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FDA Warns Doctors to Stop Using Minimally Invasive Medical Device

FDA Warns Doctors to Stop Using Minimally Invasive Medical Device

According to a series of articles published by The Wall Street Journal, the FDA has warned doctors of a serious risk associated with the use of morcellators, a type of surgical tool used in minimally invasive surgeries such as hysterectomies and laparotomies. The FDA has revealed that these devices may actually spread cancer throughout the body.

What Is A Morcellator?

First approved for use in the early 1990s, doctors have used morcellators to perform over 50,000 procedures. A surgical tool with a tube-shaped body, the morcellator contains a blade at one end and a handle at the other. After making a small incision in the body, doctors can insert the blade into a uterine fibroid or tumor. The blade then morcellates – shreds – the tissue, which can be removed through the incision. There are several types of morcellators on the market, including a popular device, the FemRx, manufactured by Johnson & Johnson. These surgical tools have been used to perform hysterectomies, myomectomies, laparotomies, and other surgeries for decades.

Serious concerns arose, however, when doctors began noticing high rates of aggressive uterine cancer in patients who had undergone morcellator surgeries. Because there is no reliable way for doctors to determine whether a fibroid or other mass is cancerous prior to these types of surgeries, the FDA has stated that the use of morcellators actually increases the risk of spreading undiagnosed cancerous tissue throughout the uterus and possibly the rest of the body. In some cases, pieces of morcellated tissue are left behind, which can cause cancer to spread.