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For millions of women that suffer from uterine fibroids and other gynecological issues, a complete hysterectomy may be their only option for relief. Instead of completely opening the abdominal cavity, surgeons are opting for a minimally invasive technique. In the past, a device called a morcellator was used to mince the uterus tissue through a tiny incision. However, the use of the device has been largely abandoned because it spread a form of uterine cancer throughout the body. Now, Philly.com reports that a manufacturer has revamped the device.
It’s rare, according to the U.S. Food and Drug administration. Only about 1 in 350 morcellation surgeries hurl an undetected uterine cancer into her abdomen, which worsens her prognosis.
Still, last year, Olympus America introduced a “contained tissue extraction system” that combines the morcellator with a bag that helps prevent cells from escaping.
Still, the FDA requires product information to caution doctors and patients that it has not been clinically proven to reduce the risk of spreading cancer and that morcellation is not the appropriate course of action in many cases.
In reaction to the FDA’s requirement, Olympus America has announced plans for the study of 140 hysterectomy patients to demonstrate that the system is safe and effective. The study will be conducted by gynecologists at the University of North Carolina.
Philadelphia cardiac surgeon Hooman Noorchashm has said that the study is unethical and too small to truly assess oncological safety. Noorchashm and his wife campaigned for a ban on morcellators after her uterine leiomyosarcoma was spread during a hysterectomy in 2013.
Uterine leimyosarcoma is rare, affecting about 1 in 100,000 women. It is life-threatening even if caught early and removed with the traditional abdominal hysterectomy.
Insurers and hospitals now restrict or prohibit the use of power morcellators. Johnson & Johnson pulled its leading brand off the shelves in 2014.
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