Bayer’s controversial permanent nonsurgical contraceptive device Essure will no longer be sold or distributed in the United States after the first of the year in response to thousands of complaints, but the Food and Drug Administration (FDA) will continue its oversight of the device still implanted in thousands of women. Its manufacturer also is required to continue to study Essure side effects for the next five years and provide reports to the FDA.
“When new safety concerns arise for particular devices, we’re committed to taking action to develop post-market information that can help patients and providers make more informed decisions and also support regulatory actions that reduce any potential risks to patients. We’ve taken a series of such steps with respect to Essure, a permanent birth control device,” FDA Commissioner Dr. Scott Gottlieb said in a prepared statement.
Bayer announced in July that it would no longer sell or distribute Essure in the U.S. after Dec. 31, 2018, citing declining implantations. At that time, the FDA assured that it would remain vigilant on its oversight of the device and required that Bayer complete its post market surveillance that it was ordered to do in February 2016.
In the statement, Dr. Gottlieb also announced that the agency had revised its protocol for the surveillance. First, women in the study will be followed for five years instead of three. Secondly, the agency required additional blood tests on the women in the study to better understand levels of certain inflammatory markers to evaluate potential immune reactions to the device and whether these findings are associated with symptoms that patients have reported.
The FDA received more than 12,000 medical device reports since 2017 regarding Essure, many involving device migration leading to pain, organ perforation, and ectopic pregnancy.
“We believe women who’ve been using Essure successfully to prevent pregnancy can and should continue to do so,” Dr. Gottlieb said. “Women who suspect the device may be related to symptoms they are experiencing, such as persistent pain, should talk to their doctor on what steps may be appropriate.”
Source: FDA Statement