Blog Post #3: Weak Reporting System Let Risky Surgical Device Stay in Use (Legalism and Professional Responsibility)

A surgical device used to operate on women’s bodies to help fight uterine cancer and to remove fibroids, was in use for over 20 years before the Food and Drug Administration was made aware that the device actually spread cancer around the body, sometimes transforming it into advanced stages. After harm came to a patient in 2013, it was found that through morcellation, slicing up the tissue so that it could be removed through tiny incisions, malignant cells can be sprayed throughout the body like seeds, making the disease more deadly and decreasing chances of long-term survival.

Doctors and hospitals were responsible for reporting adverse events with the morcellators, but officials told investigators that, before the FDA explicitly stated that the spread of cancer via the device is an adverse event, they would never have regarded it as such or reported it. Before 2013, the FDA received no reports, and by September 2016 nearly 300 women had died as a result of the procedure and lack of incident reporting in the former years.

“The passive reporting of adverse events is a weak system,” said Marcia Crosse, the director for health care at the Government Accountability Office.

Is this failure to report incidents stupid obedience of the rule? Claiming ignorance sounds more like a cop out from taking responsibility of the issue. The FDA knew that there was a risk when the first allowed the devices to be used in 1991, but thought the risk to be small enough to ignore. The estimated numbers were at first one in 500 to one in 10,000 (a big window). Research after the problem came to light in 2013 showed it was more like one in 350 women would be affected negatively. The doctors and hospitals which knew of the risks and adverse effects of morcellation (not to mention those in the FDA which approved the device without issuing an initial warning to the public) are completely responsible for these deaths. However, according to their reporting system, they had not technically broken any rules.

Knowing that using the morcellators involved risks and not disclosing this to the patients or public can be seen as blind obedience. The doctors and officials were simply doing their jobs without concern or consequence of the possible outcome. There is one missing element, however. Those that were aware of these happenings and didn’t report the incidents failed to exercise due care when it came to the health and lives of the patients. They had adopted a negligent obedience of the rules. However foolishly interpretive they were or however bad the outcome, they acted within the rules and they insulated themselves from full responsibility. Meanwhile the lives of hundreds of women were lost and even more left worse off from the effects of the surgery.

The FDA issued a warning about the devices in 2014 and their use in fibroid surgery has fallen dramatically, but morcellators are still available today.

Source: New York Times


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