At least 11,300 people have now signed a petition to ban power morcellator use in laparoscopic fibroid removal procedures, according to an update posted on its Change.org webpage.
As of July 7th, 2014, 11,362 supporters were included on a petition created because of a woman in Massachusetts whose Stage 4 uterine cancer diagnosis followed a minimally-invasive hysterectomy incorporated by a morcellator. The petition was launched by her husband, a thoracic surgeon at Brigham and Women’s at the end of 2013, to raise awareness about the device used to cut up uterine tissue so it can be more easily removed in certain gynecologic procedures.
A statistic posted on the Change.org webpage indicates that the lifespan of a woman whose sarcoma is disseminated via uterine morcellation may only extend between 24 and 36 months. Additionally, patients with Stage 4 leiomyosarcoma (LMS) may have only five years to live, according to the petition.
The petition was launched at the end of 2013; long before a public health alert issued two months ago by the U.S. Food and Drug Administration (FDA) raised public awareness on the issue. At the time of the April 2014 warning, the FDA estimated that 1 and every 350 women undergoing fibroid removal surgeries had previously undetected uterine sarcoma, a rare form of uterine cancer that may have life-threatening side effects if it spreads throughout the peritoneal cavity. Given this risk, the FDA advised doctors against conducting certain surgeries with a power morcellator, and alerted the public that it planned to delve into the issue further during a summer meeting with its Obstetrics & Gynecology Devices Panel.
The two-day convention was scheduled to take place on July 10th and 11th, at which time experts would discuss recommendations about the use of power morcellators, and whether their warning labels should be adjusted to reflect the risk for uterine cancer promotion. Additionally, the Johnson & Johnson subsidiary, Ethicon Inc. ceased sales of several devices following the FDA alert in April, pending the federal agency’s safety review.
Court documents indicate that numerous power morcellator lawsuit claims have been filed on behalf of women in the U.S. Two federally-filed claims in May, for example, allege the spread of uterine cancer following use of a power morcellator.