Medical Professionals Reference (MPR)FDA Clears Drug-Free Device to Prevent Intrauterine Adhesions

The FDA granted Premarket Approval to Womed Leaf, a drug-free intrauterine barrier film that prevents postsurgical adhesion reformation after hysteroscopic adhesiolysis for Asherman syndrome. The biodegradable polymer device demonstrated superior outcomes in the 160-patient PREG2 trial, with 41% achieving complete adhesion resolution versus 24% in controls, representing a significant advancement in fertility preservation options for women with intrauterine adhesions.

⚖️ Professional Impact Points

• PMA approval establishes new treatment standard for Asherman syndrome management, creating potential practice guideline updates and offering evidence-based alternative to hormone therapy or repeat procedures for adhesion prevention.
• Device mechanism eliminates drug exposure concerns through biodegradable polymer that naturally degrades and discharges, addressing patient safety preferences and reducing contraindication complications in reproductive-age women with complex medical histories.
• Superior efficacy data (51% responder rate vs 29% control) provides strong evidence for insurance coverage justification and shared decision-making discussions, with 2.72 odds ratio for two-stage improvement supporting clinical adoption.
• Immediate post-procedure insertion requirement necessitates procedural workflow modifications and hysteroscopic training updates, with device placement technique becoming standard component of adhesiolysis procedures to optimize patient outcomes.
• Zero device-related adverse events in pivotal trial strengthens liability profile and informed consent discussions, though post-market surveillance will establish real-world safety patterns across diverse patient populations and practice settings.

🏥 Practice Management Considerations

• Documentation Strategy: Establish protocols for documenting device placement, patient selection criteria, and post-procedure follow-up schedules; implement standardized second-look hysteroscopy timing and AFS scoring to monitor outcomes and support quality metrics for adhesion prevention success rates.
• Patient Communication Protocols: Develop educational materials explaining biodegradable polymer mechanism, natural discharge process, and expected timeline; train staff on addressing device-related questions and setting realistic expectations for adhesion prevention versus complete resolution guarantees.
• Legal Risk Assessment: Review informed consent language to address device limitations, success rate variations, and fertility outcome uncertainties; establish clear documentation of alternative treatment discussions and patient preference for device placement versus traditional hormone therapy approaches.
• Staff Training Requirements: Implement hysteroscopic placement technique training for proceduralists, including device unfolding verification and proper positioning; educate nursing staff on post-procedure monitoring protocols and patient discharge instructions for expected device passage symptoms.
• Quality Assurance Measures: Track adhesion recurrence rates, patient-reported outcomes, and fertility success metrics; establish adverse event reporting systems for post-market surveillance and participate in device registry programs to contribute real-world effectiveness data.

HCN Medical Memo
Practices performing hysteroscopic adhesiolysis should prepare for device availability in early 2026 by updating procedural protocols and training staff on placement techniques. Consider establishing patient registries to track outcomes and support insurance pre-authorization processes. Review practice patterns to identify patients who would benefit most from this evidence-based adhesion prevention option.

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