Is it safe to participate in an FDA Approved Study? Maybe Not.
See my latest article on the Huffington Post
This metaphor is not far off the mark because we are talking about a device that directs radiation at the incision of a cancerous breast immediately after the tumor is surgically removed. It’s supposed to be fast track radiation therapy. The woman can finish her radiation treatment before she wakes up from surgery. That was the big selling point. Instead of weeks or months of daily radiation treatments, wake up from surgery and its done. Slash and burn at its best.
In this case a silicon and tungsten shield is placed over the healthy tissue in the breast to protect the non cancerous areas of the breast from the damaging radiation exposure aimed at the fresh incision. The FDA forgot to test the safety of the silicon tungsten shields. Oops. Thirty women who received this treatment are left with metal deposits of tungsten in their breast tissue that show up on their mammograms. Not only does this make it more difficult to read the films and identify new breast cancers in women who have already had one bout of cancer, but tungsten is not without toxicity and now it is lodged in their tissue.
This is a great example of why potentially dangerous medical devices should be subject to clinical trials and inspections. Without those safeguards, it can take years to discover that a device is defective; meanwhile, thousands of patients can be harmed.
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