F.D.A. warns on Essure birth control device

Feb 29, 2016, 2:50 PM EST
Uterus art. (Source: Hey Paul Studios/flickr)
Uterus art. (Source: Hey Paul Studios/flickr)
The U.S. Food and Drug Administration has asked German drugmaker Bayer AG to conduct further studies on Essure, its controversial birth control device, and said that the product label should contain the most restrictive type of warning. Reuters reports:
Essure, acquired by Bayer in 2013, has been the target of thousands of complaints and calls for its withdrawal since it was approved for sale in the United States in 2002.
The device, promoted as an alternative to tubal ligation, consists of two small nickel-titanium coils inserted into the fallopian tubes. Scar tissue that forms around the device is meant to prevent pregnancy.
Complaints have included reports of the device breaking, moving and causing life-altering side-effects ranging from chronic pain and bleeding to autoimmune disorders such as psoriasis and lupus.
Essure is a permanent form of birth control in which a coil is implanted, nonsurgically, into the fallopian tubes. Scar tissue is supposed to form around the device to prevent sperm from reaching eggs and fertilizing them, thus preventing pregnancy. Women are instructed to use alternative forms of contraception during the three months it takes for the scar tissue to form.
"The FDA will use the results of this study to determine what, if any, further actions related to Essure are needed to protect public health," according to a press release.
"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," William Maisel, chief scientist at FDA's Center for Devices and Radiological Health, said in a statement. "They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications."