Three Power Morcellators recalled by Johnson & Johnson
Ethicon is the unit of Johnson & Johnson that is responsible in the manufacture, sales and promotion of the pharmaceutical giant’s power morcellators, namely, the Gynecare Morcellex, the Morcellex Sigma and the Gynecare X-Tract. On April 30, 2014, however, Ethicon had to cease the distribution and sales of said devices, and ordered the withdrawal of these devices from the market. This was in response to the safety alert issued by the U.S. Food and Drug Administration on April 17, 2014, which discouraged doctors and hospitals from the continued use of power morcellators in laparoscopic surgical procedures, specifically in the removal of uterine fibroids or myomas through myomectomy and in the removal of the womb or uterus through hysterectomy.
The FDA’s safety alert is based on medical reports regarding the possible spread of unsuspected cancer tissues, called uterine sarcomas, during morcellation treatment of women with uterine fibroids. Due to the lack of a device that can accurately detect the presence of uterine sarcomas, risk of spreading it beyond the uterus can happen as uterine fibroids are divided (or morcellated) into pieces.
Power morcellators are medical devices designed to cut an overgrown uterus or fibroids into pieces tiny enough to allow them to be extracted through 0.5-1cm incisions. These devices have been approved by the FDA to be used in laparoscopic (minimally invasive) surgeries. Since the early 1990s, many doctors began preferring power morcellator-aided laparoscopic surgeries over open surgeries (such as abdominal hysterectomy, which required incisions between five to seven inches long) due to the former’s many advantages, including tiny incisions that healed faster, shorter hospital stay, lesser blood loss, reduced pain and minimal chances of infection or complications.
Johnson & Johnson introduced three of the best engineered power morcellators in the market in 1998 which, many believe, actually set the standard on the way the device should be designed. Despite the accuracy and efficiency of J&J’s power morcellators, though, and the overall benefits these provide, the FDA still find the risk of cancer not worth continuing the use of the devices.
Up to 50,000 morcellation treatments are performed in the US every year, with most of these for the purpose of removing uterine fibroids. In a number of U.S. states, morcellator lawsuits are on the rise, adding to the growth in the number of women seeking compensation. Though FDA’s safety alert does not totally stop doctors from using power morcellators, the FDA reminds them of their major duty in informing patients of the risks associated with the procedure.
As stated in the website of the law firm Williams Kherkher, morcellators are no longer uniformly recognized as safe and effective medical devices to perform hysterectomy or myomectomy. Study results that demonstrated a significant correlation between the use of the devices and cancer growth is the reason why Johnson & Johnson recalled three of its power morcellators. Anyone suffering from cancer growth after a surgical procedure involving a morcellator, you can hold responsible the medical device manufacturer whose product caused you harm.