More and more often people are questioning whether or not Essure is safe. The Food and Drug Administration and local doctors in the Jacksonville area 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. Channel 4 recently interviewed two Jacksonville women who had severe complications from using Essure. Both of the women had a series of health problems and complications they blame on the birth control device.
Essure is a permanent birth control method for women that creates a barrier against pregnancy. It involves placing soft, flexible inserts into the fallopian tubes. Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception.
Local women 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 hypothyroid disease, which is also a side effect.”
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.”
According to news reports, a majority of the women are experiencing side effects from an allergy to nickel, which is a component of the coils. Originally, doctors were advised to test women for nickel allergies before implanting the Essure coils, but the manufacturer asked the FDA to remove that requirement a few years ago.
Bayer, which is the drug manufacturer for Essure, notes that the use of a nickel titanium alloy in Essure remains as a warning in the product label. The language of the warning is pasted below:
From Warnings Section:
The Essure micro-insert includes nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. In addition, some patients may develop an allergy to nickel if this device is implanted. Typical allergy symptoms reported for this device include rash, pruritus, and hives.