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FDA's Handling of Morcellators Gets Scrutiny from Congress
Nancy Crotti
August 11, 2015
2 Min Read
.svg?width=850&auto=webp&quality=95&format=jpg&disable=upscale "FDA's Handling of Morcellators Gets Scrutiny from Congress")
The 510(k) approval process is among the things some members of Congress would like the U.S. Government Accountability Office to scrutinize.
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The Gynecare Morcellex Tissue Morcellator, as shown on Ethicon's website. |
Nancy Crotti
A dozen members of Congress have asked the federal government to investigate FDA over its regulation of power morcellators.
It turns out that the devices, used for 24 years in the U.S. to slice up tissue during laparoscopic hysterectomies and myomectomies, can also potentially spread cancer in women.
Rep. Mike Fitzpatrick (R-PA), Rep. Louise Slaughter (D-NY), and a bipartisan group of lawmakers sent a letter last week to the U.S. Government Accountability Office, asking the GAO to scrutinize FDA's past performance on morcellators.
Congress wants to know why FDA ever approved power morcellators, according to the letter. The writers asked GAO to consider the following:
Did FDA's reliance on 510(k) approval policies and procedures sufficiently identify risks of adverse events before it allowed the laparoscopic power morcellator to enter the market?
Were the medical device reporting regulations (21 CFR 803) appropriately followed to protect patient safety?
What activities or training did manufacturers provide to clinicians, and what professional society standards, if any, apply to training on the use of these devices?
What steps is FDA taking after issuing a warning about the dangers of the devices to determine whether they are safe to remain on the market?
FDA warned last year that the spinning blades of the once-popular devices could spread an undetectable uterine sarcoma in the abdomen and pelvis. The FBI is reportedly investigating what Johnson & Johnson officials knew about the dangers of power morcellators in spreading cancer when they sold the device.
Johnson & Johnson's Ethicon subsidiary pulled its morcellators from the market last year, including the Gynecare Morcellex tissue morcellator, Morcellex Sigma tissue morcellator, and the Gynecare X-tract tissue morcellator.J&J was the largest manufacturer of the device.
FDA has approved at least 10 power morcellators for sale in the past 24 years, according to a report in the Wall Street Journal. The agency did not respond to the newspaper's request for comment.
Refresh your medical device industry knowledge at MEDevice San Diego, September 1-2, 2015. |
Nancy Crotti is a contributor to Qmed and MPMN.
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