Its called a power morcellator. And its a surgical tool used in many hysterectomies going back to the 1990’s. it can make the surgery easier for both the doctor and the patient. But the power morcellator appears to have a fatal flaw: it can seed and spread cancer. Very rapidly and very aggressively.
The morcellator is used in minimally invasive hysterectomies, perhaps in as many as 50,000 procedures a year in the U.S. to remove often-painful growths called fibroids. The device cuts into or “morcellates” the uterus to remove it through tiny incisions. The safety of these devices only recently gained public attention when the Food and Drug Administration issued a “safety communication” on April 17, 2014. The FDA “discouraged the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because, based on an analysis of currently available data, it poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus”.
Yet, the all Street Journal reports that there was evidence going back at least as early as 2003, that the power morcellators posed health risks. When the device is used, it sometimes leaves behind tissue fragments. if those bits were malignant, they could seed rapid cancer growth. Some morcellator makers have long recommended containing risky tissue in a surgical bag, which is thought to minimize the cancer-spreading risk. But gynecologists rarely used the bags, unlike surgeons in other specialties like urology that typically enclose an organ in a bag before cutting it by hand.
After the FDA issued its “safety communication”, one manufacturer, J & J, suspended worldwide sales of power morcellators. Critics say the decision to suspend sale of these devices does not go far enough. A prominent cardiothoracic surgeon in Boston, Massachusetts, thinks the company should recall it’s products from the market. The surgeon’s wife, anesthesiologist Amy Reed, M.D., underwent a hysterectomy with power morcellation in October 2013 for fibroid removal only to discover afterward she had a uterine leiomyosarcoma. Dr. Reed learned that the procedure might have spread the cancer through her abdomen, worsening her prognosis. Dr. Reed’s surgeon didn’t use a surgical bag and didn’t warn her of the cancer-spreading risk. Since then, Dr. Reed and her husband have lobbied regulators, lawmakers, companies and medical societies to stop using the morcellator.
As the Wall Street Journal reports, an FDA advisory panel will hold a hearing next month to weigh whether to ban the device. In the meantime, two of the country’s leading hospitals — the Cleveland Clinic and Brigham and Women’s — have suspended the use of morcellator procedures in their facilities.
If you have undergone fibroid removal or uterine surgery in which a power morcellator was used and cancer resulted, you may wish to contact Marsh, Rickard & Bryan to discuss your legal rights.
Update: On July 30, 2014, Johnson & Johnson’s Ethicon unit announced a worldwide market withdrawal of all Ethicon morcellation devices “until further medical guidelines are established and/or new technologies are developed to mitigate the risk”.