Report: Olympus study of next-gen power morcellator draws criticism

Olympus (TYO:7733) is receiving criticism after moving forward with plans to revitalize its powered morcellator devices, with a new 140-patient trial planned, according to a Philadelphia Inquirer report. Power morcellators, which use a cutting tip to shred and remove uterine tissue, have been implicated in the spread of a lethal cancer that can masquerade undetected as benign fibroids. The devices designed to be used to remove benign uterine fibroids, but when used on malignant tissue, can spread cancerous cells throughout the abdomen. Olympus won FDA 510(k) clearance for a next-generation laparoscopic PK morcellator, featuring a tissue containment system, last November. A new study of the device slated to be launched at the University of North Carolina, according to the report, but is being denounced by cardiac surgeon Dr. Hooman Noorchashm, husband to deceased patient safety advocate Dr. Amy Reed. Dr. Reed helped expose the risk associated with morcellators, which won FDA approval in 1995, after undergoing a hysterectomy in 2013 at the Boston Hospital where she worked. Dr. Reed passed away in May to leiomyosarcoma. “The study is critically flawed in its ethics and design,” Dr. Noorchashm wrote in an email to the University’s gynecologists and ethics review board, according to the Inquirer. Dr. Noorchashm alleged that women in the study could not give fully informed consent, among other complaints about the study. Dr. Noorchashm said the study design was misle...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Oncology Source Type: news