WASHINGTON, Feb. 29 (UPI) -- The U.S. Food and Drug Administration is requiring the maker of the Essure birth control device to add "black box" warnings and conduct new trials amid concerns about the safety of its use.
In a letter, the agency directed Bayer Inc. to conduct the studies and add labels alerting doctors to potential "serious or life-threatening risks," following a hearing last year about complaints filed about the device during its 15 years on the market.
While the company maintains Essure is safe for use, critics were less than happy with the length of time it took for the FDA to react to the hearing, as well as the decision to leave the device on the market while new tests get underway.
"The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them," said William Maisel, chief scientist at FDA's 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."
The announcement comes more than six months after hearings in September outlining the litany of health events reported to the agency and company since Essure was approved for use in 2002. The hearings included complaints as recent as May 2015.
The Essure device is a coil, implanted without surgery into the fallopian tubes where car tissue grows around it, preventing sperm from fertilizing eggs. The FDA says it has received 5,093 adverse event reports, including many for general or abdominal pain, heavier menstruation, headache, fatigue and weight fluctuations, with most reports including more than one symptom.
An independent investigator hired by Fitzpatrick reported more than 10,558 adverse events, including 303 reports linked to fetal death. The FDA reports 17 total death reports connected to the device, with only five involving the death of a fetus.
Fitzpatrick reiterated a desire he and Rep. Rosa Delauro, D-Conn., have for the device to be pulled from the market while the new safety trials are conducted because of the large number of health events.
"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," Fitzpatrick said in a press release.
Bayer has sold about one million of the devices and insists it is 99 percent safe and effective, reported the Washington Post.