Description
Bilateral gynecomastia is a benign enlargement of the male breast, either due to increased adipose tissue, glandular tissue, fibrous tissue, or a combination of all 3. Surgical removal of the breast tissue, using either surgical excision or liposuction, may be considered if conservative therapies are not effective or possible.

For individuals with bilateral gynecomastia who receive surgical treatment, the evidence includes case series. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related morbidity. Because there are no randomized controlled trials on surgical treatment of bilateral gynecomastia, it is not possible to determine whether surgical treatment improves symptoms or functional impairment. Conservative therapy should adequately address any physical pain or discomfort, and gynecomastia does not typically cause functional impairment. The evidence is insufficient to determine the effect of the technology on health outcomes.  

Background  
Bilateral gynecomastia is a benign enlargement of the male breast, either due to increased adipose tissue, glandular tissue, fibrous tissue, or a combination of all 3. Bilateral gynecomastia may be associated with any of the following:

• An underlying hormonal disorder (i.e., conditions causing either estrogen excess or testosterone deficiency such as liver disease or an endocrine disorder)
• An adverse effect of certain drugs
• Obesity
• Related to specific age groups, i.e.,:
  • Neonatal gynecomastia, related to action of maternal or placental estrogens
  • Adolescent gynecomastia, which consists of transient, bilateral breast enlargement, which may be tender
  • Gynecomastia of aging, related to the decreasing levels of testosterone and relative estrogen excess.

Treatment of gynecomastia involves consideration of the underlying cause. For example, treatment of the underlying hormonal disorder, cessation of drug therapy, or weight loss may all be effective therapies. Gynecomastia may also resolve spontaneously, and adolescent gynecomastia may resolve with aging. 

Prolonged gynecomastia causes periductal fibrosis and stromal hyalinization, which prevent regression of the breast tissue. Surgical removal of the breast tissue, using surgical excision or liposuction, may be considered if the conservative therapies above are not effective or possible and the gynecomastia does not resolve spontaneously or with aging.

Regulatory Status  
Surgical procedures are not regulated by the U.S. Food and Drug Administration 

Policy
Surgical treatment of gynecomastia is considered MEDICALLY NECESSARY for either of the following conditions:

• Klinefelter's Syndrome
• Either pubertal (adolescent) onset gynecomastia that has persisted for at least two years OR post pubertal-onset gynecomastia that has persisted for one year, when ALL of the following criteria are met:
  • Male is over 18 years of age with significant breast tissue present as documented in the historical medical record.
  • Glandular breast tissue confirming true gynecomastia is documented by mammography and/or tissue pathology.
  • The gynecomastia is classified as Grade IV per the American Society of Plastic Surgeons classification. (See Practice Guidelines and Position Statements)
  • The use of potential gynecomastia-inducing drugs and substances has been identified and discontinued for at least one year, when medically appropriate, before surgery has been considered.  (See reference chart)
  • Hormonal causes, including hyperthyroidism, estrogen excess, prolactinomas and hypogonadism have been excluded by appropriate laboratory testing and, if present, have been treated for at least 12 months before surgery has been considered.
  • Excessive breast development is not due to non-covered therapies or illicit drugs, e.g., anabolic steroid or marijuana.
  • Member is within 20% of ideal body weight.

Surgical treatment of gynecomastia for ANY other indication is considered NOT MEDICALLY NECESSARY.

The use of liposuction to perform mastectomy for gynecomastia is considered part of the primary procedure and is not separately reimbursed.

Rationale
Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function¾including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, 2 domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Bilateral Gynecomastia
Clinical Context and Therapy Purpose
The purpose of surgical therapy for bilateral gynecomastia is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as conservative treatment.

The question addressed in this evidence review is: Is the net health outcome of individuals with bilateral gynecomastia improved by surgical treatment?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with bilateral gynecomastia, a benign enlargement of the male breast due either to increased adipose, glandular, or fibrous tissue or a combination of the 3. An underlying hormonal disorder, obesity, and an adverse effect of certain drugs may be associated with the condition. Additionally, the bilateral gynecomastia may be related to specific age groups, including neonates, adolescents, and in aging men with decreasing levels of testosterone and relative estrogen excess.

Interventions
The therapy being considered is surgical treatment: removal of the breast tissue by surgical excision or liposuction.

Comparators
The main comparators of interest are conservative treatment, which varies based on the underlying cause of the condition and can include treatment of an underlying hormonal disorder, cessation of drug therapy, and weight loss.

Outcomes
The general outcomes of interest are symptoms, functional outcomes, health status measures, quality of life, and treatment-related morbidity. Symptoms of bilateral gynecomastia may include enlargement, tenderness, and lumps in the breast tissue.

Evaluation of the general outcomes of interest requires a long follow-up period beyond the immediate postoperative period if surgery is performed. In the existing literature evaluating surgery as a treatment for bilateral gynecomastia, follow-up is 5 years.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess longer-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Coverage eligibility for treatment of bilateral gynecomastia is largely a contract/benefits issue related to the distinction between cosmetic and reconstructive services. The surgical procedure may involve surgical excision (i.e., mastectomy). More recently, liposuction has been used.^1,2 In some instances, adolescent gynecomastia may be reported as tender or painful, and the presence of these symptoms may be presented as a basis for surgical treatment. However, the pain associated with adolescent gynecomastia is typically self-limiting or responds to analgesic therapy.

No randomized clinical trials were identified to assess various surgical interventions to treat male gynecomastia.

Nonrandomized Studies
Exposure of new techniques, quality of life assessments and other nonsurgical outcomes have been reported in the literature.

Abdelrahman et al. (2018) published a retrospective analysis of 18 patients with grade I and II gynecomastia treated with a combination of traditional liposuction and glandular liposculpturing between 2014 and 2016.³ Outcomes assessed included treatment-related morbidity and adverse events and patient-reported outcomes. Race or ethnicity of patients were not described. The patient-reported outcome included patient satisfaction using the Breast Evaluation Questionnaire. Other notable information gained include treatment-related morbidity and adverse events. The postoperative aesthetic appearance was evaluated by 5 independent plastic surgeons (“observers”) who were blinded to the surgery performed making their assessments based on preoperative and 6-month postoperative photographs. The observers concluded that an acceptable postoperative result was achieved (92% of the ratings); 8% of the ratings suggested subsequent liposuction needed to be performed. The level of agreement was assessed and statistically significant for varying aesthetic variables (e.g., nipple projection, p = .005). Treatment-related morbidities or adverse events were minimal and include wound infection (1/18, 5.56%) and complaints of breast-tissue remnants and requests for subsequent operation (2/18, 11.1%).

Nuzzi et al. (2018) published a longitudinal cohort study aimed at measuring changes in health-related quality of life following surgical management of gynecomastia using 3 surveys administered over a 5-year period to both the intervention group and age- and sex-matched controls.⁴ The surveys administered were the Short-Form 36 Health Survey Version2 (SF-36v2), Rosenberg Self-Esteem Scale (RSES), and Eating-Attitudes Test-26. From 2008 to 2017, 44 patients who underwent treatment of gynecomastia and 64 unaffected controls participated in the study. Race or ethnicity of patients were not described. Patients in the intervention group scored significantly poorer at baseline compared with controls on both the RSES and Eating-Attitudes Test-26 (p < .05, both), even after controlling for body mass index differences. Gynecomastia patients scored lower on 5 SF-36v2 domains than the controls: general health, vitality, social functioning, role-emotional, and mental health (p < .05, all). Scores significantly improved post-operatively on the RSES and in 4 SF-36v2 domains. Post-operatively, gynecomastia patients scored similarly to the control group on the SF-36v2 and RSES, indicating an improvement in quality of life.

Table 1. Summary of Nonrandomized Studies Characteristics

Table 2. Summary of Observational Comparative Study Results

BEQ: Breast evaluation questionnaire; EAT-26: eating-attitudes test-26; RSES: Rosenberg self-esteem scale; SF-36v2: short-form 36 health survey version 2; SD: standard deviation.

Section Summary: Bilateral Gynecomastia
To demonstrate improvement in health outcomes, controlled trials are needed that report clinically important outcomes such as improvement in functional status. No such trials were identified through a literature search. A systematic review published in 2015 included 14 studies on the treatment of gynecomastia.⁵ None were randomized, all were judged to be at high-risk of bias, and the body of evidence was determined to be of very low quality by Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) criteria. The literature addresses itself to quality of life patient-reported outcomes with a focus on adolescents.

Summary of Evidence
For individuals with bilateral gynecomastia who receive surgical treatment, the evidence includes nonrandomized studies. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related morbidity. Because there are no RCTs on surgical treatment of bilateral gynecomastia, it is not possible to determine with a high level of confidence whether surgical treatment improves symptoms or functional impairment. Conservative therapy should adequately address any physical pain or discomfort, and gynecomastia does not typically cause functional impairment. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in Supplemental Information if they were issued by, or jointly by, a U.S. professional society, an international society with U.S. representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Society of Plastic Surgeons
In 2002, affirmed 2015, the American Society of Plastic Surgeons (ASPS) issued practice criteria for third-party payers.⁶ The ASPS classified gynecomastia using the following scale, which was “adapted from the McKinney and Simon, Hoffman and Kohn scales”:

• “Grade I: Small breast enlargement with localized button of tissue that is concentrated around the areola.
• Grade II: Moderate breast enlargement exceeding areola boundaries with edges that are indistinct from the chest.
• Grade III: Moderate breast enlargement exceeding areola boundaries with edges that are distinct from the chest with skin redundancy present.
• Grade IV: Marked breast enlargement with skin redundancy and feminization of the breast.”

According to the ASPS, in adolescents, surgical treatment for “[u]nilateral or bilateral grade II or III gynecomastia” may be appropriate if the gynecomastia “persists for more than 1 year after pathological causation is ruled out” (or 6 months if grade IV) and continues “after 6 months of unsuccessful medical treatment for pathological gynecomastia.” In adults, surgical treatment for “[u]nilateral or bilateral grade III or IV gynecomastia” may be appropriate if the gynecomastia “persists for more than 3 or 4 months after pathological causes ruled out [and continues] after 3 or 4 months of unsuccessful medical treatment for pathological gynecomastia.” The ASPS also indicated that surgical treatment of gynecomastia may be appropriate when distention and tightness cause “pain and discomfort.”

American Society of Andrology
In 2019, the American Society of Andrology, in collaboration with the European Academy of Andrology, released clinical practice guidelines on gynecomastia evaluation and management.7, Their recommendation related to surgical intervention is as follows:

• "We suggest surgical treatment only for patients with long-lasting GM [gynecomastia], which does not regress spontaneously or following medical therapy. The extent and type of surgery depend on the size of breast enlargement, and the amount of adipose tissue [weak recommendation, low quality of evidence]."

U.S. Preventive Services Task Force Recommendations
Not applicable

Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in December 2021 did not identify any ongoing or unpublished trials that would likely influence this review.

References   

1. Rohrich RJ, Ha RY, Kenkel JM, et al. Classification and management of gynecomastia: defining the role of ultrasound-assisted liposuction. Plast Reconstr Surg. Feb 2003; 111(2): 909-23; discussion 924-5. PMID 12560721
2. Goes JC, Landecker A. Ultrasound-assisted lipoplasty (UAL) in breast surgery. Aesthetic Plast Surg. Jan-Feb 2002; 26(1): 1-9. PMID 11891589
3. Abdelrahman I, Steinvall I, Mossaad B, et al. Evaluation of Glandular Liposculpture as a Single Treatment for Grades I and II Gynaecomastia. Aesthetic Plast Surg. Oct 2018; 42(5): 1222-1230. PMID 29549405
4. Nuzzi LC, Firriolo JM, Pike CM, et al. The Effect of Surgical Treatment for Gynecomastia on Quality of Life in Adolescents. J Adolesc Health. Dec 2018; 63(6): 759-765. PMID 30279103
5. Fagerlund A, Lewin R, Rufolo G, et al. Gynecomastia: A systematic review. J Plast Surg Hand Surg. 2015; 49(6): 311-8. PMID 26051284
6. American Society of Plastic Surgeons. ASPS Recommended Insurance Coverage Criteria for Third-Party Payers: Gynecomastia. 2002 (affirmed 2015); https://www.plasticsurgery.org/Documents/Health- Policy/Positions/Gynecomastia_ICC.pdf. Accessed December 17, 2021.
7. Kanakis GA, Nordkap L, Bang AK, et al. EAA clinical practice guidelines-gynecomastia evaluation and management. Andrology. Nov 2019; 7(6): 778-793. PMID 31099174

Coding Section

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. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

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