The FDA has cracked down on the use of power morcellators in recent years. The devices are used in gynecological and general laparoscopic procedures to break up uterine fibroids and other tissue buildups that are believed to be benign.
The technology turns the tissue removal procedure into a minimally invasive one with a typically shorter post-op recovery period and reduced risk of infection. But if proper precautions aren’t taken, a power morcellator can send broken-up tissue elsewhere throughout the body, which may require a follow-up surgery to remove or result in even more serious effects if the targeted tissue turns out to be harboring hidden cancer cells.
“Proper precautions” typically entail the use of a tissue containment system alongside the power morcellator. These systems isolate the targeted tissue during the morcellation and removal process, significantly cutting down the chances that the tissue will spread beyond its original location.
In a 2020 update to previous guidance, for example, the FDA recommended that power morcellators only be used in myomectomy and hysterectomy fibroid removal procedures in women under the age of 50—as the risk of undetected cancer vastly increases after that point—and that the devices always be used in tandem with tissue containment systems.
A new draft guidance (PDF) the agency published this week focuses specifically on the containment systems, suggesting a series of nonclinical tests that the systems should go through before being submitted for FDA review, all with an eye toward helping reduce the inadvertent spread of cancer.
The draft guidance outlines testing protocols that would align new containment systems with the special controls the FDA developed in its de novo clearances of two containment systems from Advanced Surgical Concepts in 2016 and 2017.
Those rulings cover systems used in both gynecological and general laparoscopic procedures. They require all makers of containment systems to offer proof that the devices are biocompatible and sterile and can maintain those qualities throughout their listed shelf life. Devicemakers are also required to develop a mandatory training program for physicians who will be using the systems and to label the tools with a warning against using them in certain gynecological procedures and in procedures to remove tissue that’s known to be cancerous. The label must also list the potential risks of using power morcellation systems even in cleared procedures.
Additionally, the performance data submitted for FDA review must prove that the devices are impermeable to tissue, cells and fluids and can be successfully used in tandem with morcellators and other laparoscopic instruments.
In its suggested guidance, the FDA offered up methods, parameters and acceptance criteria for that performance testing to help devicemakers comply with the special controls.
While looking for microscopic holes in the devices to test for impermeability, for example, the agency suggested companies use materials that are smaller than the average cancer cell.
Meanwhile, to prove that the systems won’t be impeded or damaged while being used alongside morcellators and other instruments, devicemakers should perform tests using the bulkiest version of the system in “worst-case conditions”—at extreme ends of their indicated standards for labeling, temperature and pressure. The agency also asked developers to run tests on devices at the end of their suggested shelf life to understand how much force and pressure they can withstand before bursting or tearing.
On top of those condition-specific tests, the FDA recommended a full clinical simulation study for new devices, testing how well surgeons of multiple skill levels and specialties are able to use the system on a bench model, animal model or cadaver.
In all, the regulator said, the drafted suggestions are meant to “promote consistency and facilitate efficient review” among new tissue containment systems submitted for clearance.
“The recommendations are being made to ensure that the non-clinical test methods can effectively identify safety issues related to damage of the tissue containment system and subsequent leakage of any cancer cells and other contents,” the FDA said.