Power morcellators are medical devices that harbor risks of severely worsening the condition of patients with undetected uterine cancer. Used for grinding up tissue in minimally-invasive types of gynecological surgeries, these devices operate via spinning blades that readily disperse bits of tissue, “seeding” cancer if that tissue is malignant.
More than 20 lawsuits have been filed so far by patients who have been harmed by power morcellators, with more expected to surface. You may have seen TV commercials urging patients to look into filing a claim.
Power morcellator lawsuits can be exceedingly complicated, requiring consideration of complex background material for a comprehensive understanding.
Here at Monheit Law, we consider it of chief importance that our clients feel comfortable and confident in working with us to develop their cases. This page provides a morcellator legal FAQ which elaborates on questions regarding power morcellator litigation.
Morcellator Legal FAQ
This list is far from comprehensive and we realize that you may have many other questions regarding power morcellators.
Contact us anytime to schedule a free case evaluation with our experienced attorneys, who will be able to answer any questions you have, including those specific to your experience.
Did the FDA Issue Morcellator Warnings?
Yes, the FDA issued two separate warnings in 2014 advising against the use of power morcellators for uterine surgeries due to significant risks of spreading unsuspected uterine cancer.
The first was dated April 17, 2014 and it told patients and doctors to avoid morcellation for treatment of uterine fibroids in cases of suspected malignancy. This warning was sent out while the FDA was in the process of investigating the devices and considering a possible ban.
The second warning came out in November 2014, after the FDA performed more research review and held a comprehensive panel meeting. The warning was expanded to apply to “the majority of women,” and it included an “Immediately-In-Effect Guidance” for manufacturers to include a black box warning on all power morcellator packaging.
For more detail on these warnings and their effects on major healthcare institutions and the public, visit our FDA Warnings page.
Did the FDA Ban Power Morcellators?
No. Though a ban could still be enacted in the future, the FDA has not yet required that all power morcellators be pulled from the market or recalled from hospitals.
Ostensibly, the FDA has decided against a ban so far because a small subset of patients that has an especially low unsuspected cancer risk may benefit from having the option to receive a morcellator-aided laparoscopic operation rather than open surgery.
Critics of power morcellators remain skeptical and point out that minimally-invasive surgery and morcellators don’t necessarily go hand-in-hand, as viable alternatives to morcellation exist. The FDA continues to review the evidence and weigh the pros and cons of banning/recalling the devices.
Also, shortly after the first FDA warning was released, major manufacturer Johnson & Johnson decided to stop selling its power morcellator models, and later performed a “voluntary market recall.” For more information on the Johnson & Johnson recall, refer to the Research and Studies page.
Were Power Morcellators Tested for Safety?
Power morcellators were approved via the FDA’s controversial 501(k) clearance process, which considers a device’s eligibility for release solely based on its similarity to another device (termed the “predicate”) already on the market.
If the device submitted through 501(k) clearance is judged to be as safe as a predicate that requires no pre-market safety tests or clinical trials, then it will not be subject to the usual safety testing and monitoring.
Critics of the 501(k) process say that it favors corporate interests rather than that of patients, since it can allow for quick release of untested products with little regard for patient safety.
Do Power Morcellators Cause Cancer?
No, power morcellators cannot cause a completely-cancer free individual to develop cancer, nor does their use increase cancer risk.
The issue with power morcellators is that they can spread and escalate cancer that a patient already has, if unknowingly used on malignant tissue.
Early stage cancers may exhibit little or no symptoms. Thus, especially with the difficult-to-detect cancer varieties, uterine sacomas, that power morcellators have been known to spread, there is a significant danger of mistakenly operating on cancerous tissue and spreading the hidden cancer.
What Does It Mean to “Upstage” a Cancer?
Cancer progression is generally grouped into stages 0 through 4, with 4 being the most advanced and life-threatening stage.
There are various staging methods and doctors select the one to use depending on the specific type of cancer, but it’s common to base the stage upon the degree of spread that the cancer has reached in the body. Thus, anything that causes the cancer to spread and to get worse is said to be “upstaging” the disease.
What Type of Cancer Can Morcellators Spread?
Theoretically, research suggests any kind of malignant tissue could spread cancer if morcellated. Yet in the vast majority of available research studies, case studies, and legal claims regarding power morcellators, the type of cancer that the devices were found to spread is a rare, especially lethal uterine sarcoma called leiomyosarcoma.
Why is the spreading of this particular cancer linked with power morcellators? There are several interconnected reasons likely responsible for this:
- The leading use of power morcellators is in surgeries undergone to treat uterine fibroids, a common benign condition. Thus is it unsurprising that power morcellators would be linked with a type of uterine cancer rather than a cancer from any other organ.
- Leiomyosarcoma and uterine sarcomas (cancers starting originating in muscle) in general are difficult to detect. Unlike cancers of the uterine lining, which can be screened via in-office swab procedures or radiological imaging, sarcomas cannot be readily diagnosed prior to surgery. With no reliable screening method for sarcomas, the risks of unknowingly morcellating malignant tissue are higher than they would be for a more easily-detected cancer.
- Leiomyosarcoma tumors can closely mimic the appearance of uterine fibroids, the very condition most patients undergo a morcellator-aided surgery to treat. Though leiomyosarcoma might be rare in a general population of women, it might occur more frequently in the subset of women with uterine fibroid symptoms severe enough to warrant surgery.
Why Are Patients Filing Lawsuits?
The advanced leiomyosarcoma that these patients developed after power morcellation causes them a tremendous amount of hardship every day.
Fighting an advanced cancer is a traumatic experience that can involve intense stress, physical and emotional pain, financial difficulties, deterioration of health and quality of life, and in some cases, loss of years of life.
Affected patients and their families are taking legal action because they claim that the upstaging of their disease was directly caused by the negligence of device manufacturers and/or doctors/hospitals.
What Allegations Are Being Made?
Plaintiffs have made the following allegations:
- As patients, they were not properly informed of the risks posed by power morcellators prior to their surgeries.
- They were not given an accurate estimate of unsuspected uterine cancer;
- Research indicating the risks of power morcellators has been around for more than 20 years, and so the defendants either neglected this evidence or willfully ignored it
To read more about allegations made in power morcellator litigation, visit our Lawsuits page.
What is a Statute of Limitation?
A statute of limitation is a period of time after an event of interest during which a legal claim can be filed regarding the event. Statutes of limitation vary among states, and also for different types of lawsuits and circumstances.
For example, a statute of limitation can be extended past the regular timespan if evidence can be provided that suggests the defendant(s) concealed information, making it difficult or impossible for the plaintiff(s) to discover the source of harm within the normal period.
How Much Does it Cost to Hire Monheit Law?
You may be hesitant to file a lawsuit because you feel you cannot afford to hire a lawyer to help you win your case.
But you can lay this apprehension to rest–scheduling a case evaluation with Monheit Law costs nothing. In your free case evaluation, our experienced lawyers will carefully consider the details of your situation and determine your eligibility for legal action.
If you have a viable case, we can work for you on a contingency fee basis, which means you will pay nothing until we secure a settlement or court award in your favor.