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Gynecomastia is enlargement of the male breast caused by an increase of benign glandular tissue. Pseudogynecomastia is enlargement of the male breast caused by an increase of fat tissue rather than glandular tissue.

Gynecomastia may be due to a number of causative factors including one or more 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. Drugs associated with gynecomastia include but are not limited to hormones (e.g., anabolic steroids, androgens and estrogens), antibiotics (e.g., metronidazole, ketoconazole), antiulcer medications (e.g., cimetidine), cardiovascular drugs (e.g., digoxin. spironolactone), and some psychoactive and chemotherapeutic agents
• Obesity
• An underlying pathologic condition. These may include Klinefelter syndrome, kidney or liver failure, and presence of testicular or pituitary tumors.
• Related to specific age groups, for example:
  • Neonatal gynecomastia, related to action of maternal or placental estrogens
  • Adolescent gynecomastia, which consists of transient, bilateral breast enlargement
  • 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 an underlying hormonal disorder, cessation of drug therapy, or weight loss may all be effective therapies depending on the cause of gynecomastia. Gynecomastia may also resolve spontaneously. Adolescent gynecomastia generally resolves with aging. Prolonged gynecomastia causes periductal fibrosis and stromal hyalinization, which prevent regression of the breast tissue. Although the prevalence of breast malignancy in patients with gynecomastia is low, a careful history and physical examination are required prior to surgery to rule out underlying pathology.

Definitions

Grading System for Gynecomastia

The American Society of Plastic Surgeons has developed the following system of Classification for Gynecomastia, 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.

Pseudogynecomastia- breast enlargement due to the accumulation of fat (adipose) tissue.

NOTE: Coverage may be subject to legislative mandates, including but not limited to the following, which applies prior to the policy statements:

• Minnesota Statute 62A.25 Reconstructive Surgery

I.   Surgery for gynecomastia may be considered MEDICALLY NECESSARY AND APPROPRIATE when ALL of the following are met:

• Gynecomastia has persisted for at least:
  • 2 years if patient is younger than 18 years of age; OR
  • 1 year if patient is 18 years of age or older; AND
• Glandular breast tissue confirming true gynecomastia is documented on physical examination; AND
• Gynecomastia is classified as Grade II, III or IV per the American Society of Plastic Surgeons classification (See Definition above); AND
• Gynecomastia is associated with persistent breast discomfort despite the use of analgesics; AND
• Presence of an underlying pathologic process (e.g. breast, adrenal or testicular tumors, kidney or liver disease) has been ruled out; AND
• Use of potential gynecomastia-inducing drugs and substances has been identified and discontinued for at least one year, when medically appropriate; AND
• Hormonal causes have been excluded by appropriate laboratory testing and, if present, have been treated for at least one year prior to surgery. These include but are not limited to the following as confirmed by laboratory testing:
  • Hyperthyroidism 
  • Excess estrogen 
  • Prolactinomas 
  • Hypogonadism 
• AND 
• BMI less than 35 kg/ m²; AND 
• Patient is a never-smoker OR has abstained from smoking, use of smokeless tobacco and/or nicotine products, and/or nicotine replacement therapy for a minimum of 6 weeks prior to surgery.

II.  Gynecomastia surgery in all other circumstances including but not limited to the following is considered COSMETIC as it is performed primarily to enhance or otherwise alter physical appearance without correcting or improving a physiological function:

• To improve the appearance of the male breast or to alter the contours of the chest wall
• To remove excess adipose (fat) tissue (pseudogynecomastia)
• Use of liposuction to perform gynecomastia surgery

Documentation Submission:

Documentation supporting the medical necessity criteria described in the policy must be included in the prior authorization when prior authorization is required. In addition, the following documentation must be submitted:

• Confirmation of diagnosis, symptoms, and medical therapy
• Laboratory test results if indicated
• Exclusion of secondary causes
• Photographs are required
• Documentation that the patient is a never-smoker OR has abstained from smoking, use of smokeless tobacco and/or nicotine products, and/or nicotine replacement therapy for a minimum of 6 weeks prior to surgery.

Link to  Pre-Authorization Form:  https://www.bluecrossmn.com/sites/default/files/DAM/2021-12/BCBSMN-Pre-Auth-Request-fillable-X18509R07.pdf

Summary of Evidence:

Limited clinical data on outcomes of gynecomastia surgery in adolescents and adults are available. Criteria for medical necessity are based upon clinical reviews, published clinical guidelines and consensus statements. There is agreement among these sources regarding the need for a thorough patient history and clinical examination to distinguish true gynecomastia from pseudo-gynecomastia and to determine if an underlying condition is contributing to gynecomastia such as exposure to certain medications or substances, hormonal or metabolic disorders, or presence of testicular or adrenal tumors. Laboratory testing is required only if an underlying condition is suspected. Medical treatment is targeted at the underlying cause. Surgery is recommended only for adolescent and adult patients with persistent gynecomastia who are experiencing symptoms such as pain, after other causes of gynecomastia have been ruled out or if present, have failed conservative treatment. Specialty society guidelines indicate that surgery in adolescents needs to be approached cautiously, as pubertal gynecomastia regresses spontaneously in the majority of adolescents or after pharmacotherapy if it is persistent. For these reasons, and to ensure that physical maturity is attained prior to surgery, the policy requires gynecomastia to be present for 2 years prior to surgery in adolescents and 1 year in adults. Gynecomastia surgery in other situations, including surgery performed with liposuction, is considered cosmetic, as it is performed primarily to enhance or otherwise alter physical appearance without correcting or improving a physiological function. Although gynecomastia can occur in neonates and young children, the focus of this policy is surgical of treatment of gynecomastia in adolescents and adults. 

Rationale:

Gynecomastia is generally defined as the benign proliferation of glandular tissue in the male breast. The American Society of Plastic Surgeons (ASPS) reported in Cosmetic Plastic Surgery Statistics that 26,839 gynecomastia surgeries were performed in 2017, a 32% increase since 2000. Potential reasons for this increase were not discussed. Gynecomastia occurs during times of hormonal changes, due to the effect of altered estrogen/androgen balance or due to increased sensitivity of breast tissue to normal estrogen levels. Causes of gynecomastia are generally categorized as physiologic, pathologic, or pharmacologic. Physiologic gynecomastia includes neonatal, prepubertal and pubertal gynecomastia, and gynecomastia of aging. Adolescent gynecomastia is associated with fluctuations in sex, steroid and pituitary hormone concentrations in adolescents. In adults, gynecomastia is associated with lowered levels of testosterone as men age, an increase in body fat, and an increase in the estrogen/androgen ratio. Pathologic gynecomastia is due to an underlying disorder which may include hypogonadism, metabolic disorders, or neoplasms such as testicular and adrenal tumors. Pharmacologic gynecomastia is caused by prescription or over the counter agents. This includes, but are not limited to, cimetidine, digitalis, methadone, marijuana, clomiphene, chemotherapeutic agents, anti-retroviral agents, herbal remedies, and anabolic steroids. 

In 2017, a clinical overview of gynecomastia included the following causes in adult men seeking consultation for the condition: Persistent pubertal gynecomastia (25%), drugs (10 to 25%), no detectable abnormality (25%), cirrhosis or malnutrition (8%), male hypogonadism – primary (8%),  secondary (2%), testicular tumors (3%), hyperthyroidism (1.5 %), chronic renal insufficiency (1%). The ASPS reports the overall incidence of gynecomastia in adolescents as 38% in males ages 10-16 years. Incidence at age 14 is estimated to be 65%, dropping to 14% in 16-year-old boys; 75% of gynecomastia in adolescents regresses spontaneously within 2 years of onset, and within 3 years of onset in 90% of cases. Clinical guidelines, discussed in more detail below, generally state that the diagnostic workup for gynecomastia in adolescents is similar to that for adult men, taking the adolescent’s stage of testicular development into account. A review of gynecomastia evaluation and management, published in 2009, indicated that patients presenting with gynecomastia are found, after clinical examination, to have pseudogynecomastia, which is the accumulation of subareolar fat rather than proliferation of glandular tissue. Laboratory testing is done in cases of true gynecomastia with no clear cause. Liver, kidney, and thyroid function tests, along with hormonal testing may be indicated depending on suspected underlying cause.

Data on pathologic findings in gynecomastia were published in 2015. The researchers reviewed pathology reports of 5113 breasts of males who had undergone a surgical procedure for gynecomastia. Ages ranged from 1 to 88 years (mean 35.3±18.3 years). The overall prevalence of invasive carcinoma was 0.11% and of in situ carcinoma 0.18%. The youngest patient with invasive cancer was 65 years old and the youngest patient with carcinoma in situ was 24 years old. The overall prevalence of atypical ductal hyperplasia was 0.4%; in patients younger than 20 years, it was 0.23%. The youngest patient with atypical ductal hyperplasia was 16 years old. Pathologic findings were found more often in unilateral procedures. A 2007 study of 198 men who underwent mammography reported 9 mammograms (4%) that showed suspicious findings. Eight patients underwent biopsy, which yielded a breast cancer diagnosis in 2 (1%). All the men with breast cancer had a dominant mass on clinical examination and other findings suggestive of breast cancer. Of the 132 mammograms showing gynecomastia, 110 (83%) were from men who had taken predisposing medications or who had predisposing medical conditions. Authors concluded that mammography added little information in the initial patient evaluation of gynecomastia and that breast cancer may be suspected by the presence of a dominant mass. Most cases were due to benign causes including true gynecomastia (62%), lipomas, cysts, ductal ectasia, hematomas, and fat necrosis. 

Clinical guidance does not recommend routine mammography for gynecomastia but states that breast cancer may be suspected in the presence of palpable masses that are unilateral, hard, fixed, peripheral to the nipple, and associated with nipple discharge, skin changes, or lymphadenopathy. In these instances, thorough evaluation including imaging is recommended. 

Evidence on the safety and effectiveness of surgery for gynecomastia is confined to small nonrandomized studies. A systematic review published in 2015 included 12 studies on surgical treatment of gynecomastia, 2 on pharmacological treatment, and 3 studies that addressed quality of life after treatment. None was 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 GRADE criteria. This rating indicates that any estimate of effect is very uncertain; evidence reviewed is one or more of the following: expert opinion; no direct research evidence; one or more studies with very severe limitations. Despite these limitations, the authors concluded, “traditional excision of glandular tissue combined with liposuction provides most consistent results and low rate of complications. Pubertal gynecomastia may be safely managed by pharmacological anti-estrogen treatment.”

The American Society of Plastic Surgeons (ASPS) issued practice parameters in 2004. ASPS classified gynecomastia using the following scale, which “was adapted from 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.

The practice parameters recommend that patients be considered candidates for surgical intervention if gynecomastia is classified as Grade II, Grade III, or Grade IV and systemic conditions have been ruled out. Surgical resection of gynecomastia in adolescents, “may be withheld for at least one year as many of these cases will spontaneously resolve.”  ASPS issued recommendations for insurance coverage of gynecomastia surgery in 2015. The ASPS position statement concludes that surgery to correct gynecomastia “should be covered by third-party payers when performed to relieve specific symptomatology or signs of deformity related to excessive breast size. Weight or amount of breast tissue removed should not be used as the only criteria to determine insurance coverage for correction of gynecomastia.” Documentation for medical necessity recommended by ASPS includes results of history and physical exam. ASPS states that photographs are often used to document the preoperative condition and in surgery planning. As such, they “should only be used by third-party payers in conjunction with other recorded documentation.” 

In 2017, Gupta et al. reported on the incidence and risk factors for complications of breast surgery in 73K cases. Although the incidence of major complications was low, risk factors for major complications in males included smoking status and increased BMI. Smoking was associated with increased complications (RR 2.73, 95% CI 1.09-6.86). There was also a trend towards a higher complication rate with increasing BMI (RR 1.09, 95% CI 1.06-1.12). In the previous year, Gupta et al. reported on surgical complications in the overweight patient, with a focus on aesthetic surgery. The cohort analysis included 127K patients and focused on BMI 25 to 29.9 and BMI ≥ 30 as independent risk factors of major complications. On multivariate analysis, being overweight (BMI 25-29.9) or obese (BMI ≥ 30) were independent predictors of complication (Relative Risk, RR 1.17 and 1.51), especially infection (RR 1.63 and 2.73), and VTE (RR 1.67 and 2.56).

The American Society of Plastic Surgeons (ASPS) Evidence-Based Clinical Practice Guideline on Reduction Mammoplasty (2022) provided recommendations and information for reduction mammoplasty that included BMI information from non-gender specific studies and concluded: A large number of studies supported the association between body mass index greater than 35 kg/m2 and the risk of infection and wound healing, but with equivocal results for patients with body mass indexes between 25 and 35 kg/ m2. Concluding that patients with a body mass index greater than 35 kg/m2 have a higher risk of complications that includes infection and wound healing.

UptoDate has published 3 reviews with recommendations addressing diagnosis, evaluation, and treatment of gynecomastia in children, adolescent, and adult males. Recommendations regarding evaluation and management of gynecomastia in children and adolescents were published in 2017 with literature review last updated in February 2018. Recommendations include the following: Physiologic pubertal gynecomastia typically occurs during mid-puberty. Adolescents complain of a mass or lump behind the nipple. The breast may be tender for approximately six months after onset. Pubertal gynecomastia regresses spontaneously in the majority of adolescents, but is unlikely to regress if it persists for ≥1 year or after age 17 years; the history and examination of children and adolescents with gynecomastia focuses on the clinical features of pathologic causes of gynecomastia, including drugs/medications; age and pubertal status; family history; associated symptoms; growth parameters; palpation of the breasts; and evaluation of the testicles for size, masses, and consistency; laboratory studies generally are not necessary for adolescents with clinical features of typical pubertal gynecomastia. Initial management usually consists of reassurance and observation; the initial laboratory evaluation and management depend on whether or not a cause is suggested by the history and examination; the results of the initial laboratory tests direct additional laboratory and imaging studies.

An UptoDate literature review and recommendations on clinical features, diagnosis, and evaluation of gynecomastia in adults were updated in 2017 with literature review last updated in February 2018. The following recommendations were included: The diagnosis of gynecomastia is made on physical examination as a palpable mass of tissue at least 0.5 cm in diameter (usually underlying the nipple); in true gynecomastia, a ridge of glandular tissue (a rubbery-to-firm disk of tissue, often mobile) will be felt reasonably symmetrical to the nipple-areolar complex; gynecomastia needs to be distinguished from pseudogynecomastia, which is due to an increase in breast fat, not glandular tissue. These patients have diffuse breast enlargement without any subareolar glandular tissue; gynecomastia needs to be differentiated from other causes of breast masses, most importantly, breast cancer. Breast cancers are typically unilateral, nontender, and often fixed masses found eccentric to the nipple-areolar complex. In addition, they are firm-to-hard in texture and may be associated with skin dimpling, nipple discharge, and regional lymphadenopathy. If the differentiation cannot be made by physical examination, mammography or ultrasonography should be done; the combination of a careful history and physical examination and a few diagnostic tests can result in the identification of the cause of gynecomastia in the majority of patients. 

An UptoDate literature review and recommendations on management of gynecomastia was updated in 2017. The following recommendations were made regarding surgical treatment: Surgical therapy should be considered in men whose gynecomastia does not regress spontaneously, is causing considerable discomfort or psychological distress, or is long standing (greater than 12 months) and the fibrotic stage has been reached; for adolescents, surgery is generally not recommended until adult testicular size is attained, as there may be regrowth of the breast tissue if the surgery is performed before puberty is completed.

Cigarette smoking is associated with surgical complications, including wound healing and surgical site infection. The findings that current smokers have a higher risk of wound infection and wound disruption can be explained by the pathophysiological mechanisms related to the toxic effects and oxidative destruction induced by smoking and nicotine. Smoking impedes the innate defense system of the lung, including damaging mucus transport, aggravating mucus

production, and diminishing macrophage function, resulting in increased risk of pulmonary complications. The Centers for Disease Control and Prevention (CDC) has incorporated the use of many devices into the description of tobacco products. Vapes, vaporizers, vape pens, hookah pens, electronic cigarettes (e-cigarettes or e-cigs), e-cigars, and e-pipes are some of the many tobacco product terms used to describe electronic nicotine delivery systems (ENDS). Based on the U.S. Food and Drug Administration (FDA) definition, traditional cigarettes and e-cigarettes are in the same category. Products that meet the statutory definition of “tobacco products” include currently marketed products such as dissolvables not already regulated by FDA, gels, waterpipe tobacco, ENDS (including e-cigarettes, e-hookah, e-cigars, vape pens, advanced refillable personal vaporizers, and electronic pipes), cigars, and pipe tobacco. The FDA rule deems any additional current and future tobacco products that meet the statutory definition of “tobacco product,” For example, FDA envisions that there could be tobacco products developed in the future that provide nicotine delivery through other means (e.g., via dermal absorption or intranasal spray).

In 2022, Chiang et al. published results on a retrospective, cohort study of 1,156,002 patients, utilizing files of the American College of Surgeons National Surgical Quality Improvement Program database. Multivariable logistic regression was used to calculate the odds ratios (ORs) with 95% confidence intervals (CIs) for postoperative wound complications, pulmonary complications, and in-hospital mortality associated with smokers. Smoking was associated with a significantly increased risk of postoperative wound disruption (OR 1.65, 95% CI 1.56-1.75), surgical site infection (OR 1.31, 95% CI 1.28-1.34), reintubation (OR 1.47, 95% CI 1.40-1.54), and in-hospital mortality (OR 1.13, 95% CI 1.07-1.19) compared with nonsmoking. The length of hospital stay was significantly increased in smokers compared with non-smokers. They found that current smokers who underwent surgery had approximately 30% increased odds of developing surgical site infection (SSI) and 65% increased odds of developing wound disruption. Study conclusions state smoking status is related to increased perioperative risk for wound complications following major surgical procedures. The current literature review has shown that smoking harms wound healing. The study adds to existing evidence and improves understanding of healing complications in smoking surgical cases. Wound complications are associated with other adverse outcomes and have a significant impact on patient quality of life and health care budgets. Therefore, patients who smoke should be informed about the potentially increased risks of complications before surgery. Concluding results encourage smoking cessation prior to surgery.

In 2022, Liu et al. published a meta-analysis on the effect of preoperative smoking and smoking cessation on wound healing and infection in post-surgery subjects. This analysis incorporated 11 trials involving 218,567 patients following surgery; 176,670 were previous or non-smokers, and 41,897 were smokers. Never smokers or those who had ceased smoking had significantly lower postoperative wound healing problems (odds ratio 0.74; 95% CI 0.63-0.87, p < .001) compared with smokers. Non-smokers had significantly lower postoperative wound healing problems and surgical site wound infection compared with smokers.

In 2012, Sorensen et al. reported on the results of a meta-analysis that sought to clarify the evidence on smoking and postoperative healing complications across surgical specialties and determine the impact of perioperative smoking cessation intervention. Smokers and non-smokers were compared in 140 cohort studies that included 479K patients. Pooled adjusted odds ratios (95% CI) were 3.60 (2.62 - 4.93) for necrosis, 2.07 (1.53-2.81) for healing delay and dehiscence, 1.79 (1.57-2.04) for surgical site infection, 2.27 (1.82-2.84) for wound complications, 2.07 (1.23-3.47) for hernia, and 2.44 (1.66-3.58) for lack of fistula or bone healing. Investigators concluded that postoperative healing complications occur significantly more often in smokers compared with non-smokers and in former smokers compared with those who never smoked.

In 2020, the Society for Perioperative Assessment and Quality Improvement (SPAQI) convened a multidisciplinary panel of 17 experts in perioperative smoking cessation. Members of the Task Force were from the fields of anesthesiology, internal medicine, surgery, public health, and pharmacy from both academic and nonacademic settings in Canada, United States, Australia, New Zealand, Asia, and Europe. Consensus Statement: Interventions should occur as soon as practicable in relation to surgical scheduling. Evidence from observational studies of spontaneous quitting suggests that longer durations of preoperative abstinence are associated with lower rates of respiratory and wound healing complications. Evidence from RCTs supports an effect of preoperative smoking cessation interventions that are 4–8 weeks long.

The American Society of Anesthesiologists (ASA) issued a statement on smoking cessation in 2018. This statement indicated that smoking has a direct impact on postoperative outcomes such as wound healing, recommending patient should abstain from smoking for as long as possible both before and after surgery, and they should obtain help in doing so. Surgery may represent a teachable moment for promotion of long-term smoking cessation. 

Reference List:

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2. American Society of Anesthesiologists (ASA). Statement on Smoking Cessation. 2008, reaffirmed October 2018. 

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6. Blue Cross Blue Shield Association. Medical Reference Policy: Surgical Treatment of Bilateral Gynecomastia. February 2017. 

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