December 29, 2020
The following quote is attributed to Jeffrey Shuren M.D., J.D., director of FDA’s Center for Devices and Radiological Health:
“Providing women with access to safe medical devices to meet their health care needs is a top priority for the FDA. Today, we’ve taken two important steps on laparoscopic power morcellators as a result of listening to and acting on public comments to our draft guidance as well as considering the available scientific data.
“Reflecting that feedback and scientific review, our updated recommendations for health care providers include shared decision-making with patients, a thorough preoperative screening with the patient and a warning about the spread of benign uterine tissue, potentially requiring additional surgeries, when using uncontained laparoscopic power morcellators in gynecologic surgeries. We continue to recommend that laparoscopic power morcellation used in gynecologic surgeries only be performed for myomectomy or hysterectomy in appropriately selected patients and only used with a compatible tissue containment system, legally marketed in the U.S. for use during laparoscopic power morcellation.
“The FDA will continue to review the latest data and scientific literature on laparoscopic power morcellation, including gathering real-world evidence from patients, providers and others, and encouraging innovation to better detect uterine cancer and develop containment systems for gynecologic surgery. The FDA seeks to ensure women and their health care providers are fully informed when considering laparoscopic power morcellators for gynecologic surgeries. ”
- Today, the U.S. Food and Drug Administration issued a final guidance, “Product Labeling for Laparoscopic Power Morcellators – Guidance for Industry and Food and Drug Administration Staff,” which recommends manufacturers provide important information in labeling to enhance the safety of laparoscopic power morcellators to better inform patients and health care providers considering their use in gynecologic surgeries.
- Also today, the FDA issued an updated safety communication for patients and health care providers on the safe use of laparoscopic power morcellators during gynecologic surgeries, including that: uncontained power morcellation has been associated with the spread of benign uterine tissue; health care providers should conduct a thorough preoperative screening; and as part of shared decision-making, discuss the risks and benefits of all relevant treatment options with their patients prior to undergoing the procedure.
- Laparoscopic power morcellators 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 (removal of uterine fibroids). While laparoscopic surgeries are associated with shorter postoperative recovery time and a reduced risk of infection compared to traditional surgery, when laparoscopic power morcellators are used in gynecologic surgeries where unsuspected cancerous tissue is present, there is a risk that morcellation could spread cancerous tissue throughout the body, decreasing a woman’s chance of long-term survival.
- The FDA has communicated about safety issues related to laparoscopic power morcellators over the last several years. The agency regularly updates the public and remains committed to sharing new information as it becomes available.
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.