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FDA’s Warning Labels on Boxes for Power Morcellators – What to Know

Back in 2014, the Food and Drug Administration (FDA) warned against the use of specific surgical devices, such as laparoscopic power morcellators, to carry out myomectomy because it can spread cancer unknowingly. Only recently did the FDA finally went forth pushing to have labels on these devices to have a warning on them of the risk.

 

Power Morcellators and Cancer

 

Power morcellators are typically used in a myomectomy, also known as hysterectomy or fibroid removal, to break up the fibroids in the uterine. While the uterine fibroids themselves aren’t necessarily cancerous by any means, the women who undergo the procedure might already have uterine cancer. This means that the tools can actually spread cancer, especially while in the process of breaking up the fibroids and removing the fragments. 

 

As a result, many hospitals have put a restriction on the use of power morcellators. Not only that, but some stores like Johnson & Johnson have stopped selling these devices, and even insurance companies moved away from covering issues related to them.

 

Nevertheless, many doctors still utilize the tool for the procedure, stating that other methods of removing the uterine fibroids also carry their own risk. This has caused quite a divide among the medical community––some against the use of power morcellators while others for it.

 

Promoting Safer Use of Power Morcellators

 

Knowing that the device hadn’t changed since approval of its use back in 2016, and most likely never will change much, the FDA is working hard to create a solution in which the power morcellator is still utilized in the procedure, albeit in a much safer way. That said, one of the ways they do that is to warn warning medical firms about the risk these devices carry with them. They advised labels to be put on boxes that contain these tools to warn physicians of the risk of spreading cancerous cells.

 

The FDA states that the label should also contain advice on how to utilize the tool safely. For example, the label should recommend the physician to create a containment system to help contain the spread of cancer cells. 

 

In other words, labeling the product to educate physicians on who they should use the device on and how to utilize the tool with utmost safety is currently the best way to allow myomectomy to be carried out traditionally without putting the patient at heightened risk of cancer.

 

Conclusion

 

The FDA highlighted the issues of laparoscopic power morcellation back in 2014, talking about the risk of spreading cancer using such a device. Only until recently did the FDA start to carry out actions that will help regulate the use of these devices, effectively pushing the risk of spreading cancerous cells during myomectomy low while still allowing physicians who stand by the use of the equipment to carry out their medical examinations. With warning labels as well as advice put on the boxes on how to carry out the procedure safely, the FDA hopes that the risk will be controlled, and no one going through fibroid removal will have to worry about cancer.

 

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