The American Journal of Surgery (2015) 209, 297-301

Clinical Science

Criteria for excision of suspected fibroadenomas

of the breast
Jennifer L. Hubbard, M.D.*, Kathleen Cagle, R.N., M.P.H.,
James W. Davis, M.D., Krista L. Kaups, M.D., Miya Kodama

Department of Surgery, University of California San Francisco, 2823 Fresno Street, Fresno, CA 93721, USA

KEYWORDS: Abstract
Fibroadenoma; BACKGROUND: Fibroadenomas are benign breast tumors; however, more aggressive lesions may
Breast; mimic or arise within fibroadenomas. We sought to define criteria identifying patients who should un-
Excision; dergo surgical excision.
Criteria METHODS: Patients with a preoperative diagnosis of fibroadenoma, who underwent surgical exci-
sion between 2002 and 2011, were retrospectively reviewed. Patients with final pathologic diagnosis
of fibroadenoma were compared with those with non-fibroadenoma pathology.
RESULTS: Of the 723 patients, 681 (94%) had fibroadenomas on final pathology. The incidence of
non-fibroadenoma pathology was 6% (42 patients) and included benign phylloides (23), malignant
phylloides (2), atypical ductal hyperplasia (1), intraductal papilloma (5), and other benign pathology
(11). No cases of adenocarcinoma were identified. Non-fibroadenoma pathology was associated with
age .35, immobile or poorly circumscribed mass, size .2.5 cm, and biopsy not definitive for fibroa-
denoma.
CONCLUSION: Patients with age .35 years, immobile or poorly circumscribed mass, size .2.5 cm,
or biopsy not definitive for fibroadenoma should undergo surgical excision.
Ó 2015 Elsevier Inc. All rights reserved.

Fibroadenomas are benign, solid neoplasms of the breast
consisting of fibroepithelial elements. Their size is hor-
monally influenced, as evidenced by fluctuation in size with
the menstrual cycle and regression in postmenopausal
women. Fibroadenomas are often solitary masses, but
25% of patients present with multiple lesions. They have
a characteristic clinical presentation: rubbery, mobile, and
firm. Despite this, previous reports have indicated that
There were no relevant financial relationships or any sources of support
in the form of grants, equipment, or drugs.
* Corresponding author. Tel.: 11-559-459-3722; fax: 11-559-459-
3719.
E-mail address: jhubbard@fresno.ucsf.edu
Manuscript received July 30, 2013; revised manuscript October 25,
2013
diagnosis by clinical examination is accurate in only 50%
to 75% of patients.1
One of the clinical dilemmas facing both surgeons and
patients is the concern that the mass is something more
ominous than a fibroadenoma. Both benign and malignant
phylloides tumors may mimic fibroadenomas. Additionally,
published reports have described adenocarcinoma and ductal
carcinoma in situ arising within fibroadenomas or misdiag-
nosed as fibroadenomas. Because of the potential for more
aggressive pathology masquerading as fibroadenomas, man-
agement has been debated and recommendations changed
several times in recent decades. Until the mid-1980s, stan-
dard practice was excision of all fibroadenomas.2 Subsequent
studies in the 1980s and 1990s demonstrated the safety of
observing the presumed fibroadenomas in women under

0002-9610/$ - see front matter Ó 2015 Elsevier Inc. All rights reserved.
http://dx.doi.org/10.1016/j.amjsurg.2013.12.037
298
age 35 who had a fine-needle aspirate biopsy that did not
contain malignant or suspicious cells.1,3 More recently, the
question has been asked whether biopsy is even necessary.
Smith and Burrows4 concluded that patients under the age
of 25 with benign ultrasound findings could be safely
observed without a biopsy.
We hypothesized that risk factors for more aggressive
pathology could be identified in women with presumed
fibroadenomas. Identification of these risk factors would
assist physicians in counseling and treating women with
presumed fibroadenomas and allow the development of
guidelines for biopsy or excision.
Patients and Methods
The study was approved by the institutional review board of
the University of California San Francisco, Fresno. The patient
population was drawn from a large community hospital
system in Fresno County that includes several outpatient
clinics and 2 major hospitals. We reviewed the electronic and
handwritten medical records of all patients with a preoperative
diagnosis of fibroadenoma who underwent surgical excision
between 2002 and 2011. Men were excluded from the study.
Patient demographics and risk factors for breast cancer were
collected. Past or current use of hormonal therapy, including
contraceptives, was recorded. Additionally, the patient’s ul-
trasound results, estimated preoperative size of the mass,
preoperative biopsy results, and final size and pathology were
recorded. In patients who underwent an ultrasound, mass
characteristics including increasing size on serial studies,
height versus width, Breast Imaging Reporting & Data System
(BI-RADS) category, and echogenicity were also collected.
Because of the variability of percutaneous biopsy pathologic
interpretation, we categorized results as either fibroadenoma
or non-fibroadenoma. Non-fibroadenoma pathology included
fibroepithelial neoplasm, spindle-cell neoplasm, possible
phylloides tumor, and other nonspecific diagnoses.
Most of the data were collected from preoperative
history and physical examinations that were handwritten,
before the implementation of electronic medical records.
To make the greatest use of our data, we made some a priori
assumptions that history was negative if not otherwise
documented and physical examination was normal if not
documented. Indications for surgical excision were based
on size (or increase in size), characteristics of the mass (ill-
defined, poorly circumscribed, hard), patient discomfort,
and/or ultrasound characteristics, with the final determina-
tion made by the attending surgeon.
Statistical analyses were performed using paired Student
t test, z test, Fisher’s exact test, Mann–Whitney U test, chi-
square analysis, and Mantel–Haenszel estimates (odds ratio
analysis). A P value of .05 was considered significant. Sta-
tistical analysis was performed using IBM SPSS software
(IBM Corp, Armonk, NY).
Following analysis and identification of significant
risk factors, criteria for observation versus excision were
The American Journal of Surgery, Vol 209, No 2, February 2015
created and applied retrospectively to the patient database
to calculate how many patients could have safely avoided
an operation and how many with more aggressive pathol-
ogy would have been missed in our dataset.
Results
Characteristics of the study cohort, including demo-
graphics, are listed in Table 1. Of the 723 patients meeting
inclusion criteria, 94% (681patients) had a fibroadenoma on
final pathology. The other 6% (42 patients) had pathology
demonstrating benign phylloides (23), malignant phylloides
(2), atypical ductal hyperplasia (1), intraductal papilloma
(5), and other benign pathology (tubular adenoma, mastitis,
adenomyoepithelioma, benign neurofibroma, fibrocystic
changes, stromal sclerosis, and nonspecific fibroadipose tis-
sue). We did not identify any cases of adenocarcinoma or
carcinoma in situ in this cohort of patients.
Patient ethnicity was largely Hispanic and Caucasian and
mirrors the ethnicity of Fresno County, which is 50.9%
Hispanic/Latino and 32.4% Caucasian (US Census Bureau,
2011 Fresno County Data). Most of the known risk factors
for breast cancer were not associated with non-fibroadenoma
pathology (Table 2). Family history of cancer (other than
breast cancer), nulliparity, smoking history, breastfeeding
history, early menarche, personal history of breast cancer,
history of prior breast biopsy, and 1st pregnancy with
advanced maternal age were not significantly different be-
tween the fibroadenoma and non-fibroadenoma group. How-
ever, patients aged .35 years were significantly more likely
to have non-fibroadenoma pathology (OR 2.8, P 5 .002,
Table 2).
Physical examination
The classical description of a fibroadenoma as a well-
circumscribed and mobile mass was found to hold true
among the patients in our study (Table 2). The positive pre-
dictive value of a mobile mass being a fibroadenoma was
93%. A well-circumscribed mass correlated with a 95%
positive predictive value and a sensitivity of 99%.
Conversely, patients with an immobile mass were 9 times
more likely to have non-fibroadenoma pathology and
patients with poorly defined masses were 15 times more
likely to have non-fibroadenoma pathology.
Imaging
None of the criteria recorded on ultrasound (height vs
width, BI-RADS categories, and echogenicity) were found
to be statistically significant. There was great heterogeneity
in both the reporting of ultrasound diagnoses and de-
scriptions of the mass. Table 3 shows the distribution of
BI-RADS assessments given for fibroadenoma and non-
fibroadenoma pathology. There was no statistical signifi-
cance between all BI-RADS scores. Patients with masses
J.L. Hubbard et al. Criteria for observation of fibroadenomas 299

Table 1 Demographics and diagnostic data

Total (n 5 723) Non-FA (n 5 42) FA (n 5 681) P value OR*
Age, mean 6 SD 32 38 6 15 32 6 13 .008 N/A
Ethnicity
Hispanic 370 (51%) 15 (36%) 355 (52%) .06 N/A
Caucasian 249 (34%) 19 (45%) 230 (34%) NS N/A
Black 43 (6%) 3 (7%) 40 (6%) NS N/A
Asian 31 (4%) 3 (7%) 28 (4%) NS N/A
Eastern Indian 10 (1%) 2 (5%) 8 (1%) NS N/A
Native American 1 (,1%) 0 1 (,1%) NS N/A
Other/unknown 19 (3%) 0 19 (3%) N/A N/A
No. of patients with preop biopsy performed 190 (27%) 23 (55%) 167 (25%) ,.001 N/A
No. of patients with preop biopsy results recorded 181 (25%) 22 (52%) 159 (23%) ,.001 N/A
No. of patients with ultrasound performed 567 (78%) 35 (83%) 532 (78%) NS N/A
No. of patients with ultrasound results recorded 481 (67%) 30 (71%) 451 (66%) NS N/A
Preop size, mean 6 SD 2.3 3.1 6 3.4 2.3 6 1.4 .003 1.2 (1.04–1.4)
Final size, mean 6 SD 2.5 3.3 6 2.6 2.4 6 1.5 .001 1.3 (1.1–1.5)
FA 5 fibroadenoma; N/A 5 not applicable; NS 5 nonsignificant; OR 5 odds ratio; SD 5 standard deviation.
*Calculated using regression analysis.

that required needle localization had no difference in likeli-
hood of non-fibroadenoma pathology versus those with
palpable masses (P 5 .69).
Size
Preoperative size of the mass was recorded based on
ultrasound findings or physical examinations, if ultrasound
was not available. Size was significantly smaller in the
fibroadenoma group (mean 2.3 6 1.4 cm) versus the
non-fibroadenoma group (3.1 6 3.4, P 5 .003). Using
Fisher’s exact test, a cutoff size of greater than 2.5 cm
was significantly more likely to have non-fibroadenoma pa-
thology (odds ratio 2.3, P , .03).
Preoperative biopsy
Of the 723 patients in the study, 182 had a preoperative
biopsy, with the majority consisting of core-needle bi-
opsies. Only patients with a preoperative diagnosis of

Table 2 Clinical risk factors for non-fibroadenoma pathology

No. of missing
Non-FA FA P value* OR (95% CI) documentation
Age .35 26 (62%) 249 (37%) .002 2.8 (1.5–5.4) 0
Age %35 16 (38%) 432 (63%)
Family history of breast cancer 0 8 (1%) 1.0 N/A 109
No family history 42 (100%) 673 (99%)
Hormone therapy 10 (37%) 140 (28%) .96 N/A 198
No hormone therapy 17 (63%) 358 (72%)
Fixed mass 2 (10%) 3 (1%) .046 9.4 (1.5–59.7) 431
Mobile mass 19 (90%) 268 (99%)
Ill-defined mass 3 (43%) 4 (5%) .008 15.4 (2.5–93.2) 630
Well-circumscribed mass 4 (57%) 82 (95%)
Ultrasound diagnosis of non-FA 18 (62%) 200 (49%) .25 N/A 288
Ultrasound diagnosis of FA 11 (38%) 206 (51%)
Preop size .2.5 cm 17 (50%) 154 (30%) .03 2.3 (1.1–4.6) 181
Preop size %2.5 cm 17 (50%) 354 (70%)
Preop biopsy non-diagnostic 12 (52%) 12 (8%) ,.001 11.2 (4.1–30.8) 8
Preop biopsy FA 11 (48%) 147 (92%)
Non-palpable 9 (21%) 125 (18%) .69 N/A 0
Palpable 33 (79%) 556 (82%)
Final size .2.5 cm 21 (57%) 237 (35%) .01 2.4 (1.2–4.7) 10
Final size %2.5 cm 16 (43%) 439 (65%)
CI 5 confidence interval; FA 5 fibroadenoma; N/A 5 not applicable; OR 5 odds ratio.
*Chi-square analysis or Fisher’s exact test.
300 The American Journal of Surgery, Vol 209, No 2, February 2015

Table 3 Ultrasound characteristics

Total (n 5 549) Non-FA (n 5 37) FA (n 5 512) P value
BI-RADS
0 1 (,1%) 0 1 (,1%) .09
1 0 0 0 NA
2 45 (8%) 3 (8%) 42 (8%) .75
3 125 (23%) 6 (16%) 119 (23%) .43
4 194 (35%) 17 (46%) 177 (35%) .24
5 3 (,1%) 0 3 (,1%) .50
No score or missing 181 (33%) 11 (30%) 170 (33%) .85
Ultrasound diagnosis
Non-diagnostic for FA 220 (40%) 19 (51%) 201 (39%) .21
Fibroadenoma 216 (39%) 12 (32%) 204 (40%) .43
No diagnosis or missing 113 (21%) 6 (16%) 107 (21%) .61
BI-RADS 5 Breast Imaging Reporting & Data System; FA 5 fibroadenoma; NA 5 not applicable.

fibroadenoma were included in this study and no preoper-
ative biopsies were definitive for non-fibroadenoma pathol-
ogy. In our cohort, 159 biopsies (87%) were definitive for
fibroadenoma and 23 biopsies (13%) were not definitive for
fibroadenoma or were suspicious for phylloides, but
clinically were felt to be fibroadenomas. Of the patients
with definitive preoperative biopsies, the final pathology
was fibroadenoma in 92% of patients. In patients with a
preoperative biopsy that was not definitive for fibroade-
noma, only 48% had final pathology demonstrating fibroa-
denoma, despite the clinical diagnosis (Table 2, P , .001).
Criteria for observation
Using the risk factors identified, we developed a set of
criteria which allow safe observation of the suspected
fibroadenoma: age less than 35 years, physical examination
demonstrating a mobile and well-circumscribed mass, size
% 2.5 cm, and, if present, a biopsy definitive for
fibroadenoma. If these criteria had been applied to the
patients in this study and all criteria were met, observation
instead of excision would have occurred in 391 of the 723
patients (54%). If these criteria had been used, the
misdiagnosis rate would have been 4% compared with the
actual misdiagnosis rate of 6% (those that had non-
fibroadenoma on final pathology). The misdiagnosed
masses would have been benign phylloides tumor (10),
tubular adenoma, mastitis, atypical ductal hyperplasia,
intraductal papilloma (2), and fibrocystic changes.
Comments
Fibroadenomas of the breast are common, benign lesions,
yet indications for excision are not well-defined.3,5–8 While
some fibroadenomas are excised because they cause pain
or distortion of the breast, excision often occurs because of
concern by either the clinician or the patient that it may be
cancer or another aggressive lesion. Invasive carcinoma
and carcinoma in situ within a fibroadenoma are rare, with
about 100 cases published in case reports and small case se-
ries.9 In addition, most of the published studies were per-
formed before the development of the American College of
Radiology BI-RADS system in 1993, which was intended
to aid in standardization of mammographic reporting.
Another reason for lack of good guidelines for excision
is that previously reported series did not use surgical
pathology as the gold standard. Wilkinson et al1 described
110 patients, all under 35 years of age, of whom only 77
underwent surgical excision. Another series followed a
cohort of 70 women with 87 fibroadenomas, of which 53
were eventually excised.3 In a more recent series by Park
et al,10 although they included a large cohort of almost
1,400 patients, only 125 underwent surgical biopsy or exci-
sion. Thus, our study is the largest to date that includes
definitive pathology for all patients.
In the current literature, the factor most predictive of
carcinoma or other aggressive lesion within a fibroadenoma
is patient age, but even this is inconsistent across
studies.6,11 In this study, older age was again identified as
a risk factor for non-fibroadenoma pathology. We used a
cutoff age of 35 years and found it to be statistically signif-
icant. Ethnicity has not been shown to be a significant risk
factor except in a single recently published article.12 In that
series, Hispanic ethnicity was found to be a risk factor
for non-fibroadenoma pathology, specifically phylloides tu-
mors. In contrast, our data showed a trend toward fibroade-
noma pathology with Hispanic ethnicity. Given this
conflicting data and lack of data in any other article, we
do not recommend using ethnicity as criteria for observa-
tion or excision.
Ultrasound is a commonly employed diagnostic tool for
breast masses, and prior publications have reported a high
degree of accuracy in diagnosing fibroadenomas.4 Charac-
teristics of benign lesions include oval shape, circum-
scribed margin, parallel orientation to the skin surface,
hypoechoic or isoechoic lesion, posterior enhancement,
absence of microcalcifications, and no surrounding tissue
J.L. Hubbard et al. Criteria for observation of fibroadenomas
changes.10 In reviewing available ultrasound reports in our
study, these characteristics were poorly and inconsistently
documented. The most commonly documented findings
were echogenicity and size. Rarely was the orientation of
the lesion documented. Use of the BI-RADS classification
was also highly variable, even in more recent years. If the
patient had a biopsy before the most recent ultrasound,
the BI-RADS was usually listed as 2 or 3, whereas lesions
without pathologic diagnosis were variably diagnosed as 3,
4a, or 4. Because of this variability in reporting, we were
unable to find any statistical significance based on ultra-
sound findings. Vagueness in diagnosis and variability of
BI-RADS reporting may have led to decisions to obtain tis-
sue diagnosis, either via biopsy or excision, but this was not
documented in the medical record. We propose that more
defined reporting should be instituted. Until then, caution
and clinical judgment should be used when basing diag-
nosis on ultrasound findings.
Many physicians use biopsy as a definitive diagnostic
study for suspected breast masses. In our series, preoper-
ative biopsy had a significant incidence of being non-
diagnostic. In patients with a non-diagnostic biopsy, the
chance of the final pathology showing something other
than a fibroadenoma was 52%. Knowing this, the clinician
should have a heightened suspicion when a pathology
report shows fibroepithelial neoplasm, spindle-cell
neoplasm, or other vague and indeterminate diagnoses, as
approximately half of these patients will have some other
etiology than fibroadenoma. As with all breast biopsies,
pathologic discordance with clinical or radiographic find-
ings should also lead to further tissue sampling, either via
repeat percutaneous biopsy, surgical biopsy, or excision.
There are limitations to our study. As mentioned previ-
ously, we made some a priori assumptions that history was
negative if not otherwise documented and physical exam-
ination was normal if not documented. It is certainly
possible that some positive findings were not documented
and thus were not included in the analysis. As with all
retrospective studies, our study is subject to selection bias.
Applying these criteria to our patient cohort would have
dramatically decreased the number of excisions. However,
because none of the patients in this cohort were observed, if
our criteria are applied to all patients presenting in clinical
practice with suspected fibroadenomas, the number of
surgical procedures may actually increase. We also recog-
nize that fibroadenomas are often excised because of pain
and patient preference. Unfortunately, this indication was
rarely documented in the chart, so it could not be analyzed
in our study. We hope that providing additional reassurance
301
of the rarity of malignancy and other aggressive pathology
will help to reassure patients who wish to have a suspected
fibroadenoma excised solely because of anxiety. Other
decisions may also play into the decision to proceed with
surgical excision, such as pain associated with the fibroa-
denoma or poor cosmesis.
This study is the largest to date reviewing patients with
suspected fibroadenomas and associated risk factors for the
occurrence of more aggressive lesions on final pathology.
Our study affirms that the widely used methods of
diagnosing fibroadenomas, namely history, physical exam-
ination, ultrasound, and in some cases, biopsy, have a high
degree of accuracy. Furthermore, using the risk factors
identified, guidelines are provided to aid the clinician in
counseling patients when it is safe to observe suspected
fibroadenomas and when surgical excision or biopsy should
be recommended.
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