FDA Clears Minimally Invasive Method For Management of Non-Cancerous Breast Lumps

New Procedure for Common Condition That Affects Millions of Women Under 40

Cincinnati, OH (November 20, 2003) ? Millions of women who have non-cancerous breast lumps can now receive care in a doctor's office with a minimally invasive device rather than having the lump removed by invasive surgery in an operating room, resulting in less scarring and quicker recovery, it was announced today by Ethicon Endo-Surgery, Inc., a Johnson & Johnson company.

The company received clearance from the U.S. Food and Drug Administration (FDA) to expand the use of its MAMMOTOME? Breast Biopsy System so doctors can now use it for management of fibroadenomas (palpable non-cancerous breast lumps), a condition common among young women in their late teens, twenties and thirties. The MAMMOTOME? System has already been used for more than 1.7 million breast biopsies since 1995.

A fibroadenoma is typically a solid, round, benign tumor that has the feel of a marble inside a woman's breast. Many women have it removed with open surgery or reject surgery in order to avoid the potential scarring associated with the traditional operation.

Management of fibroadenomas has become easier, and this should increase the number of women who choose to do something about them," said William E. Burak, M.D., associate professor of surgery, Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University, and co-author of a clinical study that tested the ability of the MAMMOTOME? System to remove benign breast lumps such as fibroadenomas. "The cosmetic results are excellent and with this new procedure, women won't have to go into an operating room to manage the problem."

According to the study, reported in the American Journal of Surgery (October 2003), 100 percent of patients surveyed who had a procedure with the MAMMOTOME? System indicated they would recommend the procedure to other women.

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 U.S. According to the National Institutes of Health (NIH), fibroadenomas are twice as likely to occur in African-American women.

A procedure with the MAMMOTOME? System involves the one-time insertion of a special probe through a 1/4 inch incision (about the size of a match head) in the breast where the lump was found. Guided by ultrasound, the doctor uses the hand-held device to gently vacuum, cut and remove tissue for biopsy in a procedure that typically lasts less than an hour. The incision in the breast is so small, no stitches are required. Women resume normal activity immediately following the procedure with only a small adhesive bandage over the incision site.

Minimally invasive breast biopsies with the MAMMOTOME? System have become standard practice at many of the finest health care institutions in the world," said Cornelia Groehl, Worldwide President, Oncology, Ethicon Endo-Surgery, Inc. "This new indication for the MAMMOTOME? System will bring the benefits of minimally invasive technology to even more women, who until now may have faced open surgery to remove a non-cancerous breast lump."

The American Cancer Society recommends that beginning at age 20, women should perform a breast self-examination every month; women between the ages of 20 and 39 should have a clinical breast exam with a health care professional every three years; and women 40 and older should have one every year along with a mammogram.

More information about fibroadenomas, the MAMMOTOME? System and minimally invasive breast biopsies can be found at http://www.jnj.com/exit_warning.jsp;jsessionid=NSLVRGB0GTJJQCQPCAOSZOYKB2IIWNSC?url=http%3A%2F%2Fwww.breastbiopsy.com.

As with any medical procedure, procedures with the MAMMOTOME? System may present risks. Patients should consult with their doctors to see which procedure is appropriate for them.

Ethicon Endo-Surgery, Inc., develops and markets a broad portfolio of advanced surgical instruments and medical devices for minimally invasive and traditional surgery. The company's mission is to help physicians around the world transform patient care through innovation. The company's focus is on designing innovative, procedure-enabling medical devices for interventional diagnosis and treatment of various diseases and conditions in the areas of general and thoracic surgery, breast disease, gynecology, oncology, and urology. For more information, visit http://www.jnj.com/exit_warning.jsp;jsessionid=NSLVRGB0GTJJQCQPCAOSZOYKB2IIWNSC?url=http%3A%2F%2Fwww.ethiconendo.com.


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