Thousands of women rally against sterilization device Essure

What started as a small Facebook support group two years ago has grown as thousands of women with the Essure sterilization devices have cataloged side effects and injuries they claim were caused by the nickel-coated coils.

Essure, which received FDA approval in 2002, works by inserting small metal coils into the fallopian tubes. The coils cause scar tissue that then closes the tube and completes sterilization. When it was first introduced, it was hailed as a cheaper and safer option for sterilization that could be done in a doctor's office rather than surgical suite.

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Gabby Avina, a gynecological nurse from the Bay area, participated in some of the clinical trials. "I watched the procedure several times," she said. "I participated in it and thought this is a good option for me, so I had it."

Avina's coils were implanted in 2000 and resulted in sterilization, but she started to experience health effects that she didn't connect to the coils.

"I've had a total of five autoimmune diseases in the span of 12 years," she explained.

In the meantime, Avina spoke on behalf of Essure developer, Conceptus.

"I spoke at national conferences in favor of the device and was featured on brochures and in testimonial videos," she recalled.

Avina even testified at the FDA approval meeting for Essure, which helped the company secure a pre-market approval, which provides a shield from lawsuits over medical devices. It was only after years of illness and contact from other Essure patients online that Avina finally connected her coils to her illness.

"I ignored [the other patients] for several months until I finally got a message from one that said, 'I know you don't want to talk to us, but will you tell us if you're well.' Then I was intrigued," she said.

Avina had suffered autoimmune disease so severe it required chemotherapy. She had clinical depression due to the multiple medications and a loss of energy that she said prevented her from working.

"I really lost my identity. I wasn't able to parent like I wanted to," she explained. "I couldn't be the wife I wanted to be. I couldn't be a nurse."

Avina is one of 10,000 women now on the Essure problems Facebook page, where women list conditions they believe are related to their Essure coils. Some upload pictures of coils that have migrated into other organs and others show skin conditions they believe to be an allergic reaction to the nickel in the device. The administrators of the page have filed multiple complaints with the FDA, enlisted the support of Erin Brockovich and launched an education assault on several social media platforms.

This spring, the administrators traveled to Germany to testify before the Bayer stockholders meeting. Bayer purchased Essure from Conceptus two years ago and surprised several speakers with the requirement that all speeches before stockholders be delivered in German. Fortunately for Michelle Garcia, she had been warned by another medical activist group to be prepared to deliver her speech in German.

"I hired a language coach and trained for two hours a night for weeks," Garcia said. "I wasn't even nervous. I know my story and I know the story of thousands of women who've been injured. Bayer was not going to steal my voice. They've stolen enough from me."

Garcia and Angela Desa came home from Germany with no promises, but attracted international media attention for their cause.

"We've been interviewed by Chinese media, German media and UK outlets," Desa said.

The first lawsuit against Bayer and Essure was filed in Philadelphia this month. It claims the company did not follow up on conditions of the premarket approval and that the PMA should be nullified. The firm has hired additional attorneys to begin working with Essure patients from around the country.

When asked for a statement on the claims from the Essure Facebook group, a representative for Bayer said, "patient safety is very important to us and we have great sympathy for anyone experiencing pain, regardless of the cause. These stories, while compelling, are not representative of the hundreds of thousands of women who have relied on Essure since its FDA approval in 2002."

Bayer Statement by Kxtvweb


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