On April 9, 2018, the United States Food and Drug Administration (US-FDA) issued an order to restrict the sale and distribution of the Essure device to ensure that all women considering use of the permanent contraception device are provided with adequate risk information so that they can make informed decisions49. 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 FDA is requiring a unique type of restriction, using its authority to restrict the sale and distribution of a device, which imposes additional requirements needed to provide a reasonable assurance of its safety and effectiveness. The FDA is committed to continuing to use its full authority to ensure the post-market safety of medical products.
What is Essure®?
Essure is a permanent birth control procedure that works with your body to create a natural barrier against pregnancy. The Essure procedure involves placing soft, flexible inserts into your fallopian tubes. Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs and prevents conception. Essure was approved in 2002 by the FDA. Over 750,000 women and their doctors have chosen Essure for permanent birth control (based on units sold worldwide).
Essure is the only permanently implanted birth control device for women in the market that does not require a surgical incision. Some patients implanted with Essure have experienced adverse events, including perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain and suspected allergic or hypersensitivity reactions. In addition, women have also reported experiencing headache, fatigue, weight changes, hair loss and mood changes, such as depression. It is unknown whether these symptoms are related to Essure.
Background
Since Essure's approval in 2002, the agency has continued to monitor the product's safety and effectiveness by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency. Based on this review, in February 2016, the agency ordered Bayer to conduct a post- marketing (522) study to better evaluate the safety profile of the device when used in the real world. The agency is currently monitoring the company's progress.
In November 2016, the FDA also required Bayer to add a boxed warning to the product labeling, stating information about adverse events associated with the device"including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions." In addition to the warning, the FDA also required a more comprehensive patient decision checklist be added to the device labeling to provide women considering Essure information about the benefits and risks of this device before deciding to use it.
Since the FDA ordered Bayer to conduct a post-market study, and then to add a boxed warning and a patient decision checklist to the labeling, there has been an approximately 70 percent decline in sales of Essure in the U.S.
The FDA has determined, however, that some women still are not receiving information about the known risks of Essure before implantation.
The new Essure labeling, which will now be legally required when this product is offered to a patient, restricts 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. Specifically, the patient brochure50, titled "Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement," must be reviewed with the prospective patient by the health care provider to ensure the patient understands the risks, benefits and other information about Essure implantation. The patient must be given an opportunity to sign the acknowledgment, and it must be signed by the physician implanting the device.
Bayer, the device manufacturer, is required to implement the restrictions immediately and ensure that the process going forward results in health care provider compliance with the sales restriction. The FDA will review and monitor Bayer's plan to ensure the company complies with the restriction. The FDA plans to enforce these requirements and will take appropriate action for a failure to comply, including applicable criminal and civil penalties.
Footnotes
49 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604098.htm
50 http://labeling.bayerhealthcare.com/html/products/pi/essure_pib_en.pdf
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