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Power morcellation has allowed hysterectomies and myomectomies to be noninvasive procedures. When performed, this laparoscopic surgery involves cutting uterine tissue into smaller pieces, which is then removed through a small incision. The procedure is said to reduce blood loss and infection risk and speeds up recovery time.
Yet, in 2014, the FDA issued a safety communication warning regarding laparoscopic power morcellation. The document stated that, when uterine fibroids are removed, there’s potential for uterine sarcoma, or cancer in the abdominal area, to result. The FDA’s response comes at the same time women claim the procedure negatively impacted their health.
Background
The FDA first approved power morcellators in 1993. Since that point, doctors have used them for both surgical procedures above, as well as for kidney and spleen issues. Currently, 60,000 procedures per year involve this device.
In 2006, a Pennsylvania doctor contacted Johnson & Johnson about their Ethicon morcellation devices, warning the manufacturer about potentially spreading malignant tissue. While Johnson & Johnson included precautions in the instructions, they did not issue a wider-spread warning.
By July 2014, a study published in the Journal of the American Medical Association found correlation between increased uterine pathology and morcellator use.
The FDA’s warning, arriving around the same time, expressed that 1 in 350 women undergoing a procedure for removing benign uterine fibroids may have uterine sarcoma, and prior to surgery, doctors have no way of detecting the risk. Because of this chance, power morcellation may spread cancerous tissue throughout the abdominal and pelvic areas. When this occurs, the tissues may grow on other organs; even when benign, the growths may lead to pain, obstructed bowels, and infection.
In these extreme cases, doctors have diagnosed these patients with leiomyosarcoma, a late-stage cancer, less than a year after the laparoscopic procedure. Patients either find they have a short time to live, or have their quality of life and expectancy greatly diminished.
Along with the warning, the FDA advised manufacturers to update their products with two contraindications and a boxed warning on the product label. Later in 2014, Johnson & Johnson withdrew their Ethicon morcellator globally, while larger hospital chains began banning them.
Lawsuits
Those affected started filing lawsuits against Johnson & Johnson and other manufacturers, alleging the device and its insufficient warnings resulted in the spread of cancerous tissues. These cases further claim that manufacturers knew of the risks but failed to adequately warn medical professionals.
Patients have a right to know whether the procedure they’re about to go through is associated with any life-threatening health concerns. Manufacturers not disclosing these serious issues put many women at risk.
