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The Dangerous Effects of Power Morcellators

Posted on Feb 18, 2015 by in Injury Law, Product Liability Laws | 0 comments

Reports in a medical literature about power morcellators causing the spread of uterine sarcoma created a stir in the medical field during the very early part of 2014. Uterine sarcoma is a cancerous tissue that develops inside the uterus; there is no device, though, which is capable of detecting its presence. One type of cancer that can actually develop from uterine sarcoma is the rare, yet aggressive leiomyosarcoma, the very same cancer (already in its advanced stage) that was detected in a number of women who had undergone morcellation treatment wherein a power morcellator was used.

A power morcellator is a medical device that is capable of cutting oversized tissues into very tiny pieces. It is used in laparoscopic (minimally-invasive) surgeries, like hysterectomy and myomectomy, and was approved by the US Food and Drug Administration for this use in 1995. It became very popular among surgeons due to the many different benefits that it can provide, such as fast recovery of the patient, a surgery that resulted to lesser blood loss, much lesser pain and reduced likelihoods of infection. Compared to abdominal hysterectomy, an open surgery which required a 5-7 inches cut on the abdomen, a minimally-invasive surgery required only 0.5 – 1cm incisions.

Hysterectomy is the surgical procedure that removes the uterus or the womb, while myomectomy is the surgical removal of uterine fibroids, which are benign tumors that grow inside the uterus. The spread of uterine sarcoma occurs during myomectomy. As uterine fibroids are morcellated or cut into pieces, any cancerous uterine sarcoma tissues are also cut with the fibroids. Though already small enough to pass through the tube that will vacuum them outside the uterus, there are occasions when some pieces get left behind. According to the website of Williams Kherkher, these are the ones that spread outside the uterus and eventually develop to leiomyosarcoma.

Due to the risk of cancer, the FDA saw that the issuance of a safety alert was called for. Thus, a safety notice was indeed released on April 17, 2014, and it discouraged the further use of morcellators in laparoscopic surgeries.

Among the different manufacturers of power morcellators, the first to respond to the FDA’s alert was Ethicon, the power morcellator manufacturing unit of Johnson & Johnson. Exactly on April 30, 2014, Ethicon resolved to stop the promotion, distribution and global and national sales of its power morcellator, which included the Gynecare Morcellex Tissue Morcellator, the Morcellex Sigma Tissue Morcellator System and the Gynecare X-Tract Tissue Morcellator.

There are more than 50,000 laparoscopic surgeries (wherein a morcellator is used) performed in the US every year. A number of women, on whom the device had been used, have also been diagnosed with an advanced stage of leiomyosarcoma, a cause for them to pursue legal action against the manufacturer of the morcellator used on them. While many more lawsuits are expected to be filed, those who have undergone a laparoscopic surgery are encouraged to have a medical checkup in order to determine their real condition and take the necessary legal steps if necessary.

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