The U.S. Food and Drug Administration (FDA) has announced the approval of a new containment device for use with certain power morcellators.
The PneumoLiner system is designed to effectively isolate and contain uterine tissue not believed to be cancerous that is created by breaking up fibroids during morcellation.
Because the device has not yet been proven to reduce the spread of potentially cancerous tissue, the FDA is not recommending laparoscopic uterine surgery using power morcellation for the majority of women who require this type of surgery.
The approval comes amid lawsuits alleging that women were put at risk of serious cancer by the use of power morcellators during laparoscopic uterine surgery.
Power Morcellator lawsuits continue to be filed on behalf of women who believe the spinning blades of the morcellator spread deadly cancers to their body and worsened their outcome.
Power morcellators are used to cut and shred uterine tissue so it can be removed from the body through a small opening during minimally invasive surgical procedures.
But as the morcellator chops up tissue, it disperses this tissue throughout the abdomen, where the cells attach to the intestines or intestinal wall, or spread to other areas of the body.
If the tissue contains cancer cells, morcellation can cause immediate upstaging of the disease, taking it from a potentially treatable Stage 1 cancer to Stage 4 terminal cancer.
The PneumoLiner would contain this tissue and not allow it to be spread throughout the abdomen.
Minimally Invasive Hysterectomies Popular in the U.S.
An estimated 600,000 hysterectomies are performed annually in the U.S., and the FDA first approved power morcellators in 1991, paving the way for doctors to do minimally invasive hysterectomies.
The FDA revised its assessment of the cancer risk associated with morcellation in 2014, estimating that one in every 350 women who undergoes a hysterectomy for fibroids has an undetectable cancer that could potentially be spread by morcellation.
It is estimated that everyday that 2-5 women are exposed to cancerous tissues spread throughout their body as a result of power morcellation – a totally avoidable practice.
Women need to understand these risks before choosing the “minimally invasive” surgery.
PneumoLiner may become an answer in the future, but today, the best answer is to make women aware of the dangers and ban the use of power morcellation.
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