A Clinical Trial Participant’s Story
Kimberly Lira said she’s lived in nearly constant pain for fifteen years.
The mother of three was a patient in the original clinical trial to get Essure permanent birth control approved by the Food and Drug Administration (FDA).
“Every single day I have bloating,” she said. “Every single day, I have pain.”
In 2001, Lira reported to the Women’s Health Research clinic in Phoenix to have the device implanted. Essure consists of two metal coils placed inside the fallopian tubes to block conception permanently.
Essure, then known as STOP 2000, is marketed as a surgery-free alternative to tubal ligation, or getting your tubes tied.
“They told me that it was just a really easy procedure, and just a few minutes were all it took,” she said.
Lira said almost immediately after the procedure she was in pain. “Day three, right after the surgery, I wanted it out already,” she said.
Lira recently obtained all of her medical records related to the trial and shared them with the ABC15 Investigators.
“The stress that I get to look through those,” she said, “it’s crazy. It makes me very emotional.”
Throughout the trial, records show Lira consistently reported health issues associated with the device. Though, Lira said the nurse continuously told her that these were normal symptoms.
“I kept hearing her say this, ‘Oh, honey, that’s normal, everything is normal’.”
Lira said she also noticed some questionable notations in her records from the trial.
Like, when she reported “excessive menstrual bleeding,” it was categorized on her records as “unlikely” that it was related to the device.
And, when she reported “severe menstrual cramping,” the word “severe” was crossed out. […]
“The data makes it look like a product is safer or more effective than it really is,” said Dr. Diana Zuckerman, President of The Center for Health Research in Washington, DC.
She said clinical trials are often flawed especially when it comes to medical devices like Essure because there are fewer legal standards for them.
“Usually the scientists at FDA are very well aware that the studies are inadequate and that patients can be put at risk,” Zuckerman said. “And, yet, decisions are being made to rush these products to get them approved quickly because there’s so much pressure to do that.”
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