Surgical Tool Found to be Questionable by FDA
The laparoscopic power morcellator, otherwise known as the LPM, is a common tool used in minimally invasive hysterectomies or myomectomies. The tool is used for the division and removal of small pieces of large masses of tissue, such as the uterus or fibroids in the uterus. Typically, the tool allows for procedures to be considered minimally invasive, through its ability to require only two incisions to complete the operation at hand. The first is issued to allow for the laparoscopic camera to be inserted; this, in turn, prohibits the surgeon to see. The second incision is created so the tool can cut and extract pieces of target tissue.
However, despite the minimally invasive benefits of the LPM, concerns have emerged that the tool does more harm than good, according to an article recently completed by the Daily Digest News. The tool has been linked to awakening a form of cancer known as uterine sarcomas. Thus far, the cancer is present in one out of every three hundred and fifty women who underwent hysterectomies or myomectomies that employed the use of an LPM. From this statistic, the Obstetrics and Gynecology Devices Advisory Committee of the United States Food and Drug Administration has been forced to review the tool, specifically to weigh the risks associated with its use against the benefits of the minimally invasive nature of the procedure.
After a two-day reviewing period, the committee has mandated that, if the tool is to be used in either procedure, the surgeon must lay out the risks and benefits to the patient prior to the procedure. The clear risk of cancer must be explicitly outlined and an informed consent form must be signed by both the patient and the surgeon.
Even with the implementation of this new mandated requirement, the public backlash has continued to be strong against the tool. Many have called for the device to be banned from use entirely in either procedure. Ethicon, a division of Johnson and Johnson, a producer of laparoscopic power morcellators, has halted all production lines until further decisions are provided from the FDA on the tool.