Power Morcellator for Uterine Fibroids
Uterine fibroids are often a benign, but uncomfortable or even painful condition. Because they are not putting a woman at risk, many feel confident in leaving the condition alone until it becomes necessary to do otherwise. Generally, women may choose to have their fibroids removed because of heavy bleeding or discomfort. Because removal is a surgical procedure, few women make this choice lightly.
For many women it usually becomes a matter of having the “fibroids” removed through a process known as a myomectomy, but some women do have such extensive growth that their gynecologist suggests a hysterectomy.
In both types of procedures there has been ongoing use of a laparoscopic approach, rather than what is known as “open” surgery. It is easy to understand why women would prefer the convenience of the laparoscopic methods. They require only tiny incisions, do not sever muscle, and demand only minimal downtime in order to recover. As opposed to traditional surgery in which a large incision is made in the abdomen and a few days in the hospital are required, the laparoscopic option does seem superior.
Unfortunately, the FDA recently determined that the convenience of the laparoscopic route of fibroid removal may not be as great as it has been claimed to be.
The Problems with the Procedures
In two separate safety communications in 2014, the FDA explained that far too many women have developed aggressive cancer known as Leiomyosarcoma (the systemic variety) because of the use of a power morcellator during surgery.
The power morcellator is the laparoscopic device that is the real workhorse of the surgery and it segments the tissue into many small pieces and suctions them out of the body. This, clearly, is how the operation can be done without large incisions, and yet the very process of morcellation is what causes so much trouble.
While benign uterine fibroids should be able to be shredded into tiny pieces and removed, if the tissue is misdiagnosed it can lead to a deadly health problem. Women who do not have fibroids but who have LMS that is mistaken for fibroids (and the FDA calculated that one in 350 to 500 women are in this group) will have their treatable type of cancer turned into an aggressive and deadly one during surgery.
The morcellator will take diseased tissue and shred it into small pieces. This allows unhealthy cells and tissue to spread into the body. This then allows the cells to begin to grow in almost any area, and this leads to an almost unbeatable type of LMS. Whereas that one local growth could have been surgically removed and the patient successfully treated with chemo or radio therapies, after the use of a power morcellator the patient is quite likely to have systemic LMS that will not respond to chemo or radiation.
Contraindicated for Uterine Fibroids
The statements from the FDA came as a surprise to many, and even though around 65% of hysterectomies and myomectomies are done in the traditional or open surgical style, there are still large numbers of women being put at risk by the use of a morcellator for fibroid removal. The FDA has now specifically stated that this device is contraindicated for this procedure, and advises manufacturers to put special labels on their units.
Johnson & Johnson recalled their devices in order to reduce risks to patients, but many surgeons still want to use them to allow for less invasive surgeries. A vaginal procedure is also minimally invasive, and most surgeons are now suggesting that patients opt for this method rather than jeopardizing their health and wellbeing for the convenience of laparoscopic options.
WebMD. Hysterectomy. 2015. http://www.webmd.com/women/guide/hysterectomy?page=2