Power Morcellator Risks
In 2014, the FDA issued two separate safety communications about the use of medical devices known as power morcellators. The first was issued in response to a growing concern over the possible spread of certain types of cancer when the tool was used to remove fleshy masses from the uterus of a patient. The second message was an update on the initial communication, and it upheld the recommendations from the FDA that surgeons cease using power morcellators for hysterectomies and myomectomies on patients with fibroid tumors.
Why was this safety communication updated and upheld? After investigating several claims and assessing available data, the FDA determined that there was a one in 350 to one in 500 rate at which women with undiagnosed Leiomyosarcoma would receive treatment. When such patients are treated with a morcellator, it turns a very treatable form of cancer into one that is systemic and nearly impossible to overcome.
Leiomyosarcoma and Power Morcellators
To fully understand LMS and power morcellator risks, you have to know about the condition. Essentially, it is cancer of the soft tissue and involuntary muscle, and it is extremely unpredictable. It can appear in almost any part of the body and it does not spread in the same way as other cancers. Rather than traveling through lymphatic tissue, it can spread through blood vessels.
Thus, when a woman with undiagnosed LMS in the uterus is misdiagnosed with fibroids, and the tissue is shredded using a morcellator, it disperses the dangerous and diseased cells and tissue into the body cavity. In several notable cases, this has caused the woman to develop what is known as systemic LMS, but which is also simply metastatic cancer that is almost impossible to overcome.
LMS is a rare condition, and yet it can often be treated if it is identified early. Surgical excision of local tumors, followed up by radiation and/or chemotherapy, is a traditionally successful route. Unfortunately, if the growths cannot be excised (either because they are too numerous or metastasized) the use of chemotherapy and radiation is unlikely to destroy the unhealthy tissue.
So, the use of the morcellator on patients with undiagnosed uterine LMS turns their condition into a death sentence.
Other Diseases and Issues
Unfortunately, medical experts now feel that this is not where the power morcellator risks come to an end. For in addition to spreading tissue and cells into the body cavity, it is also felt that the use of the device may not give a surgeon enough control to leave the kind of wide margins necessary to ensure a positive prognosis. Additionally, even patients receiving non-gynecological procedures on the liver and spleen may be at risk for the spread of tissue that can adhere and cause disseminated disease.
Further studies and reports have also shown that some physicians have valid concerns relating to injuries of surrounding tissue when a power morcellator is used. For example, the bladder, vascular structures, pancreas, bowel, and other major organs can be damaged or suffer parasitic growth of tissue that has been inadvertently retained during a procedure.
The FDA has made it clear that it is unwise for surgeons to continue to use the devices for uterine procedures, and this has led to Johnson & Johnson recalling of the devices they have available on the market. Though no other manufacturers have followed their example, there have been several large lawsuits filed against makers of power morcellators over the risks and threats that they pose.
If you have been told to have a procedure and that a power morcellator is to be used to remove large amounts of tissue, make sure you are not at any risk and speak at great length with the surgeon about the choice to use this somewhat risky device.
DrugDangers.com. Power Morcellator. 2014. http://www.drugdangers.com/power-morcellator/
Wikipedia. Morcellator. 2015. http://en.wikipedia.org/wiki/Morcellator