Upon her six-month check-up, doctors found high-density particles of tungsten in the treated breast. The tungsten, a metal element, had allegedly broken off from a device, the XOFT/iCAD Axxent Flexishield Mini, used by the system.
The Flexishield Mini had been designed to protect patients from single-dose radiation during the procedure, Milman said.
The manufacturer recalled the Flexishield Mini in February, referencing a customer — Jane Doe — who reported finding high-density particles during a six-month follow-up mammogram, Milman said.
"No patient injuries were reported, and we believe this issue has no impact on the safety and efficacy of the radiation therapy delivered by the Axxent System, as the Flexishield Mini is a radiation shield," according to the recall statement.
However, Milman said that three more patients had contacted him, also claiming to have tungsten particles in their breasts after undergoing the treatment at Hoag.
"There is no good, long-term data as to how safe tungsten is," Milman said, adding that doctors have recommended that Doe have her breast removed as a precaution against the metal particles migrating to other parts of her body.
Milman, who practices in Irvine, likened a woman's breast to the rest of the body as a "highway" upon which particles can travel to other organs.
"The issue is going to be whether she has a single or a double mastectomy," Milman said. "Most doctors and plastic surgeons recommend a double in order to achieve a more natural appearance."
No other patients have been scheduled for Intraoperative Radiation Therapy, the treatment used by the Axxent System, while the situation is being investigated, according to a statement from Dr. Jack Cox, senior vice president and chief quality officer for Hoag.
"The highest quality patient care and safety are absolute top priorities at Hoag. We take this responsibility very seriously," according to the statement provided to the Daily Pilot. "…The physicians involved in IORT took immediate action upon discovering the situation and notified all involved patients. In addition, Xoft/iCAD (the company that provided the shield) and the FDA were notified. Xoft/iCAD subsequently issued a voluntary recall of the device with the approval of the FDA."
The patient filed suit against both the hospital and the manufacturer in February. She is seeking compensation for pain and suffering, future medical expenses and lost earnings, which Milman expects once his client undergoes surgery, and possibly other damages.
All patients who underwent the treatment signed releases, according to Hoag.
The claimant also signed a release form before undergoing treatment, Milman said.
"At this point, we just don't know where she's going to go medically."
