Ethicon Endo-Surgery Inc, a Johnson & Johnson company, announced that two million women have now had a minimally invasive breast biopsy with its Mammotome Breast Biopsy System, the 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 six out of 10 women needing a biopsy went to the operating room for an open surgical biopsy. Today, only three out of 10 women have open surgical biopsies, the release said.
"When we first started using the Mammotome System I knew it had the potential to change the way breast biopsies were performed. Now that two 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, a radiologist from the Sally Jobe Breast Centre 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, 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," he added.
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 release said.
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.