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power morcellator 46 articles

FDA warns against robotically assisted surgical devices for mastectomy

Doctors should be cautious when using robotically assisted surgical devices for mastectomy and other cancer-related surgeries that are not approved by the Food and Drug Administration (FDA), the agency said in a Safety Communication. The robotic devices are not generally used for cancer surgeries, and the safety and effectiveness of these devices for mastectomy have not been established, said Terri Cornelison, M.D., Ph.D., assistant director for the health of women in the FDA’s Center for Devices and Radiological Health. The Safety Communication comes three weeks after Medscape Medical News published a story in which Hooman Noorchashm, M.D., Ph.D., a surgeon ... Read More

Power morcellation still bad idea for ‘vast majority of women’

Women with undiagnosed uterine cancer who undergo a laparoscopic procedure using a surgical tool called a power morcellator for hysterectomy or myomectomy (uterine fibroid removal) have higher rates of previously undetected uterine cancer spreading and worsened odds of survival, the Food and Drug Administration (FDA) reiterated in a white paper. “Since the FDA first issued warnings about the risk of spreading unsuspected uterine cancer from use of laparoscopic power morcellators, we have continued to review new research to ensure our recommendations reflect the current scientific evidence,” said Jeff Shuren, MD, Director of the FDA’s Center for Devices and Radiological Health. ... Read More

Morcellator maker faces wrongful death lawsuit

Sumaira Khan passed away in 2016 from cancer before she could file a product liability and medical negligence lawsuit against a medical device maker and a hospital claiming the two should have known that the device could cause the spread of cancer, worsening her odds of survival. However, her estate prevailed last week with the filing a wrongful death lawsuit in New Jersey court, Law360 reports. Kahn claimed that she was never told by her doctors at Valley Hospital in Ridgewood, New Jersey, that using the Rotocut power mocellator made by Karl Storz GMBH & Co. to perform her minimally ... Read More

Olympus settles power morcellator case

A group of Olympus Corporation of Americas subsidiaries settled a lawsuit with a Georgia couple who had sued the companies over claims that their medical device used in gynecological surgeries caused the spread of the plaintiff’s uterine cancer, immediately worsening her odds of survival, according to Law360. Betty Dobson underwent a hysterectomy in 2010 with Olympus’ PSK PlasmaSORD Bipoloar Morcellator, a type of power morcellator used to perform hysterectomies and myomectomies (uterine fibroid removal). The device is fitted with a tube-like blade that minces uterine growths or entire uteruses within the body and removes the tissue through a small incision ... Read More

Power morcellator advocate loses battle with cancer

Dr. Amy Reed worked alongside her husband, Dr. Hooman Noorchashm, to urge the Food and Drug Administration (FDA) to ban a surgical tool called a power morcellator for hysterectomies and myomectomies (uterine fibroid removal) because the device could spread undiagnosed uterine cancer, worsening a woman’s odds of survival. The issue was close to the hearts of Reed and Noorchashm, because in October 2013, Reed had undergone a power morcellation procedure after which she learned she had leiomyosarcoma of the uterus. She simultaneously fought the FDA to remove the device as she fought to save her life. On Wednesday, Reed lost ... Read More

Power morcellator victim who shed light on cancer spread risk with device dies

Bonnie Davis was healthy and in shape in Feb. 1, 2012, when she underwent a hysterectomy to relieve uterine fibroid symptoms. Her doctor opted to use a less invasive surgical tool called a power morcellator, which was fitted with a tube-like blade that would mince her uterus within her body and extract the tissue through a small incision in her abdomen. The procedure was ideal, allowing Davis far less recovery time than if she had undergone open surgery. She was also at less risk for infection and scar tissue buildup. What doctors didn’t know – and couldn’t know until the ... Read More

Public invited to report medical device makers who violate the law

The Food and Drug Administration has launched a new portal on its website for consumers to report medical device manufacturers or medical device marketers who may be in violation of the law. The website, called Reporting Allegations of Regulatory Misconduct, invites anyone to report any suspected suspicious activities by makers or marketers of medical devices. Examples of allegations include promoting or advertising a device that has not been cleared or approved by the FDA; failing to report safety concerns or adverse events to the FDA; manufacturing devices that don’t meet design requirements; or hiding information from the FDA such falsifying ... Read More

FDA may be making same deadly mistake it made approving power morcellators

Philadelphia-area doctors and husband-and-wife advocates Hoosman Noorchashm, M.D., Ph.D., and Amy J. Reed, M.D., Ph.D., published an editorial in The Inquirer Daily News warning that the Food and Drug Administration (FDA), in approving a new device, may be repeating the same deadly mistake it made when it approved the use of power morellation for hysterectomies and myomectomies. Power morcellators are surgical tools fitted with tube-like blades that shred uterine growths or entire uteruses within the abdomen and remove the tissue through a small incision in the belly. The procedure has been preferred in recent years to open surgery because it ... Read More

Lawsuits target makers of power morcellators due to cancer spread risk

Dozens of lawsuits have been filed against the makers of a surgical tool used during gynecological surgeries, alleging the devices have caused undiagnosed uterine cancers to spread aggressively, worsening the odds of survival. The device, known as a power morcellator, is used to perform laparoscopic hysterectomies and myomectomies (uterine fibroid removal). It is fitted with a tube-like blade that minces uterine growths or entire uteruses inside the body and then removes the tissue through a small incision in the abdomen. Power morcellation procedures have been favored over open surgeries because they are less invasive, leave less scar tissue, and offer ... Read More

FDA investigating why hospitals did not report cancer risks with power morcellators

The Food and Drug Administration (FDA) has conducted investigations of several hospitals to find out why doctors and administrators did not report patient injuries and deaths caused by complications for gynecological procedures using power morcellator devices. Under the Code of Federal Regulations, manufacturers of medical devices and hospitals are required to report to the FDA within 10 to 30 days adverse outcomes such as serious injuries and deaths that a medical device may have caused or contributed to. But in the case of power morcellators, this required reporting system appears to have failed. Power morcellators are surgical tools that shred ... Read More