Olympus America Inc. is moving ahead with efforts to revamp the electric morcellator, a gynecological surgical device that has been largely abandoned because it can spread a hidden uterine cancer.
Power morcellators typically have spinning blades that enable doctors to mince and then remove a uterus or uterine fibroids through tiny incisions, making recovery faster than with traditional cut-open-the-belly operations. But in rare cases — the U.S. Food and Drug Administration estimates 1 in 350 — morcellation hurls bits of an undetected uterine sarcoma around the woman's abdomen, worsening her prognosis.
Late last year, Olympus introduced its new "contained tissue extraction system," which combines a morcellator with a bag intended to prevent cells from escaping. But the FDA requires the product information to warn that it "has not been clinically demonstrated to reduce the risk" of spreading cancer, and that morcellation is not appropriate in most cases.
Now, Olympus has announced plans for a clinical study of 140 hysterectomy patients to try to show that the system is safe and effective. The trial will be led by gynecologists at the University of North Carolina.
The study has been denounced as unethical and too small to assess oncological safety by Philadelphia cardiac surgeon Hooman Noorchashm. He and his wife, anesthesiologist Amy Reed, campaigned for a ban on morcellators after her uterine leiomyosarcoma was spread during a hysterectomy in Boston in 2013. Despite intensive treatment, the mother of six died of her disease in May at age 44.
"The study is critically flawed in its ethics and design," Noorchashm wrote in an email sent to the North Carolina gynecologists and ethics review board, and copied to reporters. Among other things, he argued that women who participate in the study can't give fully informed consent.
"Thank you for reaching out to us," North Carolina research compliance officer Robin L. Cyr emailed in reply. "The university is looking into this matter."
In a response to the Inquirer, a North Carolina spokesman said the same thing, adding that the university "takes our responsibility for the protection of human subjects seriously."
Asked for comment, Olympus, which has American headquarters in the Lehigh Valley town of Center Valley, emailed: "Because of our commitment to continuing innovation, improvements to our products, and increases in patient safety and service, Olympus frequently conducts additional research, development, or studies related to our products, including after they are approved by the FDA."
The FDA first approved electric morcellators more than 20 years ago, but did not warn of the cancer hazard until Noorchashm and Reed called attention to it.
Gynecologists' organizations have argued that the risk-benefit trade-off is complicated. Uterine leiomyosarcoma is rare (about 1 in 100,000 women) and life-threatening even when caught early and removed with traditional abdominal hysterectomy. The tumor can't be reliably detected by pre-operative tests, and may be mistaken for benign uterine fibroids — the most common reason for hysterectomy.
Fibroids are often too large to be removed intact through the vagina or a small abdominal incision. With the ability to mechanically fragment a fibroid and then remove the tissue through dime-size incisions, physicians can spare women the long recovery, pain, and complication risks of traditional abdominal surgery.
Insurers and hospitals now restrict or prohibit the use of power morcellators, and Johnson & Johnson pulled its leading brand off the market in 2014, after the FDA warned against morcellation in most cases.
Several studies have found that the controversy has reduced the rate of minimally invasive hysterectomies and fibroid removals. But an analysis of California's Kaiser Permanente health plan data published two months ago found that between 2008 and 2015, minimally invasive hysterectomies steadily increased, even as power morcellation basically disappeared. The researchers say this reflects a campaign to promote minimally invasive techniques, and reliance on traditional tissue-cutting using a scalpel. (Noorchashm also opposes the traditional method of morcellation because of the possibility of cutting into an undetected cancer.)
Over the years, various researchers have developed isolation bags to use with power morcellators, but such systems have not caught on because they pose technical problems.
Olympus has showcased its new containment system at medical meetings and trade shows. The company says that in laboratory tests, the bag did not leak cells or body fluids, and withstood the pulling expected to occur during actual use.
Even so, the clinical trial, which is not yet open, "will be declared a success if no more than one bag rupture will be observed in 140 procedures," according to the protocol published on the government website, clinicaltrials.gov.
The trial plans to recruit premenopausal and perimenopausal women, aged 35 to 50.
In his letter, Noorchashm called the study design "highly misleading" because it doesn't explicitly say the purpose is to demonstrate oncological safety. Moreover, he said, none of the women is likely to have cancer in the small study group, based on the incidence of sarcoma in hysterectomy patients.