Axxent Brachytherapy System Recall-Device Released Particles of Tungsten Throughout Woman’s Breast During Treatment-Lawsuit

I can only imagine what the patient is going through after specifically waiting for this device to become available as a safe method of treating her breast cancer. This happened at Hoag Hospital in Orange County and luckily enough the particles were found on a check up and now she may need to have her breast removed as a result of the malfunction. As you can read below the treatment was new in the fact that it does no require isotopes, which are used commonly with most radiation treatments. The device was being used in clinical trials being conducted at Hoag.

From the website about the device:

“The Axxent® Electronic Brachytherapy System® is a leading-edge technology that utilizes a proprietary miniaturized X-ray source to apply radiation directly to a tumor bed within the body. The Axxent® X-ray Source delivers high-dose rate, low energy radiation treatment without the use of radioactive isotopes. Axxent does not use radioactive isotopes, so it can be used without the need for a lead-shielded room. This enables veterinarians and therapists to remain with their patients during treatment, ensuring their safety and the treatment's accurate delivery.”

Below is what was recommended from the manufacturer and Hoag Hospital immediately reported to the FDA. This goes to further substantiate a national registry of incidents with medical devices, especially those treating patients for cancer. The toxicity of the tungsten in her breasts is stated to be low but it appears from what I am reading here that the only way to be sure the particles are gone is to remove her breasts. As you can see now from the recommendations below MRIs will now be required as a follow up. The patient was the first to undergo the new treatment and there’s no mention of any other patients in the article and hopefully there won’t be more. BD

iCAD recently acquired Xoft, Inc., developer of the Axxentbrachytherapy system Axxent uses non-radioactive miniaturized X-ray tube technology and is FDA-cleared for treatment of early stage breast cancer, skin cancer and endometrial cancer, so you can see device might face some scrutiny in other areas of treatment. At any rate you can almost be assured that additional inquiries and reports may follow. BD

A woman treated for cancer at Hoag Hospital in Newport Beach may end up losing her breasts because of a flaw in a new radiation system, which has been recalled, according to a lawsuit.

The 58-year-old “Jane Doe” was the first person at Hoag to undergo the treatment on her left breast and had specifically waited for the system to become available.

Now doctors want to remove her breasts after a shield used with the system shed tiny particles of tungsten throughout her chest, said her attorney, Jeff Milman of Irvine. The tungsten was found as part of her six-month checkup.

“There are no definitive studies that talk about long-term risk,” Milman said.

Jane Doe, a clinical psychologist, filed suit in February, targeting the manufacturer, Xoft Inc. and Hoag Hospital.

The device in question is the XOFT/iCAD Axxent Flexishield Mini, which protects parts of the body from unwanted radiation during use of the Axxent Brachytherapy System. After conducting an investigation, the company recalled the flexishield device in February. Patients are advised to follow up with their physicians to help them monitor for side-effects.

“We believe this issue has no impact on the safety and efficacy of the radiation therapy delivered by the Axxent system,” said the recall notice. To see the full notice click here Xoft_recall_02-04-11.