Uterine myomas or fibroids, are benign tumours arising from the smooth muscle cells of the myometrium of the uterus. They are the most common pelvic tumor in women. The estimated rate of leiomyosarcoma, found during surgery for presumed benign leiomyomas, is approximately 1 in 2000.
Treatment options for symptomatic uterine leiomyomas include medical, surgical, and radiologically‐guided interventions. Laparoscopic myomectomy is the gold standard surgical approach for women who want offspring, or otherwise wish to retain their uterus. A limitation of laparoscopy is the inability to remove large specimens from the abdominal cavity through the laparoscope. To overcome this challenge, the morcellation approach was developed, during which larger specimens are broken into smaller pieces in order to remove them from the abdominal cavity via the port site. However, intracorporeal power morcellation may lead to scattering of benign tissues, with the risk of spreading leiomyoma or endometriosis. In cases of unsuspected malignancy, power morcellation can cause unintentional dissemination of malignant cells, and lead to a poorer prognosis by upstaging the occult cancer. Dispersed tissue fragments can implant on abdominal organ surfaces and lead to several complications, including inflammation and infection
A better strategy to optimise women’s safety is to morcellate the specimens inside a bag. In‐bag morcellation may avoid the dissemination of tissue fragments and also reduces the chance of secondary fibroids also the chances of internal organ damage during power morcellation.
The FDA continues to recommend limiting the use of laparoscopic power morcellation to certain appropriately selected women undergoing myomectomy or hysterectomy. In addition, the FDA recommends that when morcellation is appropriate, only contained morcellation be performed.
RECOMMENDATIONS FOR PATIENTS: Discuss all options available to treat your condition with your health care provider. There are benefits and risks associated with all medical devices and procedures.
- If your health care provider recommends laparoscopic hysterectomy or myomectomy, ask:
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- If power morcellation will be used
- Why power morcellation use is appropriate for you
- Whether a containment system will be used, and
- If other treatment options are available.
- If you have undergone a myomectomy or hysterectomy for fibroids, be aware that tissue removed during the procedure is usually tested for the presence of cancer.
- If you were informed these tests were normal, continue routine follow-up with your health care provider.
- If you have any questions or concerning symptoms, consult your health care provider.
- Know that additional surgical treatment options are available for women with symptomatic uterine fibroids. These include traditional surgical hysterectomy and myomectomy, performed either vaginally or abdominally, laparoscopic hysterectomy and myomectomy without morcellation, and laparotomy using a smaller incision in the abdomen.
RECOMMENDATIONS FOR HEALTH CARE PROVIDERS: Perform laparoscopic power morcellation with a legally marketed laparoscopic power morcellation containment system ( Example: LIMAS MORCELLATOR® & PNEUMOSAC® Morcellation Bags) when morcellation is appropriate. The containment system should be compatible with the laparoscopic power morcellator.
- The FDA continues to recommend limiting the use of laparoscopic power morcellation to certain appropriately selected women undergoing myomectomy or hysterectomy; when morcellation is appropriate, only contained morcellation should be performed.
- Do not use laparoscopic power morcellators in gynecologic surgery when the tissue to be morcellated is known or suspected to contain malignancy.
- Do not use laparoscopic power morcellators for removal of uterine tissue containing suspected fibroids in patients who are:
- Post-menopausal or over 50 years of age, or
- Candidates for removal of tissue through the vagina or via a mini- laparotomy incision.
- Tell patients about the risk of occult cancer (cancer that cannot be identified during pretreatment evaluation) and inform them that use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease their long- term survival.
- Tell patients that while unsuspected cancer can occur at any age, the risk of occult cancer, including uterine sarcoma, increases with age, particularly in women over 50 years of age.
UPDATED RECOMMENDATIONS:
Be aware that uncontained power morcellation has also been associated with the spread of benign uterine tissue, such as parasitic myomas and disseminated peritoneal leiomyomatosis, potentially requiring additional surgeries.
DR. LALU JOSEPH Ph.D.Inventor of Universal Improved Tissue Morcellator (LIMAS MORCELLATOR®) & Safety Isolation Bags for contained morcellation (PNEUMOSAC®) WINNER EDISON AWARD 2020
2023 ASIA-PACIFIC GOLD STEVIE AWARD WINNER