RICHMOND, Va. (WRIC) — An advisory panel is now recommending limited use of the popular birth control Essure until more is known about its safety.
The advisory panel suggests women with an allergy to metal, an autoimmune disease or history of pelvic inflammatory disease stay away from Essure right now.
Click here to view a summary of the panel’s review and suggestions.
This is just the panel’s suggestion after a public hearing last week; the FDA does not have to implement the recommendations.
The recommendations come as independent researchers speak out to 8News calling the clinical trials to put Essure on the market flawed.
The tiny nickle coil device marketed as less invasive and less expensive than having one’s tubes tied hit the market 13 years ago.
“When we first looked at studies this looked like a great product, few complications were noted but when she talked to women saw different story,” says Diana Zuckerman, President of the National Center for Health Research.
Zuckerman tells 8News she began to research the clinical trials after thousands of women, so called “e-sisters” like Mechanicsville Mom Lacy Bradley, turned to Facebook to complain about the device.
“I woke up in the middle of the night covered head to toe in hives,” says Bradley.
And 8News investigation found 5000 complaints filed with the FDA ranging from allergic reactions to pregnancy to perforations of the uterus and more.
Zuckerman’s review found when some women were surveyed about their experience with Essure, if they marked “yes” to pain or health issues, their answers were sometimes changed to “no.” She also says sometimes comments about pain were crossed off.
“When you do that to the data you are basically manipulating the data, some people would call it fraud,” says Zuckerman.
At the recent FDA hearing, a woman once part of the trials and a former spokesperson for Essure, Gabriella Avina, said, “I am here today 13 plus later to say I was wrong.”
In the New England Journal of Medicine, Yale doctors found key data missing.
It’s prompted a federal lawsuit.
Attorney Allison Gordon says, “In terms of fraud we think the company didn’t adequately report issues that they were seeing, as you could see in the FDA hearing, 30 percent were lost to follow up.”
In a statement to 8News the manufacturer of Essure, Bayer, says:
“We strongly disagree with the characterization of the changes made to the referenced clinical trial records, which were initialed and dated. Some of the changes provide further information about the patient’s symptoms.”
They go onto say Essure remains a safe and effective birth control device.
Still, that advisory committee would like to see more data, perhaps a registry to track complications and more training for doctors on how to remove Essure.
There is no timeline for when the FDA will respond to the panel’s recommendations but a spokesperson says it is a priority.
The “e-sisters” say that’s not enough.
They want Essure pulled from the market and they are calling on women to contact lawmakers.