Despite an appalling lack of safety testing and a long history of research suggesting its capacity for spreading cancer, the power morcellator was cleared for “routine” uterine surgeries and used on thousands of women per year until recently.
The device grinds up organs for removal through tiny incisions, in a supposedly safer alternative to traditional methods of surgical removal. But if used on patients with undetected uterine cancer, the power morcellator’s spinning blades can scatter malignant tissue inside the abdomen/pelvis, advancing the cancer and severely limiting the patient’s chances of survival.
The medical community is in an uproar over the dangers of the device, especially after the FDA issued multiple cancer risk warnings regarding its use. Patients who have been stricken with advanced cancers after morcellation are leveling claims against morcellator manufacturers, with 22 lawsuits already filed nationwide.
Did Morcellator Manufacturers Fail to Warn Consumers of Risks?
In these lawsuits, plaintiffs describe receiving little or no information on the possible cancer-spreading risk posed by the power morcellators that would be used in their surgeries. If such risk was mentioned at all prior to surgery, patients were led to believe they were practically negligible, according to their allegations.
A figure commonly quoted to patients as supposed evidence of low cancer risk was that only “1 in 10,000 women” seeking treatment for uterine fibroids has undetected uterine cancer. This incidence ratio is much lower than the FDA’s current “1 in 352 women” figure, as well as lower than many estimates published in medical journals, some of which had been available before power morcellators were even released.
Plaintiffs are citing publicly-available research that they say manufacturers willfully ignored. All of these estimates come from published studies of women requiring uterine fibroid surgeries:
- A 1990 paper estimated an incidence ratio of 1 in 140 women for uterine leiomyosarcoma, an aggressive cancer that morcellators have been found to spread
- A 1999 study put the incidence of undiagnosed uterine cancer at about 1 in 1000 women
- A 2011 case study compilation calculated a rate of “uterine malignancy” incidence of 1 in 100 women
These cancer incidence studies, as well as research literature directly expressing concern over morcellator cancer risk, should have prompted manufacturers to take precautions to safeguard patient health or to at least properly warn the doctors and hospitals buying their products, plaintiffs assert.
The Association Between Morcellators and Uterine Cancer
The power morcellator is simply an electromechanical grinding tool and cannot cause disease-free patients to develop cancer, so the danger lies in mistakenly operating on malignant tissue. But two factors in particular make it difficult to determine whether or not a morcellator patient has uterine cancer before surgery.
Leiomyosarcoma: Notorious for Evading Detection
The particular type of uterine cancer that morcellators are known to spread is leiomyosarcoma, which is rare but extremely lethal. It’s classified as a uterine sarcoma, a cancer that that arises in the smooth muscle or connective tissue of the uterus, and is particularly challenging to detect and treat.
In fact, leiomyosarcoma is virtually impossible to diagnose before surgery, because lab testing on surgically-obtained tissue samples is the only reliable detection method. Other common methods of detection, such as analysis of in-office swabs or radiological imaging, are only effective for cancers of the uterine lining.
Uterine Fibroids Can Mimic Leiomyosarcoma
Indeed, when viewed with radiological techniques such as MRI and CAT scans, leiomyosarcoma tumors mimic the appearance of uterine fibroids, a very common benign condition. Adverse symptoms from fibroids happens to be the leading reason why women undergo morcellator-aided hysterectomies and myomectomies in the first place.
Yet malignant tumors can also cause the same symptoms experienced by some fibroid sufferers, such as pelvic pain and heavy bleeding. Since uterine fibroids are so common, doctors and patients tend to assume adverse symptoms simply originate from fibroids rather than leiomyosarcoma, further compounding the possible cancer-spreading risks of morcellation.
Because surgeons currently cannot reliably screen for uterine leiomyosarcoma before the operation, some medical professionals feel that morcellator use is never safe enough to be justified.
How Do These Devices Affect Uterine Cancer?
You may ask how morcellator manufacturers can be held liable if cancer is already present before morcellation. The key injustice is how dramatically morcellators worsen the patient’s condition by causing new tumors to take root throughout the body.
The progression of disease for cancer is marked by “stages,” generally indicated by the degree to which the cancer has spread from the site of origin. Early stages of uterine cancer are mostly confined to the uterus and can respond well to treatment, whereas when cancer spreads and reaches an advanced stage, prognosis can be extremely poor.
Numerous plaintiffs have described having no signs of cancer prior to surgery, which likely indicates that their unsuspected cancer was still at an early stage. They allege that morcellation quickly “upstaged” their cancer, as many received post-operation diagnoses of stage IV leiomyosarcoma, the most advanced and life-threatening stage, with a shocking five-year survival rate of only 16%. At this stage, the disease is considered practically “incurable.”
Other Allegations from Victims
Along with failure to properly inform doctors and patients of accurate uterine cancer incidence rates, plaintiffs accuse manufacturers of:
- Defective design. Researchers have long shown concern over the potential cancer-spreading risk posed by the messy grinding of morcellators. Some critics say that manufacturers should have altered their products to include safety precautions such as surgical containment bags.
- Failure to adequately test. Manufacturers submitted the first morcellator models for approval through the FDA’s 501(k) process, which allowed for bypassing of rigorous safety testing before release. Plaintiffs also maintain that manufacturers should have regularly tested their products after release.
- Breach of warranty. Each product intended for human use includes either an implied or explicitly stated assurance that it will be safe for its intended use unless stated otherwise. Morcellators can prove extremely dangerous for cancer patients, as seen in multiple allegations.
These are just a few of many allegations being fired at device manufacturers. Most of the currently-pending morcellator lawsuits are framed as product liability suits and thus focus on how the design, manufacture, distribution, and advertising of morcellator products may have led to patient harm.
Have You Been Wronged by Manufacturers?
If you or your spouse underwent a morcellator-aided surgery and were later diagnosed with advanced cancer, you may be eligible to file a claim. Compensation for your suffering is possible—one morcellator lawsuit has already been resolved with a settlement, and at least 21 more are currently in progress.
Contact Banville Law today for a free case evaluation. Our highly-experienced lawyers will analyze your case, and if it’s viable, we will work for you on a contingency-fee basis, accepting no pay until we secure a settlement or court award in your favor.