Debate Over Gynecology Tool Sheds Light On Regulation By Dr. Lori Gore-Green

Doctors from all over the country are sticking by a gynecological tool even after a warning from the

U.S. Food and Drug Administration about its ability to spread undetected cancer.

As reported in a recent article from the Wall Street Journal, the face off between doctors and

regulators is showcasing what some might call intransigence on the part of doctors

Others might call overreach on the part of the government. What is certainly clear is that quality gynecological care lies somewhere in the middle.

The device in question is called a laparoscopic power morcellator, and it is used by its proponents to remove benign uterine growths called fibroids.

The tool is normally employed during routine hysterectomies to slice and remove the fibroids

through small incisions.

The issue with the morcellators is that they have the potential to leave tissue behind that can grow and then spread throughout the body, including tissue

that has not been identified as malignant.

This potential threat prompted the warning from the FDA and caused many hospitals to stop using

the tool, including Brigham and Women’s Hospital in Boston and Philadelphia’s Temple

University Hospital.

Many insurers across the country have stopped covering procedures involving morcellators.

However, there are gynecologists who believe that reports of the threat are unwarranted and

continue to use the tool routinely. Doctors like Jeffrey Thurston of Dallas say that the treatments he performs with his patients are between he and

his patient, and that regulators are simply interfering.

In his practice, he has patients sign a release that states that the risk of spreading undetected

sarcoma is somewhere between 1 in 300 and 1 in 1000. He also tells his patients verbally that he

does not believe those numbers.

In the tug of war between the FDA and doctors, it can be difficult for patients to know whom to

trust. Where one stands on the use of morcellators may have more to do with politics than any

insights on patient welfare.