Regulatory Focus™ > News Articles > Study Finds Fewer Michigan Women Getting Minimally Invasive Hysterectomies after FDA Warning

Study Finds Fewer Michigan Women Getting Minimally Invasive Hysterectomies after FDA Warning

Posted 11 September 2015 | By Zachary Brennan 

Study Finds Fewer Michigan Women Getting Minimally Invasive Hysterectomies after FDA Warning

A new retrospective study has found that following calls from the US Food and Drug Administration (FDA) discouraging the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids, the use of morcellation decreased in Michigan, though major complications and 30-day hospital readmissions increased.

Background

Laparoscopic power morcellation is a minimally invasive method of removing fibroid tumors from the uterus or removing the entire uterus by fragmenting it into smaller pieces. In April 2014, FDA raised concerns that the technique could potentially spread unsuspected uterine sarcoma within a woman's abdomen and pelvis, thus worsening her likelihood of long-term survival.

"For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids," FDA said in its warning.

Results

For the University of Michigan study, published recently in the American Journal of Obstetrics & Gynecology, researchers analyzed 18,299 hysterectomies during the study period and compared data from the 15 months preceding the FDA warning to the eight months afterward.

Researchers noted that in the eight months following the FDA safety communication in April 2014, when compared to the 15 months preceding the warning, utilization of laparoscopic hysterectomies decreased by 4.1% (p=0.005) and both abdominal and vaginal hysterectomies increased (1.7%, p =0.112 and 2.4%, p=0.012,respectively). Major surgical complications not including blood transfusions significantly increased after the date of the FDA safety communication, from 2.2% to 2.8% (p=0.015), and the rate of hospital readmission within 30 days also increased from 3.4% to 4.2% (p=0.025). But the rate of all major surgical complications or hospital reoperations did not change significantly after the date of the FDA communication.

"We found that since the FDA communication, the risk of postoperative complications for women undergoing hysterectomies actually increased," John Harris, M.D. M.Sc., a Robert Wood Johnson Foundation Clinical Scholar in the U-M Department of Obstetrics and Gynecology said in a statement. "We did not examine the underlying cause for these changes, but it is associated with the FDA communication on morcellation and cancer risk."

Researchers also note that the study did not examine any outcomes around diagnosis of occult cancer or the rate of morcellation surgeries. The study also did not compare whether the same patient is more or less likely to receive a more invasive technique.

American Journal of Obstetrics & Gynecology Study


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