Bayer has decided to voluntarily discontinue sales and distribution of the Essure System for Permanent Birth Control in the United States after December 31, 2018. This decision is based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable.
According to a statement from Bayer, “the benefit-risk profile of Essure has not changed, and we continue to stand behind the product's safety and efficacy, which are demonstrated by an extensive body of research, undertaken by Bayer and independent medical researchers, involving more than 200,000 women over the past two decades.”
Bayer has informed the U.S. Food and Drug Administration (FDA) of the company's decision. This decision follows the FDA’s patient safety action in April, in which the agency issued an order restricting the sale and distribution of Essure; it was a unique type of restriction where the FDA used its authority to impose additional requirements to provide a reasonable assurance of the device’s safety and effectiveness.
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“Consumers rely on the FDA to oversee the regulation of vital medical products. In turn, the agency also relies on consumers for important feedback to help us learn more about the benefits and risks of medical products when they’re used outside of clinical trials in the real world,” according to a statement from FDA Commissioner Scott Gottlieb, M.D. “The device has been associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen. As the FDA learned more from patients about the serious adverse events associated with this device, we took a series of important actions to better understand the benefits and risks, and to address patient safety concerns."
The FDA has conducted a review of their database and medical literature and convened an expert panel to discuss new concerns. Additionally, the FDA has ordered Bayer to conduct a new post-market surveillance study to better evaluate the safety profile of the device when used in the real world; and Bayer has been required to add a boxed warning to the labeling and a Patient Decision Checklist to help women considering Essure to be fully informed about potential risks.
“In April, when the FDA became aware that many patients were not being adequately counseled, we required a restriction which limits the sale and distribution of the device to only health care providers and facilities that provide information to patients about the risks and benefits of this device and gives patients the opportunity to sign an acknowledgement that they fully understood these potential risks before having the device implanted,” according to the FDA statement. “Since the FDA ordered Bayer to conduct the post-market study and then to add a boxed warning and a Patient Decision Checklist to the labeling, there has been an approximate 70 percent decline in sales of Essure in the U.S. The company stated its decision to halt sales and distribution of the device was due to commercial reasons.”
Bayer will continue to enroll patients in the Essure postmarket surveillance study and will work closely with the FDA to ensure appropriate follow up. Bayer will also continue to fully comply with its other regulatory responsibilities regarding Essure.