Morcellators: Risks, Cancer Concerns & Lawsuit Information

Morcellator devices are surgical tools that break down large pieces of tissue so they can be removed through small incisions. They are often used in abdominal surgeries like hysterectomies (uterus removal) and myomectomies (uterine fibroid removal).

The U.S. Food & Drug Administration (FDA) first cleared power morcellators for sale in 1991. The benefits of the devices included smaller incisions, less post-operative pain and faster recovery compared to open abdominal surgery.

However, hidden dangers of these devices came to light over time, including the device’s ability to spread undetected uterine cancer throughout the patient’s abdominal cavity.

Surgery using a power morcellator can lead to typical surgical side effects, like bruising and infection. These devices can also cause the spread of fibroid tissue. This tissue is usually benign but can attach to other tissues and organs in your abdomen, causing more fibroids to grow.

Some of these side effects are not unique to morcellators and can occur with any abdominal surgery.

Power morcellators can spread undetected cancer cells during surgery. Uterine sarcomas are often undiagnosed before morcellator surgery. These aggressive cancers are hard to detect with standard imaging and are often mistaken for benign fibroids.

If you have undetected uterine cancer, the morcellator’s spinning blades can shred cancerous tissue and scatter malignant cells throughout your abdominal cavity. This can advance the disease from an early, treatable state to an aggressive, often fatal one.

One study about the dangers of morcellators found that 12 women had irregular tissue samples that were undiagnosed before surgery. Ten of these women had cancer cells. Types of cancer found included uterine myoma, endometrial stromal sarcoma and leiomyosarcoma.

A separate study found that women with undiagnosed uterine sarcoma who underwent power morcellation had a roughly 2.7 to 4.7 times higher risk of death than patients who had traditional surgery. In some cases, five-year survival rates dropped by over 37%.

Uterine Cancer After Morcellation

When cancer is diagnosed after morcellation, it is usually stage III or IV. These are advanced stages with a poor prognosis. A tumor is considered stage IV if it has spread to your lymph nodes, bladder, rectum, spine, lungs or other distant organs.

If tumors affect other organs or bones like your spine, symptoms could include back pain or nerve issues.

Leiomyosarcoma and Morcellators

Leiomyosarcoma (LMS) is a rare cancer that is most commonly seen in smooth muscles of hollow organs like your uterus, stomach, bladder, blood vessels or intestines. Uterine LMS specifically is one of the more dangerous and aggressive types of uterine cancers.

Depending on when it’s caught, the five-year survival rate for uterine LMS is 13% to 61%. More favorable outcomes occur when a diagnosis is made early.

Power morcellators do not cause LMS, but they can lead to it spreading rapidly if it’s already present and undiagnosed. Before undergoing surgery, you should be evaluated to determine if you are at a higher risk of uterine cancer.

In a 2014 study, researchers evaluated how morcellation for hysterectomy patients can spread malignancies. They wrote, “patients considering morcellation should be adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure.”

Data from the FDA supports this finding, indicating that LMS may be present in an estimated 1 in 495 to 1 in 1,100 women who undergo surgery for uterine fibroids.

Survival and Spread of Cancer

Typically, cancer is easiest to treat if it is localized, which means it has not spread. Treatment becomes more difficult if your cancer spreads to other organs (regionalized) or to the rest of your body (distant).

The FDA first issued a warning in April 2014, highlighting the cancer risk and advising against routine use of morcellators in most women. However, according to a 2017 report from the U.S. Government Accountability Office, the FDA was aware of potential risks as early as 1991.

Following the FDA’s 2014 safety warning about the cancer risks linked to power morcellators, the medical community responded quickly. Hospitals began suspending use of the devices, and insurers re-evaluated coverage.

One study found that use of power morcellators dropped from 66.7% at the end of 2013 to 13.3% in the second quarter of 2018. A separate study found that there had been a decline in minimally invasive procedures since the “banning” of morcellators.

Johnson & Johnson’s Ethicon division, which produced various morcellator devices, voluntarily recalled the products. The company was the only manufacturer to recall devices based on the FDA’s safety warning.

In a letter to health care providers, Ethicon acknowledged the uncertainty around the devices’ safety.

“We believe Ethicon morcellation devices perform as intended and there are patients who can benefit from procedures using laparoscopic power morcellators, but the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures for removing fibroids remains uncertain,” the company stated.

After developing advanced uterine cancer following fibroid surgery, many women and their families filed lawsuits against the makers of power morcellators.

Lawsuits alleged that defendants failed to adequately warn about the cancer risks associated with morcellators and didn’t properly test the devices before selling them. Plaintiffs also claim the defendants negligently designed and marketed the products.

Most of the legal action centered on Johnson & Johnson’s Ethicon division.

In 2015, the Judicial Panel on Multidistrict Litigation consolidated several morcellator cases against J&J’s Ethicon unit in the U.S. District Court for the District of Kansas. In 2016, roughly 100 power morcellator lawsuits were settled. Potential payouts ranged from $100,000 to $1 million.

Because of J&J’s settlements, both the company and plaintiffs’ attorneys asked a federal judge to dissolve a multidistrict litigation in which the lawsuits were consolidated. Only two cases were unresolved when the MDL was closed.

After the FDA issued warnings about the cancer risks linked to power morcellators, doctors began turning to safer surgical methods. Alternatives like vaginal or abdominal hysterectomies and abdominal myomectomy can help prevent the spread of hidden cancer.

Since there is no single reliable way to detect uterine sarcoma before surgery, you should talk with your doctor about the safest surgical approach based on your age, health history and cancer risk. In some cases, laparoscopic procedures may still be an option, but only with added precautions like containment systems.

Power morcellators were once seen as a breakthrough in minimally invasive surgery. But for many women, these devices caused devastating harm by spreading undetected cancer during routine procedures.

The turning point came in 2014 when the FDA issued its first safety warning. That guidance, driven by patient reports, expert reviews and lawsuits, acknowledged that power morcellators could spread cancer and that the risk was far higher than previously believed.

The morcellator story serves as a cautionary tale in system failure and defective device litigation. Devices entered the market without full clinical testing, early warning signs were overlooked and patients felt the consequences.

If you or a loved one developed cancer after fibroid surgery or a hysterectomy involving a power morcellator, you may still have legal options. Visit our power morcellator lawsuits page to learn more.