Morcellators are medical devices used during a handful of medical procedures, mostly hysterectomies, myomectomies and the surgical removal of fibroids or noncancerous growths in the uterus. Morcellators have rapidly spinning blades that cut tissue into pieces that can be removed from the body through tiny slits made during minimally invasive surgery. Using them to cut out benign tumors which are hiding malignant cells can cause advanced stage cancer. Where there is undetected cancers, morcellators spray malignant cells around the inside the abdomen like seeds, speeding the progression of the disease.
Although all women who undergo hysterectomies and the removal of uterine fibroids are required to undergo screening for various forms of cancer, the signs of the most aggressive types of cancer are often undetectable. Some cancers, like leiomyosarcoma, cannot be detected preoperatively.
The researchers reviewed 232,882 minimally invasive hysterectomies performed in 500 hospitals nationwide between 2006 and 2012, including 36,470 procedures that involved morcellation. Of these, 99 women had uterine cancer that was detected after their surgeries. That averages out to 27 missed cancers in every 10,000 women who had surgery with morcellation or one in every 368 women.
In November, 2014, the FDA said morcellators should not be used in the “vast majority” of women, but the device was not taken off the market or banned. The FBI investigated suspicions that adverse events were not reported to the FDA. The FBI investigated Johnson & Johnson, previously the largest manufacturer of morcellators, on suspicion that it knew of the dangers. Johnson & Johnson stopped manufacturing morcellators when the FBI inquired into the potential of the spreading of undetected cancer, and have since recalled three morcellator models. Lawsuits have been filed against Johnson & Johnson after the recall.
If you have been injured by a procedure involving a morcellator, contact Weisfuse & Weisfuse, LLP for a free consultation.