After receiving reports on complications linked to the use of Essure, a permanent birth control device, the Food and Drug Administration (FDA) has warned the public of its possible negative effects.
In a press release, the FDA has mandated the makers of Essure to run mandatory clinical studies to determine the efficacy and safety of the device for human use. The agency issued the notice after reported complications linked to the use of the device.
Essure birth control works by blocking sperm cells from reaching and fertilizing egg cells. It is a permanent device (coil) inserted into the fallopian tubes.
The permanent birth control device made by Bayer has been available in the market and widely used by women in the U.S. since 2002. Although there has been no conclusive clinical study that links the use of Essure in developing complications, reports have become more alarming, thus the action taken by the FDA.
Dr. William Maisel of FDA’s Center for Devices and Radiological Health, said that the order of the agency aims to clarify things and rule out speculation whether Essure could cause certain complications. It also aims to ascertain whether such women are at high risk for complications.
“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,” Maisel said in the FDA press release.
Although the FDA did not order the recall or ban on Essure products in the market, the agency, however, ordered Bayer to accompany each Essure birth control product with a “black box,” which provides a warning on potential complications, TIME reports. This is on top of FDA’s order on Bayer to conduct trials in real-world environment to shed light on the issue.