The Axxent FlexiShield Mini was developed to offer safe high-dose radiation therapy to women undergoing surgery for breast cancer. Less than two years after earning fast-track approval by the US Food and Drug Administration, however, the silicone rubber shields were taken off the market. The FDA, upon issuing the Class I recall—their highest category of severity—said women exposed to the shields risk serious health complications. Class I recalls indicate a risk for death.

In the operating room, immediately following a lumpectomy for breast cancer, the round pads were temporarily placed on the skin or inside the open incision. Delivering radiation to the operative site with the pads in place was accomplished without the use of radioactive isotopes. That allowed medical personnel to remain at the patient’s side without the need for lead-shield protection.

Another benefit, the pads enabled precise delivery of radiation directly into the tumor site, while at the same time protecting the surrounding healthy tissue from radiation damage. The Mini Shields were designed to be cut as needed to conform to the shape and size of the radiation beam—therein lies the problem. Cutting the pads allowed for the shedding of hundreds of tungsten particles from inside the pads, into the breast and chest cavity.

The metal particles were detected in post-surgery mammograms. Research has yet to reveal the long-term effects of tungsten in a woman’s body. What is known: tungsten particles in the breast complicate the interpretation of mammograms. The metal particles make reading a mammogram difficult because they look like calcium deposits.

The FDA is concerned the tungsten particles may be mistaken for calcifications, cancer, or, worse, they may block cancerous lesions from view. It is not known whether the tungsten particles will disperse from the breast and chest muscles into other parts of the body, or what kind of problems that might create. The only way to rid the breast of the metal bits is mastectomy, removal of the breast.

Sadly, that is what some women are opting for, especially those with a previous diagnosis of breast cancer or those who have a family history of breast malignancy. They know that tungsten particles may hide suspicious lesions, and, upon considering their options and their increased risk for breast cancer, they are not willing to gamble on cancer being missed by diagnostic imaging.

What You Need to Know – Product Details

Product Name		XOFT/iCAD Axxent FlexiShield Mini
Model Number		F5300
Lot numbers		800218, 800239, 800240, 800321, 800334, 800335
Manufactured		September 2009 through June 2010
Distributed in the U.S.		October 2009 through December 2010
Taken off the market		February 2011

FDA Follow-up Recommendations to Physicians Treating Affected Women

• For a minimum of 5 years: Mammogram and MRI of the breast at least every 12 months, alternated, 6 months apart

• Manual breast exams at regular intervals, preferably by a breast surgeon

• Blood and urine tests for tungsten levels every 12 months, until levels are in line with the Agency for Toxic Substances and Disease Registry (ATSDR) recommendations

Take Precautions if You Were Exposed

The FDA system of fast-track 501(K) approval for new devices aims to provide treatment options for people with rare or serious health conditions. All those involved in the treatment, from the medical professionals to the patient, approach the undertaking with hopes of positive results. In the case of the Axxent FlexiShield Mini, serious, unexpected consequences occurred. If you think you may have been treated with the device, inform your physician at once and protect yourself by taking the necessary steps to monitor the situation.

If you have been affected, it is important that you maintain regular follow-up visits with your physician and have manual breast exams, preferably by a breast surgeon, at regular intervals. Take the FDA’s advice; stay on schedule with mammograms and breast MRIs. Also important are blood and urine tests to measure the amount of tungsten in your body.

Concentrating on areas of your life over which you have control may help decrease worry and anxiety. Take control of your health by eating well, in modest quantities; including water in your daily liquid intake; and getting enough sleep. Try to get in some exercise every day, and make time for meaningful activities. Keep in mind that as of yet there is no evidence of bodily harm incurred as a result of the tungsten deposits.

By Laura DeLeon