Federal health experts are taking another look at Essure, a permanent birth control device for woman that is associated with numerous serious side effects.
The Food and Drug Administration will be asked to consider further clinical studies on Essure, and will be asked to make changes to the device’s warning label.
Some 17,000 women have taken to Facebook to discuss Essure, which they say did them more harm than good. The women allege the contraceptive caused them chronic pain, heavy bleeding, fatigue, and skin allergies. They’ve created a group on the site called “Essure Problems.” [1]
Essure was purchased by Bayer for $1 billion when the medical device maker acquired Conceptus in 2003. The company maintains that Essure is safe and effective. About 750,000 devices have been sold, mainly in the U.S.
The device consists of two tiny metal coils made of nickel-titanium alloy that are inserted into the fallopian tubes, where scar tissue develops around the coils, preventing a fertilized egg from making its way to the uterus.
“This device has been sold to tens of thousands — probably hundreds of thousands — of women as a very safe and easy way to permanently end any concerns about pregnancy,” says Diana Zuckerman, who heads the National Center for Health Research, a Washington-based watchdog group that has been studying Essure. “We know that’s not accurate,” she says.
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According to Zuckerman, the FDA was never informed by Bayer about the adverse events that Essure could cause when the agency approved it in 2002. While Essure is marketed as 99% effective, Zuckerman says recent studies suggest it may fail 10% of the time. [2]
“What we’d like to see is new research that’s carefully monitored that can actually tell us how often women have these serious complications from Essure and how often the product does not work to prevent pregnancy. That’s what we really need,” Zuckerman says.
Dr. Sebastiaan Veersema, a gynecologist at St. Antonius Hospital Nieuwegein in the Netherlands, believes a stronger screening process could help doctors avoid implanting Essure in women who have uterine fibroid tumors. He also believes more research needs to be done concerning whether Essure is the source of the health problems reported by women.
“If there is something wrong with the device I want to know,” he said.
One person who will be testifying on Bayer’s behalf is Dr. Cindy Basinski, who has been implanting Essure in women since 2006 and estimates she has conducted about 1,100 procedures with minimal complications.
While Dr. Basinski admits she has had “a couple” of patients complain about Essure side effects, and one patient who asked to have the device removed, she says it’s not possible to draw any scientific conclusions from anecdotal information.
Additional Sources:
[1] NBC News
[2] NPR
Featured photo courtesy of Bayer HealthCare