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Laparoscopic Power Morcellators Pose Serious Risk of Spreading Unsuspected Cancer, Significantly Worsening Patients' Long-Term Survival Odds


Posted By Brendan Faulkner of D'Amico & Pettinicchi, LLC on Oct 16, 2014 in Product Liability

Wall Street Journal reports http://online.wsj.com/articles/gynecologists-push-back-on-fdas-caution-about-cancer-when-using-morcellation-in-hysterectomies-1411358341 that doctors across the country continue to use a gynecological tool, called a morcellator, to remove common benign uterine growths called fibroids even after the FDA warned, this past April http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm393689.htm that it can spread undetected cancer.

Laparoscopic power morcellators are medical devices used during different types of laparoscopic surgeries such as a myomectomy (removal of uterine fibroids). Morcellation refers to the division of tissue into smaller pieces or fragments and is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision sites.

The FDA warned that laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus, and that health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids.

As explained in the Wall Street Journal article, some in the gynecological community have resisted the FDA's recommendations in this regard. This reaction would seem in part to be fueled by the idea that the FDA has overreached by giving the appearance that it was telling clinicians how to practice medicine. That is folly however, and fails to put patient safety first. The FDA is responsible for protecting and promoting public health through the regulation and supervision of medical devices, pharmaceuticals, and other products.

Several product liability suits have been filed against morcellator manufacturers, and the use of morcellators even in the face of mounting evidence of their very significant risks may constitute medical malpractice. Some manufacturers have withdrawn their morcellators from the market, and some large insurers have declared that they will not cover laparoscopic morcellation surgery.

The FDA estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. Likewise, a recent report in the Journal of the American Medical Association found that 1 out of 368 women who undergo hysterectomies have an undetected uterine sarcoma, a dangerous cancer that morcellators can spread.

As the FDA explained: If 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, significantly worsening the patient's likelihood of long-term survival. 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.

This problem is yet another example of the dangerous shortcomings of the FDA's 510(k) process, which is how morcellators were cleared for sale, because it allows for the sale of a new device based on a previously approved "substantially equivalent" device, without requiring testing to demonstrate safety and effectiveness.