Empowering Consumers Hurt by Big Businesses

Local (415) 319-8833
Toll Free (855) 534-0061

MEDICAL DEVICES USED IN MINIMALLY INVASIVE SURGERIES COULD LEAD TO SPREADING OF CANCEROUS TISSUE

MEDICAL DEVICES USED IN MINIMALLY INVASIVE SURGERIES COULD LEAD TO SPREADING OF CANCEROUS TISSUE

The FDA recently issued a safety communication about the health risks associated with the use of laparoscopic uterine power morcellators. These medical devices are often used during various types of minimally invasive surgeries involving the uterus. Many women undergo such types of surgery due to "shorter post-operative recovery time and a reduced risk of infection", among other benefits. However, based on currently available information, the FDA discourages the use of laparoscopic power morcellators during surgeries in women with uterine fibroids.

FDA's concern is that, "[i]f laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis." This would "significantly [worsen] the patient's likelihood of long-term survival." The FDA thus recommends that uterine power morcellators are not used in women with suspected or known uterine cancer. The agency has further asked manufacturers of power morcellators "to review their current product labeling for accurate risk information for patients and providers."

Sources:

FDA,

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm

Categories