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Novilase Laser Ablation for Breast Fibroadenomas

Fast Laser Procedure Gives Great Results and Speedy Recovery

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Updated January 18, 2010

Written or reviewed by a board-certified physician. See About.com's Medical Review Board.

Novilase Laser Ablation for Breast Fibroadenomas

Novilase Laser Ablation for Breast Fibroadenomas

Art © Pam Stephan

Breast fibroadenomas, usually removed during a lumpectomy, may be removed instead with a laser during a procedure called Novilase laser ablation therapy. Currently being studied for long-term outcomes, Novilase uses an ultrasound-guided laser device to destroy the fibroadenoma, leaving behind only a tiny scar, no sutures, and no change in breast shape. An outpatient procedure, laser ablation is done in about 30 minutes, with local anesthesia, and rapid recovery.

Troublesome Breast Fibroadenomas
Fibroadenomas are benign breast tumors that are usually not bothersome unless they are large or near the breast skin. About 10 percent of all fibroadenomas will disappear on their own but most of these benign tumors persist. Breast fibroadenomas may be felt during your breast self-exam as smooth, flexible lumps. On a mammogram, these may look like cysts or a well-contained tumor. If you are over 40 years old and have one or more painful fibroadenomas, many doctors recommend having them removed. Traditionally, that has meant a lumpectomy, but laser ablation may be used for breast fibroadenomas as well as uterine, esophageal, colon and prostate tumors.

A Surgeon's View of Laser Ablation for Benign Breast Tumors
Dr. Coleen Hagen, a general surgeon with Midwest Surgical Associates, is using Novilase on breast fibroadenomas as part of a clinical trial - American Breast Laser Ablation Therapy Evaluation (ABLATE). Dr. Hagen has been a surgeon for 25 years and for patients who meet the clinical trial criteria, she offers them a choice between lumpectomy and laser ablation. "Some women have multiple fibroadenomas, and when they want them surgically removed, it's like doing a mastectomy in bits and pieces," noted Dr. Hagen. Novilase is much easier on women than a lumpectomy, particularly if there is more than one fibroadenoma. "I want to get the word out to my referring primary care physicians, gynecologists, and radiologists that this is an option," says Dr. Hagen.

Meeting The ABLATE Clinical Trial Requirements
Not everyone will be able to participate in the clinical trial for Novilase. To qualify, a woman must be over 18, not pregnant or breastfeeding, with a fibroadenoma no larger than 2 centimeters in diameter that can clearly be seen on a mammogram or ultrasound. You must have a clear diagnosis of fibroadenoma - usually confirmed by a breast biopsy - and the lump has to be 0.5 centimeters away from your skin. If you have more than one breast fibroadenoma, you can still join this clinical trial. The ABLATE clinical trial will end December 2012.

Patients Perspective: Very Pleased
Several women have already tried laser ablation for a breast fibroadenoma. Judy Gilberts had the Novilase procedure and said that it exceeded her expectations. Gilberts had already been through two painful surgical biopsies with general anesthesia and slow recovery. Following her laser ablation procedure, she said, "I felt good enough after having the procedure done to walk back to my hotel and (later) take a mile-long walk! I was not able to do this after having my biopsy done." Gilberts remarked that in contrast to a lumpectomy, the laser ablation did not change her breast shape and caused very little pain. "I also am very pleased with the fact that there is basically no scar at all!" said Gilberts.

How Fibroadenomas Are Destroyed By Laser Ablation
Dr. Hagen said that the Novilase procedure is done under local anesthesia, after the patient has been made comfortable. "It could take 5 to 10 minutes to visualize the lesion on ultrasound, maybe change the patient's position and anesthetize the area. The actual ablation takes about 15 to 20 minutes." A hollow probe is inserted into the center of your fibroadenoma, and then a laser fiber is threaded into the probe. A temperature probe will be inserted nearby to monitor the laser's heat. The laser heats your benign tumor while your surgeon watches the temperature on a nearby monitor. When the fibroadenoma has been destroyed, the probes are removed, and a small bandage is placed over the skin.

Advantages and Drawbacks of Laser Ablation of Fibroadenomas
When compared with lumpectomy, laser ablation appears to win out with many patients. Since you have only a small nick in your skin, there's less risk of infection. You won't need general anesthesia, sutures, surgical drains, or more than a day for recovery. Instead of a two- or three-inch scar, you will have a tiny scratch on your breast. The shape of your breast won't change, as healthy tissue overtakes the lasered fibroadenoma tissue. But there are some drawbacks - patients must join the clinical trial at one of four locations in the United States. Novilase is FDA-cleared for fibroadenomas up to 2 cm, but such benign tumors can grow up to 15 cm (5.9 inches) - and it is not yet known whether laser ablation will be effective on larger fibroadenomas.

Laser Ablation of Breast Tumors
Novilase is considered interstitial laser therapy (ILT) because it works from inside the breast tumor. Interstitial radiation is already used as adjuvant breast cancer treatment. But surgeons hope that someday, malignant breast tumors may be eliminated by laser ablation. In 2008, surgeons in Sweden used a laser probe to treat invasive breast cancer in 19 patients. Three of the patients had small tumors and their treatment was completely successful. Larger tumors were partially destroyed, and appeared greatly weakened due to loss of blood supply. All of the tumors were later surgically removed for study, and to examine their margins. Laser ablation of tumors appears to be the wave of the future for benign breast tumors, and may even pave the way for nonsurgical treatment of breast cancer.

Sources:

Personal correspondence with Dr. Colleen Hagen, December 11, 2009.

Personal correspondence with Judy Gilberts, December 15, 2009.

American Breast Laser Ablation Therapy Evaluation (ABLATE) ClinicalTrials.gov, U.S. National Institutes of Health. Accessed: December 27, 2009.

Lasers in Cancer Treatment: Questions and Answers. National Cancer Institute. Reviewed: 08/10/2004.

Interstitial laser thermotherapy (ILT) of breast cancer. Haraldsdóttir KH, Ivarsson K, Götberg S, et al. Eur J Surg Oncol. 2008;34(7):739-745.

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