Olympus America Inc. is moving ahead with efforts to revamp the electric morcellator, a gynecological surgical device that has been largely abandoned because it can spread a hidden uterine cancer.
Power morcellators typically have spinning blades that enable doctors to mince and then remove a uterus or uterine fibroids through tiny incisions, making recovery faster than with traditional cut-open-the-belly operations. But in rare cases — the U.S. Food and Drug Administration estimates 1 in 350 — morcellation hurls bits of an undetected uterine sarcoma around the woman’s abdomen, worsening her prognosis.
Late last year, Olympus introduced its new “contained tissue extraction system,” which combines a morcellator with a bag intended to prevent cells from escaping. But the FDA requires the product information to warn that it “has not been clinically demonstrated to reduce the risk” of spreading cancer, and that morcellation is not appropriate in most cases.
Olympus America Inc.’s new tissue-containment bag is put in the abdomen during gynecological surgery. It attaches to a tissue-cutting device.
Now, Olympus has announced plans for a clinical study of 140 hysterectomy patients to try to show that the system is safe and effective. The trial will be led by gynecologists at the University of North Carolina.
The study has been denounced as unethical and too small to assess oncological safety by Philadelphia cardiac surgeon Hooman Noorchashm. He and his wife, anesthesiologist Amy Reed, campaigned for a ban on morcellators after her uterine leiomyosarcoma was spread…