The U.S. Food and Drug Administration is implementing a number of steps for long-term safety monitoring of the permanent birth control device Essure, which will no longer be sold or distributed in the United States after Dec. 31, 2018.
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Device maker Bayer announced in July that it would halt sales due to declining use of the device, which has been the subject of a number of FDA safety actions, including being classified as a restricted device.
When Bayer said Essure will no longer be available in the U.S., the FDA said the company must complete the postmarket surveillance study the agency ordered in February 2016. The FDA also said it planned additional steps.
Those measures were announced Thursday and include having women in the postmarket surveillance study followed for five years rather than the initially-required three years.
“This extension will provide us with longer-term information on adverse risks of the device, including issues that may lead women to have the device removed,” FDA Commissioner Dr. Scott Gottlieb said in a statement.
“Second, we’re requiring additional blood testing of patients enrolled in follow-up visits during the study to learn more about patients’ levels of certain inflammatory markers that can be indicators of increased inflammation. This could help us better evaluate potential immune reactions to the device and whether these findings are associated with symptoms that patients have reported related to Essure,” Gottlieb said.
“The FDA is also requiring Bayer to continue to enroll patients who might still opt to receive Essure in advance of its full discontinuation from the U.S. market, and to continue to submit more frequent reports to the FDA on the study’s progress and results,” Gottlieb said.
The FDA “will continue its efforts to monitor Essure’s safety and effectiveness since its approval in 2002 by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency,” Gottlieb said.
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