What are the indications and recommendations for using the Myosure device in adult women with uterine fibroids or other intrauterine pathologies?

Myosure Device: Indications and Recommendations

Primary Indication

The Myosure device is indicated for hysteroscopic removal of intrauterine pathology, specifically endometrial polyps and type 0 or type I submucosal fibroids, with optimal results for lesions ≤4 cm in diameter. 1, 2, 3

Specific Clinical Indications

Endometrial Polyps

• The Myosure device achieves near-complete resection rates of 98-100% for endometrial polyps, making it the preferred hysteroscopic approach for these lesions 1, 2, 3
• Effective for polyps causing abnormal uterine bleeding in both office and ambulatory surgical center settings 1

Submucosal Fibroids (Leiomyomas)

• Type 0 and Type I submucosal fibroids between 1.5-4 cm are ideal candidates for Myosure resection 1, 2
• Complete resection rates vary by fibroid characteristics:
  • 87% complete resection for fibroids ≤40 mm 2
  • Only 48% complete resection for fibroids >40 mm, requiring repeat procedures 2
  • 73.7% overall complete resection rate for leiomyomas compared to 98.1% for polyps 3

Type II Fibroids: A Critical Limitation

• Type II submucosal fibroids (predominantly intramural with <50% intracavitary component) have significantly lower complete excision rates (OR = 1.8, p = 0.01) 3
• These lesions may require alternative approaches such as laparoscopic or open myomectomy 4

Retained Products of Conception

• 100% complete excision rate for retained products of conception, making this an excellent indication 2, 3

Clinical Outcomes and Efficacy

Symptom Improvement

• Significant and durable improvement in quality of life metrics at 12 months post-procedure 1
• Uterine Fibroid Symptom-Quality of Life (UFS-QOL) scores improved from baseline mean of 67.5 to 22.3 at 12 months (p < 0.01) 1
• Health-Related Quality of Life (HRQOL) scores improved from 38.7 to 83.9 at 12 months (p < 0.01) 1
• 76% of patients achieved complete symptom resolution 2

Reintervention Rates

• 10% of patients required further surgery (repeat hysteroscopy or hysterectomy) 2
• This is primarily due to incomplete resection of larger or Type II fibroids 2, 3

Setting and Safety Profile

Office-Based vs. Ambulatory Surgical Center

• The Myosure device can be safely performed in both office-based settings and ambulatory surgical centers with equivalent outcomes 1, 3
• 99% of patients would undergo the procedure again or recommend it, indicating high patient acceptability 3

Pain Management

• 73% of patients report mild pain, 17% moderate pain, and only 7.3% severe pain during the procedure 3
• This favorable pain profile supports office-based use without general anesthesia in selected patients 3

Safety

• No intraoperative complications were reported in prospective studies 2
• The device avoids risks associated with traditional electrosurgical resection, including thermal injury and fluid overload 4

Training and Learning Curve

• 61% of procedures can be safely performed by trainees with similar clinical outcomes to senior clinicians 2
• No statistically significant difference in outcomes when procedures performed by attending physicians versus residents for polyps 2
• Leiomyomas are more likely to be completely resected by attending physicians or senior residents, though this did not affect overall clinical outcomes 2

Contraindications and Limitations

Size Limitations

• Fibroids >4 cm have significantly reduced complete excision rates (OR = 1.6, p = 0.02) and should be considered for alternative treatments 3
• Multiple procedures may be required for larger lesions 2

Anatomical Limitations

• Type II fibroids with predominantly intramural components are poor candidates 3
• Distorted uterine cavities or anatomical abnormalities incompatible with device insertion preclude use 4

Fertility Considerations

• For women desiring pregnancy with submucosal fibroids <4 cm, hysteroscopic resection (including Myosure) is recommended regardless of symptoms 5
• The device preserves the endometrium better than traditional resection techniques 1

Clinical Algorithm for Patient Selection

Proceed with Myosure if:

• Endometrial polyps of any size causing symptoms 1, 3
• Type 0 or Type I submucosal fibroids ≤4 cm 1, 2, 3
• Retained products of conception 2, 3
• Patient desires office-based or minimally invasive approach 3

Consider alternative approaches if:

• Fibroids >4 cm (consider UAE, myomectomy, or MRgFUS) 4
• Type II fibroids (consider laparoscopic/open myomectomy) 4, 3
• Multiple large fibroids (consider UAE or myomectomy) 4
• Concurrent adenomyosis requiring treatment (Myosure will not address this) 4

Common Pitfalls to Avoid

• Do not attempt complete single-session resection of fibroids >4 cm—plan for staged procedures or alternative treatment 2, 3
• Do not use Myosure as sole treatment for Type II fibroids—incomplete resection is likely 3
• Do not overlook concurrent adenomyosis—this will not be treated by hysteroscopic morcellation and may require additional therapy 4
• Ensure adequate preoperative imaging (transvaginal ultrasound with saline infusion sonohysterography or MRI) to accurately classify fibroid type and size 4