FDA Cautions about Surgical Instrument to Remove Fibroids

On April 17, 2014, the U.S. Food and Drug Administration (FDA) issued a new statement concerning a surgical instrument used to remove fibroid tumors of the uterus during minimally-invasive procedures (surgery performed through small “band-aid” incisions).

Uterine fibroids—also called leiomyomas—are benign growths (not cancerous) that develop in the muscle wall of the uterus (womb). Fibroids are very common. Over thirty percent of women will develop a fibroid within the uterus by age 35. Women who develop fibroids often have several, from 3 or 4 to as many as 20 or 30. Sometimes the condition causes no symptoms, but fibroids can cause problems with pain and bleeding. Even when a woman has no symptoms, the fibroid may need to be removed because it is enlarging. (In my years of practice, I have removed fibroid tumors that had enlarged to the size of a basketball). In rare cases, cancer cells may develop within the fibroid tumor.

Fibroids are the most common problem for which a woman seeks a hysterectomy (surgery to remove the uterus). If they are causing significant problems before childbearing is complete, we recommend removing the fibroid tumor from the uterus and leaving the uterus in place. This procedure is called a myomectomy. You can read more about uterine fibroids in a previous blog post.

With the new minimally-invasive surgical instruments, women needing a hysterectomy or myomectomy can usually avoid a large incision. This technique is called laparoscopy or laparoscopic surgery. Robotic surgery is a further advance in this type of surgery. Although we are now able to offer nearly all of our patients requiring surgery a minimally-invasive procedure, some limitations still exist. You can easily understand the problem of removing the entire uterus or a large fibroid through a tube (the laparoscope) that has a diameter of around 10 to 12 millimeters (less than half an inch). A small uterus can be removed through the vagina. But this is problematic if the uterus or fibroid is very large.

A surgical instrument called a morcellator was developed to allow us to remove large tissue specimens through the tiny laparoscopic tube. The morcellator is like a tiny “roto-rooter.” A rapidly-turning blade on its tip allows the surgeon to remove the uterus or fibroid through the laparoscope in small pieces. Using the morcellator, small pieces of tissue may be left behind in the abdomen.

The new FDA statement raises the concern that about 1 in 350 fibroid tumors removed by the morcellator turns out to contain cancer cells (leiomyosarcomas). The small pieces of tissue left behind (if they contain cancer cells) could potentially seed a cancer within the abdomen. For this reason the FDA statement now cautions against using the morcellator to remove fibroids from the uterus or to remove a uterus containing fibroids.  The statement reads, in part:

“… the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”

The FDA did not ban the use of the morcellator. Rather, it advised women and their physicians to weigh this risk against the risks of their other options (such as the traditional hysterectomy through a large incision).

The good news for our patients is that, as our robotic surgery experience has advanced, we are now able to remove a large fibroid uterus through the vagina without using the laparoscopic morcellator. We have been using this technique—rather than the morcellator—for most of the past year preceding the FDA statement. For us, using the robot has virtually eliminated the need for the procedure known as “supra-cervical laparoscopic hysterectomy,” (a laparoscopic hysterectomy that does not remove the cervix). That procedure required using the morcellator to remove the uterus.

The likelihood that a uterine fibroid will contain a cancer is extremely low. In my private practice, I have not had a final pathological diagnosis of leiomysarcoma (cancer in the fibroid tissue sent for laboratory examination) following a hysterectomy or myomectomy. Still, we are pleased with the FDA recommendation. Our own professional group, the American College of Obstetricians and Gynecologists, is currently conducting a thorough review of published scientific evidence about the morcellator and cancer risk in gynecologic surgery. At Sparks & Favor, we feel that the FDA statement will have little effect on our ability to offer our patients who need surgery a minimally-invasive procedure. We continue to recommend minimally-invasive, robotic-assisted hysterectomy to our patients needing a hysterectomy because of uterine fibroids.