Released without extensive safety testing, the power morcellator was once a common instrument in gynecological surgeries, routinely used on thousands of women per year in the U.S. But the surgical grinding tool can severely worsen disease in patients with undiagnosed uterine cancer. After a series of major FDA warnings acknowledged the morcellator’s dangers, women and surviving loved ones across the nation have begun to file lawsuits.
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Harmed Patients Pursue Legal Action
More than 20 lawsuits have already been filed by patients who describe suffering from advanced cancer shortly after undergoing morcellator-aided surgeries.
If you or a loved one experienced a similar situation, you may be entitled to significant compensation for all hardships and loss endured. Determining your eligibility to file a claim is as easy as scheduling a free case evaluation with the top-notch legal team at Banville Law.
In addition to being highly experienced, attorneys at Banville Law seek to make clients feel confident in our support . We make it a priority to thoroughly inform, and we will answer your specific questions regarding both legal and practical aspects of power morcellator litigation.
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Understanding the Power Morcellator
How can one surgical instrument have such grave effects on patients? To gain a comprehensive understanding of the risks harbored by the power morcellator, we need to look into its design and applications.
What is It & How Is It Used?
Power morcellators can finely grind tissue, providing surgeons a way to perform organ removal laparoscopically — that is, through abdominal incisions much smaller than those required for traditional open surgery.
Organs are minced up with the morcellator’s spinning blades and vacuumed up and out of the body through a thin tube.
Laparoscopic Hysterectomy or Myomectomy
Because of purported benefits such as shorter recovery times, laparoscopic options were becoming increasing popular among women seeking surgical treatment of uterine fibroids, an exceedingly common benign condition.
Though many women experience no symptoms, when fibroids cause serious problems such as abnormal bleeding and infertility, treatment via removal of the uterus (hysterectomy) or of the fibroids alone (myomectomy) is often pursued.
How Can The Device Spread Cancer?
However, many patients were unaware of the fact that symptoms associated with uterine fibroids sometimes actually originate from tumors harboring leiomyosarcoma, a rare yet deadly form of uterine cancer.
This reveals the central issue: If a power morcellator is used on cancerous tissue, its spinning blades can readily disperse tissue remnants throughout a patient’s abdomen/pelvis, “seeding” more cancer. This can bring a patient from an early stage of cancer with no noticeable symptoms to a severely life-threatening advanced stage, in a matter of weeks.
Tragically, a number of patients report choosing laparoscopic surgery with power morcellation, thinking it a relatively safe, routine option, and then facing a terrifying advanced cancer diagnosis after the operation.
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Approved Despite Lack Of Safety Testing
The FDA approved power morcellators via a controversial process called 501(k) Clearance, in which a device’s eligibility for market release is based solely on its similarity to a device already sold on the market.
Shockingly, because the first power morcellator was compared to a previous device that was considered “safe,” it was not subjected to the usual set of rigorous safety tests and clinical trials prior to release.
FDA Morcellator Warnings & Risk Estimates
After receiving complaints about power morcellators from patients stricken with advanced uterine cancer, the FDA considered recalling the devices and began surveying published research on them to make an informed decision.
Research dating back at least 20 years contained many observations about morcellated patients that supported claims of cancer-spreading risks in power morcellators.
The FDA found the research implications so unsettling that it issued a warning against power morcellator use in April 2014, while its recall investigation was still underway, as well as an updated warning in November 2014.
“Risky For Most Women”
The first “safety communication” the FDA sent the public regarding power morcellators stated that the use of the devices for the surgical treatment of uterine fibroids was “discouraged.”
After reviewing more research and holding a comprehensive panel discussion, the FDA now maintains that power morcellators should not be used in “the majority of women.”
Furthermore, the FDA issued a new type of urgent warning, an “Immediately-In-Effect Guidance” telling morcellator manufacturers to include specific warnings on their product labels. One of these was the prominent “black box” warning, which is the FDA’s more severe warning.
Cancer Incidence Rates Higher Than Expected
Based on the research surveyed, the FDA estimated that 1 in 352 women undergoing uterine fibroid treatment harbors undetected uterine cancer and that 1 in 498 women specifically has uterine leiomyosarcoma.
These incidence rates are much higher than the “1 in 10,000 women” rate that many patients had reported being given prior to their surgeries as an indication of supposedly negligible risk.
Did The FDA Issue A Recall?
The FDA has decided so far to stop short of a complete ban/recall of power morcellators, believing that the devices could prove relatively safe for a small subset of women.
However, as described in the next section, other influential organizations in the healthcare industry did find it necessary to ban/recall morcellators.
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Public Response To The FDA Warnings
These multiple warnings sent out by the FDA elicited a considerable response from major establishments in the healthcare industry, from the public at large, and even from U.S. legislators. Decisive action was taken to safeguard patients from the power morcellator:
- Leading device manufacturer Johnson & Johnson recalled its morcellator products
- Hospitals banned or severely restricted power morcellator use
- Major health insurance companies excluded coverage of morcellator-aided surgeries
- State legislators enacted a constitutional amendment affecting tracking processes for such “high-risk” devices as power morcellators
Can Manufacturers Be Held Liable?
Though some device manufacturers took swift action against power morcellators after the FDA warnings surfaced, affected patients are filing claims saying that such action should have taken place much sooner.
These patients hold device manufacturers liable for the pain, suffering, and loss resulting from advanced cancer caused by their power morcellator products.
Citing research studies that have been publicly available long before the FDA issued alerts, the plaintiffs say that manufacturers “should have known” about the risks even before the release of the first power morcellator, and yet failed to take steps to safeguard consumers.
Therefore, the lawsuits state, the patients were harmed due to manufacturer negligence and other misdeeds.
When Should I File a Case?
22 power morcellator lawsuits have been filed so far, and about 300 more claims are currently under investigation. The first morcellator suit filed has already been resolved in a settlement.
If you think you may have a power morcellator case, it is wise to obtain a case evaluation as soon as possible, or you may lose the right to file.
Each state enforces a statute of limitations–a period of time within which a suit regarding a particular event can be filed. Contact Banville Law today to determine your case eligibility at no cost.
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