Results of a recent study published in the Journal Obstetrics & Gynecology raise concerns that the power morcellator device, once regularly used by surgeons to perform laparoscopic hysterectomies, may also present an increased risk of spreading other commonly benign uterine diseases.
The power morcellator has been under scrutiny following reports that the device spreads undetected uterine cancer throughout the abdomen.
Morcellators are used in laparoscopic female surgeries such as hysterectomies, myomectomies (the removal of uterine fibroids), oophorectomies (removal of the ovaries), and salpingectomies, which take out the fallopian tubes.
Uterine fibroids are noncancerous growths of the uterus that often appear during childbearing years. They are not associated with an increased risk of uterine cancer and almost never develop into cancer, according to the Mayo Clinic, but may cause pain, pressure, prolonged menstrual bleeding, frequent urination, constipation, backache, and difficulty urinating.
A power morcellator shreds uterine tissue so it can be removed through laparoscopic incisions, a far less invasive procedure than traditional surgery.
“If you cut the tumor in pieces inside of the abdomen, there is the potential of spread of the cancer throughout the abdomen, so that makes the stage of cancer more advanced,” a Temple University physician told CBS News.
The new study raises the specter of concern that morcellation may spread benign (non-cancerous) tumors as well, requiring women to undergo additional surgeries to have the tumors removed. If other studies confirm the recent findings, many more women will be at risk of morcellation complications than previously believed.
The study cited in the Journal Obstetrics & Gynecology found that three women who had laparoscopic surgery with the power morcellator were faced with additional surgeries because benign tumors allegedly developed as a result of the device.
According to the recent study results, a 36-year-old woman developed soft tissue tumors following morecellation surgery and required more surgery to remove parts of her ovaries, spleen, diaphragm, colon, and other organs to prevent the soft tissue tumors from developing into cancer.
Another woman developed a bowel obstruction and mass in her pelvis after surgery and had to later have her fallopian tubes and right ovary removed. A third woman developed an abdominal mass and had to undergo similar organ-removal procedures.
Some 50,000 women annually undergo hysterectomy morcellation surgery, and one-in-350 women who have had a robotic hysterectomy or myomectomy are found to have uterine sarcoma, a type of uterine cancer.
In April 2014, the FDA issued a safety notice discouraging the use of laparoscopic power morecellation for hysterectomies and myomectomies after analyzing data showing the procedure may unwittingly spread unsuspected cancerous tissue outside the uterus.
Then in November, the FDA issued a stronger warning, but stopped short of banning the device outright. Instead, the FDA added a “black box” warning to power morcellators.
“Uterine tissue may contain unsuspected cancer,” the black box warning reads. “The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”
Many doctors continue to use the power morcellator despite Johnson & Johnson — which manufactures the laparoscopic morcellator — having removed the device from the market and many hospitals issuing moratoriums on them.
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If you or a loved one were diagnosed with cancer in the uterus, pelvis or abdomen within two years of undergoing surgery for a myomectomy (removal of fibroids), hysterectomy (removal of the uterus), oophorectomy (removal of the ovaries), or salpingectomy (removal of fallopian tubes), you may have a legal claim. See if you qualify by filling out the short form below.
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