FDA actions intended to improve safety of laparoscopic power morcellators for gynecologic surgery
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The FDA has taken three steps intended to increase safety of laparoscopic power morcellators when used in gynecologic surgeries, according to a statement released by the agency earlier today.
These steps include issuing draft guidance regarding additional safety information that should be included in product labeling of laparoscopic power morcellator (LPM) systems; granting marketing authorization for updated labeling on a previously approved PneumoLiner (Olympus) containment system; and updating a safety communication to recommend LMPs be used only for certain types of gynecologic surgeries and with a containment system that is compatible with morcellator.
Power morcellation involves the insertion of a tiny instrument with a rapidly rotating blade into the uterus to grind up uterine fibroids and allow for their removal through a small incision. It allows for a quicker recovery period, fewer side effects and a lower rate of morbidity than open surgery.
Previous FDA guidance — issued Nov. 24, 2014 — recommended that manufacturers of laparoscopic power morcellators include a boxed warning to acknowledge that undetected leiomyosarcomas or other malignancies within uterine tissue can be disseminated throughout a woman’s pelvic and abdominal cavities during morcellation, increasing risks for morbidity and mortality.
In 2016, the FDA approved use of the first containment system for certain LPMs that removed tissue and placed it into a sealed bag to avoid transfer into the abdominal cavity during the morcellation process. At that time, the FDA required specific label warnings about the risks of using the device and outlined the specific patient population for which the procedure and device were intended.
“Today, we are providing marketing authorization for the PneumoLiner containment system with updated labeling,” Jeffrey E. Shuren, MD, JD, director of the FDA Center for Devices and Radiological Health, wrote in a statement. “[Although] the device itself remains unchanged since its prior marketing authorization, today’s clearance updates the labeling for this device to better define the appropriate patient population for the safe and effective use of this device, including stating that the device should only be used in women who have fibroids if they are premenopausal and [aged younger than] 50 years.
“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 [with] younger women,” he added.
Shuren also noted that the FDA was issuing draft guidance to update its 2014 final guidance on the content and format of certain labeling information for LPM systems. The draft guidance will include contraindications and warnings that highlight the following points regarding use of LPMs during gynecologic surgeries:
- Use of uncontained LPMs has been associated with the spread of benign uterine tissue.
- Risk for occult cancer — including uterine sarcoma — increases with age, especially among women aged older than 50 years. This information should be shared with women when considering the use of LPM devices.
- LPMs should be used only in concert with a compatible containment system.
- LPMs are contraindicated in gynecologic surgery when the tissue to be morcellated is known or suspected to contain malignancy.
- Laparoscopic power morcellators are contraindicated for removal of uterine tissue that contains suspected fibroids in women who are postmenopausal or aged older than 50 years, 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 health care 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 wrote in the statement.
In the third and final step, the FDA will update its 2014 safety communication on the use of LPMs for gynecologic surgeries.
“The FDA recommends performing laparoscopic power morcellation for myomectomy or hysterectomy only with a tissue containment system, legally marketed in the U.S. for use during laparoscopic power morcellation, and performing these procedures only in appropriately selected patients,” the updated safety communication stated. “The FDA continues to recommend limiting the use of laparoscopic power morcellation to certain appropriately selected women undergoing myomectomy or hysterectomy. In addition, FDA recommends that when morcellation is appropriate, only contained morcellation be performed.”
The updated safety document provides recommendations for patients and health care providers, in addition to the FDA’s rationale on how surgeries using LPMs are safer when used in tandem with containment systems.
“Ensuring the safety of women’s health devices, including LPMs, remains a top priority for the agency,” Shuren wrote in the statement. “We will continue to review information on laparoscopic power morcellation, including the latest data and evolving scientific literature, and are committed to continued communication to the public regarding our current thinking.”
Reference:
FDA. Update: The FDA recommends performing contained morcellation in women when laparoscopic power morcellation is appropriate. Available at: www.fda.gov/medical-devices/safety-communications/update-fda-recommends-performing-contained-morcellation-women-when-laparoscopic-power-morcellation. Accessed Feb. 25, 2020.