Pending Policies - Surgery
Laparoscopic, Percutaneous and Transcervical Techniques for the Myolysis of Uterine Fibroids
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Laparoscopic ultrasound-guided radiofrequency ablation (e.g., Acessa™) for the treatment of uterine fibroids may be considered medically necessary for the following:
• Excessive uterine bleeding as evidenced by either profuse bleeding lasting more than eight days, or anemia due to acute or chronic blood loss; or
• Pelvic discomfort caused by leiomyomata, manifested as:
o Acute severe pain, OR
o Chronic lower abdominal pain; OR
o Low back pressure; OR
o Bladder pressure with urinary frequency not due to urinary tract infection.
Laparoscopic, percutaneous and transcervical techniques of myolysis as a treatment of uterine fibroids other than laparoscopic ultrasound-guided radiofrequency ablation (e.g., Acessa ™) are considered experimental, investigational and/or unproven, including Nd:Yag Lasers, bipolar electrodes, and supercooled cryoprobes.
Various minimally invasive treatments for uterine fibroids have been proposed as alternatives to surgery. Among these approaches are laparoscopic and percutaneous techniques to induce myolysis, which includes radiofrequency volumetric thermal ablation (RFVTA), laser and bipolar needles, cryomyolysis, and magnetic resonance imaging-guided laser ablation.
Uterine fibroids are one of the most common conditions affecting women in the reproductive years; symptoms include menorrhagia, pelvic pressure, or pain. Surgery, including hysterectomy and various myomectomy procedures, is considered the criterion standard treatment for symptom resolution. However, there is the potential for surgical complications and, in the case of hysterectomy, the uterus is not preserved. In addition, in the case of multiple uterine fibroids, myomectomy can be a time-consuming procedure.
There has been longstanding research interest in developing minimally invasive alternatives for treating uterine fibroids, including procedures that retain the uterus and allow for future childbearing. Treatment options include uterine artery embolization, (See SUR701.015 Therapeutic Embolization and Vessel Occlusion) and the transcutaneous procedure magnetic resonance imaging (MRI)-guided focused ultrasound therapy (MRgFUS) (See SUR701.022 Magnetic Resonance Imaging-Guided Focused Ultrasound (MRgFUS)). Various techniques to induce myolysis have also been studied including Nd:YAG lasers, bipolar electrodes, cryomyolysis, and radiofrequency ablation. An energy source is used to create areas of necrosis within uterine fibroids, reducing their volume and thus relieving symptoms. Early methods involved the insertion of probes multiple times into the fibroid and were performed without imaging guidance. There were concerns about serosal injury and abdominopelvic adhesions with these techniques, possibly due to the multiple passes through the serosa needed to treat a single fibroid. (1) Newer systems using radiofrequency energy do not require repetitive insertions of needle electrodes. Ultrasonography is used laparoscopically to determine the size and location of fibroids, to guide the probe and to ensure the probe is in the correct location so that optimal energy is applied to the fibroid. Percutaneous approaches using MRI guidance have also been reported.
Transcervical Uterine Fibroid Ablation
A new technology from Gynesonics-the SonataTM System (previous generation referred to as VizAblate) uses radiofrequency energy to ablate fibroids under intrauterine ultrasound guidance. This technology allows transcervical access for incision-free, uterus preserving fibroid treatment. In a press release dated August 4, 2015 on the Gynesonics website notes the U.S. Food and Drug Administration (FDA) approval of the SONATA IDE pivotal trial for their latest generation Sonata™ System. (20) Review of NCT02228174 Sonography Guided Transcervical Ablation of Uterine Fibroids (SONATA) on the ClinicalTrials.gov website in October 2016, indicates that participants are currently being recruited. (21) As of October 2016 the Sonata system has not been approved by the FDA.
In November 2012, the Acessa™ System (Halt Medical, Brentwood, CA) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for percutaneous laparoscopic coagulation and ablation of soft tissue and treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. The technology was previously approved in 2010, at which time it was called the Halt 2000GI™ Electrosurgical Radiofrequency Ablation System (Halt Medical, Brentwood, CA). The intended use of the Halt 2000GI™ system was for percutaneous laparoscopic coagulation and ablation of soft tissue. Unlike FDA clearance of the Acessa™ System, the intended use statement for the Halt 2000GI™ system does not specifically mention treatment of uterine fibroids. FDA Product Code: GEI.
Radiofrequency Volumetric Thermal Ablation
In 2014, Brucker et al. in Germany published a single-center industry-sponsored randomized controlled trial (RCT) comparing radiofrequency volumetric thermal ablation (RFVTA) with the Acessa system to laparoscopic myomectomy. (2) The trial included 51 premenopausal women at least 18 years old with symptomatic uterine fibroids less than 10 cm in any diameter and a uterine size of less than 17 weeks of gestation. Pregnancy and lactation were exclusion criteria. Prior to randomization, all women underwent laparoscopic ultrasound mapping. Data on 50 of the 51 women were analyzed. The primary study outcome, mean (SD) time to hospital discharge, was 10.0 (5.5) hours in the RFVTA group and 29.9 (14.2) hours in the myomectomy group. The criterion for noninferiority (no more than 10% longer hospital stay with RFVTA than laparoscopic myomectomy) was met at a significance level of p<0.001. All patients in the myomectomy group were hospitalized overnight; although not explicitly stated, this appeared to be the standard procedure at the study hospital. In the Acessa group, there was 1 unplanned hospitalization due to unexplained vertigo and 4 hospitalizations as standard procedure because the patients also underwent adhesiolysis.
Secondary outcomes of the RCT were reported in a 2015 publication by Hahn et al. (3) (12-month outcomes) and a 2016 publication by Kramer et al. (4) (24-month outcomes). Analysis was per protocol and 43 (84%) of 51 randomized participants were available for both the 12- and 24-month analyses. Each publication reported on 12 symptoms: heavy menstrual bleeding, increased abdominal gait, dyspareunia, pelvic discomfort/pain, dysmenorrhea, urinary frequency, urinary retention, sleep disturbance, backache, localized pain, and “other symptoms” (not specified). At 12 months, no participants reported 4 of the symptoms (dyspareunia, urinary retention, sleep disturbance, uterine pain) and there were no statistically significant between-group differences in the frequency of any of the remaining 8 symptoms (at the p<0.05 level). The most commonly reported symptom at 12 months (heavy menstrual bleeding) occurred in 7 (33%) of women in the RFVTA group and 2 (9%) of women in the laparoscopic myomectomy group (p=0.069) after controlling for baseline bleeding. At 24 months, no participants reported urinary retention or “other” symptoms, and there were no statistically significant between-group differences in any of the 10 reported symptoms. The most commonly reported symptom at 24 months (dysmenorrhea) occurred in 8 (38%) in the RFVTA group and in 78 (32%) in the laparoscopic myomectomy group (p=0.67). Patients were also assessed using several validated questionnaires (e.g., the Uterine Fibroid Symptom and Quality of Life). There were no statistically significant between-group differences at 12 or 24 months on these validated questionnaires. In addition, the authors described pregnancy outcomes. Three patients in the RFVTA group conceived and all delivered a healthy neonate; the number of women who desired to become pregnant was not reported. Limitations of the 12- and 24-month analyses included lack of intention-to-treat analysis and failure to describe secondary study hypotheses and statistical analyses clearly. The RCT was relatively small in size and thus may have been underpowered to detect clinically meaningful differences in secondary outcomes, so these results do not rule out potential differences between treatments.
In addition to the RCT, several uncontrolled case series with longer term follow-up (i.e., at least 2 years) were identified. In 2013, Chudnoff et al. published a prospective industry-funded multicenter study. (5) It included 135 premenopausal women at least 25 years old with symptomatic uterine fibroids, a uterine size of 14 weeks of gestation or less, and 6 or fewer treatable fibroids, with no single fibroid larger than 7 cm. In addition, women desired to preserve their uteri but not to have children in the future. RFVTA was conducted using the Acessa system. According to the study protocol, most fibroids less than 1 cm in diameter were not treated. The primary efficacy outcomes were change in the volume of menstrual bleeding and the surgical reintervention rate after 12 months. A total of 127 (94%) of 135 women completed the study. From baseline to 12 months, 53 (42%) of 127 women (95% confidence interval, 32% to 49%) experienced at least a 50% reduction in the volume of menstrual bleeding. Most women (104/127 [82%]) experienced a decrease in menstrual bleeding at 12 months. Only 1 woman underwent a surgical reintervention through 12 months (this woman had been lost to follow-up and was not included in the other efficacy analyses). Three-year outcomes were reported by Berman et al. in 2014. (6) A total of 104 (77%) of the 135 women who participated in the study were evaluable at 3 years. Fourteen underwent reintervention over the 3 years to treat uterine fibroid symptoms. Eleven women had hysterectomies, 2 had myomectomies, and 1 had uterine artery embolization. Bleeding outcomes were not reported at 3 years, but the authors stated that quality-of-life variables improved from baseline to 36 months and that most of the improvement in quality of life occurred within 3 months of the procedure.
A large retrospective case series was published by Yin et al. in 2015. (7) The study was conducted in China and used Chinese gynecologic radiofrequency ablation devices. It included 1216 consecutive patients treated at a single hospital over a 10-year period. All fibroids were less than 6 cm in size and mean diameter was 4.5 cm (range, 3.1-6.0 cm). Mean follow-up time was 36.5 months. Among the 476 premenopausal women, the mean reduction in myoma diameter was 2.7 cm at 6 months, 2.4 cm at 12 months, and 2.2 cm at 24 months. Among the 740 peri- or postmenopausal women, mean reduction was 3.3 cm at 6 months, 2.3 cm at 12 months, and 2.3 cm at 24 months. Myoma diameter was significantly lower at each of these time points posttreatment compared with pretreatment. In the premenopausal subgroup, the proportion of women with dysmenorrhea decreased from 43.7% at baseline to 7.6% at 12 months and to 6.7% at 24 months; rates were significantly lower after treatment.
Section Summary: Radiofrequency Volumetric Thermal Ablation
One RCT comparing RFVTA and laparoscopic myomectomy has been published. The trial found that RFVTA was noninferior to laparoscopic myomectomy on the primary outcome, length of hospitalization. A number of secondary outcomes were reported at 12 and 24 months, none of which were significantly different between groups.
Laser and Bipolar Needles
Several case series were identified, most published in the 1990s. For example, in 1995 Goldfarb reported outcomes for 300 women with symptomatic fibroids no larger than 10 cm who underwent myolysis using either Nd:YAG or bipolar needles. (8) The author reported that the coagulating effect of the bipolar needle devascularized the fibroids, and the resulting shrinkage was comparable to that produced by Nd:YAG laser. An earlier study by Goldfarb, published in 1992, included 75 patients who presented with symptomatic fibroids 5 to 10 cm in diameter. (9) Symptoms included pelvic pain, pressure, dyspareunia, and recurrent menorrhagia. The Nd:YAG laser was inserted into the fibroid multiple times (e.g., 75 to 100 punctures to coagulate a 5-cm fibroid). Based on assessment by endovaginal ultrasound, the fibroids regressed in size and, after 6 to 14 months of follow-up, the size remained stable. No patient experienced significant complications. In 1993, Nisolle et al. reported on a case series of 48 women offered myolysis instead of myomectomy if they had completed childbearing. (10) Although the report stated that 28 of the 48 had more than 2 fibroids, it is not clear if all fibroids were treated in each patient, and, if not, how the treated fibroids were selected. The authors reported that maximal decrease in fibroid size had occurred by 6 months. However, there was no report of associated patient symptoms.
Several authors have reported pelvic adhesions as a complication, presumably due to thermal damage to the serosal surface. In addition, the Nd:YAG laser produces a significant amount of smoke, which can obscure visibility. (11, 12)
Section Summary: Laser and Bipolar Needles
Only case series were available and most were published in the 1990s. RCTs comparing laser and bipolar needles to alternative treatments for uterine fibroids and reporting health outcomes are needed.
Cryomyolysis, entails inserting a -180°C cryoprobe into the center of a fibroid, creating an “iceball” within the fibroid. Several freeze/thaw cycles are typically used. In 1998, Zreik et al. published a prospective pilot study with 14 patients, and in 2004, Zupi et al. presented their experience with 20 patients. (13, 14) In both case series, the authors reported that patients had symptom resolution. In the Zreik series, patients were given a gonadotropin-releasing hormone (GnRH) agonist before the procedure to reduce the size of the fibroid. Cryomyolysis maintained or slightly reduced the post-GnRH uterine size. In contrast, in the Zupi study, GnRH was not used, and cryomyolysis was associated with a 25% reduction in fibroid size. In 2005, Zupi et al. reported the 1-year follow-up of these patients. (15) Mean shrinkage in fibroid size continued until 9 months after surgery, to a mean volume reduction of 60%. Patients reported absence of symptoms. Interpretation of these studies is limited due to their small size and lack of a comparison group.
Section Summary: Cryomyolysis
Only several small case series are available. RCTs comparing cryomyolysis to alternative treatments for uterine fibroids and reporting health outcomes are needed.
Magnetic Resonance Imaging-Guided Laser Ablation
In 2002, Hindley et al. reported on a case series of 66 patients with symptomatic fibroids treated with magnetic resonance imaging (MRI)-guided percutaneous Nd:YAG laser myolysis. (16) Outcome measures included assessment of fibroid size and responses to a menorrhagia questionnaire. The mean reduction in fibroid size was 31%. Compared with a historical control group of women undergoing hysterectomy, the total outcome score was less in those undergoing percutaneous myolysis, but the quality-of-life score was similar. Although not entirely clear, it appears that treatment was targeted to only the largest fibroid in each patient. The series did not provide details on the number and location of fibroids.
Section Summary: Magnetic Resonance Imaging-Guided Laser Ablation
Only 1 case series was identified. RCTs comparing MRI-guided percutaneous laser ablation to alternative treatments for uterine fibroids and reporting health outcomes are needed.
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this medical policy are listed in Table 1.
Table 1. Summary of Key Trials
The Trust (Treatment Results of Uterine Sparing Technologies) Study
NCT: national clinical trial.
a Denotes industry-sponsored or cosponsored trial.
Summary of Evidence
For individuals who have uterine fibroids who receive radiofrequency volumetric thermal ablation (RFVTA), the evidence includes 1 randomized controlled trial (RCT). Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. The RCT found that RFVTA was noninferior to laparoscopic myomectomy on the trial’s primary outcome, length of hospitalization. A number of secondary outcomes were reported at 12 and 24 months, none of which demonstrated significant between-group differences.
For individuals who have uterine fibroids who receive laser or bipolar needles, the evidence includes case series. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. The case series were published in the 1990s and the procedures used may not reflect current practice. RCTs comparing laser or bipolar needles to alternative treatments for uterine fibroids are needed to adequately evaluate the safety and efficacy of this technology.
For individuals who have uterine fibroids who receive cryomyolysis, the evidence includes case series. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. Among the few case series, sample sizes were small (≤20 patients). RCTs comparing cryomyolysis to alternative treatments for uterine fibroids are needed to adequately evaluate the safety and efficacy of this technology.
For individuals who have uterine fibroids who receive MRI-guided laser ablation, the evidence includes 1 case series. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. A single case series (N=66) is insufficient for evaluating the technology. RCTs comparing MRI-guided laser ablation to alternative treatments for uterine fibroids are needed to adequately evaluate the safety and efficacy of this technology.
Practice Guidelines and Position Statements
Society of Obstetricians and Gynecologists of Canada
In 2015, the Society of Obstetricians and Gynecologists of Canada published a clinical practice guideline on management of uterine leiomyomas. (17) The guideline included the summary following statements:
• “Of the conservative interventional treatments currently available, uterine artery embolization has the longest track record and has been shown to be effective in properly selected patients.”
• “Newer focused energy delivery methods are promising but lack long-term data.”
American College of Obstetricians and Gynecologists
In 2014, the American College of Obstetricians and Gynecologists reaffirmed a 2008 Practice Bulletin on alternatives to hysterectomy in the management of leiomyomas. (18) Recommendations based on good and consistent scientific evidence are that abdominal myomectomy is a safe and effective treatment of women with symptomatic leiomyomas and that uterine artery embolization is a safe and effective option for appropriately selected women who want to retain their uteri. The bulletin contained no recommendations on myolysis using laparoscopic or percutaneous techniques.
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Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.
The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.
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The following codes may be applicable to this Medical policy and may not be all inclusive.
58674, 0404T, [Deleted 1/2017: 0336T]
ICD-9 Diagnosis Codes
Refer to the ICD-9-CM manual
ICD-9 Procedure Codes
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ICD-10 Diagnosis Codes
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ICD-10 Procedure Codes
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The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position.
A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.
1. Jones S, O'Donovan P, Toub D. Radiofrequency ablation for treatment of symptomatic uterine fibroids. Obstet Gynecol Int. 2012; 2012:194839. PMID 21961009
2. Brucker SY, Hahn M, Kraemer D, et al. Laparoscopic radiofrequency volumetric thermal ablation of fibroids versus laparoscopic myomectomy. Int J Gynaecol Obstet. Jun 2014; 125(3):261-265. PMID 24698202
3. Hahn M, Brucker S, Kraemer D, et al. Radiofrequency volumetric thermal ablation of fibroids and laparoscopic myomectomy: long-term follow-up from a randomized trial. Geburtshilfe Frauenheilkd. May 2015; 75(5):442-449. PMID 26097247
4. Kramer B, Hahn M, Taran FA, et al. Interim analysis of a randomized controlled trial comparing laparoscopic radiofrequency volumetric thermal ablation of uterine fibroids with laparoscopic myomectomy. Int J Gynaecol Obstet. May 2016; 133(2):206-211. PMID 26892690
5. Chudnoff SG, Berman JM, Levine DJ, et al. Outpatient procedure for the treatment and relief of symptomatic uterine myomas. Obstet Gynecol. May 2013; 121(5):1075-1082. PMID 23635746
6. Berman JM, Guido RS, Garza Leal JG, et al. Three-year outcome of the Halt trial: a prospective analysis of radiofrequency volumetric thermal ablation of myomas. J Minim Invasive Gynecol. Sep-Oct 2014; 21(5):767-774. PMID 24613404
7. Yin G, Chen M, Yang S, et al. Treatment of uterine myomas by radiofrequency thermal ablation: a 10-year retrospective cohort study. Reprod Sci. May 2015; 22(5):609-614. PMID 25355802
8. Goldfarb HA. Bipolar laparoscopic needles for myoma coagulation. J Am Assoc Gynecol Laparosc. Feb 1995; 2(2):175-179. PMID 9050553
9. Goldfarb HA. Nd: YAG laser laparoscopic coagulation of symptomatic myomas. J Reprod Med. Jul 1992; 37(7):636-638. PMID 1387912
10. Nisolle M, Smets M, Malvaux V, et al. Laparoscopic myolysis with the Nd: YAG laser. J Gynecol Surg. Summer 1993;9(2):95-99. PMID 10171973
11. Donnez J, Squifflet J, Polet R, et al. Laparoscopic myolysis. Hum Reprod Update. Nov-Dec 2000; 6(6):609-613. PMID 11129695
12. Phillips DR, Nathanson HG, Milim SJ, et al. Laparoscopic leiomyoma coagulation. J Am Assoc Gynecol Laparosc. Aug 1996; 3(4, Supplement):S39. PMID 9074213
13. Zreik TG, Rutherford TJ, Palter SF, et al. Cryomyolysis, a new procedure for the conservative treatment of uterine fibroids. J Am Assoc Gynecol Laparosc. Feb 1998; 5(1):33-38. PMID 9454874
14. Zupi E, Piredda A, Marconi D, et al. Directed laparoscopic cryomyolysis: a possible alternative to myomectomy and/or hysterectomy for symptomatic leiomyomas. Am J Obstet Gynecol. Mar 2004; 190(3):639-643. PMID 15041993
15. Zupi E, Marconi D, Sbracia M, et al. Directed laparoscopic cryomyolysis for symptomatic leiomyomata: one-year follow up. J Minim Invasive Gynecol. Jul-Aug 2005; 12(4):343-346. PMID 16036195
16. Hindley JT, Law PA, Hickey M, et al. Clinical outcomes following percutaneous magnetic resonance image guided laser ablation of symptomatic uterine fibroids. Hum Reprod. Oct 2002; 17(10):2737-2741. PMID 12351555
17. Vilos GA, Allaire C, Laberge PY, et al. The management of uterine leiomyomas. J Obstet Gynaecol Can. Feb 2015; 37(2):157-181. PMID 25767949
18. American College of Obstetricians and Gynecologists (ACOG). Alternatives to hysterectomy in the management of leiomyomas. ACOG practice bulletin No. 96. 2008, reaffirmed 2014; Available at:<http://www.acog.org>. (accessed July 19, 2016).
19. Laparoscopic and Percutaneous Techniques for the Myolysis of Uterine Fibroids. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2016 August) OB/Gyn/Reproduction 4.01.19.
20. The SonataTM System (Gynesonics) – Product information. Available at <http://us.gynesonics.com> (accessed – 14 October 2016).
21. Sonography Guided Transcervical Ablation of Uterine Fibroids (SONATA) / NCT02228174. Available at <https://clinicaltrials.gov> (accessed-14 October 2016).
|12/1/2017||Reviewed. No changes.|
|12/1/2016||Document updated with literature review. Coverage unchanged.|
|1/1/2016||Document updated with literature review. Coverage has changed: “Transcervical” has been added to the following statement: Laparoscopic, percutaneous and transcervical techniques of myolysis as a treatment of uterine fibroids other than laparoscopic ultrasound-guided radiofrequency ablation (e.g., Acessa ™) are considered experimental, investigational and/or unproven, including Nd:Yag Lasers, bipolar electrodes, and supercooled cryoprobes. Title has been changed from: Laparoscopic and Percutaneous Techniques for the Myolysis of Uterine Fibroids.|
|10/1/2015||Reviewed. No Changes.|
|10/15/2014||New policy. Coverage for laparoscopic ultrasound-guided radiofrequency ablation (e.g., Acessa™) for the treatment of uterine fibroids has changed to conditionally medically necessary when criteria are met. Laparoscopic and percutaneous techniques of myolysis as a treatment of uterine fibroids other than laparoscopic ultrasound-guided radiofrequency ablation (e.g., Acessa ™) are considered experimental, investigational and/or unproven. This topic was previously addressed on SUR701.014 Endoscopic, Arthroscopic, Laparoscopic and Thoracoscopic Surgery.|
|Title:||Effective Date:||End Date:|
|Laparoscopic, Percutaneous and Transcervical Techniques for the Myolysis of Uterine Fibroids||01-01-2022||07-14-2022|
|Laparoscopic, Percutaneous and Transcervical Techniques for the Myolysis of Uterine Fibroids||11-15-2020||12-31-2021|
|Laparoscopic, Percutaneous and Transcervical Techniques for the Myolysis of Uterine Fibroids||07-01-2019||11-14-2020|
|Laparoscopic, Percutaneous and Transcervical Techniques for the Myolysis of Uterine Fibroids||12-01-2017||06-30-2019|
|Laparoscopic, Percutaneous and Transcervical Techniques for the Myolysis of Uterine Fibroids||12-01-2016||11-30-2017|
|Laparoscopic, Percutaneous and Transcervical Techniques for the Myolysis of Uterine Fibroids||01-01-2016||11-30-2016|
|Laparoscopic and Percutaneous Techniques for the Myolysis of Uterine Fibroids||10-01-2015||12-31-2015|
|Laparoscopic and Percutaneous Techniques for the Myolysis of Uterine Fibroids||10-15-2014||09-30-2015|