On April 30, 2014, Johnson & Johnson’s Ethicon unit, the world’s largest manufacturer of laparoscopic power morcellators ordered a cessation in the manufacture, promotion and sales of its devices following the April 17, 2014, safety communication notice from the US Food and Drug Administration which persuaded doctors against the continuous use of the device in hysterectomy and myomectomy procedures.
The FDA’s safety alert was based on medical reviews and reports which showed that, when used in laparoscopic procedures, a morcellator can cause uterine sarcoma, a cancerous tissue, to spread beyond the uterus.
Hysterectomy is a surgical procedure performed to treat cancers of the uterus, cervix and ovary, infections of the uterus, persistent pelvic pains, uncontrollable vaginal bleeding, endometriosis, pelvic inflammatory diseases, endometriosis, uterine prolapse, and heavy and painful periods due to adenomyosis. Its main purpose, though, is to remove a part of, or the whole, uterus and/or uterine fibroids or myomas, which are benign or non-cancerous tumors that grow in the muscular wall of the uterus (uterine fibroids can be removed either through hysterectomy or myomectomy).
The National Institutes of Health states that any woman has the tendency to develop uterine fibroids. This may render doctors no actual reason for concern except for the fact that there are women, according to a study by the FDA, with fibroids and who also have uterine sarcoma, a cancerous tissue. These cancerous tissues, though, are almost undetectable, but, when subjected to a morcellator treatment these too are cut and made to spread outside the uterus, thus, putting the patient’s life in much greater danger.
Though Johnson & Johnson’s Ethicon might have ceased sales, other manufacturers have not and some doctors still continue to use the device as the FDA has not issued a total ban on its use. Morcellator lawsuit attorneys have already filed complaints and more are still expected to be brought to court. Women, who have been harmed, should not have second thoughts about filing a lawsuit against the manufacturer of the harmful device used to treat her. A lawsuit may also determine her worthy of receiving compensation from the accused.Read More