Women across the country may have been seriously endangered by the cancer-spreading risks of power morcellators, once-common surgical devices that were denounced by the Food & Drug Administration in 2014.
More than 20 lawsuits have already been filed by patients who report contracting advanced uterine cancer shortly after undergoing morcellator-aided surgeries. These patients feel their grave condition could have been avoided, if morcellator manufacturers had only taken sufficient action to protect patient safety.
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What Is A Power Morcellator?
A power morcellator is a surgical instrument used to cut up internal organs for removal through small abdominal incisions. They were heavily employed in routine hysterectomies until recently.
Released Without The Usual Safety Testing
The first power morcellators were cleared for release on the market in the early 90’s, via the FDA’s much-criticized 501(k) process. To gain 501(k) approval, a device only has to be judged “substantially equivalent” to a previously approved device. This permits manufacturers to bypass the rigorous safety testing usually required of new, potentially dangerous products.
20 Years of Research “Ignored”
Medical researchers have long shown concern over the possible health threats inherent in the power morcellator’s grinding mechanism. In multiple studies, the device’s high-speed rotating blades were observed to readily disperse bits of tissue.
If the tissue happens to be cancerous, such scattered remnants can “seed” new malignant tumors all over surrounding organs, spreading disease.
Research on the possible risks of morcellation has been publicly available since 1990, before power morcellators were even released. Morcellator plaintiffs cite these studies to support their claims that manufacturers “should have known” about the serious cancer-spreading risks of their products and yet “failed” to take appropriate action.
Risk Compounded by Cancer-Screening Challenges
A power morcellator’s threat to patients is unleashed when a surgeon operates on cancerous tissue. But screening for cancer prior to surgery can be exceedingly difficult.
In fact, leiomyosarcoma (LMS), the type of uterine cancer that morcellators have been found to spread, is impossible to reliably diagnose without surgery. Common cancer screening methods such as MRI or CAT scans are ineffectual for uterine sarcomas (smooth muscle/connective tissue cancers) like LMS.
The most reliable way to detect LMS involves surgically-extracted tissue samples, but after the surgery is performed, the damage has already been done.
Even worse, the leading reason why women were given morcellator-aided hysterectomies was for treatment of uterine fibroids, benign growths that can closely resemble LMS tumors.
For more information on the problem with diagnosing uterine cancer prior to surgery, visit Fibroids: A Gynecologist’s Second Opinion.
The Lethal Effects Of Advanced Cancer
The extreme difficulty of pre-screening for LMS has led many critics to claim that morcellation is “never safe.”
After all, the possible threat posed by morcellators is literally a matter of life and death. If uterine cancer has not yet spread past the uterus, it’s likely at an early stage, which may respond well to treatment.
As cancer becomes more widespread in the body, it is said to be “upstaged.” Advanced stage cancers are considered “incurable” by doctors and quickly ravage patients. Advanced LMS patients have died less than a year after diagnosis.
Were Patients Misled by Inaccurate Cancer Incidence Ratios?
Many patients report being assured that power morcellation would be safe because it was highly unlikely for them to harbor undiagnosed cancer. As supposed evidence, patients were told that only “1 in 10,000” women requiring uterine fibroid surgery harbors undetected uterine cancer.
But many studies found much higher ratios. The figure below contrasts the commonly-quoted low incidence ratio against ratios calculated in various published studies:
FDA Finds Morcellators Risky for Most Women
After receiving complaints about power morcellators from cancer patients, the FDA started considering a total morcellator recall. An initial survey of available morcellator research proved so alarming that the agency issued an urgent warning in April 2014.
In the warning, doctors were advised to inform patients thoroughly of the device’s risks and even advocated for exploring alternatives to morcellation. Power morcellator use was especially discouraged in cases of suspected cancer.
The FDA decided to hold off banning the devices for the time being, to leave them available for a small population of women that might safely undergo morcellation. However, another warning was issued in November 2014.
This “Immediately-in-Effect Guidance” admonished manufacturers to package morcellators with the FDA’s most severe cautionary label, the “black box” warning. The FDA also now considers morcellators risky for “the majority of women.”
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The Industry Backlash From The FDA Warnings
Though the FDA hasn’t yet enforced a complete morcellator recall/ban, some major healthcare companies took matters into their own hands after receiving the FDA warnings.
As we can see, Johnson & Johnson, once the world’s largest morcellator manufacturer, quickly pulled its devices off the market after concerns were raised. Major insurance companies, including Aetna, and hospital chains like HCA have restricted the use of power morcellators in all but the rarest circumstances.
Congress has already taken a stand for patient safety. The Wall Street Journal reports that Representative Mike Fitzpatrick, a Republican from Pennsylvania, has begun making legislative in-roads over a number of bills that would strengthen the FDA’s safety regulation of medical devices.
Taking A Stand Against Manufacturers
Patients and surviving loved ones are now taking legal action, blaming morcellator manufacturers for causing extreme hardship and loss that they feel could have easily been prevented. Dozens of lawsuits are currently pending in federal courts across the nation, and an additional 300 cases are being investigated.
Typical Allegations In Lawsuits
Most morcellator lawsuits take the form of product liability suits, which focus on various failures to safely design, manufacture, distribute, or label products for consumers.
|Type of Allegation||Basis||Examples|
|Negligence||Failure to act reasonably to protect consumer safety||A manufacturer failed to test its morcellator models for safety|
|Breach of Warranty||Failure to uphold warranty that implied or explicitly stated product is safe||A morcellator caused harm to patients while employed for its intended use|
|Wrongful Death||Death of a loved one caused by negligence or malicious intent||A patient died from cancer that was severely worsened by a morcellator|
|Medical Malpractice||Patient harmed by negligence of a doctor or other medical staff member||A doctor used a morcellator on a cancer patient despite knowing the device’s ability to spread cancer|
First Suit Ends In Early Settlement
The first lawsuit involving power morcellators was filed by Scott Burkhart on behalf of his late wife Donna, against device manufacturer LiNA Medical.
Donna was alleged to have “no signs” of cancer prior to her hysterectomy, but was diagnosed with advanced LMS shortly after. The Burkhart lawsuit was framed with “wrongful death” claims as well as those regarding product liability, because of Donna’s tragic death just 11 months after the cancer diagnosis.
Just before the case was scheduled to go to trial, LiNA Medical offered settlement negotiations, and the case was resolved. Scott was relieved to end the case early, as he had mostly filed the lawsuit to raise public awareness of morcellator risks.
Filing A Lawsuit – Made Easier With Experienced Counsel
If you or a loved one underwent a morcellator procedure and were diagnosed with advanced cancer afterwards, you could be entitled to significant compensation for the considerable hardship and loss you have endured.
It’s best to look into your legal options as soon as possible. If too much time elapses after the cancer diagnosis that you or your loved received, you may exceed your state’s statute of limitations and lose your right to take legal action.
Many patients think filing a claim will be difficult and expensive. But our experienced morcellator lawyers won’t accept any payment until you secure compensation first.
Latest Power Morcellator Updates
By Laurence P. Banville
September 28, 2017 – Patient Preferences Influence Regulator Decisions For Medical Devices
A new FDA blog post, with 3 contributors, discusses their Patient Preference Initiative that was started in September 2013 in order to assist in medical device decision-making. The blog contributors discussed how the FDA has seen increasing benefits by taking feedback from patients. Two recent improvements they have seen were in safe use of glucose monitors by pediatric Type 1 diabetes patients and the availability of more therapy options for kidney patients. The most recent example of the implementation of the Patient Preference Initiative is called the System One which is designed to help determine and develop methods for estimating patient assessment of the benefits and risks regarding specific devices.
August 17, 2017 – Olympus Faces Criticism Over New Power Morcellator Study
After many adverse event reports and lawsuits regarding power morcellators and their potential to spread deadly cancer cells during gynecological surgeries, Olympus Inc. introduced a new version of the medical device last year. This new morcellator includes a “contained tissue extraction system” to prevent cells from escaping which could pose a risk of spreading previously undetected cancer. The company is now facing criticism, as it announced plans to conduct a clinical study of 140 hysterectomy patients to prove the new device is safe and effective. This study will take place at the University of North Carolina but is not yet open.
July 11, 2017 – Power Morcellator Cancer Problem Cited In JAMA As Need For Better FDA Surveillance
The Journal of the American Medical Association (JAMA) recently published an editorial in which the power morcellator cancer problem was cited as a reason why the FDA needs to strengthen its post-marketing surveillance. Many medical experts consider the FDA to have failed in this instance due to the fact that several hundred women had cancer cells spread after undergoing laparoscopic hysterectomies or uterine fibroid procedures before the issue was even discovered. The authors indicated that a better system of gathering and using post-marketing data needs to be implemented in order to ensure patient safety.
June 22, 2017 – Olympus Settles Power Morcellator Lawsuit
A lawsuit filed by two plaintiffs over laparoscopic power morcellators has been settled. A subsidiary of Olympus has agreed to settle the lawsuit which alleges that the medical device used during one of the plaintiff’s hysterectomy in 2010, which the company manufactures, caused her physical injury. The suit also alleges that the injury could be permanent or fatal and she could suffer from further conditions or diseases which haven’t yet been diagnosed. According to court documents, the suit also cited the 1991 patent application which “describes the potential for laparoscopic power morcellators to disseminate and implant malignant tissue fragments in the body.” The terms of the settlement have not been disclosed.
May 26, 2017 – Dr. Amy Reed Dies At 44 After Long Fight With Cancer
Dr. Amy Reed was a physician and cancer patient who fought tirelessly not only against the disease but to end the use of the power morcellator which spread and worsened her cancer during a gynecological procedure. Dr. Reed and her husband, Dr. Hooman Noorchashm won some victories to ban the surgical tool. Due to their efforts, the FDA studied data on morcellation procedures and many insurers declined coverage of their use in gynecological procedures. The FDA, in November 2014, recommended that power morcellators not be used for women having fibroid surgery due to the risk of spreading previously undetected cancer cells and upstaging the cancer. Johnson & Johnson pulled their device off the market, and use of the device declined. Dr. Reed passed away from leiomyosarcoma of the uterus on Wednesday night in her home in Yardley, PA.
April 19, 2017 – Patient Safety Advocate Awakens From Coma
Dr. Amy Reed has become a spokesperson and patient safety advocate after receiving a uterine cancer diagnosis when a power morcellator was used during her hysterectomy. She and her husband have fought, since her stage 4 cancer diagnosis, against the use of power morcellators which, like in Dr. Reed’s case, can spread previously undetected cancer cells, upstaging the cancer to a very difficult to fight disease. Earlier this month Dr. Reed went into cardiac arrest due to an abdominal tumor cutting off blood to her heart. With the help of many people on her medical team Dr. Reed survived but was in a coma. After 5 days, her husband Dr. Hooman Noorchashm is reporting that while she is weak, she is conscious.
March 27, 2017 – Study Shows Active Surveillance Is More Reliable Than Adverse Event Reports
A study was recently conducted, with funding from the FDA, in which researchers compared the FDA Adverse Event Reporting System to the outcomes of a strategy of active surveillance of usage of medical devices and post-market data. The findings were published in the New England Journal of Medicine on January 25. Researchers were able to determine that when using active surveillance, rather than adverse event reports, a greater risk of complication with the medical device Mynx was found in just a few short months. The FDA, according to the study has prioritized evaluating and implementing a system to continuously monitor large clinical data sources rather than waiting on reports which are made voluntarily.
February 27, 2017 – Lengthy Wait For Release Of GAO Report Comes To An End
In August of 2015, 12 Representatives, members of a bipartisan group, wrote to the Government Accountability Office (GAO) to have the GAO investigate the FDA’s handling of the reports of laparoscopic power morcellators and their connection to the spread of cancer. The report found that the FDA may have slowed its own ability to discover a problem with the devices due to several problems, including underreporting of adverse events and issues with surveillance systems. The FDA told the GAO that they are working to improve and develop better surveillance systems as well as working closely with hospitals to identify problems.
January 25, 2017 – Advocate For Power Morcellator Awareness Passes Away
A Brentwood Pennsylvania resident has passed away at the age of 57 after battling cancer for several years. The woman was diagnosed with leiomyosarcoma just six days after undergoing a hysterectomy with a power morcellator to remove uterine fibroids in 2012. In 2014, the FDA released a warning regarding the use of the medical device during surgery stating that it could help spread undetected cancer. She became an advocate for awareness of the risk of cancer and for banning the use of the device. She was one of the key people who helped at least one insurance company to stop paying for power morcellator procedures.
December 28, 2016 – FDA Finds Problems In Reporting Of Patient Injury And Death From Medical Devices
An investigation by the FDA concluded that out of 17 institutions surveyed the large majority did not file timely reports of deaths and injuries caused by medical devices. The inspections were initiated after power morcellation came under public scrutiny when it was connected to the spread of uterine cancer via the device’s spinning blades, as well as reports of infections associated with contaminated duodenoscopes became public. The FDA released their findings in a report which outlined which hospitals failed to comply with the set of requirements, yet no penalties were imposed.
November 29, 2016 – FDA Grants Clearance To New Olympus Power Morcellator
Olympus received the FDA 510 (K) clearance and launched a new power morcellator which has a contained tissue extraction system. The company specified that it shouldn’t be used to remove uterine tissue of patients suspected or known to contain malignancy. The device has been specifically designed for a laparoscopic surgery in order to avoid open surgery. Power morcellators continue to be a source of controversy after hundreds of personal injury and wrongful death lawsuits were filed by women who claim the devices spread previously undetected cancer cells quickly upgrading the disease and making it difficult to survive and/or treat.
October 27, 2016 – Medical Device Safety Hearing Requested By PA Representative
At the end of last month PA Representative, Mike Fitzpatrick, asked Congress for a medical device hearing in the hope of updating the current safety laws which govern devices such as the power morcellator. Six fellow Congress members joined Fitzpatrick in his letter of request in which he stated “Many devices prove lifesaving, however some devices are having devastating effects on patients. . . “ Fitzpatrick prominently features devices such as laparoscopic power morcellators and “permanent” birth control device Essure in his efforts but is not limited to just those particular items.
September 27, 2016 – Study Concludes Declined Use Of Morcellators Hasn’t Led To More Hysterectomy Complications
Researchers from Columbia University conducted a study to determine if complications were increasing in women who underwent hysterectomies due to the decrease in morcellator use. Warnings were released in April 2014 by federal regulators after several wrongful death claims were made claiming power morcellation spread previously undetected uterine sarcomas causing women to suffer upstaged uterine cancer. The study which was published in the Journal of the American Medical Association concluded that while morcellator use has significantly declined during hysterectomies, the rate of complications has not changed. Johnson & Johnson has stopped selling the device, that was created to simplify surgeries and lesson recovery time, but still faces several lawsuits alleging the company failed to warn the medical community of the risks the device posed.
August 18, 2016- Motion Seeking To Dissolve Ethicon Morcellator MDL After Case Settlements
Most of the morcellator cancer lawsuits filed against Johnson & Johnson’s Ethicon unit have now been settled. This is according to a recent motion that seeks to dissolve the federal multidistrict litigation (MDL) which was established for lawsuits that were filed all over the country by families of women who were diagnosed with various forms of aggressive uterine cancer. The aggressive uterine cancer is said to have been spread by a surgical tool that was used during laparoscopic hysterectomy or uterine fibroid removal procedures. Decisions to dissolve the Ethicon MDL will not have an impact on future lawsuits against other manufacturers of similar devices.
June 8, 2016- New Bill Under Consideration For Doctors To Report Medical-Device Hazards
A pair of lawmakers is due to introduce a new bill in Congress. The new bill will require doctors to report potentially dangerous problems with medical devices they use to the U.S. Food and Drug Administration (FDA). The legislation is called the “Medical Device Guardian’s Act”, and it was motivated by the long delay in raising public awareness of the risks of the power morcellator.
May 26, 2016- Johnson & Johnson Quietly Settling Power Morcellator Lawsuits
A report by the Wall Street Journal states that Johnson & Johnson has been quietly settling power morcellator lawsuits. So far approximately 70 cases have been settled and more are in the process of being settled. A few months back, the Judicial Panel on Multidistrict Litigation consolidated a number of power morcellator lawsuits against Ethicon, a J & J unit, in U.S. District Court for the District of Kansas.
April 29, 2016- Hospital Deaths Linked To Power Morcellators Are Being Investigated By The FDA
In early April 2016, the U.S. Food and Drug Administration (FDA) reported that investigations were conducted that were linked to deaths where power morcellator procedures took place in hospitals. The hospitals that the agency investigated included Brigham & Women’s Hospital, Rochester General Hospital and University of Rochester Medical Center. These investigations were a direct response to a letter sent to the FDA by Congressman Mike Fitzpatrick to Director George Karavetsos.
March 12, 2016- Power Morcellator Lawsuits Are Anticipated To Increase
As the risks of power morecellators become more well known and documented, it is believed that it will not be long before there are more filings brought to court. The reason behind this prediction is because of the 650,000 statistic of women who undergo hysterectomies in America each year due to uterine fibroids. In addition, the FDA is yet to take the power morcellator off the market, further leaving women at risk.
February 18, 2016- PA Congressman Pushes For FDA To Launch A Criminal Probe Into Morcellator Deaths
United States Representative Mike Fitzpatrick R-Pa. has called for the U.S. FDA to further examine deaths that have been associated with power morcellators. In addition, he wants the device’s manufacturer, Johnson & Johnson’s subsidiary, Ethicon to be investigated as well. The December 18, 2015 letter the congressman sent to Director George Karavestos of the Office of Criminal Investigation at the FDA , questioned whether or not hospitals correctly disclosed side effects, such as deaths, linked to power morcellators.