Clinical Effects of the U.S. Food and Drug Administration's Newest Restrictions on the Etonogestrel Implant.
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- Record sourced from PubMed, PMID 42208067.
- Also identified by DOI 10.1097/AOG.0000000000006333.
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Abstract
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.