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FDA Approval of Medical Devices Raises Questions

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At some point in time, the U.S. Food and Drug Administration (FDA) should consider the efficacy of its 510 (k) fast track approval process and the importance of favorable test results prior to approving medical devices for implantation in humans. As FDA continues to allow devices similar to those already approved to proceed through its fast-track approval process, it also has permitted those devices which have caused deleterious effects in patients. It seems that the wisdom of the fast-track process should be checked.

A case in point are the results of allowing Xoft’s product, the Axxent FlexiShield to proceed through the fast-track process without human testing, only for it to be recalled in February 2011 after adverse events occurred to patients.[1] The shield apparently permitted the ejection of tungsten metal particles into the breast tissues of patients who were receiving radiation treatments for breast cancer. Since the February 2011 recall, there have been at least 29 such reports.

The fast-track approval process was originally designed for minimal-risk products to reach the marketplace expeditiously in order to benefit patients in 1976. Since that time, due to intense lobbying by device manufacturers, the regulation has been modified so that “about 90 percent of the devices on the market are cleared for use through the 510 (k) process.”[2] The device manufacturers uphold the approval process, noting that “less than 1 percent of the estimated 3,000 to 4,000 devices cleared each year are recalled because of concerns about death or serious injury.”[3]

One well-known medical that was approved through the 510(k) process is the DePuy ASR prosthetic hip implant. That device was recalled by Johnson & Johnson (DePuy) in 2010 because it was failing at unacceptably high rates. The ASR implant, because of issues concerning the metal on metal design, caused the release of toxic metals like chromium and cobalt into its recipients blood streams. The long-term ramifications of these toxic metals in the bloodstream has not yet been fleshed out.

Xoft and its parent company iCad have been sued but deny negligence or liability and blame the plaintiffs or the hospitals. Former FDA counsel Peter Barton Huff, a Washington lawyer who assisted in formulating the 510 (k) statute, also defended the process, “There's no proof that it is a broken system.”[4] Perhaps that sentiment should be expressed to the women who may have tungsten in their bodies because of the Axxent FlexiShield.


[1] “FDA Rule Clears Medical Devices Without Human Testing”, Saavedra, Tony and Perkes, Courtney, The Orange County Register, May 18, 2012. http://www.ocregister.com/news/devices-354854-fda-device.html

[2] Op. Cit.

[3] Ibid.

[4] Ibid.