Essure’s manufacturer, Bayer, was ordered in 2016 to conduct a long-term study on the permanent birth control implant’s safety. But a blockbuster new letter written by three State Representatives accuse the company of dragging its feet, even as thousands of women continue to suffer severe side effects that may well be caused by the device.
Congress Members Question FDA On Essure Safety Study
In a letter dated October 30, 2017, State Representatives Rosa DeLauro (D-CT), Jan Schakowsky (D-IL) and Louise Slaughter (D-NY) express their “deep concerns” to Dr. Scott Gottlieb, the current Commissioner of the Food & Drug Administration.
The FDA, according to the Congressional letter, has failed to act. The federal agency maintains the public stance that Essure may be the right choice for some women, thus refusing to issue a mandatory recall for the device in America. And now, it looks like the FDA is failing to hold Bayer to its agreements.
Only One Patient Enrolled In Study, Lawmakers Say
When the agency first looked into Essure, serious concerns about the device’s long-term safety made an ongoing study on side effects absolutely necessary. So the FDA ordered Bayer to do it.
The company drew up a study proposal, which was approved by the Food & Drug Administration in September 2016. Bayer’s plan, as the State Representatives note, was to set up dozens of test sites, where women with Essure implants could be monitored rigorously. At the same time, the testing sites would monitor an equal number of women who underwent tubal ligation, the standard method of permanent contraception.
In total, the company expected to enroll 2,800 women in the study, including 1,400 Essure patients. To do so, Bayer said it would enroll 78 patients every month until the study’s proposed conditions were met.
“The FDA Cannot Continue To Allow Bayer To Drag Its Feet”
Well, Bayer has now had over a year to enroll those patients and kick-off its long-term study on Essure. And while 60 test sites have been approved by the Food & Drug Administration, only 1 patient has been enrolled, according to the Representatives’ letter.
“A year and a half after the study was initiated,” the lawmakers write, “it is unclear whether Bayer has acted with urgency to enroll patients, or if the study results will be delayed. The FDA cannot continue to allow Bayer to drag its feet on this post-market study while women are continuing to suffer.”
Despite Global Withdrawal, US Essure Battle Continues
The FDA has now received more than 18,000 reports of complications and side effects attributed to the Essure implant, the three Democratic Reps write. And in over half of these reports, patients have been forced to undergo invasive surgical procedures, including hysterectomy, to end their pain, menstrual abnormalities and newly-emergent autoimmune disorders.
Combined with the efforts of protest groups worldwide, media coverage on these alleged side effects led to a drastic decrease in patient demand for Essure. And dropping revenues forced Bayer to remove the contraceptive implant from every market around the globe except for the United States.