What are power morcellators?
Power morcellators are medical devices used in the surgical treatment of various women’s health conditions. These minimally invasive (laparoscopic) devices are used to treat certain medical conditions including the following:
- Treatment of uterine fibroids;
- Removal of uterine fibroids (myomectomy); and
- Removal of the uterus (hysterectomy).
The process of morcellation allows for pieces of tissue, such as uterine fibroids, to be broken down into smaller fragments, allowing for the extraction of tissue from smaller incision sites (laparoscopic surgery). The incision sites in laparoscopic surgery appeal to both healthcare providers and patients alike because they are smaller than those done in traditional gynecological surgeries that may be more invasive. Furthermore, the recovery time from procedures done by power morcellators is shorter than the recovery time for procedures done in traditional gynecological surgeries.
Serious risks
Although the less invasive procedure may be appealing, power morcellators pose serious medical risks when used to treat women with uterine fibroids. This is because the use of these medical devices may spread unsuspected cancerous tissue (uterine sarcomas) beyond the uterus to other parts of a patient’s body.
The FDA estimates that 1 in 350 women who undergo treatment for fibroids, including having a hysterectomy or myomectomy, may suffer from unsuspected uterine cancer (uterine sarcoma). Alarmingly, if a power morcellator is used to treat a woman with unsuspected uterine cancer, the device may actually spread the cancer to other parts of the body, including the pelvis and abdomen. The spread of the cancer may tragically cut the life expectancy of the patient.
*Image from NIH website
Types of power morcellators
The FDA held a panel of the Obstetrics and Gynecology Devices Advisory Committee from July 10-11, 2014 to discuss Laparoscopic Power Morcellation during Uterine Surgery for Fibroids. In the meeting, the panel identified the following device manufacturers and models of laparoscopic power morcellators (LPM):
|
Manufacturer/Distributer |
Model(s) |
| Ethicon |
|
| Karl Storz |
|
| Richard Wolf(Manufactured by NouvagAG) |
|
| LiNA Medical |
|
| Trokamed GmbH |
|
| Gyrus (Subsidiary of Olympus Medical) |
|
*Information obtained from FDA website
The panel also provided information on the outcomes for patients with unsuspected tumors that underwent morcellation procedures versus other types of gynecological procedures. Data shows that those patients with an unsuspected tumor who underwent a morcellation procedure have a higher risk of mortality than those who did not undergo a morcellation procedure.
Recent FDA warning
On November 24, 2014, the U.S. Federal Drug and Safety Administration (FDA) issued a safety communication advising healthcare providers to seek alternative procedures to remove uterine fibroids from their patients. The FDA further warned healthcare professionals regarding the serious risk of spreading unsuspected cancer that may result from using power morcellators. Specifically, “the FDA is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.” The Furthermore, the FDA strongly advised that the manufacturers of power morcellators include this warning on their product labels.
Recalled power morcellators
The following power morcellators have been recalled:
- Gynecare Morcellex tissue morcellator;
- Gynecare X-Tract tissue morcellator; and
- Morcellator Sigma tissue morcellator.
All three devices were manufactured by the Ethicon unit of Johnson & Johnson. The company voluntary recalled the three morcellator devices in July, 2014.
Protect your rights
If you or a loved one has suffered an injury resulting from a power morcellator, please contact our firm at 1-800-247-1623 or johnhart@hartlaw.com for a free consultation to discuss your legal rights.