At a recent FDA meeting with Essure Problems Group, Madris Tomes from Device Events spoke and presented to the FDA data from its own MAUDE database that they seemingly didn't know about.
York, PALast month a group of women, including "Essure Problems" Facebook representatives and Madris Tomes from Device Events, met with FDA chief Scott Gottlieb in an attempt to have the Essure sterilization device withdrawn from the U.S. market. At the meeting, Tomes presented data from the FDA's own MAUDE ((Manufacturer and User Facility Device Experience) database that the FDA and their legal counsel in attendance were seemingly unaware of. One would think the FDA may be embarrassed being caught off-guard like this, to say the least.
"I attended this meeting because the FDA's data I have is not reflected on the agency's website," says Tomes. "When I presented Gottlieb with the data, he asked if I had obtained it through discovery. When I told him that it came from their MAUDE database he looked surprised." Gottlieb then asked a few people from the FDA's specific device division if they had this information. Negative. Tomes then stepped in and explained that the FDA does indeed have this data (how else could she have obtained it?) but not in the format that she does. "And a woman from this device division asked if she could view my information. Of course! It is important that the FDA has proper access to their own data so they can make informed decisions.
"I can pull up 26,000 Essure reports in seconds but the FDA doesn't have the correct systems in place to search the data and detect patterns that I can," Tomes explains. She explained to Gottlieb the difficulty for both physicians and patients to obtain data through MAUDE and how the FDA's translation of their own data is actually false. She presented data indicating how Essure complaints spiked over the past two years, reports of 18,000 women undergoing either full or partial hysterectomies and reports of 5,000 pregnancies. At the FDA's Essure hearing in September 2015, however, the agency only noted 631 reports of pregnancies.
MAUDE Database Broken
Tomes isn't the only one voicing concern about the FDA's database. Jeanne Lenzer, former physician's associate, medical journalist and author of The Danger Within Us, said in a recent interview with NPR.org that implanted medical devices are approved with far less scrutiny and testing than drugs, and as a result, some have caused harm and even death. She went on to say that medical devices are approved with far less scrutiny than drugs, and many high-risk devices go to market without clinical trials. And one study says that as few as one percent of adverse events reported wind up in MAUDE database.
"It is important that the FDA has proper access to their own data so they can make informed decisions"
Tomes' goal at February's Essure meeting was to get Gottlieb and the FDA to see their database through her eyes. "Since this meeting I have seen no plans for the FDA to change course," says Tomes, "even though Gottlieb asked us what the women want. They asked for the FDA to remove Essure from the market until after the post-market study conducted by Bayer". Gottlieb expressed that not only does he need to wait for Bayer to finish its safety study five years from now, which is supposed to include 2,800 women, but as of October 2017 the drug company had only enrolled 136 patients. The aim of this study is to compare Essure patients with tubal ligation patients to determine just what risks the coils presented to women. But why endanger another few thousand women when there are 30,000 women who were already implanted with Essure and are willing to provide their data to this post-market study?
The Attorneys Invitation List
A few days before the meeting, Tomes and the "Essure Problems" group of women received a list of attendees. The group received a call from a woman saying she was from the FDA, telling them that they couldn't bring their attorneys. "The Essure women looked at the list and found the woman who called - an attorney!
Bayer's Essure Reports to the FDA
"Initially Essure reports to the FDA and MAUDE came from patients themselves," Tomes explains. "After the public hearing in September 2015, there were many more Essure reports by doctors, so physician understanding of these issues became more well known. Consequently, thousands of these reports from patients have been updated to include information from their physicians." Tomes further said that 95% of the reports last year came from the manufacturer. "Bayer reported 12,000 reports of surgical removal, or about 30 hysterectomies per day," adds Tomes, and she presented these statistics at the meeting. As well, the majority of the reports stated that Essure had to be removed surgically. Essure has long been touted as a non-surgical sterilization option, but surgery is often required to remove the device.
Given this information, why hasn't the FDA withdrawn Essure from the market, like every other country has done? This reporter asked Tomes why she thinks Essure is still on the U.S. market. Did she think it was because at one time there was money at stake, maybe the FDA was in bed with Bayer? "I learned about Essure after leaving my job with the FDA so I wasn't involved at that level," says Tomes. "Going into this meeting, I thought when [Gottlieb and the FDA] saw the data the way it was presented they would change their minds. They would have the opportunity to say, 'Maybe we made a mistake' but I don't know that the FDA can say they made a mistake…"
When Madris Tomes started her company Device Events in 2015, she spent the first 18 months cleaning data from MAUDE. She says the data was so dirty for so long that people, including the FDA, couldn't use it as a reliable source of information. She says it's always dirty because the FDA doesn't clean it and they aren't permitted to do so…
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