JACKSONVILLE, Fla. - The Food and Drug Administration and local doctors say the Essure birth control device is safe, but women across the country, including here in Jacksonville, say their stories are proof it is anything but.
Two Jacksonville women who were done expanding their families went about making that permanent choice a reality in different ways but were left with the same result.
That result was a series of health problems and complications they blame on the popular birth control device.
Essure has been on the market since 2002. Since then, the manufacturer -- Conceptus Inc. -- reports some 750,000 procedures have been performed worldwide.
Amber Epley and Rebecca Howell both turned to the Internet to help get through what they call "medical disasters."
They're two of nearly 15,000 women involved in social media support groups aimed at taking Essure off the market.
Nearly 950 women have now filed complaints with the FDA.
"I knew my body was telling me something was wrong," Epley said.
She said she had her health stolen after a five-year battle she believes is due to Essure.
"I've had my gallbladder removed; gall stones are a side effect," she said. "I've had hypothryoid disease, which is also a side effect."
The birth control device consists of two small metal coils, which are placed inside each fallopian tube. Scar tissue then grows to block conception.
Dr. Kenneth Sekine said he's heard complaints over the years, but is quick to point out the device isn't for everyone and recommends a thorough evaluation first.
"There are going to be a majority of people that have the expected results, and then there with the numbers, there's going to be potential problems," Sekine said. "Overall, it's extremely safe, and side effects from it are very rare."
According to the FDA, it's received 943 reports of adverse events related to Essure between 2002 and 2013. The most frequent problems reported were pain, hemorrhage, patient device incompatibility, mal position of the device, and device breakage.
Through EssureProblems.webs.com, Epley found hundreds of other women with stories just like hers, including Howell, who chose Essure after her third child.
"On Dec. 20, five days before Christmas, I'm getting an early Christmas present, which is a hysterectomy at 30," Howell said. "I never thought I'd be happy about a hysterectomy at 30, but that's Essure."
Thousands of other women on social media pages are posting pictures as well, including X-rays that show coils cutting through fallopian tubes and coils that have broken after insertion, issues Epley wants more women to be aware of.
"I just don't want it to happen to other women," she said. "And I'm sure it's happened to more women. If it's happened to me, I'm sure there's more."
In a statement, the FDA said it will "continue to monitor the safety of Essure to make certain that its benefits of providing women with a non-incisional sterilization choice continue to outweigh its risks."
Famed activist Erin Brockovich has now joined in this fight for change. She's started an online petition on Change.org, which at last check has been signed by more than 950 people.
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