The January-February 2016 edition of the medical journal Women's Health Issues will publish what might be considered the U.S. Food and Drug Administration's "I Told You So" study. In the piece, Boston University Medical Center researchers validate the risk that an electronic uterine fibroid treatment known as laparoscopic power morcellation can spread previously undetected uterine cancer.
A woman who has been diagnosed with cancer after undergoing laparoscopic power morcellation for the removal of the uterus (hysterectomy) or for the removal of uterine fibroids (myomectomy) should contact an attorney to find out whether she is entitled to compensation.
Researchers pulled data from 2007 to 2012 out of an administrative database of diagnostic and treatment data for 55.7 million commercially insured women in the United States. They looked at the number of women who underwent the procedures, and they tracked the incidence of post-operative complications, such as uterine cancer.
The study looked at when certain diagnoses occurred within certain post-operative windows.
"Distinct time cutoffs were used when describing cancer and hyperplasia outcomes," the authors wrote. "The follow-up period for uterine cancer and endometrial hyperplasia cases after laparoscopic supracervical hysterectomy ended either when the subject was no longer present in the database owing to change of insurance or lack of contact with the medical system or at the end of the study period, namely, December 31, 2012. This included 1 to 5 years of data per patient. We included uterine cancer or endometrial hyperplasia cases occurring at any time after the initial surgery because uterine cancer or hyperplasia after hysterectomy was considered evidence of seeding, and tissue growth after seeding during morcellation can present years after the initial procedure."
Researchers looked for certain cancers to be diagnosed within a month of surgery. They wrote, "Cervical, ovarian, and fallopian tube cancer cases after laparoscopic supracervical hysterectomy and uterine cancer cases after myomectomy were counted as cases only if they occurred within 1 month of the surgery date because our goal was to describe the prevalence of these unsuspected conditions at the time of surgery, and occurrence remote from surgery in organs left in situ would not be related to morcellation."
So what did this mean? It meant that a lot of morcellation patients had undetected cancers. The conclusion reads, in part, "The rate of undiagnosed uterine cancer in women undergoing laparoscopic supracervical hysterectomy seems to be approximately 1 in 350, and the risk increases with age. The routine use of endometrial biopsy on all patients before hysterectomy might increase the number of cancers diagnosed before surgery, but would not eliminate the risk of undiagnosed cancer."
Indeed, the FDA in 2014 wrote, "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."
And, after setting the statistical stage, the FDA leveled its warning against the procedure, writing in a statement, "If laparoscopic power morcellation is performed in women with unsuspected 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. While the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood. 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."
Many women who underwent a morcellation procedure and who since were diagnosed with the spread of cancer were allegedly victims of an unreasonable risk about which the morcellator manufacturer should have known and should have minimized. If you believe you are in that number, strongly consider getting an attorney to fight for the justice you deserve.
Reich & Binstock is taking these cases and is offering a free consultation to patients in any state.