In July 2014, manufacturing giant Johnson & Johnson recalled its power morcellator products from the market, after halting sales and promotion worldwide. The market withdrawal and recall took place after a major FDA investigation alerted the public that the devices could dramatically worsen unsuspected uterine cancer, posing a severe threat to patients’ lives.
20 Years of Literature on Morcellator Cancer Risk, Ignored by Manufacturers?
A number of lawsuits have been filed against device manufacturers, including Johnson & Johnson’s Ethicon unit. Such lawsuits allege that these companies knew about the possible risks posed by power morcellators and either ignored them or purposely concealed them from doctors and patients.
Plaintiffs in pending lawsuits accuse device manufacturers of neglecting to perform proper research before creating and releasing power morcellator models and/or failing to monitor case studies after their products were on the market.
But what does the research say? Are the risks of power morcellators clear from the literature? The following is a selection of studies, grouped by the specific allegation they’ve been invoked to support.
Device Manufacturers Knew Morcellators Could Spread Cancer
Studies that support this allegation provide evidence that morcellators tend to disperse ground-up tissue and either speculate about or directly infer the possibility of spreading cancer if malignant tissue is morcellated.
1991: Patent Introduces Containment Bag Designed to Avoid “Increase in Morbidity” from Potentially Malignant Tissue Fragments
- Patent title: Surgical Tissue Bag and Method for Percutaneously Debulking Tissue
- Patent filed by: Vance Products, Inc. (a former name for Cook Urological Instruments)
- Authors/Inventors: Ralph V. Clayman and Edward D. Pingleton
- Published: Aug. 6, 1991
In this patent, a method and improved device design for “debulking” (cutting a large mass into smaller pieces) tissue is introduced.
The design includes a containment bag for the purpose of capturing any loose tissue fragments that may otherwise be dispersed throughout the abdomen. The authors say that such dispersal is a “major problem” resulting from debulking methods such as morcellation due to the risk of spreading “malignant cells to healthy tissue in the body cavity,”
Such spreading of cancerous fragments can have deadly consequences, stated in no unclear terms by the authors as follows: “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 citing this patent point out that it was readily available to the public before the release of power morcellator models for gynecological surgeries. They also maintain that manufacturers should have heeded its warning against open morcellation and its call for design modifications such as containment bags.
1997: Patient Develops Cancerous Mass After Being Morcellated
- Study title: Recurrence of Unclassifiable Uterine Cancer After Modified Laparoscopic Hysterectomy with Morcellation
- Author: Dr. Achim Schneider
- Journal: American Journal of Obstetrics & Gynecology
- Published: Aug. 1997
This is a case study of a patient who died within a year from the “rapid progression” of glandular cancer only a year after receiving manual morcellation during a laparoscopic hysterectomy.
Though biopsies from the patient’s hysterectomy initially appeared “unremarkable,” and she exhibited no cancer symptoms before the surgery, a large mass of malignant tissue was found in her pelvis just 5 months post-surgery,
Further pathological testing of the initial biopsies revealed that the tissue was indeed cancerous.
The author stressed that the increase in morcellation due to the introduction of laparoscopic surgeries makes it especially important, even “mandatory,” for doctors to screen for cancer prior to uterine surgery.
2005: Patient Develops 5 Pelvic Masses Likely “Implanted” from Morcellation Fragments
- Article Title: Retained Fragments After Total Laparoscopic Hysterectomy
- Authors: Dr. D. Yvette LaCoursiere et. al.
- Journal: Journal of Minimally Invasive Gynecology
- Published: Jan. 2005
The subject of this study suffered from heavy pelvic bleeding and sought treatment by a laparoscopic hysterectomy aided by a power morcellator.
Within 10 months following the hysterectomy, the patient experienced pain in her pelvic area, difficulty urinating, and painful sexual intercourse. She was examined and 5 abnormal tissue masses were found in her pelvis, which were likely the cause of her mysterious adverse symptoms.
These masses were likely “seeded” from tissue bits flung around her pelvis by the power morcellator.
The authors note that it is of prime importance to remove as many fragments as possible after the use of power morcellators, since “implantation, rather than resorption of residual fragments….can occur.” They also mention that the use of power morcellators may result in smaller, harder-to-remove remnants than other methods of breaking up tissue.
Though implantation of benign tissue can already lead to serious problems, as the patient in the study experienced, the authors acknowledge serious implications for cases of malignancy.
2010: “Parasitic” Growths from Morcellation May Spread Cancer
- Article title: “Iatrogenic” Parasitic Myomas: Unusual Late Complication of Laparoscopic Morcellation Procedures
- Author: Dr. Demetro Larraín (University of Auvergne) et. al.
- Journal: Journal of Minimally Invasive Gynecology
- Published: Jul. 2010
In this study, 4 patients were observed to develop pelvic masses after undergoing power morcellation.
The authors describe these masses as“parasitic,” as they likely grew from bits of tissue left over from morcellation.
The patients were affected differently from the pelvic growths:
- The growths caused pain for 2 patients
- The other 2 patients reported no symptoms from the growths
- 1 of the patients was diagnosed with cancer after surgery.
Though the authors were unsure whether or not the patient’s cancer was related to the growths, they take the possibility of morcellation spreading cancer seriously, writing:
“[I]t is of concern that in situations in which an unsuspected malignant lesion is inadvertently morcellated, aberrant fragments will grow and metastasize.”
Device Manufacturers Knew Morcellated Patients Could Suffer Worsened Prognosis
This allegation is supported by the host of studies directly comparing the effect of power morcellators on the prognosis of patients that harbored unsuspected uterine cancer prior to surgery.
2003: Comprehensive Study Advises Against Morcellator Use
- Article title: Prognostic Value of Initial Surgical Procedure for Patients with Uterine Sarcoma: Analysis of 123 Patients
- Author: Dr. P. Morice, et. al.
- Journal: European Journal of Gynecological Oncology
- Published: February 2003
This study followed 123 uterine sarcoma patients pursuing surgical options for treating their cancer. The surgical options included in the study were hysterectomy (either vaginal or laparoscopic), myomectomy, hysteroscopy, or plain biopsy.
The studied patients fell into 2 distinct groups: those who were morcellated in their surgeries (34 women) and those who received corresponding surgeries without morcellation (89 women).
Examination of the patients 3 months after their surgeries reveialed that the morcelleted women experienced considerably more recurrence of uterine sarcoma than those who hadn’t been morcellated.
The authors conclude by advising against using morcellator-aided techniques for uterine sarcoma patients or those who might have the disease, citing alternative methods as more optimal.
2008: Patients Undergo Operations for Benign Conditions and End Up with Uterine Cancer
- Article Title: Management of Uterine Malignancy Found Incidentally After Supracervical Hysterectomy or Uterine Morcellation for Presumed Benign Disease
- Author: Dr. M.H. Einstein et. al.
- Journal: International Journal of Gynecological Cancer
- Published: Sept 2008
In this article, the authors reviewed all case studies from 2000-2006 of patients that opted to have their benign conditions treated by a hysterectomy. Some received morcellation and the others didn’t.
17 of these patients were found to have uterine cancer after their operations. All of these patients needed to have a second surgery to help treat the cancer.
The authors note “worse outcomes in patients who had morcellation procedures.” Biopsies from the cancer treatment surgeries revealed that 40% of patients who were morcellated in the initial surgery developed upstaged cancer.
On the other hand, only 8% of who had avoided morcellation harbored advanced cancer by the 2nd surgery.
2011: Five-Year Survival Rates Drastically Impacted by Power Morcellators
- Article title: The Impact of Tumor Morcellation During Surgery on the Outcomes of Patients with Apparently Early Low-Grade Endometrial Stromal Sarcoma of the Uterus
- Author: Jeong-Yeol Park MD, PhD, et. al.
- Journal: Annals of Surgical Oncology
- Published: November 2011
This subject group studied in this article consisted of 50 patients who received post-operative diagnoses of “low-grade endometrial stromal sarcoma.” 23 of these patients were morcellated during their operations and 27 were not morcellated.
The authors observed a large difference in outcomes between morcellated and non-morcellated patients, writing that “rupture and….spillage of tumor may adversely affect the outcomes of patients.”
The subset of patients who weren’t morcellated had much higher five-year survival rates than those who were morcellated. To be exact, the morcellated patients had “five-year disease free survival rates” and “abdominopelvic five-year disease free survival rates” of 55% and 58%, respectively, whereas the non-morcellated patients’ corresponding rates were 88% and 84%,
Device Manufacturers Knew About Higher-than-Cited Risk Estimates
Though an incidence of “1 in 10,000 women” was commonly believed prior to the release of estimates by the FDA in 2014, there have been many studies, some conducted before the introduction of power morcellators.
1990: Estimate of a 1 in 140 Chance of Uterine Leiomyosarcoma in Fibroid Patients
- Article title: Leiomyosarcoma in a Series of Hysterectomies Performed for Presumed Uterine Leiomyomas
- Author: Dr. Steven Leibsohn, et. al.
- Journal: American Journal of Obstetrics & Gynecology
- Published: April 1990
This study included data from 1432 women who were treated for symptoms thought to be due to uterine fibroids between the years of 1983 and 1988. The authors came up with an estimate of “1 in 140 chance of having a uterine leiomyosarcoma” for patients that experience “signs and symptoms of [benign] uterine leiomyomas [fibroids] that warrant hysterectomy.”
1999: About 1 in 1,000 Women Found to have Unsuspected Uterine Cancer
- Article title: Risk of Complications and Uterine Malignancies in Women Undergoing Hysterectomy for Presumed Benign Leiomyomas
- Author: Dr. S.Takamizawa, et. al., et. al.
- Journal: Gynecologic and Obstetric Investigation
- Published: October 1990
This study examined the medical records of 923 women who, seeking treatment for symptoms presumably resulting from benign uterine fibroids, received total hysterectomies.
4 of these women were found to harbor “uterine malignancies” after their operations. 1 of the women had leiomyosarcoma.
These findings translate into an unsuspected leiomyosarcoma incidence of about 1 in 1,000, which is 10 times greater than the 1 in 10,000 estimate.
2011: Estimate of 1 in 100 Women Harboring Unsuspected Malignancies
- Article title: Risk of Occult Malignancy in Morcellated Hysterectomy: A Case Series
- Author: Dr. I.S. Hagemann, et. al
- Journal: International Journal of Gynecological Pathology
- Published: September 2011
In this article, the authors looked at data from 100 morcellator-aided hysterectomy patients from a 4-year period. 1 of these patients turned out to have a malignant tumor, which corresponds to an estimated unsuspected malignancy rate of 1 in 100.
The authors note that “morcellation of occult uterine malignancy remains a possibility,” even after extensive cancer screening prior to surgery.
2014: An Estimated 1 in 370 Incidence Rate from Comprehensive Study
- Article title: Uterine Pathology in Women Undergoing Minimally Invasive Hysterectomy Using Morcellation
- Author: Dr. Jason D. Wright, et al.
- Journal: Journal of the American Medical Association
- Published: September 2014
In order to “investigate the prevalence of underlying cancer in women who underwent uterine morcellation,” the authors conducted a comprehensive study that included a total of 232,882 patients treated from 2006 – 2012 for minimally-invasive hysterectomies. These data were culled from insurance claim databases from more than 500 hospitals.
Out of all the hysterectomies included in the study, 15.7% (i.e. 36,470 operations) involved power morcellators, In 99 of these cases, the patient was diagnosed with uterine cancer after surgery. This translates to an unsuspected uterine cancer incidence rate of 1 out of 370 women.
The authors stress the importance for hysterectomy patients to be informed of “the prevalence of cancerous and precancerous conditions prior to undergoing the procedure.”
Affected Patients Deserve Justice
As we have seen, an extensive body of literature detailing the possible morcellator cancer risk has been publicly available for decades. Some studies even conducted before power morcellators were released in the early 90’s.
These studies form the basis for allegations that the defendants in power morcellator lawsuits could have discovered the potential for harm caused by morcellation and done something to prevent it, but instead either neglected or willfully ignored the available evidence.
According to the pending morcellator lawsuits, this negligence from device manufacturers condemned patients to the nightmare of advanced cancer, resulting in tremendous stress, pain, hardship, and in some cases, an excruciating, premature death.
22 lawsuits have been filed thus far by those seeking justice and compensation for suffering allegedly caused by power morcellators. Given the popularity that morcellation experienced for nearly 2 decades, lawyers expect that many more cases will be filed.
Contact Monheit Law for a no-cost case evaluation today if you think you may have an eligible power morcellator case. Our team of experienced lawyers are here to help you fight for your rights.