Mini Metal
Tungsten Leaked Into Patient’s Bodies By FDA-approved Device
Thirty women who agreed to participate in a breast cancer research have been left with tungsten, a possibly dangerous metal, in their bodies. These patients had agreed to undergo a surgical treatment intended to shorten treatment time. The treatment had been approved by the Food and Drug Administration. The FDA fast-tracked authorization of this medical device; since the tungsten accidents, however, the device has been pulled off the market. Article source – Fast-track approval leaves cancer patients riddled with metal by Newsytype.com.
Implantation of the FlexiShield Mini
The Accent FlexiShield Mini has had about 30 patients participating, all with breast cancer. This is just a small shield put in the body. It protects the healthy tissue from radiation exposure. Doctors would perform a lumpectomy, then implant the FlexiShield Mini and give a large dose of radiation directly to the affected area. The idea behind it was to make it so long ongoing treatments aren’t necessary. Only one dose would be needed. The implant is made of silicone with tungsten, which blocks radiation.
Issue with metal in bodies still
The research of the FlexiShield Mini was called off and the product pulled off the market. There were pieces of tungsten being found in the bodies of the women testing it. This was only about 30 percent of women. It was not supposed to leak tungsten. The silicone was designed to stop it from leaving. X-rays, however, showed that the tungsten had leaked out and embedded itself in their breast tissue. There have been no studies of the long-term effects of tungsten in the body. One thing known for sure is that tungsten shows up much like calcium deposits on X-rays, making detecting further breast cancer very difficult. A complete mastectomy is needed for the women unless they want to leave the tungsten in their bodies.
Approving the device easily
The approval of the FlexiShield Mini was a part of a fast-track program developed by the FDA. Medical devices that seem close to devices we already are can go to this 501(k) program for fast track. The Food and Drug Administration is informed of the use of the product in this program. The company does not have to show outcomes of human studies before the Food and Drug Administration will approve the medical device. The Food and Drug Administration did many reforms to the 501(k) program after issues in the past for 2011 which the FlexiShield program didn’t have to abide by.
Articles cited
FDA
fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/default.htm
US News
health.usnews.com/health-news/managing-your-healthcare/articles/2011/03/21/health-highlights-march-21-2011
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