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.

Source: Olympus introduces new version of troubled gynecological device

Author: Marie McCullough, Staff Writer

Photo 1 Credit: Olympus America Inc.

Photo 2 Credit: Jonathan Wilson, For The Inquirer