Recalls of Power Morcellators
Although the FDA issued two safety communications in 2014 around the use of power morcellators during certain surgical procedures, only one of the major manufacturers has since issued a recall. This is an astonishing fact since the FDA first issued a statement in April 2014 (pending further investigation) and then issued a second and more authoritative statement in November of that same year.
The FDA statements summarily pointed towards the devices known as power morcellators as representing a major threat to women whose medical teams were using them during surgical treatments for fibroid tumors. Essentially, the FDA expressed that the use of a morcellator was contraindicated for a woman receiving a hysterectomy or myomectomy because of fibroids.
Fibroids are uterine tumors normally seen as benign. However, there is a form of cancer known as Leiomyosarcoma (LMS) that is often undetected and which presents many of the same symptoms as fibroids. Unless specific blood panels are run prior to surgical treatment, a patient may have a case of undiagnosed LMS, and this puts her at risk for serious complications. Essentially, LMS is unique and rare in that it does not spread via lymph nodes and because it affects involuntary muscle and soft tissue. That makes it capable of appearing anywhere in the body.
When a surgeon uses the morcellator to remove diseased tissue, it segments the tissue and then suctions it out of the body. This often allows cells and tissue to escape and spread. When it does, it can cause cancer to appear, as well. Because LMS is so aggressive, and best when treated as a single local tumor, the use of a morcellator has been known to cause it to become a systemic condition. There are several noted cases of otherwise healthy women have surgery to remove fibroids only to end up with deadly cases of systemic LMS.
This is what cued the FDA to release its statement advising consumers and medical experts against the use of morcellators for these treatments. And this did cause at least one of the major manufacturers to willingly recall all of their devices.
The Ongoing Recalls of Power Morcellators
To date, the only manufacturer of power morcellators to recall the devices based on the FDA report was Johnson & Johnson. Their division known as Ethicon, Inc. has since issued recalls for their Gynecare Morcellex, Morcellex Sigma, and Gynecare X Tract devices.
This was a wise move since there have already been lawsuits initiated against the makers of the devices. These lawsuits can claim everything from fraudulent misrepresentation and negligence to a failure on the part of the makers to warn or properly test the gear. Some claims of consumer risk can also be made. The recalls done by Johnson & Johnson, then, stand as one of the few proactive moves yet made by morcellator manufacturers.
It is important to note that the FDA has suggested that makers begin to label their gear with warnings about the risks that the devices pose when used for certain procedures on specific groups. Though morcellators have long been used for other treatments apart from gynecological ones, this current threat indicates that a moratorium on their use may be wise.
Many major medical centers and hospitals have moratoriums in place, even after the second FDA safety communication in 2014. The simple fact is that the spread of LMS is too serious and too harmful to put anyone at risk.
Surgeons understand that LMS can be removed, but it requires wide margins (a lot of space around the affected area remaining free of disease) to prevent a reoccurrence. And most understand that if LMS becomes systemic, it can be said to be a death sentence. The use of morcellators has been, and will continue to be, a cause for the shift from local to systemic LMS, and that demands more recalls and different surgical protocols.
DrugWatch.com. Power Morcellators. 2014. http://www.drugwatch.com/morcellators/