New York, New York (PRWEB) July 19, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, notes that the U.S. Food and Drug Administration (FDA) sent a warning letter to Intuitive Surgical on July 17 after inspections by the agency in April and May found deficiencies, including the company’s failure to adequately report device corrections and patient adverse events, according to a July 19 Bloomberg report. The da Vinci surgical robot’s safety and cost effectiveness have also fallen under scrutiny, Bloomberg added, noting in the same report that, in February, U.S. regulators had started surveying surgeons about the robots on the heels of a rise in adverse event reports that included as many as 70 deaths since 2009.
“The FDA has clearly noticed and acknowledged Intuitive’s failure to disclose an increase in adverse events,” said Gary Falkowitz, Managing Attorney from Parker Waichman LLP. “Failing to disclose such issues is concerning.”
The Bloomberg report also noted that Intuitive’s surgical robotic system, used in more than 1,300 hospitals, is the company’s flagship product and has been the subject of negligence lawsuits alleging that patients were injured during surgeries with the device. Cancer surgery, hysterectomies and gall bladder removals are among the main procedures performed with the assistance of the surgical robot, which cost about $1.5 million each, the report added.
On March 14th, the American Congress of Obstetricians and Gynecologists (ACOG) issued a statement warning consumers not to let aggressive marketing overshadow the risks of robot-assisted surgery. According to the news release, there is no good evidence to show that procedures with the da Vinci surgical robot are as good as less invasive, far cheaper alternatives. ACOG, a group that represents 56,000 physicians, is not the only organization to express concerns about the safety and efficacy of robot-assisted surgery.
In March, the Massachusetts Board of Registration in Medicine also highlighted the potential for serious complications in an advisory. The advisory stated that, in light of growing reports of injuries associated with the da Vinci, there should be more oversight for surgeons, and patients should be better informed about the risks. The Board cited examples of patients who had suffered bleeding, adhesions and damage to the bowel and ureter; in one case, a piece of rectal tissue was mistakenly left inside a patient’s abdomen.
Parker Waichman LLP continues to offer free legal consultations to alleged victims of da Vinci surgical robot injuries. 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 yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney
Read the full story at http://www.prweb.com/releases/Intuitive_warning_letter/FDA/prweb10947040.htm.
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