[Posted 04/13/2011]

AUDIENCE: Risk Manager, Radiology, Surgery

ISSUE: Xoft Axxent Flexishield Mini product, Model 5300, may shed particles of tungsten. After use during Intraoperative Radiation Therapy (IORT) for in breast tissue, these particles can be mistaken for suspicious calcifications during follow up X-rays or scans. After laboratory testing and a comprehensive literature review, Xoft has concluded that there is no evidence that these tungsten particles are toxic – only a few health effects have been reported in humans with this material, each of which involved exposure at much higher levels. No permanent impairment of bodily functions or permanent damage to body structures is anticipated.

BACKGROUND: The Xoft Axxent Flexishield Mini device consists of a circular silicone rubber pad containing tungsten particulate. The pad is 12.7 cm in diameter and 0.1 cm (1 mm) thick. It is designed to shape a therapeutic radiation therapy beam from a low energy source to provide a means to accommodate different shapes of treatment fields to limit the amount of radiation encountered by the skin or healthy tissue by shielding areas that do not need radiation therapy.  The pad should be placed over the surface that needs shielding from the radiation therapy, it can be cut to accommodate the shape of the radiation therapy beam.

RECOMMENDATION: Customers were instructed to stop using all units of the Flexishield Mini Catalog Number F5300 in their inventory and return them to the company. It is recommended that health care professionals inform the patient about the likelihood of post-operative tungsten particles in the breast and continue the imaging recommended in your clinical protocol for the full 5 years, unless otherwise directed by the patient’s treatment team. For the recalled lot numbers and additional recommendations please see the Recall Notice.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[04/13/2011 - Recall Notice - FDA]

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