Director – CDRH Offices: Office of the Center Director
Dr. Jeffrey E. Shuren MD, JD
Today, we are taking several important steps to make the use of laparoscopic power morcellators (LPMs) safer in gynecologic surgeries, including granting marketing authorization for updated labeling of the PneumoLiner containment system (a device that contains tissue to be morcellated during certain gynecologic surgeries), releasing a draft guidance recommending the addition of specific safety information to the product labeling for LPMs, and issuing a Safety Communication recommending that an LPM only be used in certain gynecologic surgeries with a containment system that is compatible with the LPM.
LPMs are used during laparoscopic (minimally invasive) surgeries to cut tissue into smaller pieces so the tissue can be removed through a small incision site. These devices can be used in a variety of surgeries, including various gynecologic surgeries such as a myomectomy, a surgical procedure to remove uterine fibroids from a woman’s uterus. While laparoscopic surgeries are associated with shorter post-operative recovery time and a reduced risk of infection compared to traditional surgery, there are known risks associated with the use of LPMs, specifically in gynecologic surgeries. For example, current scientific evidence indicates that cancerous tissue may be present in uterine fibroids presumed to be benign (non-cancerous). When LPMs are used in surgeries where unsuspected cancerous tissue is present, there is a risk that morcellation could spread cancerous tissue throughout the body, decreasing a woman’s long-term survival.
The FDA has taken many actions over the years to ensure the safe and effective use of LPMs. Some of these actions include the issuance of a Safety CommunicationExternal Link Disclaimer, holding a panel meetingExternal Link Disclaimer to seek outside expert opinions, issuance of an FDA guidance recommending the addition of safety statements to the labeling for LPMs, and ensuring that up-to-date information regarding LPMs for gynecologic use is publicly available on the agency’s website.
In 2016, the FDA authorized the use of a first-of-kind tissue containment system, called the PneumoLiner, for use with certain LPMs to isolate uterine tissue that is not suspected to contain cancer. The device includes a containment bag where the tissue to be removed is placed in the bag and sealed such that morcellated tissue is not spread throughout the abdominal cavity during the morcellation process. Although the device effectively contains morcellated tissue, to ensure that the benefits of this device continued to outweigh the risks, this device was only authorized for use in specific patient populations, including women without uterine fibroids undergoing hysterectomy and pre-menopausal women with fibroids who wish to maintain their fertility. We also required specific warnings to be included in the labeling so that both patients and health care providers were aware of the risks of morcellation during certain gynecologic procedures.
Today, we are providing marketing authorization for the PneumoLiner containment system with updated labeling. While 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 pre-menopausal and under 50 years old. 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.
In addition to our efforts to ensure these devices are used in the appropriate patient population, as uncontained power morcellation has been associated with the spread of cancerous tissue, we are issuing draft guidance proposing to update our recommendations in the 2014 final guidance concerning the content and format of certain labeling information for LPMs. Specifically, the FDA is recommending that the labeling of LPMs include contraindications and warnings highlighting the following information regarding the risks of use of LPMs in gynecologic surgeries:
The risk of occult cancer, including uterine sarcoma, increases with age, particularly in women over 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, i.e., parasitic myomas and disseminated peritoneal leiomyomatosis.
- Laparoscopic power morcellators should only be used with a containment system. The containment system should be compatible with the laparoscopic power morcellator.
- Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
- Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are post-menopausal or over 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 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.
Finally, today we are issuing an updated Safety Communication that provides important information to patients and health care providers on the risks associated with LPMs when used in certain gynecologic surgeries. This Safety Communication now recommends that an LPM only be used in certain surgeries with a containment system that is compatible with the LPM. This communication also contains recommendations for patients and health care providers if they are considering using LPMs for gynecologic surgery—such as discussing the risks and benefits of all available treatments options to determine whether morcellation is appropriate—and provides specific questions that patients can use to start a dialogue with their physician.
Ensuring the safety of women’s health devices, including LPMs, remains a top priority for the agency. In taking these actions and making these recommendations, we considered available scientific information pertaining to the risk of spreading uterine tissue with uncontained power morcellation during gynecologic surgeries. 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.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.