On July 2, 2026, the U.S. Food and Drug Administration (FDA) granted marketing authorization for the Claria System, an integrated system that combines a gynecologic electromechanical tissue morcellator with a tissue-containment system. The system is used to morcellate, fragment, and extract tissue believed to be benign during laparoscopic hysterectomy through the vaginal route, and its use is limited to a specific group of patients.
According to the FDA, the specified group includes women who do not have uterine fibroids and premenopausal patients younger than 50 who have fibroids. The agency describes Claria as the first system of its kind to combine both functions in a single device.
Why does this update matter?
Laparoscopic electromechanical morcellators, which are Class II medical devices, are used to divide tissue into small pieces that can be removed through a small surgical incision, typically 2 centimeters or less. These devices are used in some hysterectomies and myomectomies, procedures that may be associated with shorter recovery and a lower risk of infection compared with surgery through an open abdominal incision.
However, morcellation may spread cancerous tissue within the abdomen and pelvis if a tumor believed to be a fibroid conceals a uterine sarcoma. The FDA indicates that uterine sarcoma is being detected in women undergoing surgery for fibroids at a higher rate than previously believed, and that distinguishing a fibroid from a sarcoma before surgery can be difficult with available tests.
The FDA estimates that the likelihood of an occult uterine sarcoma is approximately one in every 225 to 580 women undergoing surgery for fibroids, based on the published literature. The likelihood of leiomyosarcoma, a specific type of uterine sarcoma, ranges according to more recent estimates from one in every 495 to 1,100 cases. Before 2014, clinical estimates indicated a much lower rate, as low as one in every 10,000 women.
What changes in practice?
The FDA recommends that health care providers not use laparoscopic electromechanical morcellators in gynecologic surgeries for patients with suspected or confirmed cancer. It also warns against their use in women older than 50 who are undergoing myomectomy or hysterectomy because of fibroids. The agency emphasizes that the risk of undetected cancer increases with age.
When electromechanical morcellation is appropriate for a selected patient, the FDA recommends using a tissue-containment system and ensuring that it is compatible with the morcellator. These systems are intended to isolate and contain tissue believed to be benign during the procedure; nonclinical testing shows that the containment system confines the fragmented tissue within it.
There is currently no reliable way to predict whether a woman with fibroids has uterine sarcoma. Therefore, the agency recommends that the physician and patient discuss preoperative testing and known risk factors, such as age, previous exposure to radiation therapy in the pelvic area, previous use of Tamoxifen, and race, before choosing a surgical approach. The benefits of minimally invasive surgery may outweigh the risks for some younger patients, including those who wish to preserve fertility, depending on the assessment of the individual case.
Device safety monitoring
The FDA requires patients, health care providers, and manufacturers to report problems associated with electromechanical morcellators, tissue-containment systems, and integrated systems such as Claria. Voluntary reports may be submitted through the MedWatch program, while personnel at facilities subject to reporting requirements must follow their facility’s procedures, and manufacturers must comply with medical-device reporting regulations.