Advantages
A breast biopsy using the Mammotome® System can help a doctor make a highly accurate diagnosis of a breast abnormality without the need for open surgery. The Mammotome® can also be used for a non-cancerous breast lump such as a fibroadenoma. A lump may be reduced in size at the same time it is biopsied, often to the point where the lump may no longer be seen under ultrasound or felt during self examination.
Risks and Complications
The Mammotome System is for diagnostic use only and is not indicated for therapeutic use. Use of the Mammotome instruments is contraindicated for those patients where increased risk or complications may be associated with core removal or biopsy based upon the physician’s judgment. Patients receiving anticoagulant therapy or who may have bleeding disorders may be at increased risk. As with any breast biopsy procedure, a breast biopsy with the Mammotome® System may present risks. Patients should consult with their doctors to discuss which type of breast biopsy procedure is appropriate for them.
How It Works
Through the use of imaging methods such as X-ray or ultrasound, a breast abnormality or breast lump can be detected, even in its earliest stages. Using the same imaging methods, a physician can guide a Mammotome® probe into a suspicious area of the breast to gently collect the abnormal tissue through one small, ¼-inch incision.
With the Mammotome® System, a breast biopsy can be performed in an outpatient setting under local anesthesia. A doctor can make a precise analysis with minimal pain, scarring and recovery time. The biopsy procedure takes less than an hour, and patients can return to their normal daily activities immediately.
The Mammotome® System also can be used for fibroadenomas (non-cancerous breast lumps). Millions of women can now receive care in a doctor's office with the Mammotome® System rather than having the lump removed by invasive surgery in an operating room
What is Vacuum-Assisted Biopsy?
The relatively new vacuum-assisted breast biopsy is a percutaneous ("through the skin") procedure that relies on stereotactic mammography or ultrasound imaging. Stereotactic mammography uses computers to pinpoint the exact location of a breast mass based on mammograms (x-rays) taken from two different angles. The computer coordinates will help the physician to guide the needle to the correct area in the breast. With ultrasound, the radiologist or surgeon will watch the needle on the ultrasound monitor to help guide it to the area of concern. The patient will either by positioned in the upright or prone (face down) position for a vacuum-assisted biopsy.
Vacuum-assisted biopsy is a minimally invasive procedure that allows for the removal of multiple tissue samples. However, unlike core needle biopsy, which involves several separate needle insertions to acquire multiple samples, the special biopsy probe used during vacuum-assisted biopsy is inserted only once into the breast through a small skin nick made in the skin of the patient's breast.
| The Mammotome Biopsy System made by Johnson & Johnson Ethicon Endo-Surgery |
Two companies currently manufacturer vacuum-assisted breast biopsy systems, and often, vacuum-assisted biopsy will be referred to by the brand name: either Mammotome made by Johnson & Johnson Ethicon Endo-Surgery or MIBB (which stands for Minimally Invasive Breast Biopsy) made by Tyco/United States Surgical Corporation. In 1999, a hand-held version of the Mammotome was also approved by the U.S. Food and Drug Administration (FDA).
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Needle Biopsy Increasingly Replacing Open Surgery in Diagnosing Breast Disease
CINCINNATI, July 21 /PRNewswire/ -- Ethicon Endo-Surgery, Inc., a Johnson
& Johnson company, today announced that two million women have now had a
minimally invasive breast biopsy with its Mammotome(R) Breast Biopsy System,
the number one vacuum-assisted breast biopsy device that offers an alternative
to open surgical biopsies.
"This is a significant milestone for our company, but an even more
important occurrence for the two million women and their doctors who have
benefited from the Mammotome System," said Cornelia Groehl, Worldwide
President, Oncology, Ethicon Endo-Surgery, Inc.
When the Mammotome System was introduced in 1995, approximately 6 out of
10 women needing a biopsy went to the operating room for an open surgical
biopsy. Today, only 3 out of 10 women have open surgical biopsies.
"When we first started using the Mammotome System I knew it had the
potential to change the way breast biopsies were performed. Now that 2
million women have had a breast biopsy with this minimally invasive breast
biopsy device, it is a clear sign that this technique has become accepted as
the standard of care by physicians and trusted by patients," said Steve
Parker, MD, a radiologist from the Sally Jobe Breast Center in Colorado and
one of the developers of the Mammotome System.
The Mammotome System has proven to be as diagnostically reliable as open
surgery, but without the stitches and the scarring associated with an open
procedure. It is available in more than 2,000 breast centers, hospitals and
physician offices throughout the country.
"We have entered into a new era in the diagnosis of breast disease where a
needle has replaced a scalpel," said Melvin J. Silverstein, MD, Professor of
Surgery and the director of the University of Southern California's Norris
Comprehensive Breast Center in Los Angeles. "No longer do most women have to
go into the operating room to get a definitive diagnosis. The Mammotome
System has helped to make this possible."
A procedure with the Mammotome System involves a single insertion of a
needle equipped with a vacuum device into a tiny 1/4-inch incision (about the
size of a match head). The device gently vacuums, cuts and removes suspicious
breast tissue for analysis. Since the incision is so small, no stitches are
required. Instead, only an adhesive bandage is needed and most patients can
return to normal activity immediately following the procedure. The outpatient
procedure can be performed in a doctor's office and typically takes less than
an hour. Scarring is minimal.
The use of the Mammotome System has expanded beyond diagnostic sampling
and now includes the management of benign breast disease. The condition
occurs in about 10 percent of all women and is particularly common among
younger women in their late teens, twenties and thirties.
"Now even more women will have access to the Mammotome System and realize
the benefits of a minimally invasive approach to breast disease," commented
Ms. Groehl.
As with any breast biopsy procedure, procedures using the Mammotome System
may present risks. Patients should consult with their doctors to see which
type of breast biopsy procedure is appropriate for them.
More than 1.6 million biopsies are performed each year and about
eight-out-of-ten turn out benign (non-cancerous). According to the American
Cancer Society, nearly 216,000 women will be diagnosed with breast cancer and
about 40,000 women will die from the disease this year.
Ethicon Endo-Surgery, Inc., a Johnson & Johnson company, is headquartered
in Cincinnati, Ohio. The company is the world leader in the development and
sale of medical devices for minimally invasive and traditional surgery.
Ethicon Endo-Surgery, Inc. markets the Mammotome(R) Breast Biopsy System. For
more information about the Mammotome System, visit
http://www.breastbiopsy.com.
The Mammotome Biopsy System from Ethicon is a comprehensive, minimally invasive breast biopsy procedure that can be used with prone or upright stereotactic guidance or with ultrasound guidance using a hand held device. The Mammotome enables thorough sampling and control with the SmartVac™ computer-controlled vacuum system. The SmartVac contains a high-speed, rotating cutter that gives the physician maximum control throughout the procedure. With the SmartVac, the physician can selectively sample the target area of a lesion by rotating the aperture in vivo. Imaged evidence of the abnormality is completely or partially removed for a thorough biopsy.
You can perform a Mammotome biopsy in an outpatient setting using local anesthetic. You only need insert the probe once into the patient's breast through a 1/4-inch incision, from which you can obtain large tissue samples in and around the targeted area. There is minimal procedure prep time and no need for sutures. Patients generally experience minimal discomfort or scarring and may return to normal activity immediately following the procedure.
The Mammotome ST (Stereotactic) and the Mammotome HH (Hand Held) use computer-generated images to locate breast abnormalities to accurately pinpoint and map the affected area. Additionally, with the Mammotome system you can deploy a radiographic MicroMark® II Tissue Marker directly to the site, providing a tool for use in the future to help identify where a biopsy was performed or where additional follow-up may be required. The Mammotome HH is available with a 14, 11, and 8-gauge probe—which removes three times the tissue per specimen, compared to the 11-gauge probe.
The MAMMOTOME® Biopsy System has been helping physicians accurately diagnose breast cancer since 1995. No other vacuum-assisted breast biopsy device can match us in:
The tumors, called fibroadenomas, are common among women in their late teens through their 30s. The typically solid, benign tumors have the feel of a marble inside a woman's breast, according to Ethicon Endo-Surgery, producer of the device called the Mammotome system.
The system, originally approved in 1995 to help doctors perform breast biopsies, involves insertion of a probe into a quarter-inch-long incision. Guided by ultrasound, the doctor uses the device to remove tissue in a procedure that typically lasts less than an hour, the company says. As compared to conventional biopsy/tumor removal surgery, no stitches are normally required, there is less scarring and recovery is much faster, Ethicon adds.
Fibroadenomas occur in about 10 percent of all women and account for about half of the 1.6 million breast biopsies performed each year in the United States, according to a company news release.
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