Danger of morcellators highlights grave issues with FDA approval process

Uncovering the dangers associated with a common surgical tool poses a question: Why is the FDA still following a 1976 process that systematically approves devices based on similarity to other devices instead of evaluating each individual device based on safety?

According to the Wall Street Journal, an FDA device approval process — called 510(k) — was created in 1976 to expedite approval and is the type of review the FDA used in 1991 to first approve laparoscopic power morcellators, a type of surgical instrument that removes large masses during minimally-invasive procedures, presented by Cook Urological.

Laparoscopic power morcellators have been commonly used to perform hysterectomies on women. Last month, the FDA warned surgeons not to use the device to perform such procedures because it can spread hidden uterine cancer.

By 1991, medical professionals largely understood that cutting cancer in the body could spread it, and physicians typically cut tumors out intact, usually in surgical bags to prevent the cancer from spreading, the article says. Cook Urological says its morcellators were designed to be used with such protective bags, but the FDA didn't ask about cancer-spreading risk during the review of the device.

Since gynecologists believed uterine sarcoma was rare and it can't be detected until after surgery, most gynecologists did not use the bags during surgeries because they thought they were clumsy or unreliable. However, later studies found that hidden uterine sarcomas appeared more frequently than previously believed. The FDA referred to these studies during an advisory this April.

The FDA did not begin researching how morcellators could harm women until December 2013, though concerns about the danger of spreading cancer through the use of morcellators existed for more than a decade. In January 1995, FDA medical officer Daniel Schultz expressed concerns that a 1994 morcellator developed by Karl Storz Endoscopy-America could spread dangerous cancer cells, according to WSJ.

Cook Urological cited four devices as precedents when applying to approve its laparoscopic power morcellator in 1991. According to WSJ, Cook documents didn't list any clinical trials because 510(k) reviews don't require controlled human tests. Numerous other morcellator devices were approved through 2011, with each new application citing earlier models for approval.

According to WSJ, the FDA used this process to review 99 percent of about 3,000 medical device applications in 2013. In 2011, a panel at the Institute of Medicine called for the recreation of the approval process. The main test, which determines whether the device under evaluation is "substantially equivalent" to another approved device, does not effectively evaluate whether or not the new device is safe to use.

Former FDA Commissioner David Kessler told the WSJ the 510(k) review was meant as an exception and was not intended to emphasize safety, but "the exception became the rule."

More articles on quality:
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