New, Less Invasive Breast Biopsy Approach Receives FDA Approval to Remove Benign Tumors (dateline October 25, 2001)

A new breast biopsy approach that involves freezing and destroying benign breast tumors called fibroadenomas has recently received approval by the U.S. Food and Drug Administration (FDA). Fibroadenomas are the most common form of benign breast tumors and do not pose an increased risk of breast cancer. However, some women with fibroadenomas require breast biopsies to have the tumors removed. The new biopsy technique offers women with fibroadenomas an alternative to the traditional surgical biopsy technique.

Approximately 65% to 80% of women who are referred for breast biopsies are found to have benign, non-cancerous conditions. However, the majority of women who undergo breast biopsies have traditional surgical biopsies, which require more recovery time and are often associated with more scarring and other potential complications than less invasive breast biopsy alternatives. The newly approved biopsy method provides a quicker recovery time than surgical biopsy and reduces the risk of complications.

The new biopsy technique is based on cryoablation technology. This technique involves freezing the tissue of the breast tumor. The technique, which takes approximately 20 minutes in a physician’s office, is only performed on women who have confirmed fibroadenomas (a needle biopsy is required to make the fibroadenoma diagnosis). 

To perform the cryoablation biopsy, the physician uses ultrasound (sonography) to guide a small needle to the fibroadenoma in the woman’s breast. The needle is then inserted into the breast tumor, which is frozen, destroyed, and reabsorbed into the breast within three to six months. The procedure is performed using local anesthesia and no stitches are required. According to Endocare Inc., the maker of the cryoablation technique, most patients are able to resume normal activities the day following the procedure.

Fibroadenomas are often too small to be felt by hand, though occasionally, they may grow to be several inches in diameter. They are the most common form of benign breast tumors and usually occur in women in their twenties and thirties. Fibroadenomas tend to be round and have borders that are distinct from the surrounding breast tissue, so they usually feel like a small marble within the breast. The tumors stop growing or even shrink on their own without any treatment, and in these cases, physicians may recommend not having the tumors removed. However, a biopsy to remove the fibroadenoma may be performed on women whose tumors do not stop growing or on women with special circumstances.

One risk of performing a traditional surgical biopsy to remove a fibroadenoma is that the scar tissue that results from the surgery will make future mammograms and physical breast exams more difficult to perform. However, because the cryoablation biopsy technique is associated with less scarring and complications than surgical biopsies, the risk of breast cancer being obscured on future mammograms or physical exams due to scar tissue is reduced with the new technique.

Additional Resources and References

• The October 17, 2001 Endocare Inc. press release, "Endocare Receives 510(K) Clearance From FDA To Market Minimally Invasive Treatment For Breast Tumors," is available at http://www.endocare.com/
• To learn more about benign breast conditions, including fibroadenomas, please visit http://www.imaginis.com/breasthealth/benign.asp
• To learn more about breast biopsy methods, please visit http://www.imaginis.com/breasthealth/biopsy/