FDA Issues Safety Communication on Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy

Written by on August 29, 2014 in Research & Technology - No comments

DoctorWomanWEBRecently, the FDA issued a safety communication regarding the laparoscopic uterine power morcellator that gynecologists use during hysterectomy and myomectomy. This device has been used since 1993 to fragment a uterus or fibroid into smaller pieces so that they may be removed through incisions only a few centimeters in length. The concern is that during the fragmentation there is a small risk that unsuspected cancerous tissue, most specifically uterine sarcoma, may be spread throughout the peritoneal cavity.  This spread of cancer could potentially worsen the patient’s long-term survival rate, which is why the FDA is discouraging the use of power morcellators. The American College of Obstetricians and Gynecologists (ACOG) is currently conducting a review to evaluate power morcellators and gynecologic malignancies.

The FDA has estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of uterine fibroids will have an unsuspected uterine sarcoma.  Previous estimates based on limited retrospective studies have been an estimated 2:1000 women will have an unsuspected uterine sarcoma, although no study has been done determining how many of these sarcomas were morcellated.  Overall, the annual incidence of uterine sarcoma is quite low, approximately 0.64 per 100,000 women.

Unfortunately, uterine sarcomas are extremely difficult to diagnosis prior to surgery. Unlike cervical cancer, which can be diagnosed quite accurately with a pap smear and biopsy, or endometrial cancer, which can be diagnosed by symptoms and a biopsy, there is no reliable test to diagnose uterine sarcomas.  The best a physician can do is utilize known risk factors for uterine sarcomas to develop a high suspicion of a sarcomas presence.  These risk factors are older age, menopausal status, documented rapid growth of uterine fibroids, certain hereditary conditions, history of pelvic radiation, and tamoxifen use greater than 5 years.

Laparoscopic use of the uterine power morcellator is not the only treatment option for surgical removal of the uterus or fibroid, but rather one of many surgical choices that may be considered. Another option is to dissect the uterus or fibroid laparoscopically and then remove the tissue through a mini-laparotomy, colpotomy, or laparotomy incision. Alternatively, the surgical approach can be changed to a vaginal hysterectomy, abdominal hysterectomy, or a laparoscopic assisted vaginal hysterectomy.

It has been reported that some physicians and institutions are recommending the use of a peritoneal bag during morcellation to help mitigate the risk of tissue spreading throughout the abdomen. Unfortunately, these bags are not specifically designed for use with the uterine morcellator. If the bag is used during power morcellation it can potentially limit the ability to simultaneously view the tissue being morcellated and the surrounding tissue, which may increase unintentional damage to other tissue. Also, the bags are not designed to withstand tearing from the morcellator. Future development of bags designed for use in conjunction with the morcellator may be an option to help reduce the risk of tissue spread during morcellation.

ACOG is currently recommending that the power morcellator not be used in any patient undergoing surgical treatment for a gynecological cancer. In patients who are undergoing surgery for benign disease they are recommending a thorough preoperative evaluation. All patients should have current cervical cytology and if clinically indicated, a pelvic ultrasound and an endometrial biopsy.  ACOG is also endorsing the FDA’s recommendation for appropriate patient counseling on the risks associated with uterine power morcellation and informed consent.

At the moment, neither the FDA nor ACOG are asking for the removal of the device from the market, but rather both want time to gather more information. Up to this point, there have been no studies done that include enough patients to give an accurate rate of preoperatively undiagnosed uterine sarcomas in patients undergoing hysterectomy. Since uterine sarcomas are relatively rare, it is estimated that a patient cohort of approximately 100,000 would be required to give a more accurate risk assessment. ACOG is therefore encouraging the FDA to establish a national prospective morcellation surgery registry to help assess this risk. The FDA is planning to hold public meetings of the Obstetrics and Gynecology Medical Device Advisory Committee prior to any further action being taken.

References:
www.fda.gov
www.acog.org

By Carrie A Noriega, MD

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