By Roni Caryn Rabin
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 in 2000, 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, 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.
“I realized something could go wrong in a clinical trial, but I thought they would take care of me, and that if something wasn’t right, they’d fix it,” said Hudak, who eventually had a hysterectomy to remove the implants in 2013 and has filed a claim against Essure’s manufacturer for compensation for her injuries.
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 they could not possibly have been caused by Essure, and referred them elsewhere for treatment. Continue reading