First, the U.S. Food and Drug Administration issued warnings about a uterine fibroid treatment known as laparoscopic power morcellation. Now, the FBI has begun investigating what one of the morcellator makers may have known about the cancer risks linked to the device.
As power morcellation lawsuits are being filed across the nation, the FBI probe is centered on Johnson & Johnson executives' knowledge of the supposed risk of cancer being spread by the procedure. A process used in removing the uterus (hysterectomy) or removing uterine fibroids (myomectomy), power morcellation is the method by which a surgeon uses an electronic medical device to divide tissue into smaller pieces so that they may be extracted through small incision sites.
Several people, including a cancer victim, her husband and a retired physician, reportedly confirmed in May that they spoke to FBI investigators. Johnson & Johnson is not the only power morcellator manufacturer. It happens to be the one that pulled its product off the market in 2014.
The problem with power morcellation, according to the FDA, is that the procedure may spread an undetected uterine sarcoma.
As the agency reported in both of its 2014 safety advisories, "Based on an FDA analysis of currently available data, we estimate that approximately 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. At this time, there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma."
If the procedure is performed on women who do not know and whose doctors cannot tell that they have uterine sarcoma, "there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient's long-term survival," the agency explained in a November 2014 statement. "While the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood."
The FDA's bottom line since November is this: "Because of this risk and the availability of alternative surgical options for most women, the FDA is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids."
Not only has the FDA weighed in before the investigation, several U.S. senators have written to the FDA, demanding answers and calling for safety measures, long before the FBI got involved.
The scientific community triggered the chain of investigative and public health events. The FDA reviewed scientific literature on patients who underwent power morcellation from 1980 to 2011 and wrote, "The FDA conducted a review of published and unpublished scientific literature ... to estimate the prevalence of unsuspected uterine sarcoma and uterine leiomyosarcoma in patients undergoing hysterectomy or myomectomy for presumed benign fibroids (leiomyoma). This analysis led us to believe that the prevalence of unsuspected uterine sarcoma in patients undergoing hysterectomy or myomectomy for presumed benign leiomyoma is 1 in 352, and the prevalence of unsuspected uterine leiomyosarcoma is 1 in 498. Both of these estimates are higher than the clinical community previously understood."
FDA brass and researchers at a prestigious hospital seem to be on the same page now.
Researchers at Brigham and Women's Hospital, the teaching hospital for Harvard Medical School, co-wrote an article about the results of their analysis for the November 2012 edition of the medical journal PLOS ONE. They examined data from 1,091 uterine morcellation recipients who underwent the procedure at BWH from 2005 to 2010.
The researchers wrote, "Unexpected diagnoses of leiomyoma variants or atypical and malignant smooth muscle tumors occurred in 1.2 percent of cases using power morcellation for uterine masses clinically presumed to be 'fibroids' over this period, including one endometrial stromal sarcoma, one cellular leiomyoma, six atypical leiomyomas, three smooth muscle tumors of uncertain malignant potential, and one leiomyosarcoma."
The risk findings were staggering.
"The rate of unexpected sarcoma after the laparoscopic morcellation procedure was 0.09 percent, 9-fold higher than the rate currently quoted to patients during pre-procedure briefing," the BWH study reads, "and this rate may increase over time as diagnostically challenging or under-sampled tumors manifest their biological potential. Furthermore, when examining follow-up laparoscopies, both from in-house and consultation cases, disseminated disease occurred in 64.3 percent of all tumors. Only disseminated leiomyosarcoma, however, was associated with mortality."
A woman who underwent a hysterectomy or myomectomy for the treatment of uterine fibroids and who since has been diagnosed with cancer may contact an attorney for advice on her legal options. The cancer victim may be entitled to compensation.
The product liability attorneys at Reich & Binstock, a law firm that operates in all 50 states, may be reached either by calling the toll-free number, 1-866-LAW-2400, or by submitting an electronic message through this web page.