Morcellator Lawsuits Still being Filed Against Johnson & Johnson

On April 30, 2014, Ethicon, the unit of Johnson & Johnson that is responsible for the manufacture, sale and promotion of power morcellators, ceased distribution and sales of said devices, and ordered their withdrawal from the market.

Ethicon’s move came barely three weeks after the U.S. Food and Drug Administration issued a safety alert on April 17, 2014, which advised doctors and hospitals against the continuous 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.

FDA’s decision 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 that are 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. Due to the many advantages of power morcellators, including performance of surgeries that require very tiny incisions that healed faster, shorter hospital stay for patients, lesser blood loss, reduced pain and minimal chances of infection or complications, many doctors began using them in the early 1990s to perform laparoscopic surgeries instead of the traditional open surgeries (such as abdominal hysterectomy, which required incisions between five to seven inches long).

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. These devices included the Gynecare Morcellex, the Morcellex Sigma and the Gynecare X-Tract. Despite the accuracy and efficiency of J&J’s power morcellators, however, the FDA found the risk of cancer a valid reason for doctors and hospitals to cease use of the device.

As mentioned in the website of the law firm Williams Kherkher, up to 50,000 morcellation treatments are performed in the U.S. 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.

Many more patients are expected to come to the open and file civil lawsuits they are legally entitled to pursue. These lawsuits may be their chance of seeking compensation for whatever damages the devices have caused in them.

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