RICHMOND, Va. (WRIC) — Members of Congress now accuse the Federal Drug Administration (FDA) of “inaction” and are demanding a meeting with the agency’s commissioner.
8News has been investigating complaints about Essure for years, with women reporting severe abdominal pain, hives, hair loss and even reports of fatalities.
After thousands of complaints about the device, Bayer — the makers of Essure — were required to do a post market study of the contraceptive device.
A year and a half later, the lawmakers Reps. Rosa DeLauro (D-CT), Jan Schakowsky (D-IL) and Louise Slaughter (D-NY) said it’s unclear if Bayer is acting with urgency.
8News has now learned just since September, patient and doctor complaints about Essure have soared from 15,000 to 18,000.
In a letter to the FDA commissioner, the congresswoman wants to know how many people are actually enrolled in this post market study of the device. Up until recently, the FDA’s website noted only one patient.
8News can see that has now been updated to show 136 patients enrolled. Still, the congress members believe Bayer is dragging its feet and this could delay critical results.
The lawmakers write, “The FDA is the leading regulatory authority on medical device safety, and as such, should uphold its responsibility by requiring Bayer to complete the post-market study in a timely fashion.”
8News reached out to Bayer for comment and we were told the letter includes false accusations and that Bayer has fulfilled its obligations with the study saying:
“In fact, Bayer has met every milestone, and even began enrolling subjects into the study three weeks early.”
The FDA says it received the letter and will respond to the lawmakers.
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