FDA Spoke and Power Morcellator Use Dropped

Posted in Regulatory and Compliance by Nancy Crotti on August 24, 2016

Or was it the fear of lawsuits that curtailed use of the laparoscopic surgical devices? 

Nancy Crotti

Gynecare Morcellex Tissue Morcellator Ethicon
Johnson & Johnson's Ethicon subsidiary pulled its Gynecare Morcellex Tissue Morcellator from the market in 2014 amid cancer spreading concerns. (Image courtesy of Ethicon)

Use of power morcellators to perform hysterectomies dropped following a 2014 FDA warning, according to a study by Columbia University researchers.

The study, published this month in the Journal of the American Medical Association, tracked use of the laparoscopic devices, which may spread undetected cancer, before and after FDA’s April 2014 safety communication.

Nearly 60% of 203,250 U.S. hysterectomy patients from 2013 to the first quarter of 2015 underwent minimally invasive procedures, the researchers found. Power morcellation was used in 13.5% of those cases in during the first quarter of 2013, peaking at 13.7% by the fourth quarter of 2013, and falling to 2.8% by the first quarter of 2015, the study says. The researchers used data from the Perspective database, which includes more than 500 U.S. hospitals.

Fears of more complications from hysterectomies via abdominal wall incisions were apparently unfounded. Overall complications from abdominal hysterectomies actually declined, because intraoperative complications declined, the researchers found. Complications remained stable for minimally invasive hysterectomy and vaginal hysterectomy. So did the prevalence of uterine cancer, endometrial hyperplasia, other gynecologic cancers, and of other uterine tumors in women who underwent morcellation, the researchers found.

"The FDA warnings might result in a lower prevalence of cancer among women who underwent morcellation due to greater scrutiny on patient selection,” they wrote. “However, the high rate of abnormal pathology after the warnings highlights the difficulty in the preoperative detection of uterine pathology. Continued caution is needed to limit the inadvertent morcellation of uterine pathology."

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Another possible deterrent to using power morcellators? Lawsuits.

“I would think the FDA‘s actions have helped, but certainly the class action lawsuit has gone a long way to deterring physicians from using the device,” said Madris Tomes, a former FDA public health analyst who recently launched York, PA–based Device Events and its Web-based tool that searches medical device postmarket surveillance data.

Tomes, who analyzed power morcellator adverse event reports, found that many injuries appear to be from the morcellator being difficult to control and cutting through vessels, nerves, and organs. “If a physician felt they did not have control of the device, they may have stopped using the device for that reason,” she said.

Power morcellators have been used in the U.S. since 1993 to ease removal of tissue through small incision sites by dividing it into smaller pieces or fragments. The problem with the procedure is that cutting a tumor into fragments can make it difficult to remove all of the tumor tissue. In addition, small tumor fragments can be seeded throughout the body, leaving the patient in many cases with multiple tumors.

The Wall Street Journal first raised concerns about morcellators in late 2013.

By November 2014, FDA was advising physicians not to use power morcellators to remove the uterus (hysterectomy) or uterine fibroids (myomectomy) from patients who are peri- or post-menopausal, or are candidates for removing tissue intact through the vagina or a minilaparotomy incision.

In March 2015, the Journal reported that some doctors had found other minimally invasive ways to perform hysterectomies and myomectomies without using morcellators. By September of that year, the U.S. Government Accountability Office had agreed to investigate FDA’s handling of power morcellators amid accusations that the agency overlooked cancer risks associated with the devices, according to WSJ.

“We do have ongoing work related to power morcellators,  which we expect to complete by the end of the year,” wrote GAO spokesman Ned Griffith in an email to Qmed

Nancy Crotti is a contributor to Qmed.

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