Clinical Effects of the U.S. Food and Drug Administration's Newest Restrictions on the Etonogestrel Implant.

In 2026, the U.S. Food and Drug Administration introduced a new Risk Evaluation and Management Strategy (REMS) for the etonogestrel contraceptive implant. Although the intent was to maintain safe practices for device insertion and removal, the large body of long-standing safety data should raise questions about the need for these new requirements. In the absence of safety concerns regarding device insertion and removal, a REMS requirement on the etonogestrel contraceptive implant may lead to decreased reproductive health care access and provision.