The Power Morcellator lawsuit claims the medical device increases the risk of upstaging undiagnosed cancer during laparoscopic uterine fibroid removal surgeries.
Upstaging means a change in the stage of a person's cancer from a lower stage (less extensive) to a higher stage (more extensive).
What Do We Know About the Power Morcellator Lawsuits
Power morcellators are used in laparoscopic uterine surgeries, including hysterectomies and myomectomies. The main manufacturer of the power morcellator is Ethicon, a subsidiary of Johnson & Johnson.
If women undergoing these surgical procedures have undiagnosed uterine cancer, the use of this device can upstage that cancer, which can dramatically decrease the chances for survival.
The FDA has estimated that 1 in 350 women undergoing surgical procedures where power morcellators are used have undiagnosed uterine sarcoma. The type of cancer most frequently seen with the use of this device is known as leiomyosarcoma.
Power Morcellator Lawsuit NewsDOJ Agrees to Investigate the Power Morcellator and Potential Link to Cancer
Morcellators, which have been in use for almost a quarter of a century, were designed to simplify hysterectomies by tearing uterine tissues into small bits in order to remove them with a laparoscope (this is sometimes known as “keyhole surgery”). It was touted as a minimally invasive procedure that would reduce hysterectomy recovery time from five days to two. To read more, click Drug Safety NewsDoctor with cancer raises alarm about medical device
Is the FDA doing enough to protect patients from potentially dangerous medical devices? Two Philadelphia area doctors say no. They're fighting to prevent more tragedies, while living through their own medical nightmare. 42-year-old Dr. Amy Reed and her husband, Dr. Hooman Noorchashm, have been fighting their battle since Reed was diagnosed with cancer in 2013. CBS Philly's Stephanie Stahl has been following their story for a year. Reed's cancer was found after an operation to remove uterine fibroid tumors. Surgeons used a device called a power morcellator to shred the fibroid tissue so it could be easily removed through a small incision. But the shredding ended up inadvertently spreading cancer that hadn't been detected. To read more, click CBS NewsTwo New Studies Add to Scrutiny of Gynecology Tool
New research is adding to scrutiny of a surgical tool called the laparoscopic power morcellator that the Food and Drug Administration has warned against using in a vast majority of cases because of its potential to spread hidden cancer in common gynecological procedures. To read more, click Surgical Tool Gets Strongest Warning: Morcellator Used in Hysterectomies Can Spread Undetected Cancer, FDA Says
The top U.S. health regulator warned Monday that a common surgical tool shouldn’t be used on most women during hysterectomies, a decision that caps nearly a year of debate and is expected to sharply curtail a procedure that the agency said can spread hidden cancer. The Food and Drug Administration used its authority to call for an immediate “black box” warning for laparoscopic power morcellators, the strongest caution the agency issues. Typically, such warnings on product labels undergo a lengthy comment period before being completed, lawyers for device makers said. To read more, click Wall Street Journal
For additional news stories, click Levin Law Morcellator News