Olympus America has announced the U.S. Food and Drug Administration (FDA) cleared its next-generation morcellator surgical tool as an option in gynecological procedures.
Officially introduced November 15 at the American Association of Gynecologic Laparoscopists Annual Meeting, the PK Morcellator is a device designed to cut and extract tissue in minimally invasive procedures.
This comes as surprising news in the medical community after the use of power morcellators dropped significantly following a 2014 announcement by the FDA warning that the devices could spread undetected cancer throughout the body.
A morcellator is an electric tool that minces the uterus into smaller pieces for extraction through the abdomen. However, the FDA estimates that one in 350 women undergoing hysterectomies or myomectomies have undetected cancer.
“If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival,” the FDA warned in 2014.
New PK Morcellator Aims to Make Device Safer
Despite the past controversies related to the devices, some in the medical field are hopeful that the new device will avoid the pitfalls of the previous generation.
“As surgeons, it is our duty to evaluate potential solutions to the surgical challenges we face in clinical practice,” said Dr. Arnold Advincula of Sloane Women’s Hospital in a press release. “We are pleased that Olympus has taken the initiative to develop a unique and well tested system designed specifically to facilitate the option for a laparoscopic approach in women who are at a low risk of having an unexpected malignancy at the time of surgery.”
The new morcellator is designed to be used in conjunction with a containment device called the PneumoLiner. This device is intended to isolate uterine tissue from the rest of the body. Olympus calls the two devices working together the Olympus Contained Tissue Extraction.
“The Olympus Contained Tissue Extraction System provides gynecologists and their appropriate, low-risk patients with what they want again: a choice,” said Todd Usen, President of the Olympus Medical Systems Group at Olympus Corporation of the Americas. “The Olympus Contained Tissue Extraction System is the solution that will allow gynecologists to once again safely and effectively offer minimally invasive hysterectomies and myomectomies as options to certain low-risk patients.”
Olympus continues to emphasize that the system and morcellator should not be used in tissue that is known or suspected to contain cancer.
Safety Concerns Over Morcellators Persist
Opponents of the new Olympus device say it is just as dangerous as the previous generation. Cardiac surgeon Hooman Noorchashm, who has campaigned for an outright ban of the device after his wife’s cancer was spread by a morcellator during her hysterectomy, is critical of the decision to renew interest in the devices.
“The FDA has essentially released this new device without any clinical safety testing,” Noorchashm told The Philadelphia Inquirer.
The surgical tool was approved under the FDA’s 510(K) exemption in which the manufacturer has to prove that the medical device is “substantially equivalent” to other legally marketed devices, according to the FDA. This means no testing was required.
And despite approval by the FDA in April 2016, the PneumoLiner has not been proven to reduce the spread of cancerous tissue during procedures with morcellators.
“This new device does not change our position on the risks associated with power morcellation,” said Dr. William Maisel of the FDA in the April announcement. “We are continuing to warn against the use of power morcellators for the vast majority of women undergoing removal of the uterus or uterine fibroids.”
Even with the new containment device, the PK Morcellator may carry all of the same risks as previous iterations.
As lawsuits against manufacturers of earlier morcellator devices continue to grow, critics wonder whether Olympus will be the next manufacturer to endanger women and face legal action.