Surgery

Power Morcellator Surgery

It should be quite enough to read that the FDA, “Used its authority to call for an immediate ‘black box’ warning for laparoscopic power morcellators, the strongest caution the agency issues.” (Kamp, 2014) Just this alone should make consumers well aware of the risk of any surgical procedure that relies on the device, but even in the face of the strong FDA comments, many surgeons are still putting them to use.

A power morcellator is a unique device that allows a surgeon to robotically or manually segment, shred, and suction away material from inside of the body. The use of the laparoscopic device means that there is less time needed for recovery and that larger muscles are not severed to allow the surgery to be done. That sounds like an advantage, but when you learn about the risks during power morcellator surgery, you understand the FDA’s heavy-handed statements.

Cancer Spreads

In early 2014, the FDA issued the first of two warnings about the devices. Pointing out that concerns had been raised about the large number of women developing a very serious (and often fatal) form of cancer due to the use of the devices, the organization suggested that morcellators were contraindicated for hysterectomy and myomectomy.

What made them so concerned? Essentially, the devices allow for undiagnosed cancer to be spread throughout the body. The way the devices work is to shred tissue and remove it. As it does so, though, it often allows tiny cells and bits of tissue to be left behind. However, when the undiagnosed cancer is Leiomyosarcoma (LMS), the device actually turns the tissue and cells into cancer “seeds” that can take root wherever they land.

In fact, the FDA had discovered that around one in every 350 women operated on for fibroids were actually carrying undiagnosed LMS into the surgery with them. The use of the morcellator then turned a very treatable case of “local” LMS (cancer contained within an easily removable tumor) into a rampant and nearly impossible to cure “systemic” case of LMS.

Surgery Risks

This cancer is really resistant to chemotherapy and radiation, and sadly the only way to attempt to control it once it is systemic is through the use of these less effective methods. When it is still local (as it is when it is mistaken for a fibroid tumor), the tissue can be removed in one large mass, and the area can then be treated with radiation or chemo to ensure that it is clean. This often remedies the issue and results in a very positive prognosis.

So, power morcellator surgery for fibroids (either in a hysterectomy or a myomectomy) is more often than not going to end up spreading the disease. Sadly, it is not just women with LMS who are at risk. There are experts who believe that the very same risks posed to women having these procedures are also going to be a threat to anyone having, “Renal (nephrectomy) or spleen (splenectomy) surgery. In these cases, benign or cancerous tissue spread to the abdomen in women or men, causing problems.” (DrugWatch.com, 2014)

FDA on Surgery

So, the FDA is warranted in its concerns around the safety of power morcellator surgery. Because of the gravity of the situation, and the seriousness of the FDA’s two safety communications in 2014, one major maker of power morcellators recalled all of its devices. Johnson & Johnson issued recalls on any of its morcellator units, but to date none of the other makers have done so.

If you are scheduled for abdominal surgery and are told that laparoscopic surgery is your best choice, ask about the use of morcellators and seriously discuss the risks they might pose to your health.

Source

DrugWatch.com. Morcellators. 2014. http://www.drugwatch.com/morcellators/

Kamp, Jon. Surgical Tool Gets Strongest Warning. WSJ.com. 2014. http://www.wsj.com/articles/fda-adds-new-warning-to-labels-for-laparoscopic-power-morcellator-1416842439