The US Food and Drug Administration (FDA) has announced updates to a post-marketing study of Bayer’s Essure to strengthen the birth control device’s long-term safety data.
The regulatory agency asked Bayer to conduct a post-market surveillance study to better assess the device’s safety profile in the real world. It has now added new steps to the study in order to strengthen the information obtained.
Follow up period of the study has been extended from three to five years, and Bayer will collect longer-term adverse risks data during this phase.
The FDA has also mandated additional blood testing of patients in follow-up visits. This is intended to track patients’ levels of certain inflammatory markers that can be indicators of enhanced inflammation.
Results are expected to enable better assessment of potential immune reactions to the device and their connection to Essure-related symptoms reported by the patients.
Bayer is required to continue recruiting women who may still opt for Essure in advance of its complete discontinuation from the market. The company should also provide the FDA more frequent reports on the study.
In a statement, the FDA said: “Following Essure’s removal from the market, the FDA is committed to continuing to monitor women who have the device implanted.
“In addition to the post-market surveillance study, the agency 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.”
The regulatory agency also plans to collect and review reports of adverse events associated with device removal.