The US Food and Drug Administration (FDA) is further restricting the distribution of Bayer’s Essure as sales of the permanent birth control device have plummeted by 70 percent in the last two years. The US regulator will now require that healthcare providers use a Patient-Doctor Discussion Checklist to educate patients on the risks associated with the implantable device – a regulation which will be reflected on Essure’s label. Those physicians who do not provide this pre-implantation counseling will be restricted from purchasing the Essure product.
“Patients deserve the most accurate and comprehensive information to help them make their healthcare decisions, and Bayer has educated and continues to educate healthcare providers about the importance of appropriately counseling each patient on the benefits and risks of Essure,” said a press release issued by Bayer. “The FDA requested we update the label to emphasize this point.”
According to the FDA, the decision to implement these new restrictions on the distribution and sale of Essure was motivated by the revelation that some patients considering the form of permanent birth control were still not being informed about the risks associated with the device. A variety of adverse events have been reported by women implanted with the Essure device, including pain, allergic reactions, migration of the permanent birth control device within the abdomen, and perforation of the uterus.
“We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” said FDA Commissioner Dr. Scott Gottlieb. “Every single woman receiving this device should fully understand the associated risks.”
In early 2016, the FDA required Bayer to add a black box warning to the product packaging for Essure to communicate the risks of the device to both doctors and patients. At the same time, they told Bayer to conduct an additional post-market surveillance study to compare the Essure device to a more conventional form of permanent birth control, laparoscopic tubal ligation, in terms of real-world reports of pelvic pain, unplanned pregnancy and device removals.
“We take the concerns of all women affected by Essure very seriously,” said Gottlieb. “I’ve personally had the opportunity to meet with several women and hear their important concerns about this product. Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information. That is simply unacceptable.”
Unlike other intrauterine devices (IUDs) which are designed to be long-acting, but reversible, forms of birth control, Bayer’s Essure is a permanent contraceptive device. Essure is implanted in a non-surgical procedure in which the device is inserted into the fallopian tubes through the vagina. The body forms scar tissue around the device over the course of three months after the procedure, which prevents sperm from fertilizing the eggs released during ovulation each month.
Originally approved in 2002, FDA’s persistent post-approval monitoring of the safety of Essure has driven them to restrict sales of the device in the US. While Bayer’s post-market surveillance study is ongoing, sales of Essure have declined by 70 percent since the FDA originally mandated inclusion of the black box warning in 2016. While the regulator commends Bayer for increasing the number of women enrolled in their safety study three-fold in the past six months, they say the drugmaker will need to establish new study sites to improve the sample size.
“Ensuring informed decision making is just one important step in our ongoing efforts to monitor this device. We remain committed to carefully and thoroughly considering all new data and evidence and will continue to work with patients affected by this device as part of our process,” said Dr. Terri Cornelison, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health. “While some women may continue to choose Essure as their birth control option based on current information, as new information becomes available, the FDA will continue to keep the public informed of the agency’s evaluation and findings, and consider regulatory options that appropriately balance benefits and risks for Essure.”