Girardi | Keese

Study backs FDA's controversial position on surgical instrument

While most people might not realize it, a debate has been raging between the Food and Drug Administration and certain sections of the U.S. medical community over the ongoing use of a medical device that the agency claims can be linked to an increased cancer risk.

The medical device in question is a power morcellator, which for the uninitiated is a surgical instrument that is designed to cut up larger pieces of tissue inside the body for extraction via smaller laparoscopic incisions. The device is frequently utilized by OB/GYNs during hysterectomies or surgical procedures to remove uterine fibroids.

Back in April, the FDA began discouraging OB/GYNs from using power morcellators, arguing that the devices can actually serve to spread previously undetected cancerous cells.

As justification for this position, the agency pointed to an internal study, which determined that as many as one in 350 women undergoing either of the aforementioned procedures have undetected uterine cancer that could be inadvertently spread via power morcellators.

The FDA even went so far as to lobby for a black box warning, the most extreme, to be included on the product labeling for power morcellators.

Any sort of definitive action has yet to be taken, however, as many physicians' groups -- including the American Congress of Obstetricians and Gynecologists -- expressed skepticism regarding the FDA study and argued that the risks of using power morcellators were clearly outweighed by the benefits of the otherwise minimally invasive procedure.

In recent developments, the FDA may see its position regarding power morcellators strengthened following the publication of a recent study by researchers at Columbia University.

As part of the study, published in the latest edition of the Journal of the American Medical Association, the researchers looked at the cases of over 36,000 women who underwent hysterectomies using a power morcellator from 2006 to 2012 at 500 hospitals. Shockingly, they found that one out of every 368 women had undetected uterine cancer.

"This is an answer to some of those criticisms and might mitigate the concerns of those who disagree with the FDA figures," said the primary author of the study.

It will indeed be interesting to see how the medical community reacts to this report, and if the FDA responds by renewing its call for a black box warning or starting a new call for an outright ban.

Stay tuned for updates ...

If you have suffered serious personal injuries or lost a loved one because of a defective product, consider speaking with an experienced attorney to learn more about your rights and options for seeking justice.

Source: The Washington Post, "Research supports FDA warning about a medical device that could spread cancer," Caelainn Hogan, July 22, 2014

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