Regulatory Focus™ > News Articles > 4 > FDA Invokes Authority to Issue ‘Unique Type of Restriction’ on Essure Contraceptive Device

FDA Invokes Authority to Issue ‘Unique Type of Restriction’ on Essure Contraceptive Device

Posted 09 April 2018 | By Ana Mulero 

FDA Invokes Authority to Issue ‘Unique Type of Restriction’ on Essure Contraceptive Device

In a “unique type of restriction,” the US Food and Drug Administration (FDA) issued an order Monday to limit sales and distribution of Bayer’s permanent contraception device, Essure, over the numerous health risks that have been associated with its use.

The decision is based on a “review of a growing body of evidence” that led FDA to conclude “previous efforts to alert women to the potential complication of Essure” have not been enough to ensure they receive “this important information,” FDA Commissioner Scott Gottlieb said in a statement. The birth control product, thus, “requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” Gottlieb added.

FDA actions aimed at addressing the issues and concerns include requiring Bayer to create a plan—which received FDA approval in 2016—for conducting a nationwide postmarket surveillance study. New labeling for Essure, with an added boxed warning on adverse events, was approved in 2016 as well.

Patients’ use of the contraceptive device—which continues to remain on the US market—called into question FDA’s effectiveness in monitoring the birth control device’s safety as thousands of adverse events, including four adult deaths, have been linked to its use since its 2002 approval.

Essure is the “only permanently implanted birth control device for women on the market that does not require a surgical incision,” according to FDA.

Bayer also has raised concerns among lawmakers over whether it has “acted with urgency to enroll patients” in the postmarket study. Also, the device maker announced in 2017 its decision to cease foreign Essure sales, at least temporarily, due to commercial viability, rather than safety concerns.

As part of the new FDA order, Essure sales are now legally restricted to “only healthcare providers and facilities that provide information to patients about the risks and benefits of the device,” FDA said. The decision checklist—included in the 2016 labeling design change—must be reviewed with prospective patients, which must also “be given the opportunity to sign the acknowledgement,” the agency added.

It remains to be seen whether the new labeling requirement will be sufficient to ease users’ concerns.

As the device maker pointed out in a statement, Essure’s benefit-risk profile “has not changed and remains positive,” adding that FDA has “repeatedly determined” it to be “a safe and effective medical device.”

Bayer recognized, however, the agency’s request to, again, update the device’s label. This time the label update will “emphasize” the “importance of appropriately counseling each patient.”

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.