The Food and Drug Administration (FDA) has issued an order restricting sales and distribution of the contraceptive device Essure. Physicians will only be able to purchase the device after agreeing to go over a comprehensive FDA-sanctioned brochure and checklist with potential patients to ensure they are aware of the risks associated with the device.
Essure consists of two small coils made of a nickel alloy and polyester-like fiber which are inserted into the fallopian tubes through the vagina. Build-up of scar tissue around the coils creates a barrier that prevents sperm from fertilizing an egg. The device is the only permanent implantable contraceptive for women that does not require a surgical incision. Some patients who have received it have reported adverse events, including uterine and/or fallopian tube perforation, migration of inserts to the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions.
In the recent announcement, the FDA noted that the restriction was based on evidence that some women were not getting adequate information about the risks of the device, despite previous efforts to educate patients and doctors. The recent action will require both physician and patient to sign a form with a checklist acknowledging that they have gone over and been advised of the implants’ risks.
In February 2016, the FDA ordered Bayer, the manufacturer, to conduct a post-marketing (522) study to further evaluate the safety of the product in real-world application. This study is ongoing and is expected to be completed by 2023.
In November 2016, the FDA also required the manufacturer to add a boxed warning to the product labeling that stated the associated adverse effects. In addition, the FDA required that a more comprehensive patient decision checklist be added to the device labeling.
The new restrictions must be implemented immediately and the FDA will monitor and review the manufacturer’s plans for compliance. The FDA also noted that failure to comply will result in FDA action. Additional action may be required following the results of the post-marketing study.