Power morcellators are surgical instruments that are used when performing less evasive abdominal procedures that include laparoscopic hysterectomies and fibroid removal. The FDA sent out an alert to the public that laparoscopic morcellators may be the reason why undiagnosed uterine cancer is being spread and upstaged.
This device is used in cases where the doctor is required to cut bigger chunks of tissue into smaller ones. Along with their use during laparoscopic hysterectomies and fibroid removal (myomectomy) some surgeons also use it for gall bladder surgery, spleen removal and liver surgery.
The electric morcellator was first approved by the FDA for sale in 1991 and in 1995 the first laparoscopic morcellator entered the market. This device got a class II classification from the FDA which meant that the device was allowed to be used without extensive clinical trials.
Before the FDA warning about the morcellators was issued these devices were used in around 60,000 hysterectomies and myomectomies every year. This device was designed to help reduce the size of a enlarged uterus that can be removed through small laparoscopic incisions or through a woman’s vaginal canal as an alternate to the more traditional methods.
In 2014, FDA warned that out of 350 women who went through this procedure at least 1 may be suffering from undiagnosed uterine cancer and the power morcellator could shred the cancerous tissue and help it spread which would cause a stage 1 tumor to turn into a stage 4 cancer after morcellation which makes it difficult for the woman to survive. After the FDA warning some hospitals banned the use of this device and some insurance companies stopped covering surgeries involving power morellators.
How does it work?
Types of Morcellators
- Laparoscopic morcellators
- Hysteroscopic morcellators
Each of these procedures has a different device that they use. The FDA warning for hysteroscopic morcellators is not the same as those for laparoscopic morcellators as the former comes with tissue traps or collections pouches that collect the broken down tissue and none of it is allowed to go back into the body.
In the case of Laparoscopic morcellators, the FDA warns that the shredding of the tissue occurs in an open environment and bits of the tissue including the cancerous tissue can spray into the abdominal and pelvic area and can cause the spread of cancer.
Side effects and complications of Power Morcellators
Along with the risk of spreading cancer there are a few other side effects that are also associated with the use of these power morcellators.
- Bleeding or infection
- Bowel obstruction
- Recurrence of fibroids
- Damage to organs
- Oozing at the incision site
- Pain at incision site
- Pelvic and abdominal pain
- Soreness of muscles
- Intra abdominal abscesses
- Intestinal obstruction from new fibroids
- Additional surgery
- Inflammation of the abdominal lining or peritonitis
Leiomyosarcoma and morcellators
Power morcellators are the reason why most undiagnosed cancers including leiomyosarcoma (LMS) can be spread these morcellators do not cause any form or cancer. In a study done by the American Association of Gynecologic Laparoscopists it was found that out of the 1091 patients who had undergone power morcellator surgeries 12 women were found to have irregular tissue samples that were not previously diagnosed. In a study published by Dr. Jason D. Wright and colleagues in September 2014 they stressed the need to do a proper screening of patients with any history of cancer before the surgery was carried out.
Symptoms of Uterine Cancer After Morcellation
If any kind of cancer was diagnosed after power morcellator surgeries these were usually Stage III or Stage IV and have a poor prognosis as they are very advanced cancers. These are a few symptoms that can signal that there is a possibility of the cancer being upstaged in the body.
- Vaginal discharge
- Vaginal bleeding or spotting, this occurs between periods and after menopause
- Abdominal or pelvic pain
- Abdominal or pelvic swelling
- Nausea or vomiting
- Weight loss
FDAs Warning Against Power Morcellators
The FDA first published its warning against power morcellators in April 2014, in this warning it stated the risk of spread of cancer with the use of these power morcellators. In the data that the FDA reviewed they found that there was a risk of 1 in 350 women of the spread of cancer as opposed to the 1 in 10,000 that was previously suspected.
In its safety communication the FDA said that “Because there is no reliable method for predicting whether a woman with fibroids may have uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids”
The FDA also released a set of safety guidelines and required that a black box warning be printed on all of the products. It also required that the patient fill out a patient consent form that explains all the risks that are involved with the use of this device.
Johnson and Johnson stops sales of Morcellators
Johnson and Johnson’s subsidiary, Ethicon, was one of the main manufacturers of power morcellators, however, immediately after the FDA warning about power morcellators they pulled out all of their morcellators from the market.
Alternatives to Open Power Morellators
There are a few types of procedures that the patient can opt for instead of open power morcellators.
- Power morcellators in a bag: in this process the surgeon inserts a bag in the abdominal cavity to enclose the space in which the surgery will take place and reduce the risk of spread of cancerous tissue.
- Manual morcellators in a bag: this procedure also involves the insertion of a bag in the abdominal cavity and the doctors manually cut the fibroids into smaller pieces.
- Vaginal Hysterectomy: in this process the entire uterus is removed from the vagina and in case the uterus is too big to be directly removed it is cut into smaller pieces and then removed.
- Abdominal hysterectomy and myomectomy: the whole uterus is removed from an incision that is made in the abdomen. However, this procedure requires a longer recovery time and there is a higher risk of wound infection due to the larger size of the incision.
- En Bloc Resection: in this operation the entire uterus, cervix, bladder, and part of the rectum are removed. As this is a major surgery there are also many complications that can arise with it.