In 2013, the I-Team was first to interview Kim Hudak, a clinical trial participant from Ohio who claims her answers were altered on some of the clinical trial surveys used to support Essure’s FDA approval.
Now, at least two other clinical trial participants are making similar claims -- that their answers to questions about comfort and pain were inaccurately recorded by the scientific investigators paid to study the safety and effectiveness of Essure.
“The FDA is aware of allegations from women who participated in the original Essure clinical trials that the feedback they provided about the comfort wearing the device was not recorded accurately by clinical staff,” wrote Eric Pahon, an FDA spokesman, in an email to the I-Team.
Pahon said federal regulators cannot comment on the status of ongoing investigations, but the claims of botched research are being followed up on as a “trade complaint.”
Tara DiFlumeri, a spokeswoman for Bayer, denied answers were manipulated on clinical trial surveys.
“Bayer strongly disagrees with any suggestion or allegation that the Essure clinical trial data collection was fraudulent or inappropriately altered,” DiFlumeri wrote in an email to the I-Team.
The original manufacturer of Essure, a company called Conceptus, designed and conducted the survey research being challenged by some birth control patients. Two years ago, Bayer bought Conceptus for just over $1 billion.
The Essure birth control system consists of two nickel alloy coils that are inserted into a woman’s Fallopian tubes. After three months, the coils produce enough scar tissue to form a permanent block to conception.
Last week, the FDA Obstetrics and Gynecology Devices Advisory Committee held a day-long hearing where dozens of women implanted with Essure complained of painful symptoms they believe are caused by coils migrating and sometimes piercing soft tissue. Some said they believe allergic reactions to the coils have caused severe auto-immune problems.
Peter Schalack, a Harvard dermatologist on the advisory panel, suggested Conceptus should have done more research on how Essure might interact with women who have allergies or hypersensitivities to nickel.
“Where is your data? Where did you test these people? How did you test these people,” Schalack asked.
Among other recommendations, the advisory panel asked the FDA to require Bayer do more research on how the metal coils might cause allergic or other auto-immune irritations.
Gabriella Avina was a clinical trial patient from Northern California who was initially so satisfied with Essure that she became a spokesperson for Conceptus. Her photo is on one of the early Essure brochures.
But a few years after her implantation in 2000, Avina says she was diagnosed with four autoimmune diseases. She began to suspect the metal coils might be causing adverse reactions. Around that time, Avina says Conceptus researchers stopped contacting her for follow-up surveys.
“As part of the clinical trial, I didn’t have any follow up. They were supposed to follow up with me for five years,” she said.
Avina is now trying to get her medical records from the Bay Area Reproductive Science Center where she was implanted. So far she has had no luck.
“They lost my medical records,” Avina said. “They’re all of the sudden missing.”
A representative of the Bay Area Reproductive Science Center did not immediately respond to the I-Team's request for comment.
Elena Mendez, a nurse from Yonkers, said one of her coils became embedded in her endometrial cavity.
“It felt like this constant either dragging or shooting, stabbing pains. Almost like someone literally had a knife -- sitting inside of you with a knife like poking downward,” Mendez said.
After she had the coils surgically removed, Mendez said the pelvic pain subsided.
Despite a spike in adverse event reports to the FDA, some doctors attended the advisory committee hearing to defend Essure.
“I feel Essure should remain an option for women,” said Rupal Juran, a gynecological surgeon who practices in Indiana.
“We have a very high rate of patient satisfaction and I’m very glad we were able to offer that to our patients instead of abdominal surgery,” the doctor said.
The FDA says its initial approval of Essure was based on “the totality of the evidence available at the time,” but regulators did not audit findings concerning “case report forms” or “patient comfort/satisfaction data.”
In case reports of three patients, including Hudak, the I-Team found repeated reports of severe pelvic pain, even though clinical investigators marked the patient’s comfort of wearing the Essure device as either “excellent” or “very good.”
Ultimately, researchers concluded 99 percent of clinical trial participants felt the comfort of wearing Essure was good to excellent.
DiFlumeri suggested it’s possible patients felt their pelvic pain was unrelated to the coils in their fallopian tubes.
“It is possible that if a patient did not think the pain she was experiencing was related to the device, then she could have rated her comfort with the device as high,” DiFlumeri said.
Aileen Gariepy, an assistant professor of obstetrics at Yale, said she believes the Conceptus clinical trial underestimates the number of adverse medical events women experience after implantation.
“This is incredibly concerning that patients who were enrolled in the clinical trials are reporting that they were coached for their answers or that their answers were changed,” Gariepy said.