The US Food and Drug Administration (FDA) has announced several new steps designed to make the use of laparoscopic power morcellators (LPMs) safer in gynecologic surgeries.
The agency granted marketing authorization for updated labeling for the PneumoLiner morcellation tissue containment system; released draft guidance recommending the addition of specific safety information to the product labeling for LPMs; and issued a Safety Communication recommending that an LPM only be used in certain gynecologic surgeries with a containment system that is compatible with the morcellator.
The FDA estimates that about 1 in 350 women who have hysterectomy or myomectomy for fibroids will have an unsuspected uterine sarcoma. Uncontained power morcellation has been associated with the spread of cancerous tissue.
In 2016, as reported by Medscape Medical News, the FDA approved use of the PneumoLiner, the first tissue containment system for use with certain LPMs to isolate uterine tissue that is not suspected to contain cancer.
Although the PneumoLiner effectively contains morcellated tissue, to ensure that the benefits of the device continued to outweigh the risks, the FDA only approved its use in specific patient populations, including women without uterine fibroids undergoing hysterectomy and premenopausal women with fibroids who wish to maintain their fertility.
The agency also required specific warnings on the label to make both women and healthcare providers aware of the risks of morcellation during certain gynecologic procedures.
The updated labeling for the PneumoLiner containment system is designed to better define the appropriate patient population for the safe and effective use of this device, Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, explained in a statement.
It states that the PneumoLiner should only be used in women who have fibroids if they are premenopausal and younger than 50 years of age. "The likelihood of unsuspected cancer in women undergoing hysterectomy or myomectomy increases with age such that the benefit–risk profile of using LPMs is worse in older women when compared to younger women," Shuren said.
The updated safety communication now recommends that an LPM only be used in certain surgeries with a containment system that is compatible with the LPM. It also contains recommendations for patients and healthcare providers considering use of LPMs for gynecologic surgery. They include discussing the risks and benefits of all available treatment options to determine whether morcellation is appropriate.
Finally, the FDA issued draft guidance to update recommendations on the content and format of certain labeling information for LPMs. Specifically, the agency recommends that the labeling of LPMs contain the following contraindications and warnings:
– The risk of occult cancer, including uterine sarcoma, increases with age, particularly in women older than 50 years of age. This information should be shared with patients when considering surgery with the use of these devices.
– Uncontained power morcellation has been associated with the spread of benign uterine tissue (eg, parasitic myomas and disseminated peritoneal leiomyomatosis).
– LPMs should only be used with a containment system. The containment system should be compatible with the LPM.
– LPMs are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
– LPMs are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are postmenopausal or older than 50 years of age, or candidates for en bloc tissue removal through the vagina or via a mini-laparotomy incision.
"We believe that the inclusion of accurate and detailed information in the labeling for LPMs, such as what is recommended in the draft guidance, will help both healthcare providers and patients understand the risks of using these devices, and aid in their decision to determine whether morcellation could be appropriate for them," Shuren said.
Cite this: FDA Updates Steps to Make Power Morcellators Safer in Gynecologic Surgery - Medscape - Feb 25, 2020.