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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The Government Accountability Office will inspect the Food and Drug Administration’s hasty approval of power morcellators.

Despite the fact that power morcellators are associated with minimally invasive surgery, Congress holds these controversial medical devices accountable for hundreds of cancer-related deaths.

After a multitude of dangers linked to power morcellators, the federal government is finally paying attention.

The U.S. Government Accountability Office (GAO) has launched an internal investigation to evaluate the Food and Drug Administration’s approval of the widely used surgical instrument.

How Could Surgery Spread Cancer?

Power morcellators are often used to fibroids, also known as benign growths, in the uterus.
Image: Journal of Ultrasound in Medicine

Many are inclined to believe that minimally invasive surgeries are safe, but that’s not always the case. Laparoscopic power morcellation procedures, which provide relief from uterine fibroids through small incisions, have extremely dangerous long-term side effects.

The devices treat uterine fibroids through two different kinds of procedures. Hysterectomies involve removing the uterus while a myomectomy focuses on eliminating the actual fibroids. A myomectomy is preferred for women wanting to have children. Less frequently, the devices are also used for renal nephrectomy or splenectomies.

Fibroids are painful mounds of tissue that cause heavy menstrual bleeding, extended periods and radiating pain. Fibroids are very common and can be removed by a medical professional.

During the power morcellation removal process, pieces of tissue are often left behind. The remaining tissue spreads throughout the body, forming undetected tumors that develop into cancer.

Women who underwent these procedures are increasingly being diagnosed with uterine cancer, causing the medical community to speculate on the safety of the devices. Since then, multiple studies have linked power morcellation to occult uterine cancer.

The Long-Awaited Investigation

The GAO will be evaluating the FDA’s 510(k) approval process and the time it took to add a warning label to power morcellators.
Image: Facebook

The devices, which are meant to come with few risks, have been used by medical professionals since 1991. As regulators begin to evaluate the devices, the truth will finally be uncovered.

The FDA issued a warning in April 2014 urging doctors to discontinue the use of power morcellators in their practices. The warning came after a study that unveiled the true number of women who developed cancer from power morcellation surgeries.

The results proved that 1 in every 350 women who had fibroids removed were at risk for uterine cancer. After six months, the FDA finally included a warning on the product’s labeling.

The investigation, which includes two major parts, was deemed necessary by twelve members of Congress. These lawmakers are determined to find out why the FDA waited months to warn the public about the dangerous side effects of power morcellators.

In addition, the investigation will evaluate the 510(k) approval process that brought the devices into the market with little speculation. The accelerated process, which limits the need for extensive pre and post-approval safety testing, may be responsible for the lack of awareness about the cancer-causing side effects.

Legal Support For Injured Patients

Patients who developed cancer from power morcellation deserve justice.
Image: ABC News

Federal investigators are set to start looking into the devices, but the issue remains largely unresolved until new regulations are enacted. Patients who underwent uterine fibroid surgery because they weren’t informed of the risks deserve justice now.

If you or a loved one developed cancer from a procedure that used power morcellation techniques, you are not alone. You are entitled to health-related compensation for problems caused by power morcellation procedures.

Click here for a free case evaluation to learn more about legal rights and remedies.

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Hysterectomy Cancer Side Effects Lawsuit

Over 50,000 women undergo laparoscopic power morcellation in the U.S. each year and potentially hundreds have cause to file a mass tort hysterectomy cancer lawsuit. In April 2014, the FDA revealed that 1 in 350 women who undergo the procedure have an undiagnosed uterine sarcoma that can spread to other parts of the body following laparoscopic power morcellation. Cases of hysterectomy leiomyosarcoma have been reported in the United States, Canada, the U.K. and Germany, and health officials in those countries have issued their own warnings about laparoscopic power morcellation, but none have issued a full ban.

Several patients have already filed hysterectomy side effect lawsuits against manufacturers and more are in the works. The FDA, anticipating patients filing a hysterectomy cancer side effects lawsuit, has ordered a “black box” warning to be put on power morcellators, and a few manufacturers have suspended sales of power morcellators.

The first hysterectomy cancer side effect lawsuit was filed in March 2014 on behalf of a 53-year-old woman who died from a hysterectomy leiomyosarcoma less than one year after undergoing the procedure. The main defendant named in this hysterectomy leiomyosarcoma lawsuit were Gynecare and Ethicon, Inc., both divisions of Johnson & Johnson, the largest manufacturer of power morcellators in the world.

While Johnson & Johnson publicly insists they are safe, it has already halted sales and recalled all brands of power morcellators, as it prepares to deal with thousands of potential hysterectomy cancer side effects lawsuits.

One German maker of morcellators, the Karl Storz Group, is trying to stay ahead of a hysterectomy side effect lawsuit by using shameless scare tactics against patients and their families. The Group has threatened a defamation suit against a Boston doctor who says his wife’s uterine leiomyosarcoma was caused by the company’s “Rotocut” device.

Should you File a Hysterectomy Leiomyosarcoma Lawsuit?

If you developed a uterine leiomyosarcoma at any time after undergoing laparoscopic power morcellation, you may have good cause for a hysterectomy cancer lawsuit. 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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Uterine Fibroid Treatment Side Effects

The serious uterine fibroid treatment side effects of hysterectomies and myomectomies slowly led physicians to develop “safer,” less invasive, non-surgical alternatives. However, patients have discovered the hard way that these alternative treatments may come with serious side effects of their own.

One type of uterine fibroid treatment risks a serious cancer called leiomyosarcoma.

Laparoscopic power morcellation is a new technique used to remove uterine fibroids. The procedure involves a long, thin device called a morcellator with a small rotary blade at the end, which “morcellates” the fibroids, tearing them into pieces.

Morcellation can release these dormant cancer cells into the uterus. These cells can then travel to other parts of the body, becoming malignant, inoperable and fatal. The FDA has found that 1 in 350 women who undergo laparoscopic power morcellation will develop leiomyosarcoma, a smooth tissue cancer that is present in some fibroids. The prevalence of this uterine fibroids treatment side effect is small, but significant enough for the FDA to issue a warning and for some hospitals and doctors to voluntarily stop using the procedure.

Uterine Fibroids Cancer Lawsuit

Medical trials are being conducted to gauge the safety of using morcellators equipped with small bags to contain potentially cancerous tissue; however, until they are proven to be safe, women should discuss the risks of laparoscopic power morcellation with their doctor. Patients are preparing a uterine fibroids cancer lawsuit against the manufacturers of the original devices, arguing that they ignored the potential dangers.

Side Effect Victims

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.

Alternative Treatment Options

Uterine Fibroid Embolization (UFE) is another relatively new non-surgical alternative for fibroid removal. UFE cuts off the supply of oxygen to fibroids by blocking the blood vessels that lead to them using a very small arterial tube.

Post Embolization Syndrome (PES) is a commonly reported uterine fibroid treatment side effect, consisting of nausea, fever and vomiting for several days and even weeks after the procedure. PES results from toxins released by fibroids as they decay and can usually be treated with over-the-counter medications.

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