Study Finds Fewer Michigan Women Getting

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

A new retrospective study found that following calls from the Food and Drug Administration (FDA) to discourage use of the power of fragmentation for laparoscopic hysterectomy or myomectomy for the treatment of women with uterine fibroids, decreased use Grind Michigan, if major complications and readmissions 30 days increased.

Background

Power laparoscopic fragmentation is a minimally invasive method of removing fibroids from the uterus or remove the entire uterus fragmentation into small pieces. In April 2014, the FDA has expressed concern that the technology could spread unsuspected uterine sarcoma in the abdomen and the female pelvis, exacerbating the long-term survival probability.

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

Results
For the University of Michigan study, recently published in the American Journal of Obstetrics & Gynecology, the researchers analyzed 18,299 hysterectomies during the study period and comparative data of the previous 15 months the FDA warning eight months later.

The researchers noted that in the eight months following safety communication FDA in April 2014, compared with the previous 15 months warning, the use of laparoscopic hysterectomies decreased by 4.1% (p = 0.005) and abdominal and vaginal hysterectomies increased (1.7%, p = 0.112 and 2.4%, p = 0.012, respectively). The main surgical complications of blood transfusion was not significantly increased after the date of the communication from the FDA for safety, from 2.2% to 2.8% (p = 0.015) and hospital readmission rates within 30 days also increased from 3.4% to 4.2% (p = 0.025). But the rate of all major surgical complications or reoperations hospital did not change significantly after the date of notification of the FDA.

"We found that the risk of postoperative complications for women who undergo hysterectomy communication from the FDA, increased," John Harris, MDMSc., Academic Hospital of the Robert Wood Johnson Foundation in the UM Department of Obstetrics and Gynecology in statement. "We do not treat the underlying cause of these changes, but is associated with the communication from the FDA about the fragmentation and the risk of cancer."

The researchers also point out that the study did not examine all the results of all surgical diagnosis of occult cancer rates or fragmentation. The study did not compare if the same patient is more or less likely to receive a more invasive technique.