The Laparoscopic Power Morcellator & Cancer
Up until recent years, the power morcellator was considered a choice surgical tool for minimally-invasive hysterectomies.
But after reports surfaced of the device dramatically escalating disease in patients with undiagnosed uterine cancer, the U.S. Food and Drug Administration investigated and issued serious warnings about its use.
These FDA alerts, along with activist efforts to inform the public, shocked the healthcare community and drove many influential players to take action, resulting in groundbreaking events such as:
- Bans on power morcellators in respected hospitals
- A worldwide recall of the devices from a major manufacturer
- Discontinuation of coverage for surgeries employing power morcellators in policies from the nation’s top insurance companies
- Enactment of a constitutional amendment regarding the tracking of power morcellators and similarly dangerous devices
What Is a Power Morcellator?
The power morcellator is a surgical instrument that grinds up organs and other large masses of tissue in a patient’s body. It was designed for use in a particular type of surgical option called laparoscopic surgery, where the surgeon performs the operation through incisions in the abdomen that are less than a few centimeters wide.
Design and Operation
For an organ removal surgery such as a hysterectomy to be performed laparoscopically, there must be a way to cut up the organ into small pieces inside the body and retrieve the pieces through the tiny abdominal incisions. To fit this purpose, power morcellator designs generally possess the following elements:
- A extending claw that can grasp and pull at the target organ
- A set of rotating blades, enclosed at the end of a long, thin tube, that cut up the target organ into bits of tissue as it is pulled into and through the tube by the claw
- A vacuum system that enables the ground-up tissue to be vacuumed through the tube and out of the body
- A handheld piston or robotic control box, through which the surgeon controls the device
For more about the development and history of the power morcellator, visit our research and studies page.
The problem with power morcellators lies in the way their spinning blades easily disperse bits of tissue around the inside of the body.
Even if the devices are used on healthy tissue, these remnants can take hold in surrounding internal structures and cause large, obstructive growths to take root, sometimes causing pain or other adverse symptoms for the patients.
But if a power morcellator is used on cancerous tissue, the results can be truly disastrous. Pieces of malignant tissue can “seed” cancer in new locations all over the body, dramatically increasing the severity of the disease. The “upstaging” of cancer has a huge impact on health and quality of life, and can potentially rob the patient of years of life.
Power Morcellators Released and Used Routinely Despite Evidence of Risks
The possibility of power morcellators spreading cancer had been discussed by medical researchers in peer-reviewed studies and case observation even before the device’s market release.
Placed on the Market Without Rigorous Testing
Despite that alarming body of research, the device was allowed on the market without the usual extensive safety testing and clinical trials, through a controversial FDA procedure called 501(k) clearance.
To be cleared via 501(k), a device is judged only on its similarity to a product already sold on the market. Thus, the power morcellator was not required to undergo significant safety testing before release because the “predicate device” that it was being compared against was considered safe.
Popularity of Laparoscopic Surgery Drives Power Morcellator Use
After power morcellators were cleared for gynecological use in the mid-90’s, their leading application soon became laparoscopic surgeries for treatment of uterine fibroids.
Uterine fibroids is an exceedingly common noncancerous condition, occurring in as much as 80% of women of childbearing age and older. Though many women experience no symptoms from fibroids, some women suffer from serious problems such as heavy, abnormal bleeding, chronic pain, bowel obstruction, and infertility as a result of them.
Seeking solace from these adverse symptoms, many women opt for treatment via surgical removal of the uterus (hysterectomy) or of just the fibroids (myomectomy).
When power morcellators were released, laparoscopic surgeries were becoming increasing popular. In comparison to traditional open surgery, where large abdominal incisions are made to allow room for the surgeon to maneuver with conventional surgical tools, the “keyhole” incisions from laparoscopic surgeries offered benefits such as faster recovery periods and less pain/scarring.
The perks of laparoscopic surgery were promoted by many doctors and device manufacturers, and many patients were led to believe that morcellator-aided laparoscopic operations were a safer and easier choice for their fibroid treatment surgeries. Some patients who are now filing lawsuits against manufacturers say that they were told that the risk from power morcellators was negligible.
Circumstances Compound Morcellator Risks
Tragically, the use of power morcellators for uterine fibroid removal surgeries poses a particular threat to patient health, for several reasons:
-The appearance and symptoms from uterine fibroids is similar to those of the tumors of leiomyosarcoma, a rare but deadly form of uterine cancer. Thus, some patients who are believed to suffer from uterine fibroids are actually harboring uterine cancer.
-It is virtually impossible to screen for leiomyosarcoma prior to surgery. This is because it is a type of uterine sarcoma, a cancer that arises in smooth muscle or connective tissue, and thus is not readily sampled without surgical biopsy. Also, its tumors look too similar to fibroids to be diagnosed via radiological imaging
– Though leiomyosarcoma is rare, many women who experience serious uterine fibroid symptoms also have risk factors for the disease, such as ages over 40 and high body weights.
These alarming facts are likely part of why the FDA warned against the use of power morcellators in “the majority of women.” Based on its review of available medical research, the agency estimated that 1 in 352 women undergoing treatment for uterine fibroids harbors undetected uterine cancer. This is much higher than the figure that some patients report they were told—1 in 10,000 women.
Furthermore, some patient health advocates feel that because is currently impossible to know for sure whether uterine tissue is malignant or not, morcellators should be completely banned.
Patients Take Legal Action
Another striking aspect of the public fallout about power morcellators is the pending litigation surrounding them.
More than 20 lawsuits have been filed across the country by affected patients against device manufacturers, medical professionals, and hospitals.
These heartbreaking cases describe women undergoing what they thought were routine, safe surgeries, only to later face terrifying advanced cancer diagnoses. A morcellator-aided surgery practically condemned these patients to the extreme anguish of fighting uterine cancer, undergoing exhausting treatment plans, and for some, succumbing to an early death, according to allegations.
The Burkhart Tragedy
Tragically, this is exactly what occurred in the case of Pennsylvania resident Donna Burkhart, as described in a lawsuit filed against device manufacturer LiNA Medical by widower Scott Burkhart.
In 2012, Donna Burkhart underwent a laparoscopic hysterectomy with power morcellation to treat heavy bleeding that she and her doctor thought stemmed from benign uterine fibroids.
Before the operation, Donna showed no signs of cancer, but just 9 days post-surgery, she was diagnosed with uterine leiomyosarcoma. Donna had not been informed whatsoever of the possible risks of “seeding an undiagnosed sarcoma” posed by the power morcellator that would be used in her surgery, according the Burkhart lawsuit.
Donna survived for only 11 months after her diagnosis, dying in excruciating pain in February 2013, after living a nightmare of chronic stress, pain, exhaustion, fear, and sorrow from the effects of her disease, as reported to CBS by her daughters and Scott. She was only 53 years old at the time of her death.
Burkhart Suit Ends in a Settlement
In what the Burkart’s lawyer calls “the first major federal product liability lawsuit involving a uterine morcellator manufacturer,” Scott Burkhart directed claims of negligence and wrongful death at LiNA Medical.
Scott holds the device manufacturer responsible for the suffering and untimely death of his beloved wife and mother of his children, saying that the aggravation of her undiagnosed disease could have been avoided if LiNA Medical had only properly warned doctors and hospitals about the risks inherent in their products.
Like in other pending morcellator lawsuits, Scott pointed out that LiNA Medical should have been aware of the extensive body of available research suggesting that power morcellators could spread cancer, some of which was publicly available 2 decades ago.
Just before the suit was scheduled to go to trial, LiNA Medical offered a settlement, resolving the case with Scott’s cooperation. This was an unusual occurrence, as companies will typically fight in court until similar claims have been judged in favor of the plaintiff, but it suggests that settlements are a distinct possibility for the remaining pending morcellator cases and for those yet to be filed.
More Cases Are Expected to Surface
Though the power morcellator is now generally considered a threat to public health, a staggering number of women have already been exposed to the possible risks. The device had been used on an estimated 100,000 women per year in the U.S. since its introduction in the early 90’s.
Thus, it is highly likely that many more patients that have the right to file claims, and we may see more lawsuits arising in the near future. A report filed with the Judicial Panel for Multi-District Litigation states that about 300 possible cases are currently under investigation.
Could You Have a Case?
If you or someone you love had an operation involving power morcellation and later received a cancer diagnosis, you may be entitled to significant compensation for the pain, suffering, and loss you may have endured.
Contact Monheit Law today for a case evaluation at no cost. If you are eligible to file a claim, our experienced lawyers will work to gain justice for you on a contingency fee basis—you pay nothing until we win a court award or settlement in your favor.