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| Ethicon's Morcellex Sigma Tissue Morcellator--Courtesy of Johnson & Johnson |
Amid mounting regulatory and industry criticism for gynecological tools used in minimally invasive procedures, physicians continue to defend the devices as a viable surgical option.
The FDA in April discouraged doctors from using power morcellator tools to remove benign fibroid tumors, estimating that one in 350 women undergoing the procedure have undetected cancer that the tool can spread. Months later, lead morcellator manufacturer Johnson & Johnson ($JNJ) pulled its related product from the global market. While regulators' findings proved divisive, a number of physicians still tout the device's benefits and are casting a skeptical eye toward the agency's guidance, The Wall Street Journal reports.
Dr. Jeffrey Thurston, a Dallas gynecologist, told the WSJ that he performs 80% of his hysterectomies with a morcellator and asks patients to sign an informed-consent document that describes the risks associated with the procedure. But, Thurston added, "we tell them verbally that we don't think those numbers are correct."
Thurston is not the only doctor questioning the FDA's numbers. In July, Dr. Elizabeth Pritts, director of the Wisconsin Fertility Institute, told FierceMedicalDevices that the agency is overestimating the prevalence of uterine sarcoma in women undergoing procedures for fibroid removal and that banning or restricting the device could put women at risk of upstaged cancer. Pritts and a team of colleagues found that the risk of undetected sarcoma is one in 7,450 patients, and disputed data published in July's issue of the Journal of the American Medical Association (JAMA) that estimated one in 370 women who underwent a hysterectomy with a power morcellator have hidden uterine cancer.
Before the FDA's April advisory warning, the device was used in an estimated 50,000 U.S. uterine surgeries each year, according to the WSJ.
Still, some gynecologists are exploring alternative surgical approaches and heeding regulators' warnings. Robert Graebe, chairman and program director of the Department of Obstetrics and Gynecology at NJ-based Monmouth Medical Center, told the newspaper that morcellators should be shelved until proven safe.
"What you do about it is: You stop," he said. "People want to fight back, but it's not putting patients' safety first. It's not worth playing Russian roulette with the patient."
- read the WSJ article (sub. req.)