For Healthcare Providers

For Healthcare Providers 

Patient-Friendly Fibroadenoma Treatment

The US Food and Drug Administration (FDA) cleared the Sanarus Visica® cryoablation treatment system on October 1, 2001 as a safe and effective alternative to surgical removal of fibroadenoma tumors. Since then, thousands of patients have been treated with no reports of fibroadenoma regrowth.

Cryoablation achieves tissue necrosis by alternately freezing, thawing and refreezing a targeted tissue. The freezing destroys the fibroadenoma by damaging the microvasculature that feeds the cells. After they are destroyed, the abnormal cells are reabsorbed by the body, generally within 3-12 months, depending on the size of the lesion. 

Patients and physicians both report high levels of satisfaction with the cryoablation procedure in terms of tumor removal, cosmetic results, reduced pain, and recovery time.

The American Society of Breast Surgeon (ASBS) recommends the following criteria to establish a patient as a candidate for cryoablation of a fibroadenoma.

  • The lesion must be sonographically visible.
  • The diagnosis of fibroadenoma must be confirmed histologically (with a biopsy).
  • Lesions should be less than 4 cm in diameter.

Cryoablation is a safe and effective alternative to surgery for patients who desire a minimally invasive and permanent solution and are concerned with the cosmetic outcome.

“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.”
American Society of Breast Surgeons Consensus Statement, “Management of Fibroadenomas of the Breast,” April 29, 2008.