Can a gynecological surgical device with a bad reputation make a comeback?
Olympus America Inc. hopes so. The company on Tuesday launched its new tissue-fragmenting device, called an electric morcellator, with a novel attachment: a containment bag intended to keep the machine from accidentally spreading uterine cancer.
Electric morcellators, introduced in 1993, enable doctors to dissect and remove a patient's uterus or uterine fibroids through small incisions. Although recovery is faster than with traditional cut-open-the-abdomen operations, morcellators have been largely abandoned over the last three years because in unusual cases — the U.S. Food and Drug Administration estimates 1 in 350 — the procedure can hurl bits of undetected cancer throughout the abdominal cavity.
Olympus' new system "is the solution that will allow gynecologists to once again safely and effectively offer minimally invasive hysterectomies ... as options to certain low-risk patients," said Todd Usen, president of the medical systems group at the company, which has American headquarters in Pennsylvania's Lehigh Valley town of Center Valley.
Usen acknowledged that the system will carry a warning, required by the FDA, that the new bag "has not been proved to reduce the risk of spreading cancer."
Olympus introduced the product at the annual meeting in Orlando of the American Association of Gynecologic Laparoscopists — the minimally invasive surgical group that has consistently defended the value of power morcellation. Olympus offered a two-hour training session to doctors who want to use the new system in their practices.
The prospect of renewed use of morcellators was denounced by cardiac surgeon Hooman Noorchashm. He and his wife, anesthesiologist Amy Reed, have been campaigning for a ban since late 2013, when her undetected leiomyosarcoma was disseminated by a morcellator during her hysterectomy at a medical center in Boston. Leiomyosarcoma is an aggressive cancer of the uterine lining that can't be reliably detected by pre-operative tests.
The couple and their six children now live in Bucks County. Reed returned home Tuesday after extensive surgery at the Hospital of the University of Pennsylvania to fight the latest recurrence of her metastatic cancer.
"The FDA has essentially released this new device without any clinical safety testing," Noorchashm said, noting that a study of a similar experimental containment system found that it leaked 10 percent of the time.
The Olympus bag was developed by Advanced Surgical Concepts Ltd. of Bray, Ireland. It is intended to provide an enclosed working space for the morcellator inside the woman's abdominal cavity, so all dissected tissue can be captured and removed.
In laboratory tests, the company said, the bag did not leak cells or body fluids, and it withstood the pulling expected to occur during actual use.
Before Noorchashm and Reed called attention to the potential dangers of morcellation, about 50,000 hysterectomies a year involved the device.
Now, the FDA says it should be used only in relatively rare cases, such as when younger women want to get rid of fibroids but preserve fertility by leaving the uterus intact.
Johnson & Johnson withdrew its leading morcellator brand from the market in 2014. Most insurers have stopped covering it. Hospitals have abandoned or restricted its use. And more than 300 women or their families have come forward to claim they were harmed, with dozens filing lawsuits.