The U.S. Food and Drug Administration (FDA) is charged with developing the protocols for testing new drugs and medical devices for efficacy and safety. But recent reports of morcellation cancer incidents are causing some to call on the FDA to change procedures to more strictly regulate their “fast track” for approval of certain medical devices.

Under the current FDA rules, certain medical devices can receive “fast track” approval under certain circumstances. For example, if a medical tool is similar enough to existing medical technologies, it may bypass some or even all of the normal testing procedures. In some situations, like laparoscopic morcellators, this may have allowed dangerous medical tools to hit the market.

Morcellators are a type of surgical tool. They are used in laparoscopic surgery. In this procedure, surgeons use small, specialized tools to perform the bulk of the surgery inside the patient’s body. Sometimes, laparoscopic surgery needs to remove large pieces of tissue. For example, laparoscopic surgery may be used for the following procedures:

• myomectomy (removal of fibroids)
• hysterectomy (removal of the uterus)
• oophorectomy (removal of the ovaries)
• salpingectomy (removal of fallopian tubes)

In order to remove these tissues through the small incisions made during laparoscopic surgery, they must be first cut into smaller pieces, through a process called morcellation. However, there is growing evidence that sometimes people have undiagnosed cancer cells in the tissues that are removed. When this happens, morcellation may help spread these cells throughout the body.

In July 2014, several FDA advisory panels met to decide on the best course of action regarding the new morcellation cancer data. However, the panels were unable to decide if it was better to recall the morcellators or to merely strengthen the warning label. Such a determination would be a matter of ruling whether the risk of spreading cancer was greater than the benefits of the procedure.

A letter was written by Dr. David R. Challoner, who chairs the Institute of Medicine’s Committee on Public Health and Effectiveness of the FDA’s 510(k) Clearance Process. The 510(k) process allows certain medical devices to skip most of the FDA’s approval process.

This only applies to products that are “substantially similar” to existing technologies. While this has helped some medical devices to get to the market quickly to save lives, the program has undergone scrutiny over problems like morcellation cancer risks, as well as problems with artificial hip joints. The letter advised additional scrutiny for the 510(k) program over problems with potentially dangerous medical devices, in light of recalls and morcellation cancer lawsuits.