|Johnson & Johnson's Ethicon division's power morcellation device--Courtesy of Johnson & Johnson|
Dr. Elizabeth Pritts, director of the Wisconsin Fertility Institute, believes that the FDA is wildly overestimating the prevalence of uterine sarcoma in women undergoing hysterectomies and myomectomies for fibroid removal and worries that banning or restricting use of power morcellators will fail to address the problem, putting women undergoing the procedure at risk of upstaged cancer.
Pritts said in an interview with FierceMedicalDevices that she performs morcellation routinely and has never encountered a hidden case of uterine sarcoma in her career. Moreover, the sample of papers that the FDA used to arrive at an estimate of a uterine sarcoma prevalence ratio of one in 352 patients was biased, she said. "If you're going to start out looking for a paper that says 'uterine cancer' in it, then you're more likely to find the papers that have uterine cancer and not the papers that have no uterine cancer found because they're not going to include that in the title."
An upcoming paper by her and 6 other colleagues found that the risk of an undetected sarcoma is one in7,450 patients, she told FierceMedicalDevices. The estimate was formed on the basis of 133 studies of 31,438 patients, whereas FDA's estimate was based on 9 studies. During this month's FDA hearing on the topic, she described the research that lead to one in 7,450 patient estimate, leading the panel of experts to wonder what the true incidence really is.
The FDA has asked her and her co-authors for their data, and Pritts said they will share the information with the agency once the paper is submitted for publication, an event which should occur within days.
She expects the paper to be published in about two months in an undisclosed medical journal. "It's a big one. I'm not allowed to say in case they decide they want to use it," she said. "If they don't take it, we know other journals that certainly will, because we have been in contact with some editors, but we're shooting big."
The team's research and literature review indicates that hand morcellation is just as risky as power morcellation, meaning the FDA's efforts to restrict use of the power morcellators could simply cause doctors to use the manual morcellation technique, she said: "Just banning the power morcellator is not going to change healthcare for women at all. It's not going to help us get better pre-op diagnoses. Everyone's just going to either switch to the larger incisions which have more morbidity and mortality associated with them, or they're going to chop them up with their hands, like we used to back in the day."
However, the FDA does not have the authority to ban the morcellator procedure itself, so the agency's efforts to improve patient safety are limited to restricting use of the power morcellator device.
In addition, Pritts said that the recent study in the Journal of the American Medical Association is being misinterpreted by the public and media, including some specialists in the field. The paper found that the risk of uterine cancer in women undergoing one of the procedures is about one in 370, but uterine sarcoma is a rare subset of uterine cancer accounting for 2% to 4% of the cases, she pointed out, saying most people don't understand the distinction: "I think people missed it. Because everyone's so excited about this finding and it makes great news, but everyone's caught up in the emotion of it and people aren't slowing down and looking at the data."
Although the other uterine cancers such as endometrial cancer also pose a threat to women, they are much easier to diagnose, she said, adding that at the Wisconsin Fertility Institute patients receive screening for cancer before undergoing morcellation.
She believes better preoperative diagnoses are needed for detecting uterine sarcoma, which cannot be detected 100% of the time even with an MRI. Furthermore, the consensus during the FDA panel hearing was that performing an MRI before every procedure would be very expensive and time-consuming.
But Pritts believes preop diagnosis is the key: "It might be impractical [to perform an MRI], but what if you save one woman? Aren't we worth it?" She recommended sending women whose MRI results are ambiguous to an oncologist for follow-up, and said she would not perform surgery on such patients.
In spite of her research, Pritts remains concerned about the problem, saying, "We need to be better than this. We shouldn't be morcellating a 65-year-old patient. That's ridiculous. This points out some flaws in the practice patterns of gynecologists, it really does."
Editor's Note: Pritts originally told FierceMedicalDevices the study would report an estimate of one in in 6,434 patients, but now says that was an erroroneous statement and that the study estimate will remain the same as during her testimony at the FDA meeting of one in 7,450. The article has been updated to reflect this.