Power Morcellator Research Studies

Power Morcellator Research Studies 2017-08-29T12:27:37+00:00

Anita Austin clearly remembers the pivotal moment that she unknowingly elected to undergo the surgery that all but sentenced her to a fate of advanced uterine cancer.  As a busy working mom, it was a “no-brainer” for her to choose a minimally-invasive surgery over an open surgery, given the much shorter recovery time quoted by her doctor.

The Power Morcellator: A Standard Surgical Tool That Harbors Deadly Risks

But what Anita’s doctor allegedly didn’t tell her was that the power morcellator, a surgical grinding instrument that would be used in her surgery, carries a risk of spreading undetected uterine leiomyosarcoma, an aggressive, treatment-resistant form of cancer.

Tragically, for Anita and others like her, it was only after her surgery in February 2011 that she learned of the risks she’d been exposed to.  She discovered that her undetected stage 1 cancer had been escalated to stage 4–a condition that has been termed “basically incurable” by oncologist Dr. Robin Jones.

Affected Patients File Lawsuits Against Device Manufacturers

Though the healthcare community is now well aware of the possible dangers of power morcellators because of FDA alerts sent out in 2014, thousands of women may have already been exposed to the risks.

Unsuspecting patients underwent what they believed were relatively safe, routine surgeries only to later face a terrifying diagnosis of advanced-stage cancer.

Some of these victims and their families have filed lawsuits against power morcellator manufacturers, pointing out that the FDA alerts were triggered by a body of research that was published and readily available at least 20 years ago.  Because of this, plaintiffs claim that the manufacturers “knew or should have known” about the serious risks posed by their products long before the first power morcellator warning was sent out by the FDA in April 2014.

What Does the Research Say?

To support their claims, the plaintiffs in these power morcellator lawsuits refer to a history of research dating back more than 20 years.

The list of relevant research includes research studies and other publications that did the following: suggested risks of spreading cancerous tissue with power morcellators, presented figures of undetected cancer incidence, and compared the health outcomes of patients that received power morcellation against those who underwent alternative procedures.

Summaries of specific studies highlighted in these lawsuits are given below.

Risks of Spreading Cancerous Tissue

Surgical tissue bag and tissue debulking method patent (1991)

  • Title: Surgical tissue bag and method for percutaneously debulking tissue
  • Filed by: Vance Products, Inc. (an earlier name for Cook Urological, Inc., the company that released the first power morcellator)
  • Inventors: Ralph V. Clayman and Edward D. Pingleton
  • Approval/Publication Date: August 6, 1991

This patent (available on Google Patents) describes a method of “percutaneous debulking” of tissue—that is, cutting up tissue inside the body through pinhole incisions rather than through an open surgery approach—with the use of a surgical bag to envelope fragments.

The authors state that an important reason for using a bag is “the concern for containing malignant or pathogenic tissue,” and elaborate by saying, “The morbidity of patients significantly increases when malignant cells of such large volume tissue are permitted to come in contact with surrounding healthy tissue.”

Plaintiffs have cited this patent, saying that it should have prompted device manufacturers to incorporate containment bags in their product designs to reduce the risk of spreading possible leiomyosarcoma, or at least to take notice of the risks inherent in open morcellation.

Undetected uterine cancer recurs after morcellation (1997)

  • Title: Recurrence of unclassifiable uterine cancer after modified laparoscopic hysterectomy with morcellation
  • Authored by: Dr. Achim Schneider (Friedrich Schiller University)
  • Journal / Publication Date: American Journal of Obstetrics & Gynecology / August 1997

The case study (abstract available here) describes a pre-menopausal patient who underwent a laparoscopic hysterectomy aided by manual morcellation and died within a year from the “rapid progression” of undifferentiated adenocarcinoma, a type of glandular cancer.

She showed no signs of cancer before the surgery and extracted tissue samples appeared “unremarkable,” but 5 months afterwards, she had developed a large cancerous mass in her pelvis. Later, some of the morcellated tissue from her hysterectomy was further examined by pathologists and found to be malignant.

Dr. Shchneider concluded that screening for cancer should be “mandatory” in any case where uterine tissue is to be morcellated.

Retained fragments left behind after laparoscopic hysterectomy take hold and grow (2005)

  • Title: Retained fragments after total laparoscopic hysterectomy
  • Authored by: by Dr. D. Yvette LaCoursiere (University of Utah) et. al.
  • Journal / Publication Date: Journal of Minimally Invasive Gynecology / January 2005

The study (full text available here) describes a patient who elected to undergo laparoscopic hysterectomy with power morcellation to treat heavy bleeding that was not responding to non-surgical treatment methods.

In the 10 months following her surgery, she suffered from recurring pelvic pain and trouble with urination and sexual intercourse. These symptoms were found to originate from 5 pelvic masses scattered throughout her pelvic area, which turned out to be growths that most likely started as uterine tissue fragments from morcellation.

The authors write that the study shows that “implantation, rather than resorption of residual fragments….can occur,” and thus underlines the importance of removing even the smallest fragments after morcellation, noting that power morcellators may create smaller remnants than other fragmentation methods.

The authors also show concern over the possible implications in cases of malignant tissue.

Fragments from Laparoscopic Morcellation May Grow and Spread  (published in 2010)

  • Title:  “Iatrogenic” parasitic myomas: unusual late complication of laparoscopic morcellation procedures
  • Authored by: Dr. Demetro Larraín (University of Auvergne) et. al.
  • Journal / Publication Date: Journal of Minimally Invasive Gynecology / July 2010

This observational study (abstract available here) followed 4 patients who had developed pelvic masses after morcellation procedures.

As in the aforementioned 2004 study, these masses were likely “parasitic” growths originating from morcellated tissue remnants. 2 of the patients experienced pain from the growths, while the other 2 patients experienced no symptoms, and 1 patient developed cancer that may or may not have been related to the growths.

The authors expressed alarm over the possibilities of spreading cancer, stating the following:

[i]f retained fragments [from morcellation] can establish a blood supply and grow with benign disease, it is of concern that in situations in which an unsuspected malignant lesion is inadvertently morcellated, aberrant fragments will grow and metastasize.”

Research Studies with Uterine Cancer/Leiomyosarcoma Incidence Figures

There were multiple studies that cited unsuspected leiomyosarcoma incidence rates much higher than the “1 in 10,000 women” rate that was allegedly quoted to plaintiffs prior to surgery. The following list is a summary of such studies:

  • 1990 Study by Dr. Steven Leibsohn, et. al. – “Leiomyosarcoma in a series of hysterectomies performed for presumed uterine leiomyomas.”
    • Published in the American Journal of Obstetrics & Gynecology in April 1990 (abstract available here).
    • Study included 1432 women that underwent hysterectomies between 1983 and 1988, for the treatment of symptoms presumed to be due to uterine fibroids.
    • Authors estimated a “1 in 140 chance of having a uterine leiomyosarcoma” in patients exhibiting “signs and symptoms of [benign] uterine leiomyomas [fibroids] that warrant hysterectomy.”
  • 1999 Study by Dr. S.Takamizawa, et. al. – “Risk of complications and uterine malignancies in women undergoing hysterectomy for presumed benign leiomyomas.”
    • Published in Gynecologic and Obstetric Investigation in October 1999 (abstract available here).
    • Study of medical records from 923 women who underwent total hysterectomies for treatment of presumed benign uterine fibroids.
    • Of these women, 4 were diagnosed with “uterine malignancies” post-surgery, one of which was leiomyosarcoma, corresponding to a 0.1% unsuspected leiomyosarcoma incidence, which is 10 times greater than the 0.01% incidence rate suggested by the 1 in 10,000 estimate.
  • 2011 Compilation of Case Studies by Dr. I.S. Hagemann, et. al. – “Risk of occult malignancy in morcellated hysterectomy: a case series.”
    • Published in the International Journal of Gynecological Pathology in September 2011 (abstract available here).
    • Study of 100 patients over a 4-year period who underwent morcellator-aided hysterectomies.
    • 1 of these patients had a malignant tumor morcellated inadvertently, leading the authors to estimate a 1 in 100 incidence rate of unsuspected malignancy.
    • The authors warn that even with comprehensive pre-surgery cancer screening, “morcellation of occult uterine malignancy remains a possibility.”

Possible Effects of Power Morcellator Use on Post-Surgery Patient Health

A number of research studies were conducted that directly compared the health outcomes of unsuspecting cancer patients that underwent procedures with morcellation against those of patients that were not morcellated.

Morcellators not recommended for uterine sarcoma patients (2003)

  • Title: Prognostic value of initial surgical procedure for patients with uterine sarcoma: analysis of 123 patients
  • Authored by: Dr. P. Morice (Institut Gustave Roussyone, a world-renowned cancer research institute) et. al.
  • Journal / Publication Date: European Journal of Gynecological Oncology / February 2003.

In this study (abstract available here), the authors studied a total of 123 uterine sarcoma patients undergoing surgical treatment for their cancer. These surgical treatments included hysterectomy (either vaginal or laparoscopic), myomectomy, hysteroscopy, or plain biopsy.

The patients were split into 2 groups—34 women who underwent morcellator-aided surgery and 89 women who had corresponding surgeries without morcellation.

After the patients were given follow-up examinations at 3 months post-surgery, it was discovered that the morcellator-treated women experienced a significant increase in uterine sarcoma recurrence over the women who were not morcellated.

The authors concluded that morcellator-aided techniques should not generally be used on patients that have or may have uterine sarcoma, instead recommending “monobloc” total abdominal hysterectomy and bilateral salpingo-oophorectomy (removal of the uterus, ovaries and fallopian tubes) as treatments of choice for such patients.

After surgeries for benign disease, patients fare worse if morcellated (2008)

  • Title:  Management of uterine malignancy found incidentally after supracervical hysterectomy or uterine morcellation for presumed benign disease
  • Authored by: Dr. M.H. Einstein (Memorial Sloan-Kettering Cancer Center) et. al.
  • Journal / Publication Date:  International Journal of Gynecological Cancer / September 2008

In this study (abstract available here) , the authors reviewed case studies of patients treated in their facility from 2000-2006 who underwent supracervical hysterectomy for a benign condition, either with morcellation or without.

17 of these patients were found to have uterine cancer after their operations.

After undergoing a second surgery, 40% of patients who had been initially morcellated had upstaged cancer as opposed to only 8% of those who had not been morcellated, data which the authors say “support this trend toward worse outcomes in patients who had morcellation procedures.”

Outcomes for uterine sarcoma patients adversely affected by morcellation (2011)

  • Title: The impact of tumor morcellation during surgery on the outcomes of patients with apparently early low-grade endometrial stromal sarcoma of the uterus
  • Authored by: Jeong-Yeol Park MD, PhD (from the University of Ulsan in Seoul) et. al.
  • Journal / Publication Date: Annals of Surgical Oncology / November 2011

In this study (abstract available here), the authors looked at a total of 50 patients with who had been diagnosed with low-grade endometrial stromal sarcoma after surgery, 23 of them having had morcellation and 27 of them non-morcellated.

The non-morcellated group experienced “five-year disease free survival rates” and “abdominopelvic five-year disease free survival rates” of 88% and 84%, respectively, whereas the morcellated group had corresponding rates of 55% and 58%.

The authors concluded that in patients such as those studied, inadvertent malignant tumor morcellation “adversely affect[s] the outcomes.”

Were Decades of Research Ignored and/or Concealed by Manufacturers?

As we’ve seen, researchers have been investigating the possible risks of morcellation at least as far back as 1990—years before the first power morcellator was released on the market in 1994.

Furthermore, through the following decades, medical researchers and healthcare providers have continued to explore possible adverse effects of power morcellators and even often concluded their studies with warnings about the use of the devices.

These facts are emphasized in the lawsuits filed against device manufacturers, which claim that the defendants were aware or should have been aware of the risks posed by their products, but failed to warn patients.  This resulted in the escalation of undiagnosed cancer, causing extreme emotional trauma, damage to health and well-being, and for some patients, loss of years of life, plaintiffs allege.

If you or a loved one received a leiomyosarcoma diagnosis after undergoing a power morcellator-aided laparoscopic uterine surgery, and believe that you may have been harmed by misinformation or other wrongdoing surrounding the surgery, do not hesitate to contact the New York firm, Banville Law, for a free, no-obligation case evaluation.

You may be entitled to significant financial compensation, and we’re here to help and support you on a contingency fee basis – no payment necessary until we’ve obtained a settlement or court award in your favor.

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