About 30 women who got treated for breast cancer with help from a new device now have to make heart-wrenching decisions. Image: Flickr / aithom2 / CC-BY-ND

About 30 women who were participating in a study have been left riddled with possibly dangerous metal. These breast cancer patients were being used to test a new medical device. The FDA had fast-tracked the approval of this device, which has since been pulled off the market.

Study of the FlexiShild Mini

About 30 breast cancer patients participated in a study of the Axxent FlexiShield Mini. The device was intended to act as a small, implantable shield that would protect healthy tissue from radiation. Doctors would perform a lumpectomy, then implant the FlexiShield Mini and give a large dose of radiation directly to the affected area. The intention is that this would allow breast cancer patients to undergo just one surgery and dose of radiation therapy, rather than a long, drawn-out treatment. The implant is made of silicone with tungsten, which blocks radiation.

Metal left it patients’ bodies

The study of the FlexiShield Mini was called off and the product pulled off the market. Up to 30 of the women that were participating in the study were found to have chunks of tungsten in their bodies. The tungsten was supposed to be suspended in the silicone and not come out. 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. The women are left with the choice of undergoing a complete mastectomy or leaving the tungsten in their bodies.

Fast-track device approval

The approval of the FlexiShield Mini was a part of a fast-track program developed by the FDA. Referred to as the 501(k) program, this is a program that allows companies to fast-track approval of medical devices that are very similar to already-approved devices. The company merely has to inform the FDA of the product and its intended uses. The company does not have to show results of human studies before the FDA will approve the medical device. After significant problems in the past with the 501(k) system, the FDA instituted several reforms for 2011, only some of which were in place when the FlexShield Mini was approved for use in humans.

Sources

FDA: http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/default.htm
US News: http://health.usnews.com/health-news/managing-your-healthcare/articles/2011/03/21/health-highlights-march-21-2011

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