Riddled With Metal By Mistake. Women participating in a study are now riddled with tiny particles of metal mistake. The particles are in their body along breast tissue and chest muscles from a device used during surgery.
It is not known if the metal is dangerous to health because relatively little research has been done on its long-term effects in the body. 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.
About 30 women have been affected, according to the manufacturer of the device that caused the problem, the Axxent FlexiShield Mini. The women are in a quandary. At least one, fearing that the tungsten could cause cancer or another illness, is trying to decide whether to get rid of the particles by having her breast and its underlying tissue removed in a radical and disfiguring operation.
Twenty-seven of the cases occurred at Hoag Memorial Hospital Presbyterian in Newport Beach, Calif. Eleven of those women have had mammograms, and all 11 showed tungsten. Hospital officials declined interviews, but issued a statement acknowledging that the problem had occurred.
Two other women were treated in a study at Karmanos-Crittenton Cancer Center in Rochester Hills, Mich. A hospital spokeswoman said that both patients had been informed of the recall and the potential problem but had not returned to the hospital.
The episode casts doubt on the safeguards for people who participate in medical research and on the Food and Drug Administration’s ability to protect the public from flawed medical devices.
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