Risk in Use of Power Morcellator

Posted By on Dec 1, 2015 | 0 comments


On April 30, 2014, Ethicon, Johnson & Johnson’s power morcellator manufacturing device, which is also the largest producer of power morcellators on earth, suspended all supply, 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 due to the FDA’s security alarm which persuades physicians against the additional utilization of an electric morcellator in operations that eliminated either the uterus (through a process called hysterectomy) or uterine fibroids (through myomectomy).

Reviews in medical literature show that strength morcellators cause the spread of sarcoma, a tissue that is cancerous, beyond the uterus. Uterine sarcoma is extremely difficult to find, although the United States Food and Drug Administration states that 1 in 350 women can definitely have it.  Hence, during the morcellation of uterine fibroids (also done through hysterectomy), gets minced and scattered in parts beyond the uterus. The most common kind of cancer that can lead to this is leiomyosarcoma – scarce, yet lethal.

The introduction of strength morcellators in the 90’s (with no less than a dozen versions from different makers obtaining FDA approval in 1995) resulted in an improvement that was unparalleled in how hysterectomy was performed. All these are created to mince or morcellate the uterus and additional oversize tissues into pieces small enough to be suctioned outside the woman’s body.

Besides the tiny incisions, hysterectomy was also made an experience by using an electric morcellator, lessened the total amount of loss of blood, reduced opportunities of infections, and required a shorter period on account of the quick healing of wounds for recovery. Despite these many advantages, though, the Food and Drug Administration likely thought the gains usually do not actually outweigh the chance, therefore, the security notice. The bureau still proceeds to check with people and experts concerned about the security and regulatory standing of morcellators.

For more info: http://www.williamskherkher.com/practice-areas/defective-pharmaceuticals/morcellators/

 

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