Breast Device Recall Made Most Severe

The recall of a medical device that left particles of the metal tungsten in women’s breasts has been classified as the most serious type of recall, one involving “situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death,” the Food and Drug Administration said on Wednesday.

The device, the Axxent FlexiShield Mini, was a pad made of tungsten and silicone rubber that was temporarily placed inside breast incisions during an unusual procedure in which women were given an entire course of radiation treatment in one dose after undergoing a lumpectomy for cancer. The pads were used to help direct the radiation beam and shield healthy tissue. But the pads were flawed, and left the breast tissue and chest muscles riddled with hundreds of tungsten particles.

It is not known if tungsten is dangerous because relatively little research has been done on its long-term health effects in humans. But it shows up on mammograms and may make them difficult to read, an especially troubling effect for women who have already had breast cancer and worry about recurrences. The particles resemble calcium deposits, which can indicate cancer.

That the tungsten shows up on mammograms is what made the recall Class I, the most serious type, said Karen Riley, a spokeswoman for the F.D.A. She said the particles could interfere with diagnosis, because they can be mistaken for cancerous calcifications or may hide real calcifications. Twenty-nine women are known to have been affected: 27 at Hoag Memorial Hospital Presbyterian in Newport Beach, Calif., and two at Karmanos-Crittenton Cancer Center in Rochester Hills, Mich. So far, 16 have had follow-up mammograms six months after their surgery, and all 16 were found to have tungsten particles.

Some of the women, concerned that the tungsten could be harmful, are considering having mastectomies to rid themselves of the particles. Seven are suing Hoag and the device manufacturer, according to Jeffrey Milman, a lawyer in Irvine, Calif., who is representing the women.

Mr. Milman said that for the purposes of the lawsuits, the F.D.A.’s decision to classify the recall as serious was “icing on the cake.” The device was made by a company called Xoft, which was subsequently bought by another company, iCad.

The Axxent FlexiShield Mini had been cleared by the drug agency in June 2009 in an abbreviated process used for devices that are considered equivalent to products already on the market. That process, known as 510(k), takes less time than the procedure used to approve a new device, and it generally does not require tests on humans.

The shields were cut to fit each patient, and Ms. Riley said the tungsten particles were shed after the cutting. But why that occurred is not clear, because the shields were meant to be cut and were made with that in mind.

They were taken off the market in February. But at that time the drug agency was still studying the problem and had not yet decided what class the recall should be. It announced on Wednesday that it was class I, the most serious type. There are two lower recall classes, and lesser actions called market withdrawals and safety alerts.

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