After participating in clinical trials for Essure, a contraceptive implant, several women complained of severe pain and bleeding—but they say their trial records were altered.
Kim Hudak was a young mother who was done having children when she volunteered for a clinical trial to an experimental birth control implant designed to make her sterile without tube tying surgery.But soon after Hudak, 28 at the time, got the Essure implants, she said she developed health problems, including severe pelvic and lower back pain, difficult menstrual periods, and pain during intercourse.She complained to researchers at the Cleveland Clinic and was told her problems were not related to the implant. In an affidavit to the Food and Drug Administration (FDA), Hudak alleges that answers she gave researchers in response to questions about pain, adverse health effects, and even whether her period was late had been altered on her medical record, without her knowledge. Those statements were part of the usual data collection for FDA approval of the device.[…]Hudak is one of several clinical trial participants who say that when they experienced complications with the implant, doctors and nurses ignored or belittled their symptoms, insisted Essure could not possibly have caused them, and referred them elsewhere for treatment.On Thursday, an FDA advisory committee will hold a public hearing in Silver Spring, Md., to address questions about the safety and effectiveness of Essure, which was approved in 2002. Some women’s health care advocates want the device pulled off the market, and a citizen petition filed with the FDA by a Florida law firm says that the approval process and clinical trials were “replete with fraud.”
Users have filed 5,093 complaints with the FDA citing chronic pelvic pain, debilitating periods, pregnancies that occurred with Essure (including five that ended in fetal death), hysterectomies to remove devices that moved to other organs or broke apart, and four patient deaths, including one by suicide.
Officials with Bayer HealthCare Pharmaceuticals, which purchased Essure in 2013 for $1.1 billion from the company that developed it, Conceptus Inc., said they have full confidence in the device and are not concerned about alterations in medical records. […]
But that raises concerns among some experts such as Dr. Diana Zuckerman, president of the National Center for Health Research, a nonprofit consumer think tank and research group based in Washington, D.C. “The whole point of a trial is to capture things you wouldn’t know would happen. It doesn’t matter if you think the symptoms are related or not. They should be counted,” she said.
A clinical trial participant at the Greenville, S.C., site said she was dropped from the study after complaining of acute pain. Crystal Johnson Brown, now 39, said investigators told her the pain came from pelvic inflammatory disease, an infection of the female reproductive organs, and since it was a sexually transmitted disease, she should seek treatment elsewhere.
“After that, they never called me [again],” she said in a recent interview. “I never heard from them again.”
Brown said she still has severe debilitating lower back and pelvic pain and often seeks help at emergency rooms because she has no insurance. But Zuckerman says that her infection, like all health problems, should have been recorded in the trial data. […]
But to Zuckerman, telling a patient that the pain in the pelvis is definitely not related to the device is not defensible. “If you put something in the pelvic area, it’s ridiculous to assume that pelvic pain has nothing to do with it,” she said.
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