Showing posts with label Dr.Amy Reed. Leiomyosarcoma. Show all posts
Showing posts with label Dr.Amy Reed. Leiomyosarcoma. Show all posts

Friday, March 16, 2018

New study quantifies the risk of occult gynecological malignancy in women undergoing hysterectomy or myomectomy for benign indications


The risk of finding occult gynecological malignancy in women undergoing hysterectomy or myomectomy is not negligible, especially in women more than 55 years in age reports the results of a large population-based study published ahead of print in Journal of Obstetrics and Gynecology.

This timely and interesting study not only looked at the prevalence of gynecological malignancy in women undergoing hysterectomy and myomectomy for benign conditions but also looked at the utility of power morcellators in selected patient populations.


In 2014 US-FDA issued a warning against the use of power morcellators in hysterectomy or myomectomy in women with uterine fibroids because of the risk of spreading and upstaging the cancerous tissue beyond the uterus. The researchers of this study started on the project because, besides few studies, there was no real data to support FDA’s decision to ban the use of power morcellator.

FDA has issued the warning following advocacy by Amy Reed, MD, Ph.D., an anesthesiologist who died following a laparoscopic hysterectomy in October 2013. The use of power morcellator to remove the specimen dispersed and upstaged her undiagnosed uterine sarcoma inside her abdomen.
  
The study led by Vrunda B. Desai, MD, Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut looked at data from the American College of Surgeons National Surgical Quality Improvement Program (NISQIP) for the year 2014-2015.

The sample included 24,076 women who underwent the hysterectomy and 2,368 women who had myomectomy for benign indication at the time of surgery. The researchers did not include data from surgeries performed by gynecologic oncosurgeon to eliminate the possibility of including cases of suspected malignancy before surgery.

After regression analysis, it was seen that the incidence of corpus uteri was found in 1.44%, with variation according to the route of hysterectomy. The highest incidence of 1.89% was found in specimens from total laparoscopic or laparoscopic-assisted vaginal hysterectomy followed by 1.86% in samples from the total abdominal hysterectomy. The lowest incidence of 0.23% was noted in patients who underwent the laparoscopic supracervical hysterectomy.

Other gynecological malignancies identified in the study were cervical cancer in .60% of patient and ovarian cancer in .19% of patients.

The older the women, the greater the risk of detecting malignancy with an adjusted odds ratio of 6.46 for women aged 55 years and older vs women aged 40 to 54 years. Occult cancer of uterine corpus was seen in 9.72% of those aged 55 years and older as compared to only 1.06% of women aged 40 to 54 years.

Prevalence of cancer in patients undergoing myomectomy was very rare with only five women testing positive for cancer of uterine corpus. Out of 5, two underwent vaginal myomectomy while three patients had undergone the abdominal hysterectomy. No cancer was detected in women undergoing laparoscopic myomectomy.

Hence, Desai and colleagues suggested that power morcellators can be of use in selected patients with careful preop evaluation and shared decision making. In these selected group of patients, the benefits of minimally invasive surgery may outweigh the potential risk of cancer dissemination, especially with the recent advancement in techniques such as contained power morcellation inside anisolation bag, which offers additional protection. 

Despite few limitations, the authors say that the study has important clinical implications. The study emphasizes the need of advancing research in screening methods for gynecological malignancies especially cancers of uterine corpus and ovaries. The study also calls for improvement in screening techniques for endometrial and cervical cancers.








Thursday, December 7, 2017

Yet another warning from FDA against Removal of Uterine Fibroids with Ultrasonic Aspirators


FDA issued a guidance against use of Ultrasonic Surgical Aspirators for removal of uterine fibroids because of risk of unintended spread of uterine cancer in the process of suction by the aspirators, thereby, worsening the patient’s odds for survival.

Ultrasonic aspirators are multifunctional devices that break up and emulsify both hard and soft tissues with ultrasound energy and then suck them out of the body through a small incision. They're used by a wide variety of surgeons in both open and laparoscopic procedures, including the cytoreduction of advanced malignancies that can't be removed completely.

The FDA said that the device’s oscillating tip can disperse the tissue that it breaks up with ultrasonic waves, despite the fact that it is designed to suck up the tissue, and the risk of disseminating cancer cells is outweighed by the aspirator’s benefits, which include “more extensive tumor debulking, little or no collateral thermal damage, and the ability to avoid organ resection.”

However, when it comes to removing uterine fibroids, the risk of spreading occult cancer is not outweighed by the benefits, "particularly since there are alternative treatment options available," the FDA stated. The agency noted that there is "no reliable preoperative screening procedure to detect uterine sarcoma in women with presumed benign fibroids."

Under this guidance, the FDA also requires the manufacturers to add a contraindication label to labeling of the devices, with or without 510(k) clearances, within 120 days of the Oct. 30 release of the guidance: CONTRAINDICATION: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.

ACOG has however openly opposed the FDA guidance against use of ultrasonic aspirators for fibroid removal by stating it to be “too rigid and eliminates patient choice.” ACOG also disagrees with FDA regarding existence of other safer alternatives to remove the fibroids and claims that abdominal hysterectomy carries more risk.

The US FDA  has already issued a communication discouraging the use of power morcellator was issued on April 17, 2014 and have resulted in 4% decline in rate of laparoscopic hysterectomies, says the results of cross sectional study published in forthcoming issue of Journal Obstetrics and Gynecology.

FDA issued the statement because of advocacy and anti-morcellator campaign by Amy Reed, MD, PhD, an anesthesiologist who died because of uterine leiomyosarcoma on Wednesday, May 24 at age of 44.

She underwent a laparoscopic hysterectomy in October 2013 for fibroid, but her undiagnosed, occult uterine leiomyosarcoma was upstaged because of dispersion in abdominal cavity by the use of power morcellator. Since then, the power morcellator is the focal point of a four-year debate that has divided the surgical field.

Based on an analysis of currently available data, the FDA has estimated that approximately 1 in 350 women who undergo hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma. 


Related articles:






Wednesday, October 25, 2017

Laparoscopic hysterectomies for leiomyomas on decline after FDA communication discouraging the use of power morcellator.


The US FDA communication discouraging the use of power morcellator was issued on April 17, 2014 and have resulted in 4% decline in rate of laparoscopic hysterectomies, says the results of cross sectional study published in forthcoming issue of Journal Obstetrics and Gynecology.

FDA issued the statement because of advocacy and anti-morcellator campaign by Amy Reed, MD, PhD, an anesthesiologist who died because of uterine leiomyosarcoma on Wednesday, May 24 at age of 44.

She underwent a laparoscopic hysterectomy in October 2013 for fibroid, but her undiagnosed, occult uterine leiomyosarcoma was upstaged because of dispersion in abdominal cavity by the use of power morcellator. Since then, the power morcellator is the focal point of a four-year debate that has divided the surgical field.

The researchers examined data from 4 states inpatient and ambulatory surgery database for year 2013 to 2014, and compared the rates of laparoscopic hysterectomy 15 months before and 9 months after the FDA announcement.

Women with a diagnosis of leiomyomas who underwent hysterectomy or myomectomy were included in the analysis.

Total 77,637 hysterectomies and myomectomies were performed during that period. The rate of laparoscopic hysterectomies declined from 62% of all hysterectomies before to 58% afterward with an accompanying increase in abdominal hysterectomies of 8% from 71% to 79%.
The rate of myomectomies in women with leiomyoma remained the same as compared to hysterectomies.

On April 7, 2016 The U.S. Food and Drug Administration today permitted the marketing of the first tissue containment system for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer.

"PneumoLiner is intended to contain morcellated tissue in the very limited patient population for whom power morcellation may be an appropriate therapeutic option - and only if patients have been appropriately informed of the risks," FDA deputy director William Maisel said in a news release.

"This new device does not change our position on the risks associated with power morcellation. We are continuing to warn against the use of power morcellators for the vast majority of women undergoing removal of the uterus or uterine fibroids," Dr Maisel added.

Based on an analysis of currently available data, the FDA has estimated that approximately 1 in 350 women who undergo hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma.