Frequently Asked Questions


About MammoSite® Treatment for Breast Cancer

Q. What is the MammoSite® Radiation Therapy System (RTS)?

A. The MammoSite® Radiation Therapy System (RTS) is a tumor site-specific internal radiation therapy system for breast cancer. The device is comprised of a balloon catheter that internally administers the prescribed dose of radiation to targeted breast tissue in a one- to five-day course of therapy. By internally delivering radiation directly to the tissue surrounding the original tumor, the MammoSite® RTS minimizes exposure to the rest of the breast, skin, ribs, lungs and heart. The MammoSite® RTS was cleared for use by the U.S. Food and Drug Administration (FDA) in May 2002.

Q. Why was the MammoSite® RTS developed?

A. While there are comparable positive outcomes in terms of recurrence and survival, an estimated 50 percent of women with early stage breast cancer still choose to have a mastectomy rather than lumpectomy followed by radiation therapy. Because of its minimally-invasive nature and short duration of treatment, the MammoSite® RTS could make it easier for more women to consider the choice of lumpectomy and provides physicians with an important new tool for the practice of breast conservation therapy

Q. What is breast conservation therapy?

A. Today, more and more women who have cancerous tumors are looking for options to preserve their breast while treating the cancer. For many women with early-stage breast cancer, breast conservation therapy (BCT) - in the form of a lumpectomy and follow-up radiation treatment - is one of these options. In fact, of approximately 250,000 women who develop breast cancer each year, more than one-third are able to undergo lumpectomy and radiation to treat their tumors

Q. How is treatment with the MammoSite® RTS administered?

A. During the lumpectomy procedure or shortly thereafter, the deflated MammoSite® balloon is placed inside the tumor resection cavity. The applicator shaft, a tube connected to the balloon, remains outside the breast. Once in place, the balloon is inflated with saline to fill the cavity. The balloon remains inflated for the entire time that the patient is receiving radiation therapy. After the balloon is inflated, the catheter exit site is dressed and the patient may go home. The patient returns to the hospital or clinic for treatment on an outpatient basis where a radioactive “seed” is inserted within the inflated balloon, beginning a one- to five-day sequence of treatments. No source of radiation remains in the patient’s body between treatments or after the final procedure. When the therapy is concluded, the balloon is deflated and the MammoSite® RTS catheter is easily removed.

Q. Is treatment with the MammoSite® RTS covered by health insurance?

A. Radiation therapy with internal radiation is an accepted treatment for breast cancer and is covered by most insurers. Specific coverage for the MammoSite® RTS will depend on a patient’s individual health care plan.

Q. Can any breast cancer patient be treated with the MammoSite® RTS?

A. The MammoSite® RTS is cleared to internally deliver radiation to the surgical margins following lumpectomy for breast cancer. Safety and performance of the device for internal delivery of radiation to targeted breast tissue were evaluated in a multi-center study, which involved women with early-stage breast cancer. The safety and effectiveness of the MammoSite® RTS as a replacement for whole breast irradiation in the treatment of breast cancer has not been established. The use of MammoSite® RTS is subject to physicians’ clinical judgment in consultation with their patients.

Q. Why do so many women choose to have a mastectomy when breast conservation therapy is an option?

A. There are many different answers to this question, and it depends on the patient and the patient’s physician. Physical, emotional and practical considerations, as well as a physician’s clinical preference, may all influence a patient’s decision.

Q. What is the expected role for MammoSite® RTS in the post-surgical treatment of breast cancer?

A. The MammoSite® RTS expands the range and flexibility of post-surgical treatment options for breast conservation therapy, an approach to cancer treatment in which a lumpectomy is performed rather than whole breast removal via mastectomy. The future role for the MammoSite® remains to be determined.

Q. Is internally administered radiation therapy effective?

A. Studies, including a recent article published in the April 2001 issue of the Journal of Clinical Oncology, have found that accelerated treatment of breast cancer using localized radiation therapy through conventional brachytherapy demonstrates low local recurrence rates.

Q. Does treatment with MammoSite® RTS cause side effects?

A. MammoSite® RTS has been carefully tested in a clinical trial. Following the treatment, study participants experienced breast-related side effects, such as but not limited to redness, bruising and breast pain. All of these are common side effects of breast surgery and/or radiation therapy, and are usually only temporary.



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