The FDA says surgical instruments called power morcellators may be responsible for seeding cancer in women who had hysterectomies or had uterine fibroids removed. In certain liver and spleen surgeries, the devices may spread cancerous tissue in both men and women.
- 1 What are Power Morcellators?
- 2 Serious Complications
- 3 Morcellation in Hysterectomy
- 4 Fibroid Surgery
- 5 Types of Laparoscopic and Hysteroscopic Morcellators
- 6 Laparoscopic Models
- 7 Risks of Cancer
- 8 FDA Intervention
What are Power Morcellators?
Gynecologists use power morcellators when they perform procedures, such as a hysterectomy or a myomectomy. These instruments, also called electric morcellators, do much of the cutting involved in laparoscopic and robotic surgeries. The morcellators, tiny devices with rotating blades, break large tissue masses into small fragments. Broken down tissues are then vacuumed away and out of the body.
The technique allows surgeons to make incisions of less than 2 centimeters in size and be able to remove fibroids and other tissue. These smaller entry points to the body mean doctors do not have to make large cuts through core stomach muscles. The transition to the small incisions has led to quicker patient recoveries, less post-operative pain and fewer wound complications.
Some former patients are finding more serious complications related to procedures in which doctors use morcellators. Recent medical evidence shows the removal of broken up fibroids and tissues may not be 100 percent effective. If any of those tissues contain cancer cells and do not get removed, they get spread to other areas, leading to the development of cancerous tumors.
Surgeons use these devices in women for hysterectomies and removing benign masses called fibroids. But, they may also be used in laparoscopic renal (nephrectomy) or spleen (splenectomy) surgery. In these cases, benign or cancerous tissue spread to the abdomen in women or men, causing problems.
|Devices produced by Johnson & Johnson’s Ethicon division:|
|Gynecare Morcellex Tissue Morcellator|
|Morcellex Sigma Tissue Morcellator System|
|Gynecare X-Tract Tissue Morcellator|
Surgeons also use laparoscopic power morcellation during minimally invasive surgeries to remove uterine fibroids, which affect about 250,000 women each year. The risk of developing fibroids – also called leiomyomas – increases after age 50, but young women can get them. By removing fibroids, doctors can relieve pain, bleeding and other uncomfortable symptoms without removing a woman’s uterus. This type of surgery is called a myomectomy.
According to estimates by the U.S. Food and Drug Administration (FDA), morcellators are used in about 60,000 hysterectomy and myomectomy procedures annually.
While often benign, fibroids may also harbor undetected cancer cells. This cancer is notoriously difficult to detect before surgery. Because morcellators work by shredding tissues, fragments of cancerous cells may spread throughout the abdominal and pelvic cavity and lodge in other tissues, causing the disease to spread. This makes the cancer more serious and difficult to treat.
Morcellators can also spread non-cancerous tissue fragments in the body. These fragments can cause growths on other organs and tissues, causing pain and swelling. When that happens, these masses require surgery.
Types of Laparoscopic and Hysteroscopic Morcellators
Surgeons typically perform two morcellation techniques: laparoscopic and hsyteroscopic. Each type of surgery uses a specific kind of device made by manufacturers.
The FDA warning applies specifically to the laparoscopic procedure, also called “open morcellation.” In this technique, surgeons insert the drill-like device through a small incision in the abdomen, shred and remove the tissue. However, because the shredding occurs in an open environment, bits of tissue – including cancerous cells – can spray into the abdominal and pelvic cavity. The majority of morcellators fall into this category.
In contrast, hysteroscopic morcellators are designed with tissue traps or collecting pouches. This surgical technique is newer, and studies so far revealed it not linked to increased cases of cancer. When surgeons grind up tissue, it is trapped in a pouch for testing. These devices also use mechanical versus electric energy to both cut and collect the tissue.
The FDA believes that, “when used in accordance with current indications and instructions for use, hysteroscopic morcellators do not pose the same risk as the devices addressed in this guidance because any sarcomatous tissue present does not enter the peritoneal cavity.”
Cook Urological, Inc.
- Cook Tissue Morcellator
- Gynecare Morcellex
- Morcellex Sigma
- Gynecare X Tract
Ethicon of FemRx
- VersaCut+ Tissue Morcellator
- KSE Steiner Electromechanic Morcellator
Karl Storz GmbH & Co.
- ROTOCUT G1, G2
- Swalhe II SuperCut Morcellator
- PKS PlasmaSORD
- VarioCarve Morcellator
Richard Wolf GmbH
- Morce Power Plus
Risks of Cancer
Women with uterine fibroids are routinely screened for various forms of uterine cancer before undergoing these surgeries to minimize the risk of spreading cancer throughout the body via power morcellators. However, while doctors can diagnose most forms of cancer before an operation, a rare form, called leiomyosarcoma or uterine sarcoma, may mimic the appearance of benign uterine fibroids in medical imaging and is often undetectable in preoperative testing.
Frequently, this aggressive cancer is diagnosed post-surgery after tissues are examined by a pathologist. Unfortunately, if a power morcellator was used to extract that tissue, the hidden cancer may have been spread, becoming metastatic leiomyosarcoma, which significantly worsens the patient’s likelihood of long-term survival. The rate of five-year survival drops from 50 percent to a 4 to 16 percent.
In April 2014, the FDA issued a safety communication discouraging the use of laparoscopic power morcellators for the removal of the uterus and uterine fibroids. Based on an analysis of currently available data, it cited a risk of the spread of unsuspected cancerous tissue.
The agency stated that analysis indicated that about one of every 350 women who undergo hysterectomy or myomectomy for uterine fibroids have uterine sarcoma, and there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma.
In response, Johnson & Johnson immediately suspended worldwide sales of its laparoscopic power morcellators. The FDA intends to convene a public meeting of the agency’s Obstetrics and Gynecological Medical Device Advisory Committee to discuss the possibility of further action.