CHICAGO (CBS) — It’s supposed to be an easy way to avoid pregnancy.
A tiny device. A permanent solution.
But some women tell CBS 2’s Roseanne Tellez that instead of peace of mind, they got a painful lesson about Essure.
At 28 years old, with 3 boys, Amanda Dykeman said her family was complete. So she decided on a permanent contraceptive device called Essure.
“It was this in and out procedure no downtime, no incisions,” she said.
Doctors implanted tiny coils into her fallopian tubes. Then tissue grows around the coil until the tubes are permanently blocked.
The procedure took 15 minutes.
Dykeman said, “They just make it seem like a cake walk.”
But six months later, she said, “I noticed the swelling of the abdomen. I had clots probably the size of baseballs and headaches and migraines. The fatigue. I cannot express how tired I was. I am furious that this product has taken so much time away from my children.”
An Essure problems Facebook page, started by consumer advocate Erin Brockovich, shows thousands of women are having the same problems.
The complaints aren’t just about pain.
Ellen Hanrahan said, “I told a couple of co-workers, if I didn’t know better I’d think I was pregnant.”
Nine months later, baby Leena arrived.
Hanrahan, 36, said, “I was shocked. Disbelief.”
Because of her age and those coils, Hanrahan’s pregnancy was high risk. She had heart trouble, contractions, and more.
Now both of these women, and others like them, want Essure taken off the market.
Dykeman said, “Someone just needs to fess up and say we might have misinformed you guys. We’ll change this, you know.”
The maker of the device, Bayer, said it “takes the safety of our products very seriously … over 400 peer-reviewed publications and abstracts support Essure’s safety.”
Dr. Alexander Lin at Northwestern Medicine says he’s implanted several hundred.
Do you think take if should be taken off the market? Dr. Lin said “I don’t believe so.”
“In my personal experience well over 90 percent of patients are very happy with their decision.”
For those who aren’t happy with Essure, there may be no recourse.
That’s because Bayer was granted pre-market approval.
And that generally bars consumers from suing.
To date, 943 complaints have been filed with the FDA.
There are 750,000 devices in use. One victory for dissatisfied patients is that the company has redone its literature, taking more time to spell out possible adverse side effects.