Management of Fibroadenomas of the Breast

Fibroadenoma of the breast is a common benign lesion affecting women during their reproductive years. Despite their benignity, fibroadenomas can cause physical deformity due to large size and may produce discomfort or emotional distress
in affected individuals.

The traditional management options available to women diagnosed with a fibroadenoma include observation or surgical excision. Two newer approaches, percutaneous excision and in situ cryoablation, have been developed and are less invasive than surgical excision. The purpose of this consensus statement is to put these four management options into perspective for our members and their patients.

In most patients with fibroadenoma(s), the ideal approach is confirmation with percutaneous core biopsy and conservative follow-up. Because the malignant potential of fibroadenomas is extremely low, treatment is not required on an oncologic basis. This conservative approach is the least costly in terms of dollars and morbidity. A significant minority of fibroadenomas will disappear without treatment; with the remaining lesions either increasing in size or remaining unchanged.

Because fibroadenomas can be bothersome to some patients, causing physical deformity, discomfort or emotional distress, most breast surgeons will respect an informed patient's preference for treatment. Traditional open excisional biopsy is effective treatment in such cases but it is the most costly option because of the operating room charges and time off from work. Open excision may still be the best option in some cases based on large size of the fibroadenoma or the judgment of the surgeon or patient preference.

Recently, a large multi-center study has shown that ultrasound guided percutaneous excision of palpable fibroadenomas with a vacuum assisted core biopsy device is safe, effective and well tolerated by patients. For women who prefer removal of the lesion this procedure offers minimal morbidity, cost, time off from work and cosmetic impact.

Several multi-institutional trials have demonstrated cryoablation to be a successful option for the resolution of fibroadenomas without surgical excision. The FDA has approved the use of cryoablation as a safe and effective therapy for fibroadenomas. Results of cryoablation have been followed out to 4 years and demonstrate the procedure to be safe, efficacious, and durable.

The technique of cryoablation involves ultrasound guidance for three-dimensional probe placement within the center of the fibroadenoma. Physicians practicing this technique and/or percutaneous excisional biopsy should be appropriately skilled in breast ultrasound as recommended by the American Society of Breast Surgeons.

Both techniques, in the setting of this benign disorder, are considered low risk for patients who could, if required, undergo surgical resection for unsuccessful (incomplete excision) treatment. The Society will continue to monitor outcomes to provide updated guidance as future multi- and single institutional registry data are reported at meetings and in the breast surgery literature.

The American Society of Breast Surgeons recommends the following criteria to establish a patient as a potential candidate for cryoablation or percutaneous excision of a fibroadenoma:

1) The lesion must be sonographically visible
2) The diagnosis of fibroadenoma must be confirmed histologically.
3) Lesions should be less than 3cm in largest diameter

Contraindications for cryoablation or percutaneous excision of a fibroadenoma of the breast include:

1) Core biopsy diagnosis suggestive of cystosarcoma phylloides tumor or other malignancy
2) Poor visualization of lesion by ultrasound
3) Core biopsy diagnosis of fibroadenoma where diagnosis is thought to be non-concordant with findings on imaging or physical examination

Patients undergoing cryoablation or percutaneous excision of a fibroadenoma should have clinical follow up by the treating physician. Physicians are encouraged to place these patients in a registry where available to monitor long-term outcomes.

References

1. Isaacs JH, Benign Neoplasms. In Marchant, DJ (ed). Breast Disease. Philadelphia, W.B. Saunders Company, 1997, pages 66-7.

2. Cant PJ, Madden MV, Coleman MG, Dent DM. Non-operative management of breast masses diagnosed as fibroadenoma. Br J Surg 1995; 82:792-4.

3. Fine RE, Whitworth PW, Kim JA, et al. Low-risk palpable breast masses removed using a vacuum-assisted hand-held device. Am J Surg 2003; 186: 362-67.

4. Kaufman, CS, Littrup, PJ, Freeman-Gibb, LA, Office Based Cryoablation of Breast Fibroadenomas with Long-Term Follow-up, The Breast Journal, 2005, (11), 344-350.

5. Kaufman, CS, Littrup, PJ, Freeman-Gibb, et al., Office-Based Cryoablation of Breast Fibroadenomas: 12-Month Follow-up, Journal of the American College of Surgeons, 2004, 198 (6), 914-923.

6. Edwards, MJ, et al., Progressive Adoption of Cryoablative Therapy for Breast Fibroadenoma in Community Practice, The American Journal of Surgery, 2004, (188), 221-224.

Revised, December 8, 2005
Board of Directors
The American Society of Breast Surgeons