The Food And Drug Administration’s Ability To Protect The Public From Flawed Medical Devices
A list of interesting books recently came out about a set of women that had partaken in a medical study regarding cancer treatments. The women participating in a study of patients with breast cancer have been inadvertently left with hundreds of tiny particles of the heavy metal tungsten in their breast tissue and chest muscles. The elements came from a contraption used during surgery. The device has since been recalled. 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. (The spots resemble calcium sediments, which can indicate cancer.)
The most interesting books written about this particular situation noted these facts: about 30 women have been affected, according to the manufacturer of the device that caused the problem. The women are in a quandary. At least one, dreading that the tungsten could bring on cancer or another illness, is trying to decide whether to get rid of the elements by having her breast and its underlying tissue removed in a radical and disfiguring operation. Twenty-seven of the cases occurred at a world renowned hospital in Newport Beach, California. Eleven of those women have had mammograms, and all 11 showed tungsten. Hospital administrators turned down requests for interviews, but provided a statement admitting that the setback had occurred.
Two other women were treated in a study at a cancer center in Rochester Hills, Michigan. 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 was depicted in these interesting books; the books cast 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. The device had been cleared by the 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), is a lot faster than the process used to approve a new device, and it ordinarily does not require tests on humans. This faulty equipment was recalled last month. Neither its manufacturer nor the F.D.A. could justify what went wrong with the device. A spokesperson for the agency said it was just beginning its review of the device and the recall. So far, she said, F.D.A. toxicologists had found no evidence that the tungsten was toxic or that patients were harmed.
She also noted that the 510(k) process was used to avoid “reinventing the wheel” for products that were essentially the same as others that had already passed muster with the agency. The women who were exposed to the tungsten were taking part in a study of a radiation technique that some doctors predicted would be a big advance in the treatment of breast cancer. Unlike the usual five to seven weeks of daily radiation sessions, the newer method delivers the entire course of treatment in one dose while the woman is still in the operating room after undergoing a lumpectomy for breast cancer. But in the study, a device that was temporarily placed in the women’s incisions during the radiation treatment was apparently flawed, and riddled their breasts with tungsten. So this device, a $100 disk made of tungsten and silicone, was used to shield healthy tissue from the radiation. The first patient to participate in the study mentioned above said the incidents had absolutely crushed her faith in the vigilance of the FDA, the hospital and her doctors, who she said enthusiastically talked her into participating, stressing how convenient it would be to complete radiation treatment before she even woke from surgery.