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

2. 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.

3. 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

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

5. 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.

6. 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.

7. 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.

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

9. 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.

10. 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.

11. 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.