who have received the implants in the U.S. Fallopian tube infections and perforations, unintended pregnancies, allergies to the nickel in the device, autoimmune problems, hysterectomy and even death have been reported.
The studies Bayer submitted to the FDA when requesting approval for the device are now being called into question. The device’s success rate pre-FDA approval was based on a study of only 449 women — a study which was completely funded by Bayer. In addition, of the three co-authors of the study, one received a grant from Bayer, another received consulting fees from Bayer, and the third admitted to being an adviser to the pharmaceutical giant. So much for being impartial.
In a report published in the New England Journal of Medicine, Yale doctors accused the Bayer study’s authors of ‘fuzzy math.’
According to Sanket Dhruva, a Yale researcher:
When the FDA approved Essure, they moved too quickly on a relatively incomplete set of data. We don’t really know how well it works.
Well, that’s reassuring.
Watch a report about the device and its problems below:
Here is yet another prime example of a male-dominated culture controlling women, and their reproductive health, for profit.
From the looks of the device, it appears that Bayer bigwigs had a bunch of old-fashioned ballpoint pen springs lying around and said, “Hey, we’re not using these. Let’s implant them in women to stop pregnancy and make a LOT of money!”
Let’s hope the FDA pulls approval for this device before more women are harmed.
Featured image courtesy of npr.org.