FDA orders new restrictions on sale, distribution of Essure

 

The Food and Drug Administration has restricted the sale and distribution of Bayer’s Essure permanent contraception device to only health care providers and facilities that provide patients with information about the risks and benefits of the device.

In an order issued April 9, the FDA’s Center for Devices and Radiological Health informed Bayer of the restrictions, citing a need to “provide reasonable assurance of the safety and effectiveness of the device.”

Specifically, a patient brochure entitled “Patient-Doctor Discussion Checklist–Acceptance of Risk and Informed Decision Acknowledgment” must be reviewed with the patient, and the patient must be given the opportunity to sign the acknowledgment, which also must be signed by the physician implanting the device.

Bayer must implement the restrictions immediately and must ensure health care provider compliance.

“The FDA is taking this step after becoming aware that some women were not being adequately informed of Essure’s risks before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device,” the agency said in a press release, adding that it “plans to enforce these requirements and will take appropriate action for a failure to comply, including applicable criminal and civil penalties.”

Essure, which is the only permanently implanted birth control device for women on the market that does not require a surgical incision, was approved in 2002 and has been associated with adverse events including perforation of the uterus and/or fallopian tubes, device migration into the abdomen or pelvis, persistent pain, and suspected allergic reactions or hypersensitivity. Some women have also reported headache, fatigue, weight changes, hair loss, and mood changes.

In 2016, based on product safety monitoring by the FDA, a postmarketing study was ordered, as was a boxed warning and a more comprehensive patient decision checklist to inform patients about the risk of adverse events.

 

“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,” FDA commissioner Scott Gottlieb, MD, said in the press release, adding that it is unacceptable that some women were not being adequately informed.

“Every single woman receiving this device should fully understand the associated risks,” he said.

Terri Cornelison, MD, assistant director for the health of women in the Center for Devices and Radiological Health added that ensuring informed decision making is just one important step in ongoing efforts to monitor the Essure device.

“We remain committed to carefully and throughly considering all new data and evidence and will continue to work with patients affected by this device as part of our process,” she said. “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.”

[email protected]

 

The Food and Drug Administration has restricted the sale and distribution of Bayer’s Essure permanent contraception device to only health care providers and facilities that provide patients with information about the risks and benefits of the device.

In an order issued April 9, the FDA’s Center for Devices and Radiological Health informed Bayer of the restrictions, citing a need to “provide reasonable assurance of the safety and effectiveness of the device.”

Specifically, a patient brochure entitled “Patient-Doctor Discussion Checklist–Acceptance of Risk and Informed Decision Acknowledgment” must be reviewed with the patient, and the patient must be given the opportunity to sign the acknowledgment, which also must be signed by the physician implanting the device.

Bayer must implement the restrictions immediately and must ensure health care provider compliance.

“The FDA is taking this step after becoming aware that some women were not being adequately informed of Essure’s risks before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device,” the agency said in a press release, adding that it “plans to enforce these requirements and will take appropriate action for a failure to comply, including applicable criminal and civil penalties.”

Essure, which is the only permanently implanted birth control device for women on the market that does not require a surgical incision, was approved in 2002 and has been associated with adverse events including perforation of the uterus and/or fallopian tubes, device migration into the abdomen or pelvis, persistent pain, and suspected allergic reactions or hypersensitivity. Some women have also reported headache, fatigue, weight changes, hair loss, and mood changes.

In 2016, based on product safety monitoring by the FDA, a postmarketing study was ordered, as was a boxed warning and a more comprehensive patient decision checklist to inform patients about the risk of adverse events.

 

“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,” FDA commissioner Scott Gottlieb, MD, said in the press release, adding that it is unacceptable that some women were not being adequately informed.

“Every single woman receiving this device should fully understand the associated risks,” he said.

Terri Cornelison, MD, assistant director for the health of women in the Center for Devices and Radiological Health added that ensuring informed decision making is just one important step in ongoing efforts to monitor the Essure device.

“We remain committed to carefully and throughly considering all new data and evidence and will continue to work with patients affected by this device as part of our process,” she said. “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.”

[email protected]

 

The Food and Drug Administration has restricted the sale and distribution of Bayer’s Essure permanent contraception device to only health care providers and facilities that provide patients with information about the risks and benefits of the device.

In an order issued April 9, the FDA’s Center for Devices and Radiological Health informed Bayer of the restrictions, citing a need to “provide reasonable assurance of the safety and effectiveness of the device.”

Specifically, a patient brochure entitled “Patient-Doctor Discussion Checklist–Acceptance of Risk and Informed Decision Acknowledgment” must be reviewed with the patient, and the patient must be given the opportunity to sign the acknowledgment, which also must be signed by the physician implanting the device.

Bayer must implement the restrictions immediately and must ensure health care provider compliance.

“The FDA is taking this step after becoming aware that some women were not being adequately informed of Essure’s risks before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device,” the agency said in a press release, adding that it “plans to enforce these requirements and will take appropriate action for a failure to comply, including applicable criminal and civil penalties.”

Essure, which is the only permanently implanted birth control device for women on the market that does not require a surgical incision, was approved in 2002 and has been associated with adverse events including perforation of the uterus and/or fallopian tubes, device migration into the abdomen or pelvis, persistent pain, and suspected allergic reactions or hypersensitivity. Some women have also reported headache, fatigue, weight changes, hair loss, and mood changes.

In 2016, based on product safety monitoring by the FDA, a postmarketing study was ordered, as was a boxed warning and a more comprehensive patient decision checklist to inform patients about the risk of adverse events.

 

“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,” FDA commissioner Scott Gottlieb, MD, said in the press release, adding that it is unacceptable that some women were not being adequately informed.

“Every single woman receiving this device should fully understand the associated risks,” he said.

Terri Cornelison, MD, assistant director for the health of women in the Center for Devices and Radiological Health added that ensuring informed decision making is just one important step in ongoing efforts to monitor the Essure device.

“We remain committed to carefully and throughly considering all new data and evidence and will continue to work with patients affected by this device as part of our process,” she said. “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.”

[email protected]