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# Rep Wants More Device Reporting from ‘Cancer Moonshot’
- URL: https://www.fdaweb.com/rep-wants-more-device-reporting-from-cancer-moonshot/
- Published: 2016-04-14T12:00:00.000Z
- Updated: 2026-09-14T20:54:45.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135372

> Rep. **Michael Fitzpatrick** (R-PA) is asking Vice President **Joe Biden** to include in his “Cancer Moonshot” initiative steps to improve medical device reporting to FDA. In a 4/13 [letter](http://www.fdaweb.com/download.php?file=Letter%5Fto%5FVP%5Fre%5FCancer%5FMoonshot%5Fand%5Fpower%5Fmorcellators%5F4.13.16%5FFINAL.pdf) to Biden, Fitzpatrick raises the issue of the controversial laparoscopic power morcellator that he says “proved tragically unsafe, spread cancer throughout the body of those it was designed to help, and led to the death of hundreds, if not thousands, of women.”  
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> According to the representative, while it is critically important to support development of innovative new devices and drugs to treat cancer, “it is just as important to take this opportunity to implement meaningful reforms to make medical devices safe.”  
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> He notes that it was only in 11/2014 that FDA put a Boxed Warning on the device.  
>  
> Fitzpatrick says there are steps that can be taken today to ensure that serious injuries and deaths caused by medical devices are promptly reported to FDA. “For years,” he writes, “there was evidence that morcellation was spreading cancer in women. But those reports never made it to FDA. For years, women were dying from the cancer spread by this device. But their deaths were never reported to FDA by the hospitals, the device manufacturers, or the doctors who were charged with their care. This was despite federal requirements that FDA be informed about unsafe devices. We must do more to strengthen medical device reporting regulations to ensure that dangerous devices, like the morcellator that spread cancer in women for decades, are quickly identified and removed from the market before they can do more harm.”