search
top

Johnson & Johnson Recall/FDA warning

Power morcellators were once praised for their ability to break up tissue and other fibroids during a hysterectomy or a myomectomy. According to the Mayo Clinic, a myomectomy is a surgical procedure to remove uterine fibroids — also called leiomyomas (lie-o-my-O-muhs). A morcellator is a drill-like device that worked by dicing up tissue into smaller bits that were then removed.  However, it was soon revealed that the device was responsible for the spread of cancerous tissue that could then lead to dangerous cancer growth.  The cancers caused by these morcellators were potentially deadly in women, such as metastatic leiomyosarcoma, uterine cancer, uterine sarcoma, and endometrial stromal sarcoma. When this risk became more and more prevalent, Johnson & Johnson, the makers of the power morcellators, issued a recall.

Following the recall, the FDA issued an official warning to doctors against use of the devices.  According to the website of Williams Kherkher, the FDA issued a further “black box warning” in November of 2014 due to the extreme risks associated with the device.  Essentially, this warning stated that any benefits of the device were outweighed by the risks.  In fact, 1 in every 350 women who had surgery using the power morcellators suffered from a serious cancer as a result.

Unfortunately, these warnings and recalls came too late for many women who had already developed severe forms of cancer.  Following the public outcry against power morcellators, many individuals filed lawsuits against Johnson & Johnson to possibly receive financial compensation for their suffering.  Despite these warnings, recalls, and lawsuits, power morcellators have not been officially banned.

Leave a Reply

Your email address will not be published. Required fields are marked *

top