|Essure--Screenshot courtesy of Bayer|
An advocacy group for women affected by Bayer's contraceptive implant Essure has lambasted the FDA for its alleged lack of oversight for the products. Now, the group wants Congress to weigh in on the issue.
Essure Problems recently asked Rep. Jason Chaffetz (R-UT), the leader of the U.S. House Committee on Oversight and Government Reform, to investigate and potentially hold a hearing over the FDA's regulation of Essure. The group in a letter to Chaffetz lays out different reasons why Congress should probe the agency's oversight for the device.
Clinical trials for Essure "were inadequate and inappropriate from the beginning," Essure Problems said in its note, as quoted by Legal Reader. The device's PMA was based on two studies which enrolled a total of 926 women, the group points out. And only 197, or 25% of those women were followed two years after the trial was completed.
Plus, the FDA did not heed complaints of serious side effects and injuries tied to Essure. "As long ago as 2010, the FDA was aware of thousands of complaints regarding Essure made to Conceptus, but which were never reported to the FDA," the group said. And there are about 10,000 side effect reports filed with the agency, a number that is "well recognized under-reported," Essure Problems wrote in its note.
But the problems don't stop there, the group said. In February, the FDA slapped Essure with a black box warning amid backlash over the device's safety. The agency also ordered Bayer to carry out more trials to look at Essure's risks in certain women.
The fact that regulators are allowing the device to remain on the market while Bayer carries out the new studies is "irrational and illogical," the group said. It also puts "a whole new group of unsuspecting women on a path to being harmed by the device with absolutely no legal recourse," it added.
The group's letter comes as lawmakers and patients push back over the device's safety. Rep. Mike Fitzpatrick (R-PA), a vocal critic of Essure, recently sent a letter to the FDA which questions the agency's reporting of serious side effects for the device. Last year, Fitzpatrick proposed a bill that would ban Essure altogether.
Meanwhile, regulators in Canada are taking a hard look at the devices after getting thousands of complaints from women who received the implant, The Toronto Star reports. Health Canada ordered a safety review last year, and a final report from the agency is expected in May.