United States Surgical Corporation's (USSC) ABBI* device -- the world's first instrument for minimally invasive breast biopsy -- has been cleared for marketing in the United States by the Food & Drug Administration (FDA) and will be available to the nation's hospitals, breast centers and surgeons in April. The new device has already been used in Canada with excellent results and will offer a less traumatic alternative to many of the one million women in the U.S. who undergo breast biopsies each year. This issue of The Laparoscopy Report provides background on the ABBI* procedure and highlights patient and expert reaction to this revolutionary new approach to breast biopsy.

 

FIRST MINIMALLY INVASIVE BREAST BIOPSY DEVICE ENHANCES CARE, REDUCES COSTS

The ABBI* system, a new patient friendly device for breast biopsy, allows surgeons to remove tissue for examination in a simple one-step operation requiring only local anesthesia to numb the breast. By avoiding heavy sedation or general anesthesia, patients are mobile immediately, some are even able to drive themselves home after the biopsy.

Breast biopsy procedures are typically performed in one of two ways, as a core needle or excisional (open) biopsy. With a core needle biopsy, the doctor uses a needle with a special cutting edge to remove tiny samples of tissue from the breast. Because the needle is so small it is usually inserted many times to ensure an accurate biopsy. Excisional biopsy is a two-step process -- performed under general anesthesia or heavy sedation --that begins in a radiology suite, where a radiologist manually places a needle into the breast, which marks the location of the lesion. The marker is taped to the patient's breast and the patient is moved to the surgical suite. The surgeon, using the wire marker as a road map, removes the tissue sample through an open incision.

The ABBI* procedure combines the placement of the wire marker and removal of a tissue sample into one minimally invasive procedure performed under local anesthesia. Stereotactic technology incorporated into the ABBI* system allows the surgeon to locate the suspicious mass to within 1 mm of accuracy. After the specimen is removed the opening is closed with a few stitches and a bandage.

 

BREAST SURGERY SPECIALIST: "MAJOR IMPROVEMENT" IN CLINICAL CARE FOR PATIENT

David Fleiszer, M.D., director of the Diagnostic Breast Center at McGill University, who pioneered the use of the ABBI* system at Montreal General Hospital, said, "The ABBI* procedure is really minimally invasive. It's all done under local anesthesia and there is virtually no patient discomfort other than lying still on the table. It's a major improvement in terms of clinical care for the patient."

Dr. Fleiszer, who says the ABBI* procedure is "something I've been daydreaming about for years," explains that because of the system's accuracy he is able to "home in directly on the lesion" and remove a sample without taking "a much larger piece of tissue." For patients this means minimal postoperative pain and a faster recovery.

"After we completed our first procedures, the patients sort of jumped off the table and went home -- with no recovery time whatsoever... all said the amount of discomfort in their breast was minimal to nothing."

 

PATIENTS: "NO COMPARISON" BETWEEN ABBI* PROCEDURE AND OPEN BIOPSY

While all of Dr. Fleiszer's patients say there is very little pain or discomfort associated with the ABBI* procedure, patients who have also had previous open biopsies are even more emphatic.

"I've undergone both procedures, an excisional biopsy 10 years ago and the ABBI* procedure one month ago, and I just feel there is no comparison whatsoever," says Heather Faith. Heather -- who did not even need an aspirin after the ABBI* procedure and was able to go a dinner party later in the day -- concludes: "The ABBI* procedure is a wonderful method because you really are as good as new when you have it completed and you can get up and continue with your normal life."

Judith Ann Tremblay agrees: "There's no pain from the procedure -- it's marvelous. I was at work the next day... there were no restrictions. Life went on." She adds: "Other women have asked me about the ABBI* procedure, and I highly recommend it. It's a very simple, easy procedure."

For Helen Von Enck, the ABBI* procedure meant much less anxiety as well. She was nervous before the procedure, but afterwards she said the ABBI* procedure was less stressful and she would tell others "they don't have to worry about a thing."

 

INDUSTRY EXPERT SEES BROAD APPLICATION, "SUPERIOR CLINICAL RESULTS"

In a report following the American College of Surgeons (ACS) meeting last fall, analyst Charlene Lu of Prudential Securities summed up surgeons' reactions to the ABBI* system this way: "The product of most interest at the ACS this year was U.S. Surgical's ABBI* system ....Traffic through U.S. Surgical booth was brisk...."

In addition to noting the high level of interest among surgeons, Ms. Lu said she also believes that the ABBI* system has potentially broad application. She says that of all the biopsies performed each year, approximately 500,000 are for non-palpable lesions (lesions that show up on mammograms, but cannot be felt). These non-palpable lesions, she explains, "are primary candidates for stereotactic breast biopsy, which offers a more precise way of performing a biopsy via computer guidance, resulting in more exact results and minimal disfigurement."

Ms. Lu concludes: "For non-palpable lesions, we believe stereotactic or computer-guided breast biopsy offers superior clinical results to open biopsy."


For an information kit or a video news package on the ABBI* procedure, contact Steve Rose, editor, at 203-845-1732 or E-mail to [email protected].

Items marked by an * and The Laparoscopy Report are trademarks of USSC.




Contact webteam