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Medical Device Claims: Morcellator and FDA Warning

FDA urges doctors to stop using morcellator warning that the device can spread cancer. While the device has been in use since 1995 this frightening information is coming to light just now.

August 8, 2014. 

A device that is used to perform a hysterectomy has been found to spread cancer, which is what happened to Martha Montalvo-Ariri who underwent a routine hysterectomy due to her painful uterine fibroids. A tool, called the morcellator, which is widely used in hysterectomies since it was cleared for use in 1995, spread cancerous tissue around her abdomen and pelvic area, accelerating the cancer's progression. This may lead to future medical device claims against the manufacturer. According to the Connecticut Post on Aug. 8, the morcellator is the tool most often used by surgeons to perform the hysterectomy because it's minimally invasive. It is a device that cuts the tissue into pieces, allowing the uterus to be removed through a small incision. At the same time it is cutting the tissue into tiny pieces, it is spreading fragments of tissue around the pelvic and abdomen areas. If that tissue happens to be cancerous, as it was in Ariri's case, it can promote the spreading of the cancer. This worsens the chance at long-term survival for the patient. The data collected regarding the morcellator and the spreading of cancer was reviewed by federal regulators back in April. The data supports the regulators decision to urge doctors to stop using this device. The Legal Examiner reports that the doctors at Columbia University completed a study and the results were published this week in the Journal of American Medical Association. This new reports adds support to the Food and Drug Administration findings on possibility that the morcellator device could spread cancer. The FDA reissued the warning about the device, which was originally issued in April during a two-day government hearing this month, according to Web MD. Despite that warning, the American Congress of Obstetricians and Gynecologists maintains that morcellation may be the safest option for most women. This latest report coming out of Columbia University strengthens the FDA's warning. Each year approximately 50,000 women have a hysterectomy to prevent the possibility of uterine cancer and most of these procedures were done using the morcellator device, reports the Legal Examiner. The first major health insurance company, with over Five million members, has stopped coverage on hysterectomies done with the morcellator. The Highmark Inc. Insurance Company is hoping this will urge doctors still using this device to stop using it, according to Medical Daily. If a cancer is present this device can spread the malignant cells beyond the woman's uterus. Patients who have undetected cancer can go in for a simple hysterectomy, but if this tool is used they may be looking at a cancer that has progressed much further than it would have been. Ariri did not know that she had a rare and aggressive form of uterine cancer, called leiomyosarcoma. She wasn't diagnosed with this until 10 days after her hysterectomy. The rotating blade of the morcellator spread that cancer. Many of the hospitals around the nation are heeding the advice of the federal regulators and they are not using the device to perform hysterectomies any more. One of the leading manufacturers of the morcellator, Johnson & Johnson's Ethicon subsidiary, have suspended sales of this tool. Bridgeport Hospital's Dr. Harold J. Sauer, who is the hospital's chairman of obstetrics and gynecology, told the Connecticut Post that the morcellator used by their hospital was manufactured in by Karl Storz GmbH & Co. in Germany. Sauer reports that the German company's device is still on the market. The doctor added that if Johnson & Johnson thought it worthwhile to remove the device from the market, they won't be taking any risks at Bridgeport Hospital. This hospital, as well as Stamford Hospital, are just two of the hospitals in Nutmeg State and around the nation that have stopped using the device. It is too late for Ariri, who reports that she was never told about the spread of cancer risks. The s 46-year-old mother of four from Riverside, Calif. said:
None of the forms I signed mentioned anything about cancer. They said it was in and out, very easy, and you're back to your life. Instead, they took my life away." This post by Roz Zurko originally appeared in  the Hartford Top News Examiner
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