Congressman Fitzpatrick compels the FDA to investigate the safety of power morcellation and review the effectiveness of medical device reporting.

Pennsylvania Congressman Michael Fitzpatrick is calling for an investigation into the safety of power morcellators. The call to action comes after a number of women underwent morcellator surgery and later died from uterine cancer.

Power morcellators are used in an estimated 60,000 fibroid procedures each year. The “minimally invasive” devices remove fibroids with a cutting tip that can shred and spread undetected cancer cells.

Fitzpatrick compels the Food and Drug Administration (FDA) to investigate the morcellator manufacturer Ethicon, a Johnson & Johnson subsidiary, along with three hospitals that failed to report morcellator-related deaths.

Calling For A Criminal Investigation Into Morcellation

“OCI concentrates its resources on investigations of significant criminal violations that pose a danger to the public health,” according to the FDA website.
Image: CBS News

Fitzpatrick, a Republican who represents the 8th Congressional District of Pennsylvania, has been working to raise awareness about the dangers of power morcellators. The devices, approved through an expedited 510(k) process, were cleared for use more than two decades ago without a thorough clinical examination.

On December 18, 2015, Congressman Fitzpatrick wrote a letter to George Karavetsos, the director of the Office of Criminal Investigations at the FDA. The letter questions the effectiveness of the FDA’s Medical Device Reporting regulations, which “failed to catch the severe dangers posed to women’s health by morcellation.”

The Medical Device Reporting regulations require manufacturers and hospitals to disclose when a surgical  instrument “has or may have caused or contributed to the death of a patient.”

In the letter, Fitzpatrick directed attention to three hospitals that failed to report patient death related to morcellator side effects. Women who had morcellator procedures at Brigham and Women’s Hospital, Rochester General Hospital and University of Rochester Medical Center died from leiomyosarcoma within 1-2 years after surgery.

If there’s even a small chance that a medical device could have contributed to complications, hospitals have a legal obligation to contact the FDA within 10 days of a patient’s death. Medical device manufacturers, such as J&J’s Ethicon, are legally required to report device-related deaths within 30 days.

“In fact, the first time the FDA received a report of death or serious injury was neither from a user facility nor a device manufacturer. It was ‘from a physician citing the case of a family member who has a disseminated cancer that was suspected to have resulted from a procedure in which a power morcellator was used,” Fitzpatrick wrote.

“It should not have taken a family devastated by this device to raise the issue to the FDA. Had the regulations works [sic] as intended, it is likely many women’s lives could have been spared from the horrific consequences of morcellation.”

Shedding Light On The ‘Horrific Consequences Of Morcellation’

Laparoscopic power morcellation can activate unseen cancer cells buried deep in uterine tissue.
Image: Cancer Box

Fitzpatrick made it his mission to raise awareness about the risks of morcellation, which are touted as a non-invasive way to remove uterine fibroids.

Although the devices are able to minimize infection and reduce recovery time, it’s become increasingly clear that morcellation surgeries can activate and spread hidden leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers.

“It appears that these patient safety regulations may not be working as intended, leaving patients in danger,” Fitzpatrick wrote in his letter. “As you may be aware, hundreds, if not thousands, of women are dead because of a medical device known as a laparoscopic power morcellator.”

Since the FDA first issued a morcellator safety alert in 2014, the devices have been identified as the culprit in wrongful death cases. More than 30 women diagnosed with late-stage cancer filed against the makers of the device. The lawsuits are condensed in multidistrict litigation 2652 that will be heard by Judge Kathryn H. Vratil in the U.S. District Court for the District of Kansas.

Women injured by morcellation have argued that they wouldn’t have agreed to the procedure if they had known about the risks. Attorneys question whether or not the manufacturers adequately warned patients about the potential consequences of morcellation surgeries.

If you developed cancer after having your uterine fibroids removed with a power morcellator, then you might be entitled to compensation for this medical side effect.

Complete a free, no-obligation case evaluation now to learn more about compensation eligibility. 

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A woman died shortly after filing a lawsuit against the power morcellator procedure that allegedly spread undetected cancer throughout her body.

A 44-year-old woman named Brenda Leuzzi was suffering from uterine fibroids. The painful condition caused a severe and unusual amount of bleeding, which prompted her to agree to a power morcellation hysterectomy.

The controversial procedure came with side effects and unknowingly spread uterine cancer throughout Leuzzi’s body. She filed a lawsuit in May 2014 in an attempt to get compensation for her worsening medical status. In a tragic twist of fate, Leuzzi passed away five months later.

Power Morcellator Surgery Changed Her Life

Brenda Leuzzi, 44, died from stage four uterine cancer just two years after undergoing a hysterectomy with a power morcellator device.
Image: Change

When Leuzzi made the decision to undergo power morcellator surgery, she had no idea that it would change her life forever. In the lawsuit, she complained that she wasn’t adequately warned of the dangers associated with power morcellation.

The lawsuit came in conjunction with an announcement from the University of Rochester, the medical center that discovered the fibroids. Health representatives from the center decided they would no longer use power morcellation techniques due to the possibility of spreading undetected cancer.

“Specimens can be removed from the abdominal cavity using non-power morcellation or intact through larger incisions in the abdomen or vagina,” according to the University of Rochester Medical Center.

However, Leuzzi isn’t the only one who has been affected by power morcellation. The FDA estimates that 1 in every 350 women may have undetected cancer cells that can be triggered by the procedure.

A Family That Keeps Fighting

Leuzzi’s husband George fights for justice by continuing the lawsuit and urging the FDA to ban power morcellator devices.
Image: Beta News

Although Leuzzi was unable to finalize the fight for her own justice, her family did not give up. Her husband, a firefighter named George, updated the legal complaint to reflect the circumstances of her death.

“Now that she’s passed I will do my part to carry on what she started,” George Leuzzi said. “I will help as much as I can to get this removed.”

In an ongoing FDA investigation, the governmental body evaluated the dangers of the device and considered banning power morcellation surgeries altogether. The agency issued a warning but has not yet made the decision to stop the procedure.

“I’m very disappointed in the FDA. They should have banned this by now. They’re just stalling and finding some other way to convince themselves it’s OK,” George Leuzzi said.

Many women are still suffering from cancer that may have been caused by power morcellation devices. If you or a loved one developed cancer after having your uterine fibroids removed with a power morcellator, then you might be entitled to compensation.

Complete a free, no-obligation case evaluation now to see if you qualify.

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A couple comprised of two medical professionals has made it their mission to ban power morcellator surgery.

Cardiothoracic surgeon Dr. Hooman Noorchashm and anesthesiologist Dr. Amy Reed have experienced the dangers of power morcellation surgery firsthand.

After the procedure to remove her uterine fibroids spread undetected cancer in her body, Reed and her husband launched a campaign to ban the device once and for all.

The Birth of the Campaign

Power morcellator surgery can spread fragments of cancerous tissue, leading to a worsened prognosis.
Image: Contemporary OBGYN

Laparoscopic power morcellation is a medical procedure that is used to remove painful fibroids from the uterus. Through small incisions, the morcellator device breaks and clears fibroids embedded in uterine tissue.

In October 2013, doctors at Brigham and Women’s Hospital in Boston removed Reed’s uterine fibroids with a power morcellator.  No one expected that a minimally invasive procedure could come with life-changing consequences.

As the device destroyed the fibroids, it spread hidden leiomyosarcoma cancer cells throughout Reed’s abdomen. Reed and her husband were outraged, and they began searching for answers.

The couple set out to discover how frequently undetected leiomyosarcoma was released and spread by power morcellation surgery. After consulting with doctors and other women who developed cancer as a side effect of surgery, the two took to the internet to start a Change.org petition that urged the FDA to put an end to the procedure.

“I basically used the same intensity I brought to work and focused it on this,” Noorchashm told ABC News. “What you’re seeing here is a large volume of time and non-stop sustained [work] in order to make a change.”

Reed and her husband were successful in altering the ways that doctors at Brigham and Women’s Hospital regulate power morcellator procedures, but the duo won’t stop until it has been banned altogether. The real goal is to save other women from an avoidable fate.

“We want the American College of Obstetricians and Gynecologists and the American Board of Obstetrics and Gynecology to change this ‘standard of care’ by ending the needless waste of life caused by spreading cancer with morcellation,” Noorchashm wrote on Change.org.

FDA Defines Risk Associated With Power Morcellators

Currently, there is no way for doctors to test if a mass in the uterus is a benign fibroid or a malignant uterine cancer.
Image: Medscape

Power morcellation surgery can cause pain and infections, but the most serious side effect is the possibility of developing uterine cancer. Although Reed and Noorchashm haven’t reached their ultimate goal of banning the surgery, the campaign has been successful in drawing attention to the issue.

The FDA has released figures that show 1 in 350 women are at risk of developing uterine cancer from power morcellation surgery. The regulatory agency is still looking into the procedure to determine what should be done to mediate this risk.

In the meantime, women are still suffering as a result of power morcellation surgery. Those who developed cancer after undergoing a uterine fibroid removal procedure with a power morcellator might be entitled to compensation. 

Complete a free, no obligation case evaluation now to see if you qualify.

The post Two Doctors Spearhead A Life-Saving Campaign Against Power Morcellators appeared first on Citizens Report.

Uterine fibroids are non-cancerous tumors that grow within the wall of the uterus. One study shows that by age 50, more than half of all American women had fibroids. While fibroids don’t necessarily have to cause any problems, they are capable of causing pain. When they do cause pain or when the number of fibroids is very high, doctors may recommend getting a hysterectomy – a surgery to remove the uterus.

The FDA recently warned the nation about a popular type of surgery that is commonly used for both the removal of uterine fibroids (known as a myomectomy) and hysterectomies. The FDA’s safety communication notice discouraged doctors from using laparoscopic power morcellation for these two procedures.

Most people know laparoscopic surgery as minimally invasive surgery or keyhole surgery. It’s when doctors perform surgery through small incisions in the abdomen. The doctors place surgical instruments in the incisions and then can view what they are doing via TV monitors. A morcellator is a surgical instrument used for removal of large masses of tissues. So in this case laparoscopic power morcellation refers to the procedure of when a doctor performs minimally invasive surgery on a woman, using the powered morcellator to remove her uterine fibroids or uterus.

The FDA issued this warning due to an unintended outcome of these surgeries. “Based on an FDA analysis of currently available data, it is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”

Johnson & Johnson is currently being sued for their role in laparoscopic power morcellation surgeries. A recent report indicates that Johnson & Johnson were notified of the potential risks for this surgery to spread cancer EIGHT YEARS before an FDA warning lead Johnson & Johnson to suspend the sale of their morcellator products.

Women who developed Uterine Cancer, Stomach Cancer or Leiomyosarcoma (LMS) after undergoing Fibroid Removal or a Hysterectomy may be eligible for compensation.  Don’t let your valuable legal rights expire – request a free case review by visiting:

Click here to receive your free case evaluation.

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