Cancer: The Greatest Risk in Using a Power Morcellator
On April 30, 2014, Ethicon, Johnson & Johnson’s power morcellator manufacturing unit, which is also largest manufacturer of power morcellators in the world, suspended all distribution, promotion and sales of its Gynecare Morcellex Tissue Morcellator, Morcellex Sigma Tissue Morcellator System, and Gynecare X-Tract Tissue Morcellator. This move by Ethicon was in response to the US Food and Drug Administration’s safety alert which persuades doctors against the further use of a power morcellator in laparoscopic surgeries that removed either the uterus (through a procedure called hysterectomy) or uterine fibroids (through myomectomy).
Reports in medical literatures show that power morcellators cause the spread of uterine sarcoma, a cancerous tissue, beyond the uterus. Uterine sarcoma is almost impossible to detect, though the FDA says that 1 in 350 women can definitely have it. Thus, during the morcellation of uterine fibroids (also done through hysterectomy), it too gets minced and scattered in parts outside of the uterus. The most common form of cancer that can result to this is leiomyosarcoma – rare, yet deadly.
The introduction of power morcellators in the 1990s (with at least a dozen models from different manufacturers getting FDA approval in 1995) led to an unprecedented improvement in the way hysterectomy was performed. These power devices were specifically approved for use in laparoscopic or minimally invasive surgeries, which is a type of surgery that requires about 3 – 4 very tiny abdominal incisions (about 0.5 – 1 cm, which are almost non-existent when compared to the very noticeable scar left by the 5 – 7 inches long cut on the abdomen in traditional abdominal hysterectomy). These are designed to mince or morcellate the uterus and other oversized tissues into fragments small enough to be suctioned outside the woman’s body.
Besides the very tiny incisions, the use of a power morcellator also made hysterectomy a less painful experience, lessened the amount of blood loss, reduced chances of infections, and required a shorter period for recovery due to the fast healing of wounds. Despite these many benefits, though, the FDA probably thought that the benefits do not actually outweigh the risk, thus the safety notice. The agency still continues to discuss with experts and people concerned about the safety and regulatory status of morcellators.
The website of Williams Kherkher attorneys says it could be beneficial to women who have been treated with a power morcellator in the past and then diagnosed with cancer after the treatment to consult with a morcellator lawyer. They can find out if their particular case qualifies for a morcellator lawsuit for the possibility of receiving compensation from the manufacturer of the device.