Background and Controversy on the Power Morcellator

Background and Controversy on the Power Morcellator 2017-08-29T10:49:57+00:00

Once a widely-used surgical instrument, the power morcellator has triggered raging controversy in recent years, after its propensity for spreading undetected uterine cancer surfaced in the public eye.  The U.S. government and influential establishments in the medical community are taking decisive action against the device to safeguard public health:

  • A leading manufacturer has recalled its power morcellator products
  • Doctors are speaking out against the power morcellator and hospitals have banned it
  • Major insurance companies have discontinued coverage of morcellator-aided surgeries
  • State legislators have fought to enact constitutional amendments to change the way such “high-risk” devices are approved and monitored

These watershed events occurred in response to a set of urgent safety alerts issued in 2014 by the U.S. Food and Drug Administration. The agency warned against the use of the device for certain gynecological surgeries “in the majority of women” due to the risk of worsening disease in patients with undiagnosed uterine cancer.

Surgeons Adopt the Power Morcellator in Hopes of Reducing Patient Trauma

The power morcellator is a tool that is used to mince up tissue masses inside a patient’s body during surgery. It was introduced in the early 90’s to facilitate the removal of organs or other internal structures for an increasingly popular surgical option called laparoscopic surgery.

The conventional route for organ removal is open surgery, in which large cuts are made to the patient’s abdominal wall to give the surgeon vision and room to maneuver traditional surgical instruments. Newer laparoscopic methods differ from open procedures in that they are performedDiagram of laparoscopic surgery via much smaller incisions, in general causing less pain and scarring.

Such surgeries require a laparoscope (a lighted tube as shown at right) and other tools that can be inserted through “keyhole” incisions less than a few centimeters in size. The power morcellator emerged as a prime choice of cutting instrument, with a basic design that operates as follows:

  • A grasping claw grabs the organ/tissue mass of interest
  • The tissue mass is pulled through a series of small rotating blades housed at the end of a long, thin tube for grinding
  • The ground-up tissue is vacuumed out of the body through that same tube

For more detail on the history and development of the power morcellator, visit our studies and research page.

How a “Safe” Procedure for a Benign Condition Can Escalate a Life-Threatening Disease

The leading use of power morcellators is for laparoscopic hysterectomies and myomectomies, surgeries often performed for the treatment of adverse symptoms resulting from uterine fibroids.

Uterine fibroids are noncancerous growths in the muscular wall of the uterus. They are overwhelmingly common, occurring in as many as 1 in 5 women during child-bearing years and in 50% of all women age 50 and older, according to the U.S. National Library of Medicine.

Some women experience no symptoms from the presence of fibroids, but others suffer from effects serious enough to warrant surgery, such as heavy bleeding, pain, bowel obstruction, and infertility.

Yet some patients thought to have uterine fibroids could instead unknowingly have a far worse condition—uterine leiomyosarcoma, a rare but particularly deadly type of cancer.

Leiomyosarcoma tumors closely mimic the appearance of benign uterine fibroids in radiological imaging. This makes it virtually impossible to screen for the cancer prior to surgery, as the only reliable diagnosis method is pathological testing on surgically-obtained tissue samples.

The FDA estimates that 1 in 352 women undergoing surgery for uterine fibroids is found to have an undetected uterine sarcoma, based on data analyzed from peer-reviewed research studies—a figure much higher than the 1 in 10,000 that was previously believed and often quoted to patients.

These facts reveal the potential danger posed by power morcellation: if a power morcellator is used on cancerous tissue, the spinning blades of the device can splatter tissue bits throughout the patient’s body. This spreads the cancer by “seeding” new cancerous growths, causing it to quickly reach advanced stages, which are particularly challenging to treat.

Thus, an unsuspecting patient may undergo a morcellator-aided surgery to relieve uterine fibroid symptoms, believing it to be a fairly safe, routine procedure—only to afterwards face the terrors of advanced leiomyosarcoma.

The Tragic Fate of Donna Burkhart

This is precisely what happened to the late Donna Burkhart, as alleged in the lawsuit filed by her husband Scott Burkhart against power morcellator manufacturer LiNA Medical.

distressed and crying womanDonna received a laparoscopic hysterectomy with power morcellation in March 2012, for treatment of uterine bleeding.   Prior to her surgery, she showed no signs of uterine cancer, but was diagnosed with leiomyosarcoma just 9 days afterward. The lawsuit states that Donna had been given no indication that the power morcellator used in her surgery could be “seeding an undiagnosed sarcoma.”

For 11 months, Donna struggled with extreme stress, pain, and exhaustion from the effects of the disease and cancer treatment, only to die in “horrible pain” at age 53 in February 2013, Scott and the couple’s daughters informed CBS reporters in 2014.

Scott Burkhart leveled claims of negligence and wrongful death at manufacturer LiNA Medical, saying that Donna’s suffering and untimely death could have been avoided, had the manufacturer properly warned doctors and patients about the risks in its product labeling and marketing efforts.

More Lawsuits Expected to Surface

The Burkharts’ attorney stated that their case was “the first major federal product liability lawsuit involving a uterine morcellator manufacturer,” and confirmed that it had reached a settlement with LiNA Medical in late June 2015.

At least 21 similar power morcellator lawsuits filed in 16 federal courts are still in progress, with about 300 additional cases currently under investigation, according to a report filed with the Judicial Panel on Multidistrict Litigation.

More patients are expected to come forward, especially considering that 11% or more of the estimated 500,000 hysterectomies undergone annually in the U.S. involved power morcellation.

Were You or Your Family Harmed?

If you or a loved one underwent a power morcellator-aided surgery and were later diagnosed with uterine cancer, we can help you seek justice and significant compensation for the undue pain, suffering and loss you may have endured.

New York‘s legal system can be difficult to navigate and stressful to handle, especially when so much is already resting on your shoulders. Banville Law has years of success in obtaining compensation for victims like you.

Contact us today for a free case evaluation. Our experienced personal injury lawyers will determine if you have a viable case and will work for you on a contingency fee basis—you pay nothing until a settlement or court award is obtained in your favor.

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