FDA Warns Power Morcellation Surgeries Could Spread Undetected Cancer in Women

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Federal health officials believe that use of a surgical device common to hysterectomy procedures could spread cancer. And for that reason, surgeons should stop using the device immediately.

Laparoscopic Power Morcellation-Lawsuit-Cancer-Wright-and-Schulte-LLCThe U.S. Food and Drug Administration warned recently that using laparoscopic power morcellation could enable the spread of cancer among women. In a Safety communication, the FDA says, “When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus. Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids. Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”

The warning from the agency will likely dramatically alter the way women are treated for uterine fibroids, according to a Wall Street Journal report. These are common but painful growths in the uterus and their presence often leads to about 40 percent of the hysterectomies performed in the U.S. every year.

Power morcellators work by using a tube-shaped blade to slice and remove the troublesome fibroids in the uterus, Wall Street Journal adds. The use of morcellators is preferred because it avoids open surgeries and reduces the risk of scarring. The FDA adds that power morcellators are used because patients prefer the shorter recovery time and purported lower risk of infection that’s normally associated with a traditional hysterectomy or myomectomy procedure.

The FDA says that using power morcellators in hysterectomy procedures could help spread a dangerous and undetectable cancer known as uterine sarcoma. The agency warns that 1 out of every 350 women who undergo a hysterectomy or myomectomy procedure has an “unsuspected” uterine sarcoma. Regulators warn that using a power morcellator on women with this form of uterine cancer could help spread the cancerous tissue to the abdomen and pelvis. If this happens, a woman’s chances at long-term survival are hampered.

Regulators warn in their safety statement: ” For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.” For that reason, the FDA is advising against using power morcellators for removing uterine fibroids and hysterectomy and myomectomy procedures.

Power morcellation should also not be used in women with a known or suspected case of uterine cancer. Further, women suffering from uterine fibroids should consider alternative treatments outside of a power morcellator. The FDA says that other treatments include a traditional – vaginal or abdominal – hysterectomy, a laparatomy that features a smaller incision, a deliberate block of the uterine artery, high-intensity focused ultrasound, or drug therapy. The FDA advises patients and physicians to discuss the benefits and risks of all these procedures.

Regulators are also working with manufacturers of power morcellator devices to have them update product labels to indicate the risk of cancer cells spreading after their use in hysterectomy and myomectomy procedures.

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm
http://m.us.wsj.com/articles/SB10001424052702304626304579507642833016758?mobile=y

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