Less than two weeks ago, the FDA was discouraging the use of power morcellators in the treatment of uterine fibroids, because of the attendant risk that by putting these troublesome objects through an open “blender” the act of getting rid of potential cancerous cells might in effect be spreading them about. Now a Reuters article tells us that Johnson & Johnson has suspended the sale of its power morcellators until their role in fibroid treatment is better understood and redefined by the medical community.
Uterine fibroids are typically non cancerous growths that develop in the muscle tissue of the uterus, and can be troublesome enough to warrant removal. Minimally invasive fibroid removal can require that the bulk of these structures be broken down in order to effect their removal. This so call morcellation process can be performed laparoscopically using devices such as those offered by J&J’s Ethicon division.
The problem of course comes when tissues emanating from the fibroids is found to be cancerous and as such just about the last thing one would want to disperse throughout the surrounding tissues. This risk has been picked up by the FDA and acted on by Ethicon, although the company is pointing out that withdrawal of products is at this time a suspension, pending further information that will be gleaned from the medical community. The company, in a letter to physicians, is also making it clear that it has “always included cautions in its instructions for use about the potential spread of malignant tissue”.
That said, the company is clearly taking this risk seriously enough to make the notification global, saying it is reaching out to other global regulatory agencies.