Fewer minimally invasive procedures, higher complication rates found in the months following 2014 FDA statement
In April 2014, the U.S. Food and Drug Administration (FDA) published its first safety communication discouraging “the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids.”
Due to the concern of worsening outcomes for patients with occult uterine malignancy, specifically uterine leoimyosarcoma, the FDA recommended a significant change to existing surgical planning, patient consent, and surgical technique in the U.S.
In 2015, faculty from the University of Michigan Department of Obstetrics and Gynecology, led by John Harris, MD, MSc, performed a retrospective cohort study of patients undergoing hysterectomy for benign indications during the 15 months preceding the FDA safety communication and eight months following the communication. A total of 18,299 hysterectomies were reviewed in the study.
The review revealed that utilization of minimally invasive hysterectomy decreased in the statewide population following the FDA safety communication, but major surgical non-transfusion complications, as well as 30-day hospital readmissions, subsequently increased.
Results were published online in the American Journal of Obstetrics and Gynecology in September 2015, and were extensively covered in the popular press, including the Philadelphia Inquirer.
“We know that for a significant number of women, a minimally invasive procedure that avoids the risks of surgery is a viable option and often the safest. Since the FDA communication, we saw a decrease in minimally invasive hysterectomies,” says Dr. Harris, a Robert Wood Johnson Foundation Clinical Scholar in the U-M Department of Obstetrics and Gynecology and member of the Institute for Healthcare Policy and Innovation.
“We found that since the FDA communication, the risk of postoperative complications for women undergoing hysterectomies actually increased. We did not examine the underlying cause for these changes, but it is associated with the FDA communication on morcellation and cancer risk.”
There was a nearly 25 percent increase in hospital readmissions and 27 percent increase in major postoperative complications after hysterectomy.
Take the next step:
- Read the American Journal of Obstetrics and Gynecology article or the news release about Dr. Harris’ findings.
- Learn about how U-M faculty joined other top health experts across the nation in asking the FDA to revise its warning, as published in the Green Journal last fall.
- Read published research from Sawsan As-Sanie, MD and other U-M Obstetrics and Gynecology faculty about risk of unexpected sarcoma after morcellation.
- Learn more about the Minimally Invasive Gynecologic Surgery program at University of Michigan Von Voigtlander Women’s Hospital.