Intuitive Surgical Inc. Cuts Its Growth Projection Following a U.S. Food and Drug Administration (FDA) Warning

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Intuitive Surgical Inc., the maker of the da Vinci surgical robot, cut estimates for the number of surgical procedures expected to be performed with its robot system in the wake of a federal regulator warning concerning the risk of cancer spreading during uterine surgeries when power morcellators are used.

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Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, notes that, according to an April 23, 2014 Wall Street Journal report, Intuitive Surgical slashed growth projections after the FDA issued a warning concerning power morcellators and the devices’ ties to increased risks for the spread of cancer during certain surgeries conducted to remove fibroid tumors. (The Wall Street Journal FDA Warning for Intuitive Surgical Inc., April 23, 2014)

Although Intuitive Surgical does not manufacture power morcellators, gynecologists report that it is common practice for surgeons to use the da Vinci system to perform the initial steps in a hysterectomy, following up with handheld tools to conduct the morcellating, according to the Journal report. (The Wall Street Journal, April 23, 2014)

The FDA warned that use of power morcellators may unexpectedly spread cancerous body tissue into the abdomens of patients. The agency also urged surgeons to consider other treatment options when operating on women diagnosed with symptomatic fibroids to conduct myomectomies (fibroid removal) or laparoscopic hysterectomy (uterine removal). The devices typically cut the fibroid or uterine tissue into pieces. These pieces are then pulled through the body by way of abdominal incisions. (FDA Press Release, April 17, 2014 ; FDA Safety Communication: April 17, 2014)

“FDA data continues to show that robot-assisted surgeries lead to increased risks for serious adverse events. Intuitive Surgical, along with the hospitals that use the robot system, should consider alternative methods of available treatment,” says Gary P. Falkowitz, a Managing Attorney at Parker Waichman LLP. “Surgeons and hospitals should also ensure that patient care comes first and patients fully understand the risk-benefit profile of any surgery that involves use of a robot system.”

FDA data indicates that at least one of every 350 women diagnosed with fibroids, which are typically non-cancerous, may also have a uterine sarcoma (uterine cancer). When that uterine sarcoma is sliced and the tissue is moved through the body, the cancer may spread, which may cut long-time survival rates. According to the agency, several other treatment options are available for women with symptomatic uterine fibroids that do not involve use of a power morcellator. What’s more, according to data, whenever possible, vaginal hysterectomy provides comparable or improved results and fewer complications than laparoscopic or abdominal hysterectomy. (FDA Press Release, April 17, 2014 ; FDA Safety Communication: April 17, 2014)

Parker Waichman LLP continues to offer free legal consultations to victims of injuries allegedly caused by the da Vinci surgical robot. If you or a loved one experienced surgical burns, perforated or torn organs, torn blood vessels or other injuries that could be associated with the da Vinci surgical robot, please contact their office by visiting the firm's da Vinci Surgical Robot Lawsuit page at Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).

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