CurrentAetnaPolicy 0304

Fibroid Treatment

Policy governing coverage and medical necessity of various treatments for uterine fibroids (including radiofrequency ablation, transcervical ablation, uterine artery embolization, power morcellation, and investigational therapies) for Aetna members.

Policy Summary

PayerAetna

PolicyFibroid Treatment

Policy CodePolicy 0304

Change TypeReaffirmation — no material changes

Effective DateOct 13, 1998

Next Review DateMar 14, 2024

Key ActionObtain prior authorization and document objective confirmation of heavy menstrual bleeding and prior therapies when requesting coverage for MRgFUS or other investigational approaches.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1998original policy effective date

200,000+hysterectomies/yr (approx.)

80-90%UAE symptom improvement

70.6%ExAblate >10-point symptom reduction

13.5%mean fibroid vol reduction (ExAblate 6 mo)

03/14/2024

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Coverage Criteria and Evidence Context

Medical Necessity — RFA or UAE

Covered when ALL of the following are met:

Medical necessity for RFA or UAE: Radiofrequency ablation (open, laparoscopic, or transcervical) or transcatheter uterine artery embolization (UAE) are medically necessary as alternatives to hysterectomy or myomectomy when the member has persistence of one or more symptoms directly attributed to uterine fibroids (excessive menstrual bleeding, bulk-related pelvic pain, pressure or discomfort, urinary symptoms referable to compression of the ureter or bladder, and/or dyspareunia)

Power Morcellation — Exceptions (Medically Necessary)

Power morcellation may be considered medically necessary for removal of uterine fibroids in women without known or strongly suspected uterine cancer when ANY of the following exceptions apply:

Power morcellation exceptions: Premenopausal women who wish to maintain fertility and who have no risk factors for uterine sarcoma (e.g., history of ≥2 years of tamoxifen therapy, prior pelvic irradiation, childhood retinoblastoma, Lynch syndrome, or hereditary leiomyomatosis and renal cell carcinoma syndrome)

Member must be informed of alternatives and risks.

Power morcellation exceptions: Premenopausal women who have clinical indications for hysterectomy and who have no risk factors for uterine sarcoma, where a vaginal hysterectomy is technically difficult due to a large uterus

Member must be informed of alternatives and risks.

Power morcellation exceptions: Women with comorbidities (e.g., cardiovascular, renal, hepatic, pulmonary, endocrine disorders, or morbid obesity) for whom alternative surgical options (hysterectomy without morcellation, radiofrequency ablation, uterine artery embolization) pose an unacceptable risk

Member must be informed of alternatives and risks.

MRgFUS coverage considerations

General considerations from evidence reviews and health technology assessments

Evidence summary: Systematic reviews and technology assessments report that MRgFUS/MR‑HIFU produces short‑term symptom reductions and is generally safe, but long‑term durability and comparative effectiveness versus alternatives (UAE, myomectomy, hysterectomy) are uncertain.

Patient selection considerations: Fibroid characteristics (size, location, MRI signal intensity, distance from spine/skin, absence of intervening bowel or bladder) and device/center compatibility must be met for safe and effective MRgFUS treatment; reported eligibility rates vary widely (14%–74%).

Counsel regarding other uterine-preserving options and fertility implications.

Prior therapy: Typically considered for women unresponsive to medical therapy seeking uterine‑preserving alternatives; documentation of prior medical therapy failure and imaging confirming suitability is recommended.

Prior authorization is appropriate when MRgFUS is considered due to restrictive eligibility and limited comparative evidence.

Evidence summary to inform coverage stance

Summary of clinical evidence and comparative findings relevant to coverage decisions:

MRgFUS/MR‑HIFU evidence: Randomized trials are small and limited; single‑arm studies and systematic reviews (pooled cohorts >1,300 patients) report mean immediate NPV around 68%, mean symptom reduction ~60% at 12 months, fibroid shrinkage ~37.7%, low overall AE rates but heterogeneous outcomes and re‑intervention rates ranging 0–21% (short‑to‑medium term). Improvements in 2nd‑generation systems increased NPV and reduced major AEs in comparative reports.

Supports cautious consideration with patient counseling and documentation.

Comparative effectiveness: Meta‑analyses comparing HIFU with myomectomy or UAE show higher re‑intervention rates versus myomectomy and UAE in some analyses, mixed effects on quality‑of‑life and ovarian function, and advantages in shorter hospital stay and lower immediate major AE incidence versus hysterectomy.

May inform relative positioning to standard options.

Reproductive outcomes: Available data on pregnancy and live‑birth after HIFU are heterogeneous; reported pregnancy and miscarriage rates vary across studies and current evidence is insufficient to recommend HIFU over myomectomy for fertility‑preserving intent without shared decision‑making and counseling.

Evidence summaries relevant to coverage

Study-based findings and conclusions relevant to coverage decisions

Laparoscopic UAO: Systematic reviews and RCTs indicate laparoscopic uterine artery occlusion (UAO) is less effective than UAE and myomectomy for symptomatic fibroids, with higher clinical failure and re‑intervention rates though shorter hospitalization and quicker recovery in some reports.

Choice between UAE and myomectomy should be individualized.

UAO at myomectomy (UAO+M): Meta‑analyses (Sanders 2019; Tranoulis 2019) found UAO+M was associated with significant reductions in estimated blood loss, transfusion rates, and postoperative hemoglobin drop versus myomectomy alone, but it increased operative time and evidence on reproductive outcomes is insufficient.

Further research needed before routine use in women desiring fertility.

Radiofrequency ablation (RFVTA and related RFA): Prospective trials and randomized comparisons report significant reductions in symptom severity, improved HR‑QOL, decreased menstrual blood loss, fibroid volume reduction, low re‑intervention rates through 24–36 months, shorter hospital stay and less intraoperative blood loss versus laparoscopic myomectomy in some studies.

Evidence summary and guideline context — TFA (Sonata System)

Evidence synthesis and guideline context for TFA with the Sonata System:

Evidence & guideline summary: Multiple single‑arm trials, registries, and systematic reviews report reductions in fibroid volume, menstrual blood loss, and symptom severity with transcervical fibroid ablation (TFA) using the Sonata System; reported reintervention rates range from ~0.7% to ~11.8% across studies and follow‑up durations, and device‑related adverse events are reported as low (e.g., 0.6% in preliminary SAGE registry results).

Data include SONATA pivotal trial, VITALITY long‑term study, SAGE registry, and systematic reviews.

Limitations and guidance: Health‑technology assessments rated evidence quality as low or very low; ACOG notes limited data on reproductive outcomes and that laparoscopic RFA has been studied more rigorously; NICE recommends TFA be used only with special arrangements for clinical governance, consent, and audit or research due to limited comparative efficacy data.

Uncertainty about long‑term comparative effectiveness and reproductive outcomes may affect coverage decisions.

Other uses of transcatheter uterine artery embolization (UAE) not specifically described as covered in this policy are considered experimental and investigational. The policy also lists several procedures and modalities as investigational, including acupuncture, cryomyolysis, cryotherapy, electrical ablation, interstitial thermotherapy, laparoscopic uterine artery occlusion, lasers, and focused ultrasound ablation (with or without MRI guidance). Members must be informed of alternative procedures and the risks of techniques such as power morcellation prior to treatment.

Magnetic resonance‑guided focused ultrasound (MRgFUS/MR‑HIFU) is not indicated for leiomyomas that are resectable hysteroscopically, heavily calcified, or when treatment could damage intervening bowel or bladder. Patient and fibroid anatomic factors (size, vascularity, access, presence of intervening structures) determine technical suitability and can render a patient ineligible for MRgFUS.

Several techniques and devices investigated for fibroid treatment are supported mainly by case series, heterogeneous protocols, or older restricted protocols; systematic reviews excluded such studies when assessing effectiveness. Because of the limited and low‑to‑moderate quality evidence, these approaches are not considered broadly equivalent to established surgical options (e.g., myomectomy or UAE) without higher‑quality randomized comparative data.

Complementary therapies, including herbal preparations and acupuncture, lack sufficient high‑quality randomized evidence to support their routine use for uterine fibroids. Cochrane reviews concluded current trials are small, heterogeneous, or absent, and therefore these therapies are not endorsed as established treatments.

The policy identifies specific contraindications and exclusions for power morcellation. Morcellation is contraindicated in women who are peri‑ or post‑menopausal, in women who are candidates for alternative en bloc tissue removal, and in those with known or suspected uterine malignancy or significant risk factors for uterine sarcoma. When morcellation is considered, members must be counseled about alternatives and the risks of disseminating occult malignancy.

This policy segment does not list additional explicit procedural exclusions beyond those described; however, HTA and guidance documents (for example NICE) emphasize that newer image‑guided procedures should be used only with special arrangements for clinical governance, informed consent, audit, or research due to limited comparative evidence.

The policy references U.S. Food and Drug Administration safety communications concerning laparoscopic power morcellation (including the 2014 and subsequent updates). These FDA communications warn that morcellation can spread unsuspected uterine sarcoma and advise limiting use; such safety communications are factored into coverage considerations for morcellation procedures.

Myomectomy or hysterectomy performed using power morcellation is considered experimental and investigational for removal of uterine fibroids except where specific policy exceptions apply. The policy also identifies device‑related coding (e.g., morcellator HCPCS code C1782) and lists CPT ranges that are not covered when performed with power morcellation.

When MRI‑guided focused ultrasound (MRgFUS) is selected over established alternatives, documentation should support technical suitability and clinical rationale. The policy notes that prior authorization is appropriate for MRgFUS because eligibility is restrictive, comparative evidence is limited, and records should include prior medical therapy attempts and imaging confirming suitability.

Interpretive note: for MR‑HIFU/HIFU and laparoscopic uterine artery occlusion (UAO), the document highlights evidence limitations (heterogeneous studies, case‑series predominance, and variable re‑intervention rates) rather than issuing a single blanket not‑medically‑necessary statement. These limitations support careful case selection, documentation, and prior authorization when these approaches are requested.

The Ludwig Boltzmann Institut health‑technology assessment rated the quality of evidence for transcervical ultrasound‑guided radiofrequency ablation (TFA/Sonata) as low or very low for efficacy and safety outcomes, indicating that stronger comparative data are needed before routine adoption without special arrangements.

Billing Codes and Coding Notes

Covered CPT Codes (if selection criteria met)CPTCovered

0404T	Transcervical uterine fibroid(s) ablation with ultrasound guidance, radiofrequency.
37243	Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for tumors, organ ischemia, or infarction.
58580	Transcervical ablation of uterine fibroid(s), including intraoperative ultrasound guidance and monitoring, radiofrequency.
58674	Laparoscopy, surgical, ablation of uterine fibroid(s) including intraoperative ultrasound guidance and monitoring, radiofrequency.

CPT Codes Not Covered / Experimental per CPBCPTNot Covered

0071T	Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total leiomyomata volume less than 200 cc of tissue.
0072T	Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total leiomyomata volume greater or equal to 200 cc of tissue.
37617	Ligation, major artery (eg, post-traumatic, rupture); abdomen [laparoscopic uterine artery occlusion].
58353	Endometrial ablation, thermal, without hysteroscopic guidance [interstitial thermotherapy][lasers].
58356	Endometrial cryoablation with ultrasonic guidance, including endometrial curettage, when performed [cryotherapy].
97810-97814	Acupuncture.

HCPCS (device) related to morcellationHCPCS

C1782

Morcellator.

ICD-10 Codes (covered and contraindicated lists)ICD-10

D25.0 - D25.9	Uterine leiomyoma.
E66.01	Morbid (severe) obesity due to excess calories.
C41.4	Malignant neoplasm of pelvic bones, sacrum and coccyx.
C51.0 - C68.9	Malignant neoplasm of genitourinary organs.
N30.0 - N30.9	Cystitis [current].
N39.0	Urinary tract infection, site not specified [current].
N70.01 - N73.9	Inflammatory disease of female pelvic organs.
N95.0 - N95.9	Menopausal and other perimenopausal disorders.
N97.0 - N97.9	Female infertility.
Z78.0	Asymptomatic menopausal state.

1–10 of 13

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CPT Codes Not Covered with Power MorcellationCPTNot Covered

58140 - 58146	Myomectomy (not covered when performed using power morcellation).
58150 - 58294	Hysterectomy (not covered when performed using power morcellation).
58541 - 58544	Laparoscopy, surgical, supracervical hysterectomy (not covered when performed using power morcellation).
58545 - 58546	Laparoscopy, surgical, myomectomy (not covered when performed using power morcellation).

Referenced technologies and devices (no explicit codes in this section)mixed

No codes listed

inv-24: Focused ultrasound volume threshold — total leiomyomata volume less than 200 cc vs >= 200 cc

Focused ultrasound volume thresholdCPT codes 0071T and 0072T distinguish procedures by total leiomyomata volume: 0071T = total leiomyomata volume less than 200 cc; 0072T = total leiomyomata volume greater than or equal to 200 cc.

Coding implicationReimbursement and code selection for MR‑guided focused ultrasound should follow the documented total leiomyomata volume criterion in the CPT descriptors.

Clinical relevanceVolume-based code distinction reflects procedural complexity and may affect eligibility and prior authorization review.

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior authorization for listed procedure codes — Coverage subject to meeting selection/medical necessity criteria

Prior authorization is required for the CPT/HCPCS procedure codes listed in this policy when selection and medical necessity criteria are being used to determine coverage. Providers should submit prior authorization requests per Aetna clinical policy processes and include the documentation elements described below.

Prior authorization required for listed procedure codes
Providers must follow Aetna Clinical Policy prior authorization submission processes
Include objective documentation of symptom severity and prior conservative therapies

Prior Authorization

Prior authorization recommended when MRgFUS considered — eligibility restrictive and comparative evidence limited

Providers should obtain prior authorization per Aetna Clinical Policy processes; when novel or less-established procedures (for example MR‑HIFU/MRgFUS, laparoscopic UAO, transcervical ablation in certain contexts) are considered, prior authorization is recommended given restrictive eligibility criteria and limited comparative evidence.

Background and Scope

Uterine fibroids (leiomyomas) are common benign smooth‑muscle tumors that may be asymptomatic or cause heavy menstrual bleeding, pelvic pain, bulk symptoms (pressure, urinary compression), and reproductive issues. Treatment options range from medical therapy to uterine‑preserving procedures (myomectomy, UAE, radiofrequency/transcervical ablation, MR‑guided focused ultrasound) and hysterectomy; long‑term outcomes vary by modality and evidence quality for newer techniques is limited.

Definitions and Device/Procedure Descriptions

inv-54: Uterine artery embolization (UAE) — outpatient angiographic embolization definition

DefinitionUterine artery embolization (UAE) is an outpatient angiographic procedure using angiographic techniques and fluoroscopic guidance to deliver embolic particles into the uterine arteries supplying fibroids, producing ischemic infarction and subsequent fibroid degeneration.

Typical materials/approachEmbolization commonly uses tiny particles (e.g., polyvinyl alcohol or tris-acryl gelatin microspheres) delivered via angiographic catheter under fluoroscopic guidance.

Clinical outcomes summaryAverage fibroid volume reductions approximately 50% at 3 months and 65% at 1 year; symptom improvement reported in 80–90% of patients in short-term series.

inv-55: Power morcellation — definition and safety context

DefinitionPower morcellation is a laparoscopic surgical technique/device used to fragment uterine tissue (e.g., myomas) into smaller pieces to facilitate removal through small incisions.

Policy History and Revision Notes

1998-10-13effective_date

Policy originally became effective.

2024-02-15policy_reviewLatest

Policy last reviewed.

Policy Summary

PayerAetna

PolicyFibroid Treatment

Policy CodePolicy 0304

Change TypeReaffirmation — no material changes

Effective DateOct 13, 1998

Next Review DateMar 14, 2024

Key ActionObtain prior authorization and document objective confirmation of heavy menstrual bleeding and prior therapies when requesting coverage for MRgFUS or other investigational approaches.

SourceLink

On This Page

Outcomes and limitations: Reported outcomes include symptom severity score improvements, modest fibroid volume reduction on average, variable non‑perfused volume (NPV), and re‑intervention rates (e.g., ~12.7% in one series; cumulative additional treatment incidence 19–23% at 3–4 years); major complication rates in cohorts reported ~1.6%.

Counseling required if fertility desire present.

UAO and UAO+myomectomy: UAO shows inconsistent results versus UAE and myomectomy; UAO+myomectomy reduces estimated blood loss and transfusion rates but may prolong operative time; reproductive outcome data and ovarian reserve impact remain limited.

UAO considered investigational or adjunct in many contexts.

Longer‑term outcomes and fertility data remain limited; counsel patients accordingly.

Cryo/laser ablation and other techniques: Small pilot and case‑series report symptomatic and volume improvements, but evidence is preliminary and requires larger, well‑designed studies with longer follow‑up.

Considered experimental pending stronger data.

Prior authorization recommended for MRgFUS/MR‑HIFU and investigational UAO

Prior authorization advised for procedures where NICE or other guidance requires special arrangements

Denial Risk

Power morcellation denial risk — procedures using power morcellation not covered except specified exceptions

Use of power morcellation during myomectomy or hysterectomy poses a documented risk of spreading unsuspected uterine malignancy (FDA safety communications). Procedures performed using power morcellation are generally not covered under this Clinical Policy except for narrow, explicitly listed exceptions; providers should expect denial risk when power morcellation is used outside those exceptions.

Power morcellation denial risk due to FDA safety communications
Power morcellation may be considered medically necessary only for specified exceptions (see policy Scope of Policy)

Denial Risk

Evidence limitations may trigger coverage denial — lack of comparative evidence and concerns about durability

Limited or low-quality comparative evidence, high re-intervention rates, and uncertain long-term durability for some technologies (e.g., MR‑HIFU/MRgFUS, laparoscopic UAO, certain transcervical ablation evidence gaps) may warrant coverage denial or additional prior authorization requirements. Providers should document why established alternatives (UAE, myomectomy, hysterectomy) are not appropriate when seeking coverage for newer techniques.

Evidence limitations may trigger coverage denial for MR‑HIFU/HIFU and investigational UAO
Document rationale when selecting novel therapies over established alternatives

Documentation Required

Objective outcome measures used in studies — alkaline hematin, UFS-QOL, MRI myoma volume referenced

Clinical trials and pivotal studies use objective outcome measures that may be requested as part of prior authorization or outcome reporting. Common objective measures include validated symptom scores and imaging or laboratory measures.

Uterine Fibroid Symptom and Quality of Life Questionnaire (UFS-QOL) symptom severity score (SSS)
Alkaline hematin analysis or quantified menstrual blood loss
MRI measurements of myoma/ non-perfused volume (NPV%) and fibroid volume change

Documentation Required

Informed consent and pre-operative evaluation — shared decision-making and documentation of risks/benefits

Obtain informed consent and perform pre-operative evaluation documenting the risks, benefits, alternatives, and specific device/procedure limitations. For procedures with morcellation risk, counseling must specifically address the potential for spreading occult malignancy and alternative options. Shared decision-making and documentation of reproductive counseling are recommended when fertility preservation is a concern.

Document that risks/benefits and alternatives (including non-surgical options) were discussed
Document assessment for risk factors for uterine sarcoma and fertility goals
Obtain and record signed informed consent that addresses morcellation risks when applicable

Note

Policy history and supplemental materials — reference Clinical Policy Bulletin Notes and Definitions

Include policy history and supplemental materials with prior authorization submissions or appeals as needed. Refer to the Clinical Policy Bulletin Notes, Definitions, and the policy review history for effective dates and updates.

Reference Clinical Policy Bulletin Notes and Definitions when submitting documentation
Include policy effective date and most recent review date in appeals or clinical summaries

Safety contextFDA safety communications warn morcellation can spread unsuspected uterine sarcoma; FDA estimated prevalence of occult sarcoma ~1 in 350 women undergoing hysterectomy/myomectomy for fibroids.

Policy stanceMyomectomy or hysterectomy using power morcellation is considered experimental/investigational except for specific exceptions in women without known or strongly suspected uterine cancer.

inv-56: MRI-guided focused ultrasound (MRgFUS / ExAblate) — definition and evidence summary pointer

DefinitionMRI-guided focused ultrasound (MRgFUS; e.g., ExAblate) is a noninvasive procedure that uses high-intensity focused ultrasound energy, guided by MRI, to thermally ablate targeted fibroid tissue.

Evidence summary pointerPivotal U.S. trial (ExAblate) randomized 192 women and reported short-term symptom improvement (70.6% with >10‑point UFS‑QOL reduction at 6 months) but modest mean fibroid volume reduction (13.5% at 6 months); longer-term and comparative effectiveness data are limited and further studies were required by FDA.

Suitability considerationsTechnical factors (size, location, vascularity, intervening bowel/bladder, MRI signal) affect eligibility; device labeling and reviews emphasize need for further comparative trials.

inv-57: Non-perfused volume (NPV) — definition

DefinitionNon‑perfused volume (NPV) is the portion of treated fibroid tissue that shows no perfusion immediately after ablation, measured on post‑treatment imaging.

Clinical significanceHigher NPV correlates with greater clinical success (e.g., NPV >80% associated with clinical success in >80% of patients in one series); mean immediate post‑treatment NPV reported around 68.1% in pooled studies.

Use in outcome assessmentNPV is used as a technical and prognostic outcome metric in MR‑HIFU/MRgFUS studies and may inform expected symptom improvement and re‑intervention risk.

inv-58: MRgFUS / MRgHIFU — alternate naming definition

Alternate namesMRgFUS is also referred to as MRgHIFU (magnetic resonance‑guided high‑intensity focused ultrasound) and ExAblate (a commercial system name).

ContextTerminology reflects guidance modality (MR guidance) and energy type (focused ultrasound/high‑intensity focused ultrasound) used for thermal ablation of fibroids.

inv-59: NPV — shorthand definition

ShorthandNPV = Non‑perfused volume — the immediate post‑ablation fraction of the fibroid that shows no contrast enhancement, indicating successful tissue infarction.

Reported valuesMean immediate post‑treatment NPV% reported in meta‑analysis ~68.1%; higher NPV associated with better clinical outcomes.

inv-60: MRgFUS / MR‑HIFU — device/tech definition

Device/tech definitionMRgFUS / MR‑HIFU are noninvasive technologies that converge focused ultrasound energy under MRI guidance to induce coagulative necrosis of targeted fibroid tissue without abdominal incisions.

ExamplesExAblate 2000 (InSightec) is the first FDA‑approved MRgFUS system; other HIFU systems may be ultrasound‑guided (HIFU) rather than MR‑guided.

inv-61: UAO at myomectomy (UAO+M) — definition

DefinitionUterine artery occlusion at myomectomy (UAO+M) refers to ligation or occlusion of the uterine arteries performed at the time of laparoscopic or abdominal myomectomy to reduce intraoperative blood loss and transfusion requirements.

Outcomes summaryMeta-analyses report UAO+M is associated with decreased estimated blood loss, lower transfusion rates, and reduced hemoglobin drop but may prolong operative time; reproductive outcome effects remain uncertain.

inv-62: RFVTA — Radiofrequency volumetric thermal ablation definition

DefinitionRadiofrequency volumetric thermal ablation (RFVTA) is an outpatient radiofrequency technique (laparoscopic or percutaneous) that volumetrically ablates fibroid tissue to reduce symptom severity and fibroid volume.

Clinical evidenceProspective trials report significant symptom and quality‑of‑life improvements with low re‑intervention rates through 24–36 months (e.g., cumulative re‑intervention ~4.8% at 24 months and 10.4% at 36 months in reported studies).

inv-63: Power morcellation — technique definition (duplicate/alternate)

Technique definitionPower morcellation during laparoscopy divides tissue into smaller fragments to permit removal through small incisions using a mechanical morcellator device.

Safety contextFDA issued safety communications (2014 and updates) cautioning against laparoscopic power morcellation due to risk of disseminating occult malignancy; device recalls and guidance have followed.

Policy implicationsMyomectomy or hysterectomy using power morcellation is generally considered experimental/investigational except for specified exceptions in premenopausal women without sarcoma risk factors.

inv-64: Transcervical fibroid ablation (TFA)/Sonata System — definition

DefinitionTranscervical fibroid ablation (TFA) with the Sonata System is an incisionless, uterine‑preserving procedure that uses intrauterine ultrasound guidance and transcervical radiofrequency energy to ablate non‑pedunculated leiomyomas.

Clinical outcomes summarySingle‑arm trials and registries report reductions in menstrual blood loss, symptom severity, and fibroid volume with low device‑related adverse event rates and modest re‑intervention rates (SONATA 3‑year KM re‑intervention ~8.2%).

inv-65: Transcervical fibroid ablation (TFA) / Sonata System — alternate definition

Alternate definitionTFA (Sonata) is a transcervical ultrasound‑guided radiofrequency ablation system providing intraoperative visualization and targeted coagulative necrosis of leiomyomas without abdominal incisions.

Guidance noteHealth‑technology assessments (e.g., NICE) note limited long‑term comparative data and recommend use with special arrangements in some jurisdictions.

inv-66: Laparoscopic power morcellation — definition and safety context

DefinitionLaparoscopic power morcellation is a minimally invasive surgical technique that uses a powered morcellator to subdivide uterine tissue for removal during hysterectomy or myomectomy.

Regulatory/safety contextFDA safety communications (2014 and subsequent updates) warn about the risk of spreading occult uterine sarcoma with power morcellation and have influenced device recalls and clinical guidance.

Contraindications notedMorcellation is contraindicated in peri‑ or post‑menopausal women and those with risk factors for uterine sarcoma; alternative en bloc removal is recommended when feasible.

inv-67: Image-guided fibroid ablation technologies — overview of device classes

OverviewImage‑guided fibroid ablation technologies encompass transcervical/sonography‑guided radiofrequency ablation (e.g., Sonata, RFVTA) and MR‑guided focused ultrasound (MRgFUS/MR‑HIFU), which are minimally invasive, uterus‑sparing procedures that thermally ablate leiomyomas under image guidance.

Common featuresThese technologies aim to reduce fibroid volume and symptoms while preserving the uterus; patient selection depends on fibroid size, location, imaging characteristics, and fertility considerations.

Evidence contextEvidence includes single‑arm trials, registries, and some randomized comparisons; health‑technology assessments emphasize limited long‑term comparative data and variable re‑intervention rates across modalities.