Amanda Antell  |  August 22, 2014

Category: Legal News

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mesothelioma lawyerNew research suggests that using inflated tissue collection bags during hysterectomy procedures, while using morcellator devices, may significantly reduce the risks of uterine sarcoma. This research was conducted due to the rising number of cancer cases in association with power morcellator devices.

The study was published in the August 5 issue of the Obstetrics & Gynecology medical journal, from the researchers of Brigham and Women’s Hospital, along with the Center for Minimally Invasive Gynecologic Surgery in Massachusetts. The researchers found that using morcellator collection bags did indeed make the hysterectomy morcellator procedures safer.

Morcellator collection bags have been previously been available, but this ceased when several surgeons found that to be relatively useless during the morcellation procedure. Additionally, there was no substantial evidence at the time, which would have suggested that it would have increased the procedure’s safety. These isolation bags, also known as insufflated collection bags, were designed and created to catch biological debris that was produced during the procedure, allowing efficient removal.

However last month, a panel of advisors from the U.S. Food and Drug Administration (FDA) met and determined that there was no data indicating the bags made laparoscopic power morcellation any safer. The researchers disputed this decision, stating that their results had illustrated the opposite.

They analyzed 73 women who underwent the uterine fibroid removal surgery, using the morcellator device with the aid of the collection bag at four medical institutes, from January 2013 to April 2014.

During these procedures, surgeons deposited the uterine fibroids into a 50 -by-50 centimeter bag, insufflated in the peritoneal cavity, and then used the power morcellator within the bag so that it caught the debris and fluids. The researchers stated that the average operation time was 114 minutes, with 78 percent of the patients being discharged from the hospital the same day.

Despite the results of the study, arguments have been raised about the practicality of the isolation bags, including Dr. Charles R. Rardin, of the urogynecology division at Women and Infants’ Hospital in Providence, R.I. Rardin published an editorial in the same medical journal, questioning the plausibility and safety of collection bags, and pointed out that the scientists relied on only their visual assessments to determine whether or not the bags collected the debris effectively.

Overview of Power Morcellator Cancer Complications

Power morcellators
are medical devices that are typically used for laparoscopic surgeries such as hysterectomies and uterine fibroid removal surgeries.

The morcellators are used by breaking up fibroids or tissue through small incision in the patient’s abdomen, and then the uterine fibroid is removed through that incision. However, healthcare providers have recently found that these devices may be causing uterine sarcoma by unintentionally releasing cancer cells contained with in the fibroid.

The FDA released a warning about this possibility earlier this year, stating that one out of 350 women who undergo uterine fibroid procedures while using the morcellator device may have undiagnosed uterine sarcoma.

Currently, there is no medical diagnostic method to see if women suffer from the condition before going through the procedure. Because of this, the morcellator has been linked to aggressive leiomyosarcoma, endometrial stromal sarcoma, and other cancers.

As the public learned that the morcellator devices were linked to uterine sarcoma and other aggressive cancers, many women filed power morcellator lawsuits against medical device makers. Documented plaintiffs have alleged that these devices were unreasonably dangerous, and that they were not given full disclosure of the device’s complications.

In general, morcellator cancer lawsuits are filed individually by each plaintiff and are not class actions.

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If you or a loved one were diagnosed with cancer in the uterus, pelvis or abdomen within two years of undergoing surgery for a myomectomy (removal of fibroids), hysterectomy (removal of the uterus), oophorectomy (removal of the ovaries), or salpingectomy (removal of fallopian tubes), you may have a legal claim. See if you qualify by filling out the short form below.

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