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 News

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 News

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 News

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 Wall Street Journal

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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

 

FDA and Scientific Studies Regarding the Power Morcellator

Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators

As the number of laparoscopic and minimally invasive procedures has increased with the introduction of new surgical technologies and techniques, additional safety information has become available regarding the use of LPMs. Recent discussions within the patient and clinical communities, as well as the peer-reviewed medical literature, have raised awareness of the risk of spreading unsuspected cancerous tissue beyond the uterus when LPMs are used during gynecologic surgeries intended to treat benign fibroids. Numerous case reports and case series have been published that describe the iatrogenic dissemination, implantation, and subsequent growth of unsuspected neoplastic tissue within the peritoneal cavity following laparoscopic morcellation of uterine tissue believed to contain fibroids based on preoperative diagnosis. FDA’s recent analysis of available information suggested that the risk of an occult uterine sarcoma in a woman undergoing surgical intervention for presumed fibroids is substantially higher than had previously been assumed or reported. FDA’sanalysis also suggested that patient outcomes, including survival, may be significantly adversely impacted from this upstaging of disease. To read more, click Guidance for Industry and Food and Drug Administration Staff

FDA warns against using laparoscopic power morcellators to treat uterine fibroids

The U.S. Food and Drug Administration is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids. In an updated safety communication, originally issued in April 2014, the FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women. In an Immediately in Effect (IIE) guidance, the FDA is also recommending that manufacturers of laparoscopic power morcellators include in their product labeling specific safety statements in the form of a boxed warning and two contraindications. The IIE guidance allows the FDA to issue its recommendations expeditiously to help address a significant public health issue.