|Updated: 12/13/2013 3:38 pm
||Published: 12/13/2013 2:46 pm
FOX23’s Shae Rozzi is investigating complaints about the popular birth control device known as Essure. Several women claim they’ve suffered serious complications.
Essure is marketed as the only surgery-free, hormone-free permanent birth control for women. It usually takes 10 minutes to implant the device at the doctor’s office according to the marketing material.
A Broken Arrow mother told Rozzi that her 10 minute appointment turned into a five year health battle.
Jessica Wiley says after the birth of her third child 5 years ago she was pretty sure she did not want to have any more children.
Wiley says her doctor recommended Essure. She has a nickel allergy and recalls asking if the product was made of nickel. Wiley says she was told that it wasn’t.
Wiley says she felt immediate pain in her uterus when the first of the two Essure coils was implanted and that there was trouble implanting the second device.
“I was in a lot of pain. I got home and it didn't go away,” Wiley said. “I was bleeding a lot.”
She says that pain only got worse. Her doctor recommended a hysterectomy but she says by that time she’d lost her insurance and couldn’t afford the surgery.
So she dealt with the pain for five years.
Wiley is one of more than 4-thousand members of the Facebook Group “Essure Problems.”
FOX23 met another group member who lives just inside Arkansas.
Debbi Riggins has family in Tulsa.
She sent Rozzi pictures of a rash on different parts of her body and pictures of her face which she says shows the weight she’s gained since using Essure.
The product’s website shows that Essure consists of two flexible inserts that are made with Nickel and other material.
The coiled pieces are implanted in a woman’s fallopian tubes.
Tissue eventually grows around it blocking sperm and preventing pregnancy.
In October, Jessica said her pain was so bad, she couldn’t stand up.
Medical documents she shared with FOX23 show that she suffered “chronic pelvic pain with a possible misplaced Essure.”
“It feels like someone has a spiral shaped razor knife and they are twisting it inside on either side of my pelvis area,” Wiley said.
Wiley says her doctor told her a hysterectomy is the only way to end the pain and fully remove the Essure devices.
“She told me that the Essure device had preforated my uterus and was loose in my abdomen,” Wiley said. “She told me she didn't find that out until she got my uterus out.”
Wiley is one of more than 900 women who have cited adverse events.
They have the attention of activist Erin Brockovich.
The patients and Brockovich are trying to change the FDA status of Essure so patients who’ve suffered problems can sue.
They ultimately want Essure pulled off the market.
“I wouldn't recommend it to anyone. No one,” Wiley said.
In November, Bayer, the maker of Essure updated its patient booklet listing pelvic pain and device migration as possible side effects.
Part of a statement the company sent to FOX23 reads, "We are saddened to hear of any serious health condition affecting a patient using one of our products, regardless of the cause… We continuously review the
information available about our products and, when appropriate, we work collaboratively with the FDA to update the information available to patients and physicians."
FOX23 contacted the U.S. Food and Drug Administration.
A spokesperson told Rozzi that the FDA had recently conducted a five year study of Essure.
Part of the FDA’s statement to FOX23 reads, "Although there is evidence of complications, as there are with all medical devices, overall results from the study did not demonstrate any new safety problems or an
increase incidence of problems already known."
When Rozzi was at Wiley’s home, her kids were getting excited about Christmas and getting gifts from Santa.
Now that Wiley is recovering from her hysterectomy and no longer has Essure in her body, she feels she got the gift she’s been wanting for years, her health.