What are the long-term results with the MyoSure system?
The MyoSure system is a tool to perform hysteroscopic myomectomy and polypectomy. The body of evidence regarding the clinical performance of hysteroscopic myomectomy is well documented. For the purpose of reducing bleeding associated with sub-mucosal fibroids, studies suggest that hysteroscopic myomectomy is nearly 96.4% effective in achieving symptom resolution and can be as high as 70% effective for improving fertility rates. In addition, recurrence rates have been reported as ≤ 10% five years post procedure1.
Can I remove a fundal fibroid?
With the new MyoSure REACH device, you may be able to remove fibroids located in hard-to-reach areas, including the upper third of the uterine cavity. In order to successfully remove a fundal fibroid, please adhere to the following guidelines:
- Do not use the tip of the MyoSure tissue removal device (TRD) as a probe.
- The tip of the TRD should remain a safe distance from the uterine wall at all times during the resection process.
- Resection should be performed by moving the TRD laterally.
What should I do if the fibroid begins to bleed?
Sufficient distension fluid pressure acts to tamponade minor bleeding during a procedure. Increasing distension fluid pressure will typically resolve persistent minor bleeding. Removing the MyoSure hysteroscope and tissue removal device at the conclusion of the procedure will permit spontaneous uterine contraction and the natural tamponade effect of contracted uterine walls will often resolve bleeding.
Can the MyoSure device cut into the myometrium?
Not if used in accordance with the instructions for use. Because the MyoSure tissue removal device has a side cutting window, limiting the depth of resection.
Can the MyoSure system remove large fibroids?
Yes. With the MyoSure XL device, the MyoSure system is designed to remove a 5 cm fibroid in 15 minutes or less of cutting time.
Why does the MyoSure system use saline as a uterine distension media?
The MyoSure system removes pathology via mechanical energy vs. electrical energy and therefore can use saline which is a physiologic distension media. Saline or Ringer’s Lactate, according to AAGL fluid management guidelines, have a higher intravasation safety limit (2500 cc) than is available for non-electrolyte media such as glycine ( 1000 cc). It should be noted, however, that the MyoSure procedure is compatible with all distension media.2
Can the MyoSure system truly be used with any hysteroscopy pump?
Yes, however some pumps have more optimal performance. Any pump which does not have the ability to control flow rate should be considered sub-optimal. Sub-optimal pumps may be adequate for smaller pathology less than 3 cm, but may present distension or visualization challenges with larger and more complex pathology.
Can a MyoSure treatment be followed by a NovaSure endometiral ablation procedure?
According to the product’s labeling, the NovaSure system is contraindicated in a patient with any anatomic condition that could lead to weakening of the myometrium. Use of the NovaSure system would therefore be contraindicated if there was removal of intrauterine pathology with the MyoSure device that resulted in weakening of the myometrium. Therefore it is up to the treating physician to assess whether there has been weakening to the myometrium following the MyoSure procedure.
Can we perform the MyoSure procedure in the office? What type of sedation do we need?
Limited clinical data indicates that MyoSure procedure can be used in conjunction with an oral sedation/cervical block protocol to safely remove polyps, Type 0 and Type 1 fibroids less than 3 cm in an office setting.3 Most patients report that their discomfort during the procedure is similar to that of a PAP test. That said, there is currently no universal reimbursement available for office-based hysteroscopic myomectomy treatments of any kind.
1. Emanuel MH, Wamsteker K, Hart AA, Metz G, Lammes FB, Long-term results of hysteroscopic myomectomy for abnormal uterine bleeding. Obstet Gynecol. 1999;93:743-748 (II-2).
2. Miller C, Glazerman L, Roy K, Lukes A. Clinical evaluation of a new hysteroscopic morcellator - Retrospective Case Review. Journal of Clinical Medicine 2(3):163-166, July/August 2009.
3. Wallach EE, Vlahos NF. Uterine myomas: an overview of development, clinical features, and management. Obstet Gynecol. 2004 Aug;104(2):393-406.
4. American Congress of Obstetricians and Gynecologists. Technology assessment no. 7: hysteroscopy. Obstet Gynecol. 2011 Jun;117(6):1486-91.