Technological Advances Can Spare Millions from Surgery

When Cheryl Smilgis underwent a breast biopsy in June 2003, naturally she was most concerned about the potential results of the procedure. But thanks to advanced, minimally invasive ultrasound-guided technology, Smilgis had few worries about the biopsy itself.

A resident of Billerica, Massachusetts Smilgis had her first mammogram shortly after she turned 35. An area of concern led her doctor to perform an ultrasound for further evaluation of the region in question in her breast. "The ultrasound was okay, but during another mammogram six months later, the area of concern had changed. It had grown a little bit," Smilgis says.

Because of the concern raised by the apparent growth in that region, Smilgis's physicians wanted to perform a biopsy, a removal of tissue in the area of concern. While mammograms and physical exams can point to an area of concern, only biopsy - the removal and microscopic analysis of the breast tissue - can definitively confirm the presence or absence of cancer.

"At the time, they mentioned a procedure they could do right in the office and get a good sample of the tissue," Smilgis says. That procedure - minimally invasive breast biopsy - uses advanced imaging to help the physician guide a special probe to the exact area of concern. Sophisticated tools and clearer imaging mean a good sample of tissue can be removed from the area with minimal impact on the patient and surrounding healthy breast tissue. During the biopsy Smilgis underwent, the physician used a vacuum-assisted probe that gently suctions the tissue so it can be cut and removed through a very small incision.

Within a few days of the procedure, Smilgis received news that the area of concern that her doctors targeted with the biopsy was non-cancerous. The 37-year old wife and mother of a three-year old boy, was enormously relieved. In addition, Smilgis was spared the risk and discomfort of the traditional surgical approach still used in an estimated one-fifth of all breast biopsies performed in the United States.

The benefits of avoiding surgery

Unlike traditional surgical biopsy, the minimally invasive approach is quick and does not involve a major incision and the potential risks and complications that can arise from surgery. "Any time you can avoid surgery, it's great," says Dr. Delphine Lui, Associate Medical Imaging Director at the Winchester Hospital Breast Care Center in Winchester, Massachusetts, where Smilgis underwent her biopsy.

Lui points out that 80 percent of all lesions that need biopsy are benign. In other words, of the estimated 1.6 million women who undergo breast biopsy in the United States each year, around 1.2 million will not be diagnosed with breast cancer. If these patients can be spared surgery through a minimally invasive approach to diagnosis, they should be, Dr. Lui says.

A surgical breast biopsy typically requires a one- to three-inch incision in the breast, stitches, and possible scarring. A surgical biopsy procedure takes longer, it takes longer to heal, and it can cause changes in the breast that can mimic cancer on future mammograms, Lui says.

By contrast, patients who undergo minimally invasive breast biopsy face a 10 to 15 minute procedure by Lui's estimate. The incision required to obtain the breast tissue sample is about one quarter of an inch - roughly the size of a match head.

In addition, when Dr. Lui performs a biopsy, she is able to place a biocompatible tag at the site of the tissue sample. In Smilgis's case, it is a tiny stainless steel clip that will appear on future mammograms to help physicians immediately find the area of past concern and let them closely monitor any changes in that region.

Patients who undergo minimally invasive breast biopsy can return to normal activities almost immediately. Smilgis underwent the procedure late in the day, went home that afternoon, and was back at work the next day. And, nearly a year and a half after the procedure, the site where the tiny incision was made is barely visible. "I know where to look, but it's hard to see there's even a mark there," she says.

Cost effectiveness

In addition to the benefits to patients, minimally invasive breast biopsy helps health care payers contain costs. One recent study showed that minimally invasive, vacuum-assisted biopsies offer a cost advantage over traditional surgical biopsies in every health care setting where both procedures can be performed.¹

Lui says minimally invasive breast biopsies provide sufficient tissue samples for a definitive diagnosis in 90 percent of cases. At the Winchester Hospital Breast Care Center, 85 to 90 percent of biopsies are performed with minimally invasive techniques first, Lui says. If the initial biopsy is inconclusive, a surgical biopsy must be performed.

Lui says even taking into account the small percentage of patients who may need to undergo a surgical biopsy following a minimally invasive procedure, it is more cost effective to the health care system as a whole to use minimally invasive biopsy as the first line of diagnosis.

While minimally invasive breast biopsy is the preferred diagnostic tool in the vast majority of cases, Dr. Lui says it is not appropriate for every patient. In some cases, patients and physicians opt for a surgical biopsy immediately because of the location or nature of the lesion. In other cases, patients may accept the risks and potential complications of surgery in exchange for having 100 percent of the lesion removed and analyzed.

Removal of non-cancerous lumps

In addition to the diagnostic benefits of minimally invasive breast biopsy, one of the advanced instruments used to gather the tissue sample can now be used for removing non-cancerous breast lumps.²

Called fibroadenomas, these lumps occur in about 10 percent of all women and account for about half of the 1.6 million breast biopsies doctors perform each year. They are common among girls in their teens and women in their twenties and thirties, but may occur at any age. According to the National Institutes of Health (NIH), fibroadenomas occur twice as often in African-American women.

In some cases, removing the lump may be necessary. Until recently, most fibroadenomas have been removed using an open surgical biopsy method. Open surgical removal of fibroadenomas may involve the removal of nearby breast tissue, which can cause scarring and breast disfigurement. Surgical removal requires stitches and an incision one- to two-inches long.

Now, doctors can use the same advanced tools used in breast biopsy for diagnosis to remove fibroadenomas. Like diagnostic breast biopsy, this procedure involves minimal scarring, requires no stitches and allows patients an immediate recovery.

Easier than the dentist

As she discussed her need for a breast biopsy with friends and coworkers, Smilgis talked to many people who expressed their reservations about what she was facing. "They would say things like, 'I could never do that,'" Smilgis says.

She thinks it is important to get the message out about how important procedures like this are, and how positive her experience was.

"There are a lot of misconceptions about procedures like this," she says. "I was scared, but once I understood what I would be going through, and that it was not very invasive, I felt better. I was able to watch on the monitor and see what they were doing to my body the whole time," Smilgis says. When she went back for the 10-day post procedure check up, everything was pretty much healed, she says.

Smilgis's positive experience with minimally invasive breast biopsy seems to be the norm, says Dr. Lui. "We get compared to dentists all the time - and we always win," she says.

¹ Bodai, et al, "Total cost comparison of two biopsy methods for nonpalpable breast lesions," The American Journal of Managed Care (May 2001, 7:527-538).
² The Mammotome Breast Biopsy System, manufactured by Ethicon Endo-Surgery, Inc., received FDA clearance for fibroadenomas in 2003.