Position Statement on Prophylactic Mastectomy

Society of Surgical Oncology

(Updated March 2007)

In 1993, the SSO developed a position statement on prophylactic mastectomy to guide insurance programs in determining coverage and help patients obtain reimbursement. The original statement was co-authored by Drs. Kirby I. Bland, Edward M. Copeland, and David P. Winchester and approved by the SSO Standards of Care Committee. The position statement was revised in 2001 by Drs. Douglas Reintgen, Armando Giuliano, and Suzanne Klimberg. In January 2007, the SSO Executive Council requested that Dr. Giuliano chair a Prophylactic Mastectomy Task Force and again revise the document. The following guidelines were revised by Drs. Kuerer, Morrow, Leitch, Degnim, Boobol, and Giuliano.

POTENTIAL INDICATIONS FOR BILATERAL PROPHYLACTIC MASTECTOMIES

(In Patients without a Cancer Diagnosis)

High Risk

  • BRCA mutations or other genetic susceptibility genes
  • Strong family history with no demonstrable mutation
  • Histologic risk factors

Bilateral prophylactic mastectomy in a patient without a diagnosis of breast cancer or evidence of a suspicious breast lesion is one form of risk reduction for the development of breast cancer. Ideally, indications for consideration of bilateral prophylactic mastectomies are best evaluated by a multidisciplinary team which may include a surgeon, medical oncologist, pathologist, as well as a genetic counselor. A thorough discussion of alternative approaches includes close surveillance and other risk-reduction strategies. Such strategies include preventive agents such as tamoxifen or raloxifene, participation in clinical trials, and/or bilateral prophylactic oophorectomy (in premenopausal women). This discussion is essential to properly inform the patient of the spectrum of options for risk management. The patient should also be informed of potential risks and benefits of prophylactic mastectomy as well as the fact that the procedure does not provide 100% protection against the development of breast cancer. Additional factors to consider include patient age and other co-morbidities. Prophylactic mastectomy should not be discussed without a concurrent discussion of the potential benefits and risks of immediate reconstruction.

Clinicopathologic presentations that portend an additional risk of the development of breast cancer and that justify proceeding with bilateral prophylactic mastectomies include any of the following:

  1. A known mutation of BRCA 1 or BRCA2 or other strongly predisposing breast cancer susceptibility genes
  2. A family history of breast cancer in multiple first-degree relatives and/or multiple successive generations of family members with breast and/or ovarian cancer (family cancer syndrome). Additionally a family history of multiple family members with bilateral and/or pre-menopausal and/or male breast cancer may be associated with a familial breast cancer syndrome. Genetic counseling should be strongly considered, although prophylactic surgery is appropriate in women with a family history consistent with genetic predisposition and no demonstrable genetic mutation.
  3. High-risk histology: Atypical ductal or lobular hyperplasia, or lobular carcinoma in situ confirmed on biopsy. These changes are especially significant if present in a patient with a strong family history of breast cancer.

Rarely, bilateral prophylactic mastectomies may be warranted for an exceptional patient without family history or high-risk histology. Such a patient would exhibit the following characteristics: extremely dense fibronodular tissue that is difficult to evaluate with standard breast imaging, several prior breast biopsies for clinical and/or mammographic abnormalities, and strong concern about breast cancer risk.

The opinion of a surgeon familiar with the natural history and therapy of benign and malignant breast disease is advised. Patients undergoing prophylactic mastectomy for suspected hereditary disease should consider ovarian cancer screening or consultation for consideration of prophylactic removal of the ovaries. The decision to undergo prophylactic mastectomy with or without immediate reconstruction may involve complex body image and psychosexual issues. These issues and others should be discussed with qualified professionals prior to undergoing these procedures.

There is insufficient evidence at this time to recommend routine SLN biopsy for patients undergoing prophylactic mastectomy. However, this may be considered since high-risk patients may have an unsuspected cancer and axillary staging would be difficult after mastectomy.

POTENTIAL INDICATIONS FOR PROPHYLACTIC CONTRALATERAL MASTECTOMY

(In Patients with a Current or Previous Diagnosis of Breast Cancer)

  • Risk reduction
  • Difficult surveillance
  • Reconstructive issues (Symmetry/Balance)

Unilateral mastectomy, considered to be "prophylactic," may be appropriate in a patient in whom therapeutic mastectomy has previously been performed or is being contemplated for breast cancer. Such women are at higher than normal risk for developing contralateral breast cancer. However, when considering contralateral prophylactic mastectomy in apatient with cancer, it is important to recognize that many women overestimate their risk of developing a second cancer. A detailed discussion of an individual's risk of a contralateral breast cancer, the lack of impact of prophylactic mastectomy on mortality from the index cancer, and the significant benefit of endocrine therapy in reducing the risk of contralateral cancer should be included in the discussion of prophylactic mastectomy in this circumstance.

Mastectomy of the contralateral breast may be considered in the following situations:

1) For risk reduction in patients at high risk for a contralateral breast cancer. (See indications as listed above for bilateral prophylactic mastectomy.)

2) For patients in whom subsequent surveillance of the contralateral breast would be difficult. This includes patients with clinically and mammographically dense breast tissue or diffuse indeterminate microcalcifications in the contralateral breast. Stereotactic core biopsy should be performed of any suspicious cluster in this situation to rule out carcinoma. However, diffuse and/or indeterminate calcifications in some situations may make subsequent surveillance difficult. A clinically and mammographically dense breast may also make surveillance difficult.

3) For improved symmetry in patients undergoing mastectomy with reconstruction for the index cancer who have a large and/or ptotic contralateral breast, or disproportionately sized contralateral breast. It is difficult to reasonably match these patients' breasts with reconstructive techniques, and a contralateral mastectomy with reconstruction may be indicated to maintain symmetry. Mastopexy and reduction mammoplasty are alternatives to contralateral mastectomy. In rare situations a patient having had, or who will undergo, mastectomy without reconstruction may also request a contralateral mastectomy to maintain balance and/or decrease the risk of contralateral breast cancer.