No FDA Decision on Power Morcellators
Last week, an U.S. Food and Drug Administration (FDA) panel met to consider the use of a controversial procedure to remove uterine fibroids, which are implicated in spreading cancer, through the use of laparoscopic power morcellators.
The panel failed to come to a clear decision and to reach a consensus on the safety of LPMs.
About Laparoscopic Power Morcellators
A morcellator is a surgical instrument that is used for the division and removal of large masses of tissue during laparoscopic surgery. A safety concern is that morcellation is associated with the spreading of cellular material of the morcellated tissue.
The FDA’s Obstetrics and Gynecology Devices panel met from July 10-11 to review the use of LPMs in removing uterine fibroids that were thought to be benign, which has been associated in the spread of undetected uterine cancers.
In April, the FDA issued a Safety Communication discouraging the use of LPMs, estimating that 1 in 350 women who undergo a hysterectomy or myomectomy for presumed fibroids have an unsuspected and difficult-to-diagnose type of uterine cancer called uterine sarcoma.
This warning prompted Johnson & Johnson and its Ethicon subsidiary to voluntarily suspend sales of its LPMs, although no official recalls have been initiated.
Various Suggestion Offered by FDA Panel
According to MassDevice, the panel was made up of 15 members who offered various suggestions for mitigating the risk of spreading uterine sarcomas in using the morcellators, including an outright ban, stricter product labeling, and limiting its use in some patient populations.
They urged surgeons to utilize tools such as MRI, radiologic imaging, and biopsy and to take patient age and exam findings into account to ensure a fibroid is not cancerous prior to removal. They stated that peri-menopausal and post-menopausal women should definitely not have morcellation.
Dr. Amy Reed, whose uterine sarcoma was upstaged as a result of morcellation, gave an account of a physician’s personal experience with the practice. She asked that the gynecologists on the panel be held criminally liable for defending morcellation. Her husband, a general surgeon and cardiothoracic surgeon, was one of many other speakers who demanded that morcellators be banned.