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 misleading as it didn’t indicate that the purpose was to demonstrate oncological safety, and warned that if a patient in the trial had cancer and was misled, the company “will have exposed her to an avoidable, well-established, and deadly oncological risk.”
The University is “looking into this matter,” according to the report.
Olympus has released limited information on the trial, but commented saying the trial was part of its “commitment to continuing innovation, improvements to our products, and increases in patient safety and service,” according to the Inquirer.
In April 2014 the FDA issued a warning about the cancer risk from morcellation and convened an advisory panel to consider their use in fibroid removal. The agency’s Obstetrics & Gynecology Devices committee failed to come to a clear consensus on the cancer risk from laparoscopic power morcellators, despite outraged testimony from dozens of attendees; in November of that year the FDA ordered so-called “black box” warnings for the devices. In September 2015, the Government Accountability Office said it would investigate potential safety and regulatory issues with the morcellators; legislators later called for the FDA to open a criminal probe into several deaths associated with morcellators.
The furor prompted Johnson & Johnson (NYSE:JNJ) to recall its morcellators in July 2014, after pulling them from the market in April of that year. J&J is now looking to settle 100s of product liability and wrongful death lawsuits brought over the Ethicon devices.
