The Food and Drug Administration has approved the marketing of the first ever tissue container bag for uterine surgeries involving laparoscopic procedures with power morcellators.
The new device, called PneumoLiner, is a tissue containment system that works by isolating uterine tissue not assumed to contain cancerous cells.
Power morcellators are used in certain procedures where the uterus or uterine fibroids are cut into smaller pieces and extracted through incisions. However, it has been linked to cancer spread among women.
It Has Not Been Proven Effective In Cutting Cancer Risk
Though PneumoLiner shows promise in tissue containment, the federal regulators require the manufacturer to warn patients, doctors and health practitioners that the device has not been proven effective in reducing the risk of cancer spread during procedures.
The FDA has estimated that about one in 350 women who were subjected to hysterectomy (removal of the uterus) and myomectomy (removal of fibroids), is found to have unknown uterine sarcoma, a form of cancer.
When women undergo morcellation, there is an increased risk that the procedure will cause the spread of cancerous cells and tissues within the pelvis and abdomen, which will worsen the condition of the patient.
How Does It Work?
A plunger is used to deliver the PneumoLiner into the abdominal cavity. The tissue will be removed and placed inside the bag. After which, it will be sealed and inflated, allowing better visualization.
Inflation is needed to have a clearer view of the site by having ample working space around the tissue. This will prevent the breakage of the containment bag since the morcellator could puncture it.
Reviewing Information
In 2014, the use power morcellators has been banned by the federal regulatory agency. Uterine fibroids may have potentially fatal hidden cancer called leiomyosarcoma, and morcellators may cause spread of these cancerous cells.
The FDA is still reviewing information on laparoscopic power morcellation and it will relay information to the public on any developments on the issue.
It also alerts women and their doctors of the risks linked to power morcellation of uterine tissue. A warning label should be included in the device's packaging.
Photo: Ed Uthman | Flickr
