Power morcellators, surgical tools used in minimally-invasive varieties of hysterectomy and myomectomy, have recently been exposed by the FDA and public health activists as potentially risky devices that can severely worsen uterine cancer.
Purpose of Morcellator TV Commercials
You may have seen commercials on television that advertise legal services for victims of power morcellators. These commercials typically ask if the viewer has had a surgery that involved a power morcellator and mention a link between power morcellators and uterine cancer. Viewers are urged to contact a law firm to determine if they may be able to file a claim.
However, the limited time allotted for TV commercials barely allows them to shed any light on the power morcellator controversy and the associated litigation. Some commercials even contain statements that are misleading or outright inaccurate.
Monheit Law Seeks to Inform
Here at Monheit Law, we do not produce TV commercials though we have all the expertise and experience required for a successful power morcellator lawsuit. For us, it is most important that we help you understand your rights and any underlying facts and issues vital to power morcellator litigation.
7 Essential Facts Commercials Won’t Tell You
To help clear up any confusion you may have regarding the power morcellator controversy, we provide a list of 7 key facts.
1. Power Morcellators Can Worsen Cancer
These devices cannot cause uterine cancer nor do they increase one’s risk of developing cancer, as some TV commercials mistakenly state. What they can do is aggravate cancer that the patient unknowingly already has.
Power morcellators are designed to cut up large tissue masses for easy removal from the body through a small tube. The cutting is achieved with a series of rotating blades that tend to spray loose bits of tissue everywhere, and if that tissue happens to be cancerous, then the cancer can spread to other organs.
Since the spreading of cancer in the body can drastically worsen prognosis, the FDA has warned that power morcellators may severely limit a patient’s “likelihood of long-term survival.”
Tragically, as detailed in pending power morcellator lawsuits, numerous patients have died fighting advanced cancer allegedly brought on by morcellation.
2. The FDA Issued Multiple Warnings
In October 2013, anesthesiologist Amy Reed underwent a laparoscopic hysterectomy with power morcellation and received an advanced uterine cancer diagnosis shortly after. Being a medical professional herself, she was drawn to look into the available research.
Outraged with the considerable evidence of risk she found, Amy filed a report with the FDA, calling for a ban of power morcellators.
Prompted by Dr. Reed’s report, the FDA began closely investigating research studies and clinical analyses involving power morcellators. Some of the literature was published more than 20 years ago.
The FDA found its initial survey of research so alarming that it sent out a warning in April 2014, while its investigation of power morcellators was still underway. In November of the same year, after the investigation was wrapping up, the FDA issued an “Immediately-In-Effect” guidance for the use of power morcellators.
3. Power Morcellators Were Released Without Extensive Safety Testing
The first power morcellator was approved for release with the FDA’s 501(k) clearance process, which bases the eligibility of a product on its similarity to a “predicate” device already on the market.
Since the predicate was not considered to be dangerous and the power morcellator was judged as being similar enough to be roughly equivalent, the device was not subject to the amount of safety testing, clinical trials, and post-release monitoring that critics argue it should have been.
Furthermore, the power morcellator was initially cleared for general surgery, and through the same 501(k) process, subsequent models were approved for gynecological applications.
4. Unsuspected Uterine Cancer Rates Are Higher than Once Thought
The incidence of undiagnosed uterine cancer in prospective hysterectomy or myomectomy patients is higher than allegedly often advertised, despite much higher estimates being available for decades.
The plaintiffs in pending power morcellator lawsuits often describe being told that the risks of harboring unknown cancer were negligible. Prior to 2014, it was commonly believed that only 1 in 10,000 women had undetected uterine cancer, allegedly due at least in part to marketing efforts of power morcellator manufacturers.
Based on a review of available peer-reviewed research studies, the FDA calculated an estimate of 1 in 352 women having unsuspected uterine cancer, which more than twice the risk implied by the 1 in 10,000 figure.
5. Reliable Screening for Uterine Sarcoma is Currently Impossible
Leiomyosarcoma, the type of cancer that power morcellators have been found to spread is currently impossible to diagnose before surgery.
How is this so? Since leiomyosarcoma, like other uterine sarcomas, originates in the smooth muscle of the uterus, it can only be sampled via surgical biopsy, ruling out pre-surgery pathological testing
Furthermore, in radiological imaging, leiomyosarcoma tumors are virtually indistinguishable from uterine fibroids, a commonplace benign condition.
Advocates such as Dr. Amy Reed and her husband Dr. Hooman Noorchashm believe that these facts are grounds for a complete ban of power morcellators, since it is virtually impossible to tell whether tissue to be morcellated is malignant or not.
6. Lawsuits Have Been Filed; One Has Settled
So far, 22 morcellator-related claims have been filed in federal courts across the country. The number would be greater if claims filed at the state level were included.
The first power morcellator lawsuit was filed by Scott Burkhart against device manufacturer LiNA Medical, on behalf of his deceased wife Donna. This case reached a settlement even before it went to trial.
This is an unusual occurrence as it’s more typical for defendants to wait until a few “bellwether” cases have been judged in the plaintiffs’ favor before they consider offering a settlement, but may suggest that settlements are possible for both currently pending and future cases.
7. More Patients May Have the Right to File
Many more morcellator lawsuits are anticipated to surface, especially given the fact that thousands of women per year received morcellator-aided hysterectomies and myomectomies before greater awareness of the possible risks was raised by the FDA and activists.
If you think you may have a case regarding power morcellators, do not hesitate to contact Monheit Law for a free case evaluation. You may be entitled to significant compensation for your pain and suffering, and our team of experienced attorneys are here to help you.