I-Team: Clinical Trial Patient Criticizes Study That Led to FDA Approval of Essure

A participant in a clinical trial for the birth control device Essure -- which some women have complained causes them pain and unexplained symptoms -- is now criticizing the way doctors conducted the studies that later formed an application for its FDA approval.
Kim Hudak, a mother from Cleveland who was part of a trial that looked at 464 women implanted with Essure, believes researchers ignored and even redacted painful problems she reported in follow-up appointments and phone surveys during the clinical trial. 
“There are so many symptoms and I really thought I was losing my mind. I thought nobody could be this sick,” Hudak said.
The birth control method is intended to permanently block pregnancy by implanting two metal coils in a woman’s fallopian tubes. Those coils prompt the development of scar tissue, which creates a barrier to sperm. Hudak says months after the procedure, she began to develop chronic pain symptoms that became debilitating.
Seven times during the eight years of follow-up, Hudak told researchers she was experiencing discomfort in her pelvic region and lower back. In 2001, records from the study obtained by the I-Team show she reported that “severe” pain was making it “uncomfortable when breathing or moving.”  In 2002, she reported four-hour episodes of lower back pain. In 2005, Hudak referred to pain during sexual intercourse, child care, and pain that was “constant even when relaxing.”
Despite those complaints, survey forms filled out during the clinical trial show Hudak’s “comfort of wearing the device” was “excellent.”
Hudak says Dr. Linda Bradley, one of the lead medical investigators for the clinical trial, insisted pain symptoms were unrelated to the Essure implants, so Hudak went along with the characterization that her comfort was “excellent.”
“I honestly didn’t feel like she was listening to what I was saying and I thought it was important.  I was a clinical trial participant. I thought that whatever I was saying, even if it didn’t seem related, should be taken seriously,” Hudak said.
Bradley did not respond to requests for comment.
Andrea Pacetti, a spokeswoman for the Cleveland Clinic, where Bradley conducted her research, declined to comment on the survey questions themselves or results of the clinical trial, which was paid for by Conceptus, the company that designed Essure.
“Both the institution and the patient complied and completed all study requirements until the study was discontinued by Conceptus in 2008.  At that time the collected data was submitted to Conceptus for interpretation,” Pacetti said.
At the end of the clinical trial, Conceptus reported results to the FDA indicating 99 percent of women rated the comfort of the product as good or excellent. The FDA approved Essure for widespread use.
But Hudak disputes the underlying research, not only because of her own painful symptoms, but also because she believes the survey options describing comfort levels were unbalanced.
The form offers patients a chance to characterize their comfort as “excellent,” “good,” “fair,” “very good,” or “poor.”  Hudak said the question -- which offered three positive options and one negative option -- was leading.
Morgan Liscinsky, a spokeswoman for the FDA, said regulators are not re-examining the scientific methodology used by Essure researchers.
“In general, the design of the case report forms for the Essure pivotal clinical trial was acceptable,” Liscinsky said.”
Dr. Diana Zuckerman, who leads the National Research Center for Women and Families, a non-partisan FDA watchdog, said the survey questionnaires exhibit dubious research methods.
“These studies are always done by the company that is selling the product so it is not exactly unbiased,” Zuckerman said.
Last year, pharmaceutical giant Bayer purchased Conceptus and the Essure brand for $1.1 billion. Bayer executives declined to answer questions about the safety research behind Essure.
Dr. Edio Zampaglione, vice president of Bayer's Women's Healthcare U.S. Medical Affairs Division, said in a statement that Essure is one of the most effective contraceptives and noted it has been on the market for more than 10 years, and has been used by some 750,000 women worldwide. 
The FDA has received more than 900 official adverse event reports involving Essure, and that represents less than 1 percent of all the procedures completed. 
Since the I-Team first reported on complaints about Essure, additional information about patient symptoms has been posted on the FDA website; the new disclosures stop short of issuing any new safety warnings regarding the birth control. 
The new text explains that “pain” is a known health problem experienced by a subset of Essure patients but that it is “addressed in the Essure product information (labeling).”
The update goes on to describe other patient complaints which “are not included in the labeling and were not observed in post-approval studies, or described in the clinical literature. They include extreme fatigue, depression and weight gain.”
However, after looking at official adverse event reports and reviewing results of the study Hudak participated in, the FDA concluded there is no evidence of a causal connection between Essure and those more recent symptoms.
“Although there is evidence of complications, as there are with all medical devices, overall results from this study did not demonstrate any new safety problems or an increase incidence of problems already known,” reads the FDA guidance.  
Zuckerman says it is inadequate for the FDA to simply review study results when the design of the study has been called into question.
Back in Cleveland, the chronic pelvic pain got so bad for Hudak, she decided to have a full hysterectomy in order to rid herself of any trace of the Essure implants.
She now says her symptoms are gone. She remains convinced the researchers behind Essure and the FDA let her down.
“I don’t think they had nearly enough data," she said. "And it had to be obvious to them that I was becoming more and more ill.”
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