Metro women express concerns over Essure
Across the country and right here in Oklahoma, thousands of women are experiencing what they say are horrific side effects from a product called Essure.
Essure is a form of permanent birth control that involves the placement of tiny metal coils into the fallopian tubes. The product is FDA approved, but some women say it's ruining their lives and needs to be pulled off the market.
Women FOX25 spoke with say their lives haven't been the same since they had the Essure procedure. But no doctor will attribute their symptoms to Essure, therefore no insurance will pay to have it removed. so they live with the pain day after day.
Women are experiencing hives all over their body, excessive bleeding, sharp pains in their ovaries and a host of other side effects.
in 2003 mother of two Lisa Gilcrease was done having children and wanted a permanent birth control solution that would get her back on her feet as soon as possible. Her doctor recommended Essure.
"They said it was very easy to get. it was in and out and it's done," Gilcrease said. Doctors told her there were no long term side effects and Essure was her best option.
"They said nothing about it being made from anything. They just said it's little metal coils," she said. Within a week of having Essure Gilcrease started having incredible pain.
Last year, Kimberly Smith made that same life altering decision. Smith says her doctor didn't tell her about any side effects or how Essure was made. Essure is made of nickel, and Smith believes the nickel in Essure is causing her to break out in hives and gain weight. She's always tired, has headaches, and says the pain is often intolerable.
"So I went to my doctor and told him I think I have an allergic reaction to them and of course they said no," Smith said.
Smith and Gilcrease are not alone. 3,200 women are documenting their symptoms on a Facebook page called Essure Problems. Many are frustrated no doctor will attribute their symptoms to the product. The Essure Problems Facebook page we found is a closed group, but click here for a link to another page.
"You should know what this is," said Gilcrease. "It's inside my body, you should know. It's a medical device."
Dr. Gillian Mackay is an OB/GYN at OU's Women's Center. She often performs the Essure procedure and says while she has seen reports of people having chronic pain, in the majority of cases women are satisfied.
"It doesn't really make sense to me that these tiny coils would cause long term chronic pain," said Dr. Mackay.
Bayer, the maker of Essure gave FOX25 this statement: "We are saddened to hear of any serious health condition affecting a patient using one of our products, irrespective of the cause. Essure was approved by the FDA in 2002, and has a well-documented benefit-risk profile with over 400 peer-reviewed publications and abstracts supporting Essure's safety, efficacy and cost-effectiveness."
"Oh it's something else. It's something else and they won't remove it. They leave it in there," said Gilcrease.
Doctors say the removal procedure is difficult and often results in a full hysterectomy. Smith says she already knows her insurance won't pay for it, and removing Essure would cost her $10,000-$20,000. She's only had Essure for a year, but she worries about what her life will be like down the road.
Gilcrease has dealt with it for a decade, and just found out this week she can have it removed. But Smith and Gilcrease still want to warn others about the product they say doctors told them was safe.
"It's about having something on the market that's safe," said Gilcrease. "Because if it's not safe they shouldn't put it out there."
The FDA says none of the information it reviewed establishes a connection between Essure and problems like fatigue, depression and weight gain.