Dr. Amy Reed’s tragic case brought to light the cancer risks posed by power morcellation. Her death hasn’t stopped lingering questions about the technology.
Power morcellators were used for 20 years to laparoscopically remove fibroids, benign tumors of the uterus, raising not a single adverse event report with the FDA. That all changed in 2013, when Dr. Amy Reed, an attending physician at Beth Israel Deaconess Medical Center, underwent a myomectomy using power morcellation at nearby Brigham & Women’s Hospital.
Reed’s fibroids were not benign, but instead a malignant form of cancer called uterine sarcoma that’s difficult to distinguish from benign tumors. Days after her procedure, Reed’s formerly treatable condition had been upstaged to a deadly cancer.
It turned out that power morcellation, a laparoscopic procedure in which surgeons use the device to mince the tumors, can seed malignant cells throughout the abdomen, drastically accelerating the cancer’s advance. Reed died last year at 44 of complications from her 2013 myomectomy, but not before she and her husband, Dr. Hooman Noorchasm, mounted a successful public health campaign to raise awareness of the risks posed by power morcellation. In 2014 the federal safety watchdog issued a black box warning for power morcellators, prompting Johnson & Johnson to pull its power morcellator from the market.
With the devices gone, a void emerged in the market – women who would have undergone a laparoscopic procedure with a morcellator now faced an open uterine resection. Organizations including the American College of Obstetricians & Gynecologists teamed with the Agency for Healthcare Research & Quality to lobby for the FDA to reconsider its 2014 guidance, arguing that patients need a laparoscopic option for tissue removal.
Meanwhile, some medtech entrepreneurs saw the risks posed by morcellators as an opportunity to create a device that would address the morcellator’s shortcomings. Eximis Surgical, a tiny Colorado-based company, set out to do just that.
Eximis came across Noorchasm’s radar after announcing that it raised $5 million from 33 investors to fund the development of its laparoscopic tissue removal system. He noticed that on their LinkedIn account, Eximis named Reed as the inspiration behind their technology. Noorchasm penned a letter to Eximis executives and published it online, asking them to remove any reference to Reed and, among other things, acknowledge that their technology is simply a resurrected version of a power morcellator.
“What they’re marketing is something that goes directly in opposition to what Amy and myself have been speaking out against,” he told Medical Design & Outsourcing. “It doesn’t matter what words you use, it doesn’t matter if you say morcellate, slice up, dice up, XCor out – if you take a tumor that has malignant potential and you mince it up, you’re exposing that patient to the risk of their cancer being upstaged.”
Noorchashm believes that power morcellators, or any other technology that segments a potentially cancerous mass in a woman’s uterus, violates a core tenet of surgery – never disrupt a tumor with malignant potential.
The company quickly pulled down all references to Reed. But co-founder Donna Ford-Serbu pushed back against his criticism that their XCor system is just a reincarnated power morcellator.
“[Reed] inspired us. Our inspiration is that we believe we can do better. I don’t think she had the choice of a power morcellator being used in her procedure. We understand that what happened to her shouldn’t happen and we really want to deliver something much better to the marketplace. She was an inspiration to us. I feel badly that we caused her husband anymore pain than he has already felt,” Ford-Serbu said.
“Surgeons and patients want a solution that is completely laparoscopic versus having an open or a mini-lap incision where there are co-morbidities associated with having those incisions. I believe there is a strong need for this type of innovation. I think patients deserve an opportunity to make that choice,” she added.
An industry-wide rift
Ford-Serbu and her fellow Eximis co-founders are medtech veterans, rooted in decades of experience in the industry. When they formed the company, Ford-Serbu said they saw an area that was “hungry for innovation.”
After the FDA warned against using power morcellators in gynecological procedures, some companies sought to modify the device in ways that would mitigate the risk of spreading cancerous cells around a woman’s body.
Eximis executives argue that the XCor system, which combines segmenting wires and a containment bag, is distinct from power morcellators and addresses a need expressed by gynecologists and surgeons.
On the same day that the FDA released a report reaffirming its concerns with morcellation, the ACOG and the Agency for Healthcare Research and Quality published a review arguing that the risk of unexpected leiomyosarcoma is less than 1 to 13 in 10,000 surgeries. The group has long argued that there is a need for laparoscopic tissue removal in gynecological surgeries and that the FDA should reconsider its 2014 guidance.
The FDA estimates that a hidden uterine sarcoma may be present in 1 in 225 to 1 in 580 women undergoing surgery for uterine fibroids – much higher than the ACOG estimate.
Noorchashm holds that the risk to a woman’s health is too high to ethically justify a laparoscopic tissue removal procedure that threatens to disrupt a potentially cancerous tumor.
“Several studies have come out showing that there’s no difference in outcomes or mortality [between laparoscopic and open uterine resections],” he said. “It’s not like women are dropping like flies because of open uterine resections. Yes, they are staying home for an extra week or two. Yes, they are staying in the hospital for maybe a day or two longer. But in reality, what’s happening now is that 1 out of 300 to 500 women, whose cancers otherwise would have been spread by a power morcellator, are now being protected from that complication.”
Opportunities to innovate arise, but concerns remain
Eximis is engaged in talks with the FDA about how to best move through the regulatory landscape with XCor, which is still in development. In his letter to Eximis, Noorchashm urged the company to follow a PMA pathway, which requires more stringent clinical evaluation compared to the 510(k) route.
Since it issued its 2014 guidance, the FDA has approved one device designed to address the power morcellator’s faults: Olympus’ tissue containment system, the PneumoLiner.
In a statement regarding that device’s approval, the FDA warned that PneumoLiner has not been proven to reduce the risk of spreading cancer during laparoscopic uterine tissue removal procedures.
“The PneumoLiner is intended to contain morcellated tissue in the very limited patient population for whom power morcellation may be an appropriate therapeutic option – and only if patients have been appropriately informed of the risks,” Dr. William Maisel, deputy director for science & chief scientist at the FDA’s Center for Devices & Radiological Health, said in April 2016.
“This new device does not change our position on the risks associated with power morcellation,” Maisel added. “We are continuing to warn against the use of power morcellators for the vast majority of women undergoing removal of the uterus or uterine fibroids.”
Finding out if contained power morcellation reduces the risk of spreading malignant cancer cells has proven to be challenging. A proposed trial of the PneumoLiner system at the University of North Carolina was met with such criticism, including by Noorchashm, that the school announced last year that it would review the trial’s design for ethical violations.
The two-year study, which was supposed to begin last September, is not yet recruiting patients, according to ClinicalTrials.gov.
Eximis executives insist that its XCor system is different from other approved products. Instead of relying on sharp edges to cut through tissue, it uses energized wires. The system also slices tissue within a containment system and toward the surgeon’s incision, to reduce the risk of slicing through the containment bag.
Noorchashm challenged those claims, saying that although Eximis is well within its rights to seek financial backing, the company’s system still violates a fundamental standard of surgery.
“You can’t go and say you’re doing something different than a power morcellator – you’re not,” he told us.”Yes, the tissue looks different when you cut it up, when you slice it, as opposed to grind it up, but it’s the same thing. You’re violating a surgical principle and you’re exposing these women to the possibility of their cancers being upstaged.”