Frequently Asked Questions—Fibroadenoma Cryoablation

Following are some answers to questions women ask about cryoablation.

What is benign breast disease?
It is estimated that half of all women in the U.S. will seek consultation for a breast disorder in their lifetime. Many of these women are diagnosed with benign breast disease, defined as any non-cancerous breast abnormality. The most common benign breast tumor is fibroadenoma. Fibroadenomas can grow up to 4 cm or larger, the size of a golf ball, and cause pain, anxiety and disfigurement. 

What options are available for women diagnosed with benign breast tumors?
Since benign breast tumors rarely develop cancerous cells, women diagnosed with fibroadenomas are often told to "watch and wait". Despite this recommendation, the majority of women opt to have their fibroadenoma treated due to uncomfortable physical symptoms and psychological anxiety. 

Open, excisional surgery previously provided the only option for removal of fibroadenomas. Surgery is still the most common treatment for benign tumors. This procedure involves multiple pre-and post-operative visits, typically an in-hospital procedure that may involve general anesthesia, and 2-3 days of recovery. Surgical excision also leaves scar tissue within the breast. The Visica 2™ Treatment System marks a breakthrough in treatment of benign breast tumors through an office-based procedure that involves only local anesthesia and no stitches. 

What is cryoablation therapy?
Cryoablation is a process of using cold therapy to treat a benign tumor. The process begins after your biopsy when your surgeon has determined that the lump in your breast is benign (noncancerous) by a tissue diagnosis. This procedure is used most commonly with fibroadenomas. Previously, fibroadenomas required surgery for removal. Cryoablation is a less invasive way to treat fibroadenomas. 

What is the Visica Treatment System?
The Visica Treatment System is an office-based cryoablation treatment offering an alternative to the surgical removal of benign breast tumors. The Visica Treatment is an ultrasound-guided approach that requires only local anesthesia and is is virtually pain-free with only minimal discomfort. The Visica Treatment System became commercially available for treatment of breast fibroadenomas in 2002. 

How does the Visica Treatment System work?
The Visica System freezes and destroys targeted tissue using cryoablation technology, or extreme cold, through a small incision, without requiring stitches or general anesthesia. This procedure is performed in a physician’s office and lasts 20-30 minutes. Cryoablation has been shown to be highly useful in destroying common cancers (such as prostate) in long-term studies. In addition, cryoablation is visualized using real-time ultrasound, which helps to provide a controlled and targeted procedure. 

Where can I go to receive the Visica Treatment System?
The Visica 2 Treatment System is available now at selected centers throughout the U.S. Please call 800-909-3060 for more information. 

Who is Sanarus?
Headquartered in Pleasanton, CA, Sanarus Technologies is a company focused on providing patients and physicians with the minimally invasive, office-based breast care management solutions-from diagnosis and treatment to follow up. 

What other technologies are offered by Sanarus?
In addition to the Visica 2 Treatment System, Sanarus offers the ImarC Tissue Marker System.

Can the Visica Treatment System be used for the treatment of cancerous tumors?
Clinical studies are underway currently to evaluate the Sanarus Visica Treatment System for cryoablation of cancerous breast tumors. 

Where can the procedure be done?
The procedure can be done as an outpatient in the office of a trained physician. 

How is the procedure done?
The procedure is done by first numbing your breast with some local anesthesia. Your surgeon will then make a very tiny incision to insert the probe into the lump. Ultrasound will be used to locate the lump and visualize the exact placement of the probe. Ultrasound will help guide your surgeon throughout the entire procedure. 

What happens to the fibroadenoma after the freezing is completed?
The tissue that is destroyed by freezing is reabsorbed into your body over time. Depending on the size of the lump, it can take from approximately 6 months to 1 year. 

Is the treatment painful?
Most women who have had this procedure have a minimal amount of discomfort. There is a small amount of stinging when the local anesthesia is given. The area may have minimal discomfort when the actual freezing is done. But due to the natural anesthetic properties of the cold temperature, very little pain is felt during the cryoablation procedure. The treated area may feel tender to the touch for up to several days following the procedure. 

How long does the procedure take?
The procedure is done in the physician’s office and usually takes 30 to 60 minutes to complete. 

Will I have scarring?
Since no tissue is removed from the breast, no stitches are necessary. Some bruising and swelling may occur at the site, but will go away within a few weeks. There should be no visible scarring, though sometimes a small mark is visible where the probe has been inserted. 

Sanarus' cryoablation produces this		Other procedures produce this
One month after treatment

 

Will I need a ride home after the procedure?
Since the procedure requires only local anesthesia, you should not have to arrange for a ride home. If your physician prescribes you a sedative, then you will be required to have someone to drive you to and from your appointment. 

What kind of follow-up is required after cryoablation?
We will ask you to come back in one month to check the treated area. After that, we will have you come back at three months, six months, and one year for repeat evaluation. We will follow the cryoablation site by using ultrasound and examination to determine the fibroadenoma has regressed or resolved. Usually this process takes six months to one year, depending on the size of the fibroadenoma.