By Lauren Gilger and Maria Tomasch, ABC15
February 25, 2015
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.
“Somebody dated and initialed that, like they were making a correction to what I’m telling them,” Lira said. “Why would somebody cross out my own word when I’m telling them it’s severe? Who is a nurse or whoever signed this to say it wasn’t severe?”
On the same form where Lira reported she was experiencing “severe” pain, “a lot more” unusual pain, and “pelvic tenderness,” it was reported that her comfort with the device is “excellent.”
Her records also show that she asked researchers to remove the device. Lira said that from day three until she broke down crying in 2003, she asked them to remove it numerous times. At one point, she said she went into the clinic desperate to get the device taken out. She told them she wanted to become pregnant again.
“I was crying, I told them I wanted them taken out and they told me that there was no reversal,” she said. “This is permanent.”
When Conceptus, the original manufacturer of the device, got approval from the FDA for Essure in 2002, it was reported that “there were no requests for removal of the device.”
The summary of minutes of the Obstetrics and Gynecology Devices Panel that approved the device said 92 percent of women in the trial were “very satisfied” with the device after three months of wearing it and 95 percent were “very satisfied” after one year.
“I think it undermines what I am going through,” Lira said. “It undermines the pain that I am going through.”
Bayer Health Care, Inc. bought Conceptus in 2013 largely because of the Essure device.
A Bayer spokeswoman told ABC15 they cannot comment on any individual clinical trial participant, but said numerous trials and independent studies involving thousands of patients have shown consistent results with those seen in the pivotal clinical trial for Essure.
See Bayer’s complete statement below.
The clinical trials for Essure began with 745 women; 567 women completed it according to the FDA.
Lira wasn’t one of them.
A form in her medical records shows she was “lost to follow-up” in late 2003. The form said she returned a letter withdrawing her participation in the trial.
Lira denies ever seeing a letter like that, and there’s no such letter in her medical records.
The form also said she was a no-show for a visit in 2004 and numerous attempts to reach her went unanswered.
But Lira thinks she was removed from the trial for a different reason.
“I think I became a thorn in their side,” she said. “They didn’t care. I wasn’t giving them the happy results that they wanted.”
Bayer told ABC15 in an email that all data collected on every clinical trial participant is reported to the FDA, regardless of whether they left the trial.
FLAWED CLINICAL TRIALS?
“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.”
Essure birth control received premarket approval from the FDA in 2002 after two preliminary trials and 12 months of a pivotal clinical trial, according to the FDA.
The device went through the Premarket Application (PMA) process which according to the FDA is their “most stringent regulatory pathway.”
“Like a new drug, devices approved under a PMA undergo a thorough regulatory and scientific examination of all available scientific data before FDA makes an approval decision,” FDA spokesman Eric Pahon wrote in an email statement.
In a review conducted after our stories first aired, the FDA maintains the product is safe and is 99.83 percent effective.
ADVERSE EVENT REPORTS CLIMBING
There are now more than 4,500 adverse event reports filed with the FDA by patients and doctors describing problems with or side effects from the device.
Those reports include deaths linked to the device.
Last year, the ABC15 Investigators found an adverse event report detailing the death of a woman with the device.
Now, there are three late-term miscarriages categorized as deaths in the FDA’s database.
In one report, a woman writes that she had to deliver her son after becoming pregnant while having Essure implanted, “but he had already died in utero three to four days prior,” the report said.
Another adverse event report describes premature lungs in a baby born at 26 to 32 weeks. The manufacturer’s narrative of those events concluded there was not enough information provided to suspect a quality defect in the product. The device was not returned to the manufacturer to determine if it had malfunctioned.
A third report describes a premature miscarriage after a woman with Essure became pregnant. “She couldn’t have Essure removed and in the 25th week of the pregnancy it broke and migrated, perforating the amniotic fluid. The child didn’t make it,” the report read.
The manufacturer’s narrative said this is a “non-medically confirmed, spontaneous case report” that was received from a social media website.
A Bayer spokeswoman told ABC15 they do not comment on any individual adverse events, but they take them all seriously and report them to the FDA as required.
Dr. Zuckerman has helped the more than 14,600 members of the Essure Problems Facebook page get their cause heard in Washington.
“When you see data that looks so great and you talk to women who have used the product whose experience is completely different, you have to question whether the studies were really done appropriately,” Dr. Zuckerman said.
Lira also questions the clinical trial. She doesn’t want anyone else to have to experience the pain she feels every day.
“Do I want to be pain free? I would love it,” she said, crying. “I would love to know who that Kim is. I would love to know who I could be.”
A Bayer spokeswoman told ABC15, “If clinical trial participants have questions, they should call 888-84-BAYER.”
Complete statement from Bayer Health Care:
Patient safety is our top priority at Bayer. We are saddened to hear of any serious health condition affecting a patient using one of our products, regardless of the cause. Although we do not comment on individual adverse events, we take all adverse events seriously, and report them to the FDA as required.
Per you question on clinical trials, all data collected on every clinical trial participant are reported to the FDA.
Numerous well-controlled trials along with many independently sponsored studies involving thousands of patients have demonstrated results consistent with those seen in the pivotal study. We cannot comment on the experience of an individual clinical trial participant. If clinical trial participants have questions, they should call 888-84-BAYER.
Read original article here.