Why Have Manufacturers Instituted a Power Morcellator Recall?
Following a number of adverse events, a power morcellator recall is underway for most manufacturers, including the industry’s leader, Johnson & Johnson. Until recently, these devices were used in around 50,000 surgeries annually, mostly in women dealing with benign growths known as fibroids. During surgery, the fibroids are removed from the uterus, and doctors believe around 75 percent of women will have a fibroid at some time during their lives. In most cases, they don’t cause symptoms, but when they do, they have to be taken out. However, sometimes a fibroid conceals a much more insidious threat, and one that can be unleashed with a morcellator.
These devices were once considered a major step forward in hysterectomy and myomectomy surgeries. The hope was that because the technology could be used in laparoscopic procedures, it would reduce recovery time and the likelihood for side effects. Unfortunately, there are a couple of serious side effects associated with the device, largely because it is not as effective as it should be. These devices are simple, consisting of a rotating blade at the end of a rod. Inside the rod is a powerful vacuum system. When activated, the blade spins and rapidly tears apart any tissues it comes in contact with. Simultaneously, the vacuum engulfs the tissue and deposits it outside the body, where the other end of the rod rests.
It sounds extremely simple, so why is a power morcellator recall necessary? Doctors now realize that the technology is not 100 percent effective, and can leave behind small masses of minced tissue. If this tissue travels to other parts of the body, it can result in a serious infection, especially if the tissue becomes necrotic.
However, the reason why manufacturers are migrating away from the technology is because it can activate certain cancers in the body, accelerating their growth. This is particularly true in women who have an undetected leiomyosarcoma, a uterine cancer that is extremely difficult to detect at times. Doctors believe as many as 1 in 350 women have an undetected leiomyosarcoma, and it is considered an aggressive cancer that will spread quickly. So, the last thing a person harboring a leiomysosarcoma wants is to help it spread, which is exactly what a power morcellator does. A recall was necessary once researchers noticed that the device was causing some patients to experience a sudden, aggressive emergence of cancer that often killed within a year or two. When the device minces the cancerous tissue, it deposits it in several places around the abdominal area, allowing it to root and spread from multiple areas. When this occurs, the survival rate for leiomyosarcoma drops almost 50 percent over a five year period.
Several victims and their families have already filed claims against Johnson & Johnson and other manufacturers. These claims assert that the manufacturers did not research their products carefully or institute a power morcellator recall fast enough to prevent some cancer cases. These companies likely face major judgments in the near future, and will have to compensate many families for the loss of their loved ones.