In an attempt to inform women about the potential dangers of the Essure device, the FDA has issued an order restricting the sale and distribution of the device.
Developed by pharmaceutical company Bayer, Essure is a contraceptive device that has received criticism from women who claimed experiencing strong levels of pain and discomfort. Other reported problems include the perforation of the uterus, allergic reactions, hair loss and the migration of the inserts to the abdominal or pelvic cavity.
The device is the only permanent implant for birth control that doesn’t require a surgical incision.
The FDA’s order restricts the sale and distribution of the device to healthcare providers that offer information to patients about the risks and benefits of the device.
Healthcare providers now offer a patient brochure that must be reviewed alongside the patient, so they understand the risks of the device. Patients must be given the opportunity to sign the acknowledgement and it must also be signed by the physician.
Speaking about the FDA’s decision, commissioner Scott Gottlieb, said: “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.
We take the concerns of all women affected by Essure very seriously. 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. Every single woman receiving this device should fully understand the associated risks.”
Last year Bayer ended the sale of Essure outside of the US, claiming that the decision was being made for commercial reasons rather than any related to patient safety. Further decisions by the FDA into the device have resulted in a 70% decline in sales of Essure in the US.
Terri Cornelison, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, said: “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. 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.”