The Risks of Power Morcellators
However, in recent years, the device has come under scrutiny in the medical community over concerns that it can spread undetected uterine cancer throughout the abdomen during surgery, posing significant risks to patient health and life expectancy.
Furthermore, the specific type of cancer that power morcellators risk spreading is the rare but often lethal leiomycosarcoma, which exhibits tumors that resemble benign uterine fibroids and cannot be reliably diagnosed prior to surgery.
FDA Warnings and Aftermath
In 2014, the Food and Drug Administration (FDA) warned medical practitioners, manufacturers, and the public about the possible dangers of power morcellators in two safety communications.
These FDA announcements were taken very seriously nationwide by major establishments, prompting many important events, including the following:
- Respected hospitals halted or put strict regulations on the use of power morcellators.
- Insurance companies, including Aetna, Inc., one of the top national providers, enacted policies ending or severely restricting coverage of surgeries involving power morcellation.
- Pennsylvania legislators pushed for constitutional amendments regarding approval and tracking procedures for potentially hazardous medical devices such as power morcellators.
- Leading device manufacturer Johnson & Johnson suspended sales of its power morcellator models globally shortly after the first FDA warning in April 2013 and later performed a global recall.
Johnson & Johnson Recall
Johnson & Johnson produced three power morcellator models through its subsidiary Ethicon and another one through its subsidiary FemRx, and had cornered the power morcellator market in sales volume by a large percentage.
In July 2014, about a year after the FDA warnings surfaced, the manufacturing giant initiated a “a worldwide market withdrawal” of its Ethicon line by requesting that doctors return any Ethicon morcellators purchased in the past.
The company stated that it had determined the “withdrawal” to be the best course of action during the FDA’s continued investigation of power morcellators, while waiting for the release of further guidelines or improved technologies aimed at reducing the risks of morcellation.
Lawsuits from Patients Diagnosed with Cancer Post-Surgery
Sadly, though the FDA warnings influenced many risk-mitigating policies to take effect, a number of patients had already been exposed to the risks of power morcellators, and some experienced grave consequences.
At least 22 legal claims have been filed throughout the country by patients or spouses of patients who underwent surgeries employing power morcellators and later faced advanced leiomyosarcoma diagnoses, grueling cancer treatment plans, and in some cases, an untimely death.
Many of these lawsuits were aimed at device manufacturers, including Johnson & Johnson’s Ethicon division, and took the form of product liability suits.
A Closer Look
It is important to know exactly what allegations are being made in power morcellator lawsuits, as some of the surrounding facts are complex and subtle.
Power Morcellators Can Spread Cancer
Note that the power morcellators have not been shown to cause cancer, but rather, if used on a patient who has cancer but is unaware of it, the spinning blades of the device can splatter bits of malignant tissue onto surrounding organs, “seeding” the cancer in new locations.
Generally, the further a cancer has spread from its original site, the more deleterious the effects on the patient become. Many of the plaintiffs describe going into surgery with no symptoms or indications of cancer and discovering post-surgery that they suffered from advanced, metastastic (widely spread) leiomyosarcoma, which often results in a very poor prognosis.
These experiences as well as the implications of current research studies led to the plaintiffs’ allegations that the use of power morcellators caused their undiagnosed, likely early-stage cancer to escalate to a life-threatening, treatment-averse late-stage form, causing serious physical harm, pain and suffering, emotional/mental distress, economic hardship, and in wrongful death cases, loss of years of life.
How Serious Are the Risks?
It would seem that to avoid the risks of spreading cancer with power morcellators, doctors should simply refuse to use them on cancer patients.
However, leiomyosarcoma, the type of cancer that morcellation has been seen to spread, is notoriously difficult to diagnose because its tumors often resemble benign fibroids—the very condition that most patients undergo morcellator-aided surgeries to treat. Also, the majority of patients seeking uterine fibroid removal possess multiple risk factors for uterine cancer.
Though it was previously believed that about 1 in 10,000 women who undergo uterine fibroid removal surgery will have undiagnosed uterine leiomyosarcoma, the FDA estimated an updated figure of 1 in 350 women, based on recent research.
Because of the new, much higher risk estimate and because doctors cannot reliably diagnose leiomyosarcoma prior to surgery, some experts, such as Dr. , feel that power morcellators are risky enough that they should be completely banned until new technologies are developed to mitigate the risks. from Hormones Matter
Were Device Manufacturers Aware of the Risks?
As research suggesting possible dangers of power morcellation had been available up to 20 years ago, device manufacturers should have been aware of the potential risks much earlier than the time of the FDA warnings, plaintiffs allege.
Indeed, the FBI recently initiated an official investigation of Johnson & Johnson in an attempt to ascertain how early and to what extent the manufacturer knew about serious power morcellator risks. So far, evidence has surfaced that the Ethicon unit received an alert to “reconsider the risk” posed to patients by power morcellators from Dr. Robert Lamparter, a pathologist from Pennsylvania, in 2006.
More Specific Allegations
Many of the Plaintiffs’ claims can be grouped under alleged failures to perform the following actions:
- Proper testing. Plaintiffs claim that manufacturers did not adequately test their products before and after release.
Part of this issue may originate from how power morcellators were first introduced via the FDA’s (501)k process, in which a new device is cleared for release based on its similarity to another device already on the market, which potentially allows for sidestepping of the usual rigorous pre-market safety testing.
Regardless, the plaintiffs allege that device manufacturers should have conducted their own testing to help ensure customer safety.
- Designing for safety. This group of allegations involves the design of power morcellators used on the plaintiffs and often refers to the fact that previous, non-power morcellator designs included containment bags that stop or reduce the dispersion of tissue.
- Monitoring of outcomes of product use and current research. Even if manufacturers were not initially aware of the possible risks of their products, they should have carefully monitored product use and any research studies involving their products, plaintiffs say.
- Warning consumers. These allegations criticize insufficient warnings on both product packaging and on product advertising material.
- Withdrawing from the market. Plaintiffs allege that manufacturers should have pulled their products to avoid endangering customers upon learning about the risks.
Future Lawsuits Likely to Surface
As thousands of minimally-invasive uterine surgeries with power morcellation have been performed yearly, it is expected that there may be patients suffering from adverse consequences who have not yet come forward to file a claim.
If you or a family member had a minimally-invasive hysterectomy or myomectomy aided by power morcellation and were later diagnosed with advanced uterine cancer, the New York defective device lawyers at Banville Law are here to help you gain justice. Contact us for a free case evaluation today.