How to diagnose fibroadenoma?


The ultrasound diagnosis in line with fibroadenoma is only allowed if there is a homogenous, solid mass with well defined margins, oval shape and parallel orientation.


f he ultrasound diagnosis in line with fibroadenomaa BI-RADS 3 (probably benign) can be assigned; a choice can be made between follow-up in 6 months or a (cytological or histological) punction.


In case of multiple fibroadenonomas punction of one of the laesions (often the largest) in combination with a follow-up of 6 months of the remaining laesions is sufficient.


No distinction is needed between palpable and non-palpable fibroadenomas.


Laesions that do not have all the typical characteristics of a fibroadenoma, must always be assigned BI-RADS 4 (suspicious laesion). Optionally, the BI-RADS category 4a may be assigned (low suspicion, malignancy cannot be excluded).

A (cytological or histological) punction must be performed for these laesions. This applies to fibroadenomas that

  • do not fully meet the above description
  • that are greater than 3 cm with cystic components or that have grown per dimension more than 1 cm per 6 months, because they cannot be distinguished with certainty from phyllodes tumours


When a phyllodes tumour is suspected, histological biopsy is preferred. The suspicion should be reported on the pathology request form.



Level 2

The reliability of ultrasound in diagnosing fibroadenoma that meets all typical characteristics, is very high.


A2    Stavros 1995

B      Skaane 1998


Level 2

Fibroadenomas may fluctuate in size. An increase in size to 1 cm of all 3 dimensions within a 6 month period is not alarming.


A2    Gordon 2003

C      Dixon 1996, Carty 1995


Level 3

With a fibroadenoma of more than 3 cm or with cystic components, a phyllodes tumour cannot be   excluded and a histological biopsy is indicated.


C      Liberman 1996, Yilmaz 2002


Level 3

Percutaneous ultrasound-guided vacuum-assisted excision of a fibroadenoma is a safe procedure with good cosmetic result. The diagnosis should be established prior to the procedure.


B      Wang 2009,

C      Krainick-Strobel 2007, Matthew 2007

Literature summary

According to the BI-RADS atlas, a homogenous, solid mass with well defined margins, oval shape and parallel orientation is in line with a fibroadenoma. Skaane (1998) and Stavros (1995) add a thin hyperechoic pseudocapsule to this. If it concerns a new finding, these laesions are assigned the final assessment category BI-RADS 3 (probably benign). Known, longer existing laesions are classified as BI-RADS 2 (benign).

On the other hand, a BI-RADS 4 (probably malignant) should be assigned if not all typical characteristics are present, because a malignant tumour cannot be excluded in the case of atypical characteristics.

The fibroadenoma is the most common tumour in young women.72% of 287 palpable laesions in women under 30 years of age were fibroadenomas [Vargas, 2005]. It is also the most common laesion in girls in puberty [Kronemer, 2001]. In a screening population of 117,729 women over 35 years of age, 51 fibroadenomas developed in 6 years; there were 4 in women between 50 and 52 years of age [Foxcroft, 1998]. The influence of hormonal fluctuations is not fully clear, but it is known that fibroadenomas may fluctuate in size and regress during menopause.

Ultrasound is more specific than mammography in establishing the radiological diagnosis. In their prospective study, Skaane and Stavros achieved an almost 100% accuracy in the group fibroadenomas, which met all the typical characteristics. From the below literature overview it appears that after adequate imaging technique, the choice is either a follow-up after 6 months or a punction (cytology or needle biopsy) for confirmation.


Fibroadenoma: imaging technique results







157 BI-RADS 3 laesions, some   palpable, some non-palpable

Follow-up after 6 months to 2   years, needle biopsy or excision

No malignancies



145 BI-RADS 3 laesions, non-palpable

Follow-up after 12 months or cytology

2/145 malignancies (1.38%)



78 fibroadenomas, confirmed by cytology

Follow-up up to 5 years or excision

No malignancies



219 fibroadenomas, confirmed with cytology

Follow-up up to 2 years or excision

No malignancies


Phyllodes tumour

A fibroadenoma consists of epithelial and stromal components. Rapid size increase in combination with increased growth of the stromal component, so that the tumour becomes more heterogenous, raises suspicion for a phyllodes tumour.

Gordon (2003) followed 1,070 fibroadenomas confirmed by punction.For 179 laesions, volume measurements were performed multiple times. An increase in size to 1 cm of all 3 dimensions within a 6 month period was deemed acceptable in all age categories. A size of more than 3 cm and cystic components was more indicative of phyllodes tumour. These can become very large, up to 20 cm. Phyllodes tumours display overlapping characteristics with fibroadenomas on a mammogram and ultrasound, the pathological characteristics also overlap [Liberman, 1996; Yilmaz, 2002]. The diagnosis phyllodes tumour may be made using a histological biopsy, but excision is necessary to differentiate between benign and malignant phyllodes tumour.



Patient management in the case of multiple fibroadenomas consists of careful ultrasound examination according to the abovementioned criteria by Stavros (1995) and Skaane (1998).Multiple fibroadenomas are described with cyclosporine use [Son, 2004]. Punction of one of the laesions (often the largest) in combination with a follow-up of 6 months of the remaining laesions is sufficient.



Excision of a fibroadenoma is no longer considered necessary.Different percutaneous methods have been developed to remove the fibroadenoma in a minimally invasive manner, as long as the location is suitable and the fibroadenoma no larger than 3 to 4 cm. In doing so, it is not always necessary for the fibroadenoma to be removed in its entirety. Both regression and recurrence are described [Grady, 2008]. Cryoablation in 64 patients with a follow-up of at least 12 months (a follow-up of 2.6 years for 37/64) showed good results in Kaufman (2004, 2005) as well as percutaneous ultrasound-guided vacuum-assisted excision in 56 and 109 patients respectively in Sperber (2004) and Krainick-Strobel (2007). In this last study, total removal was possible for 86%, and there was scar formation in 19%. Comparison of a group (n=51) who underwent surgical excision with a group (n=47) who underwent ultrasound-guided percutaneous vacuum-assisted excision [Wang, 2009] resulted in favour of the last group, especially due to much better cosmetic results, also after hematoma formation.

It is important, prior to the procedure, for the diagnosis fibroadenoma to be established with certainty.In the study by Matthew (2007) of 76 patients who underwent the procedure, 3 patients were found to have a malignancy. Prior to the procedure, cytology in these patients did not yield a clearly benign diagnosis.


The solid character of fibroadenomas causes more concern than a cystic abnormality and the fear of making an interpretation error and the subsequent false negative finding is great. It is therefore important only to assign a BI-RADS 3 to laesions with all the typical characteristics of a fibroadenoma. Furthermore, ultrasound is known to be operator-dependent and published studies may paint a flattering picture, also about percutaneous removal.

Authorization date and validity

Last review : 13-02-2012

Last authorization : 13-02-2012

The national Breast Cancer guideline 2012 is a living guideline, in other words there is no standard term of revision. NABON continually watches at new developments and clinical problems in the areas of screening, diagnostics, treatment and aftercare, and whether this requires an update.

Initiative and authorization

Initiative : Nationaal Borstkanker Overleg Nederland

Authorized by:
  • Nederlandse Internisten Vereniging
  • Nederlandse Vereniging voor Heelkunde
  • Nederlandse Vereniging voor Psychiatrie
  • Nederlandse Vereniging voor Radiologie
  • Nederlandse Vereniging voor Radiotherapie en Oncologie

General details

Approximately 14,000 women (and 100 men) are diagnosed with invasive breast cancer each year in the Netherlands, and about 1,900 have an in situ carcinoma. A woman's risk of having breast cancer over the course of her life is 12-13%. This means that breast cancer is the most common form of cancer in women in the Netherlands. Early detection, particularly via national breast cancer screening, combined with adjuvant therapy followed by locoregional treatment, improves the prognosis in women with breast cancer

The guideline on Breast Cancer Screening and Diagnostics, published in 2000, was updated in 2007. In 2002, the first multidisciplinary National Breast Cancer Guideline was published, it was revised in 2004, 2005 and 2006. In 2008 both guidelines were combined to Breast Cancer Guideline, which 2012 revision is now effected.

Scope and target group

This guideline is written for all the members of the professional groups that have contributed to its development.


This guideline is a document with recommendations and instructions to support daily practice. The guideline is based on the results of scientific research and expert opinion, with the aim of establishing good medical practice. It specifies the best general care for women with (suspected) breast cancer and for those who are eligible for screening. The guideline aims to serve as a guide for the daily practice of breast cancer screening, diagnostics, treatment and aftercare. This guideline is also used in the creation of informational materials for patients, in cooperation with the KWF (Dutch Cancer Society).

Samenstelling werkgroep

A core group consisting of a radiologist, surgeon, pathologist, medical oncologist and radiation therapist began preparing for the revision of the breast cancer practice guidelines in 2009. A multidisciplinary guideline development group was formed in early 2010 to implement the revision. This group consisted of mandated representatives from all of the relevant specialisations concerned with breast cancer, plus two delegates from the BVN (Dutch Breast Cancer Society) (see list of guideline development group members). The benefits of such a multidisciplinary approach are obvious: not only does it best reflect the care, but it offers the greatest possible expertise for the guideline. In composing the development group, geographic distribution of the members, balanced representation of the various organisations and agencies concerned, and a fair distribution in academic background were taken into account as much as possible.


The guideline development group received procedural and administrative support from IKNL (Comprehensive Cancer Centre for the Netherlands) and support on methodology from Bureau ME-TA. Partial funding was obtained from SKMS (Quality Funds Foundation of Dutch Medical Specialists). This subsidy would not have been possible without the extensive assistance provided by the NVvR (Radiological Society of the Netherlands).

Declaration of interest

Partial funding for the guideline revision was obtained from the Society of Dutch Medical Specialists in the framework of the SKMS. IKNL sponsored some of the cost. On two occasions, as well as at the beginning and end of the process, all of the members of the guideline development group were asked to fill out a statement of potential conflicts of interest, in which they stated their relationship with the pharmaceutical industry. A list of these statements of interest can be found in the appendices.

Patient involvement

In developing this guideline, four clinical questions were formulated. These questions emerge from an inventory of clinical problems collected in the field from professionals, patients and patient representatives.


Also, A multidisciplinary guideline development group was formed in early 2010 to create and implement the revision. This group consisted of mandated representatives from all of the relevant specialisations concerned with breast cancer, plus two delegates from the BVN (Dutch Breast Cancer Society).


Method of development

Evidence based


Feasibility has been taken into account in developing the guideline. This included attention to factors that could promote or hinder putting the advice into practice. Examples include the implementation of an analysis of problems, the multidisciplinary composition of the guideline development group, and making active use of support from the guideline development group members. Presenting the draft guideline to the field and communicating what, if anything, is being done with the responses, also promotes implementation. In this manner, a guideline has been developed that answers current questions in the field.

The guideline is distributed widely and is available in digital form on the Dutch Guideline Database. The guideline may also be brought to the attention of a wider audience in other periodicals or continuing education sessions, for example. To promote use of the guideline, we recommend that the regional tumour working groups and group practices, as well as scientific and professional organisations, repeatedly bring the guideline to the attention of their members. Any problems that may arise in using the guidelines can then be discussed and, when appropriate, submitted to the national guideline development group, as it is a "living" guideline. If desirable, parts of the guideline can be made more explicit by formulating regional additions or translation to the local situation in departmental and/or hospital protocols.

In principle, indicators are determined during development of the guideline that can be used to monitor implementation of the recommendations. Via a documentation project, these indicators can then be used to determine the extent of compliance with the guideline. The information from the documentation project becomes input for the revision of the guideline.

Methods and proces

This module has been evidence-based revised in 2008 and consensus based updated in 2012.


A revision of an existing guideline consists of revised and updated text. Revised text is new text based on an evidence-based review of the medical literature; updated text is the old guideline text which has been edited by the experts without performing a review of medical literature. Each section of the guideline states what type of revision has taken place. Each chapter of the guideline is structured according to a set format, given below. The purpose of this is to make the guideline transparent, so that each user can see on what literature and considerations the recommendations are based on.


Description of the literature

To the greatest extent possible, the answers to the fundamental questions (and therefore the recommendations in this guideline) were based on published scientific research. The articles selected were evaluated by an expert in methodology for their research quality, and graded in proportion to evidence using the following classification system:


Classification of research results based on level of evidence


Research   on the effects of diagnostics on clinical outcomes in a prospectively   monitored, well-defined patient group, with a predefined policy based on the   test outcomes to be investigated, or decision analysis research into the   effects of diagnostics on clinical outcomes based on results of a study of   A2-level and sufficient consideration is given to the interdependency of   diagnostic tests.


Research   relative to a reference test, where criteria for the test to be investigated   and for a reference test are predefined, with a good description of the test   and the clinical population to be investigated; this must involve a large   enough series of consecutive patients; predefined upper limits must be used,   and the results of the test and the "gold standard" must be   assessed independently. Interdependence is normally a feature of situations   involving multiple diagnostic tests, and their analysis must be adjusted   accordingly, for example using logistic regression.


Comparison   with a reference test, description of the test and population researched, but   without the other features mentioned in level A.


Non-comparative   trials


Opinions   of experts, such as guideline development group members



Based on the medical literature, one or more relevant conclusions are made for each section. The most important literature is listed according to the level of evidential strength, allowing conclusions to be drawn based on the level of
evidence. All the medical literature included in the conclusion is described in the bibliography.


Classification of conclusions based on literature analysis


Based   on 1 systematic review (A1) or at least 2 independent A2 reviews.


Based   on at least 2 independent B reviews


Based   on 1 level A2 of B research, or any level C research


Opinions   of experts, such as guideline development group members


Other considerations

Based on the conclusion(s), recommendations are made. However, there are other considerations that contribute to formulation of the recommendation besides literature evidence, such as safety, the patients' preferences, professional expertise, cost-effectiveness, organisational aspects and social consequences. The other considerations are mentioned separately. In this manner, it is clear how the guideline development group arrived at a particular recommendation.



The final wording of the recommendation is the result of the scientific conclusion, taking into account the other considerations. The purpose of following this procedure and drawing up the guidelines  in this format is to increase transparency.



An alphabetical list of literature references can be found at the end of the guideline.


All draft texts have been discussed by the guideline development group.

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