After thousands of women complained of pain, allergic reactions and even punctured tissue while using a contraceptive device brand Essure, the federal government wants to force its manufacturers to print a so-called black box warning on the product's packaging.
Black box warnings are the strictest labeling requirements the FDA imposes, generally notifying doctors and patients about significant risks or life-threatening adverse events.
Health regulators will also require Bayer, the maker of Essure, to conduct new safety research.
The regulatory orders come more than two years after the I-Team first revealed inconsistencies in the safety studies that led the original FDA approval of Essure
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"The actions we are taking today will encourage important conversations between women and their doctors," said Dr. William Maisel, chief scientist at the FDA Center for Devices and Radiological Health. "They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications."
Representatives of Bayer were not immediately available for comment, though in the past the company has said it stands behind the clinical trial research that supported the safety of the contraceptive.
Beginning in 2013, the I-Team began revealing clinical trial participants who say they reported severe and sometimes debilitating pain after being implanted with Essure. Despite the reports of pain and discomfort, researches marked their comfort level as "excellent" or "very good."
Although the FDA wants more research, the agency stopped short of criticizing the original clinical trials.
As part of its review, the agency conducted a “re-analysis” of clinical trial responses.
“In the end our analysis did not find evidence of systematic or intentional modifications of study subject responses. The agency believes the original clinical data relied upon represents valid scientific evidence,” Maisel said.
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The agency did not explain how a clinical trial participant could be marked down as having “excellent” comfort while at the same time reporting severe and continuing pain after implanatation.
Shortly after the FDA announced its orders for new research and warnings, a social media group called “Essure Problems” erupted with discontent.
An administrator of the group wrote “we are outraged that it appears as if the FDA is going to leave Essure on the market.”
A member of the group wrote, “Epic fail again, FDA.”
Congressman Mike Fitzpatrick (R-PA), who has sponsored a bill to circumvent FDA governance and pull Essure off the market, issued a statement saying “it’s unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market.”
Before the FDA orders for new research and a black box warning go into effect, there will be a 60-day public comment period.