The lawsuit involving the Power Morcellator concerns the increased risk of significantly 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). By upstaging an undiagnosed cancer, a patient’s chances for survival are dramatically decreased. Unfortunately, the manufacturers of these products failed to adequately warn of this risk, resulting in injuries to many women.
The main manufacturer of the power morcellator is Ethicon, a subsidiary of Johnson & Johnson.
Why is a Morcellator Utilized & What are the Risks
Power morcellators are used in laparoscopic uterine surgeries, including hysterectomies and myomectomies.
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. In fact, the FDA recently 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.
Morcellator Lawsuit Videos
FDA and Scientific Studies Regarding the Power Morcellator
Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power MorcellatorsAs 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 fibroidsToday, 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. To read more, click FDA New Release
Power Morcellator Recall Information
Ethicon voluntarily recalled all of its power morcellator products. This recall occurred among great public scrutiny and concern about the risks associated with power morcellators.
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 Wall Street Journal
U.S. health insurance companies historically have never given an tinker's damn about patient lives. In a profit-driven system, their only concern has been maximizing those profits. If a treatment or a patient's condition threatened to cut into those profits, they would simply deny or drop coverage and allow the patient to suffer and die. To read more, click Levin Law NewsSurgical 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 JournalWhile Rome Burns . . . FDA Fails to Respond to Morcellators and Uterine Cancer
Case in point – power morcellators. Already implicated in spreading potentially cancerous cells throughout patients' bodies, these devices have caused the deaths of at least three women. The most recent victim is a young woman from Rochester, New York, who underwent power morcellation two years ago. She succumbed to a cancer that spread as a result of the removal of benign fibroid cells. To read more, click LevinLaw NewsMorcellators – Still Being Used Despite Risks
The risks associated with power morcellation surgery have been firmly established, and lawsuits from plaintiffs who have seen sarcomas spreading as the result of a relatively simple procedure are being filed. Johnson & Johnson, already dealing with massive litigation over other products, has ceased all manufacture and sales of morcellators, issuing a voluntary recall of the devices from hospitals this past July. Why then, are doctors still doing morcellation surgeries? To read more, click LevinLaw NewsA Minor Surgery For Women Is Discovered To Have Major Repercussions
So you go in for simple surgery. Removal of a fibroid, a hysterectomy. You choose the hospital, maybe go so far as choosing the surgeon to take this on. ‘It’s laparoscopic’ they say, and in our minds that means safe, effective and nearly scar-free. They say they use this device – they call it the power morcellator – that is sent through the incision to break up the fibroid or the uterus into small enough pieces to suck up through the incision and make what used to be a more major procedure into a minor, safer surgery. Except, it turns out, it’s not. To read more, click Ring of Fire Radio News