In case you missed it: Here are the top 5 posts this month

FDA approves a bedside test for assessing the risk of spontaneous preterm birth

QIAGEN won FDA approval for marketing its Novel PartoSure® point of care test for estimating the risk of spontaneous preterm birth in patients who present with symptoms of preterm labor. PartoSure represents a breakthrough in research and development of diagnostic tests for preterm birth.

Predicting preterm birth is a diagnostic challenge and nearly 85% of patients admitted to the hospital for threatened preterm labor (PTL) do not deliver within the next 7 days, resulting in unnecessary interventions.

https://obgynupdated.blogspot.com/2018/04/fda-approves-bedside-test-for-assessing.html

Medical management of adenomyosis: current and future therapies

The current issue of Journal of Fertility and Sterility has focused exclusively on etiology, pathophysiology, and medical and surgical treatment of adenomyosis. Adenomyosis has long been the source of controversy and its only with the recent advent of Transvaginal sonography (TVS) and MRI that its etiology and pathophysiology been better understood.

Adenomyosis is a uterine pathology in which the endometrial glands and stroma invaginate within the uterine myometrium. This ectopic endometrium induces hypertrophy and hyperplasia of the myometrium resulting in the typical ‘globular” enlargement of the uterus.

https://obgynupdated.blogspot.com/2018/04/medical-management-of-adenomyosis.html

Significant rise in hysterectomy complications observed following the FDA’s warning against power morcellator

A significant increase in major and minor complications following hysterectomy was noted in a large retrospective cohort study that was conducted after the US Food and Drug Administration (FDA) warned against the use of laparoscopic power morcellation during a hysterectomy in November 2014.

The study was published today April 11 in JAMA Surgery.

The warning was issued because of fear of dissemination of undiagnosed occult leiomyosarcoma in the benign fibroid mass.   

https://obgynupdated.blogspot.com/2018/04/significant-rise-in-hysterectomy.html

Addition of 24-chromosome microarray analysis to standard testing identifies a probable or definitive cause in over 90% of recurrent miscarriages

The new method of 24 Chromosome Microarray, or comprehensive chromosomal screening when added to the standard Recurrent Pregnancy Loss (RPL) evaluation of American Society for Reproductive Medicine (ASRM) could provide a probable or definitive cause in over 90% of patients reports the result of a small prospective cohort study published 1 April 2018 in Journal of Human Reproduction.

In the absence of definitive etiologies and treatment strategies, RPL is one of the most frustrating and difficult to treat entity in reproductive medicine. It affects 2%-5% of couples and a cause can be found only in 50% of the couples after undergoing the standard ASRM workup.

https://obgynupdated.blogspot.com/2018/04/addition-of-24-chromosome-microarray.html

A novel, single-use Foley’s catheter fixation device protects from accidental removal and trauma

Indwelling urinary catheters are very commonly used for inpatients in hospitals and people confined to bed in hospice and nursing homes. It is estimated that 25% of hospitalized patients have catheters placed during their hospital stay.

They are also associated with Urinary Tract Infections (UTI) and account for 70-80% of iatrogenic UTI in hospital and inpatient settings. But, genitourinary trauma is also common because of the inflated balloon during accidental pulling of Foley’s catheter.

https://obgynupdated.blogspot.com/2018/04/a-novel-single-use-foleys-catheter.html

Significant rise in hysterectomy complications observed following the FDA’s warning against power morcellator

A significant increase in major and minor complications following hysterectomy was noted in a large retrospective cohort study that was conducted after the US Food and Drug Administration (FDA) warned against the use of laparoscopic power morcellation during a hysterectomy in November 2014.

The study was published today April 11 in JAMA Surgery.

The warning was issued because of fear of dissemination of undiagnosed occult leiomyosarcoma in the benign fibroid mass.  

Hysterectomy is one of the most common gynecological surgery carried out in the United States with more than 600,000 procedures per year. Following the warning, the use of power morcellator in minimally invasive gynecological surgery (MIS) plummeted from 13.7% in early 2013 to 2.8% in early 2015.

The researchers write, "The results of two surveys of gynecologists evaluating the influence of the FDA warning on management strategies in hysterectomy and myomectomy showed that a large proportion of respondents shifted from the use of minimally invasive surgery [MIS] to the use of a larger incision or open abdominal procedures, raising concerns about an increase of surgical complications."

"Furthermore, the FDA decision was criticized for overestimating the risk associated with using power morcellation compared with the risk associated with preventing its use in a large group of women who could receive benefits from morcellation."

When women waiting in the gynecologist office were offered a survey about the preferred route of surgery, most them chose MIS over open surgery despite being informed about 1 in 368 risks of a malignant tumor in the benign mass.

The researchers scanned the data from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database for major and minor surgical complications following the primary surgery.

A look at data from 603 participating academic and nonacademic hospitals, showed that 75,487 women underwent hysterectomy for benign gynecologic indications out of which nearly one-third (25, 571) was for uterine fibroid.

The investigators compared the rate of major and minor complications during the first 30 days following before and after the FDA issued the warning.

The mean age of the women was 47.8 years, of whom 32, 186 (42.6%) had the surgery before and 43, 301 (57.4%) had it after the FDA-issued warning. Nearly 60% were non-Hispanic white women followed by African American women who comprised 15.1%.

The major and minor complications were comparable in both the groups, but in a subset of women who underwent hysterectomy for fibroid, the major complication increased by 23%  after the FDA-issued warning (adjusted odds ratio [OR], 1.23; 95% CI, 1.04-1.47; P = .02), and minor complications increased by 21% (adjusted OR, 1.21; 95% CI, 1.04-1.40; P = .01).

The rate of open abdominal hysterectomies also increased from 37.2% to 43.0%, and the rate of minimally invasive surgery decreased from 56.1% to 49.7% (P < .001).

"This 20% increase in the odds of major and minor complications could translate into a large number of additional complications among the 200,000 hysterectomies performed annually for uterine fibroids in the United States," the researchers write.

The study has limitations in terms of its retrospective nature and non-availability of data about complications after 30 days.

There was also no statistics about the decrease in the prevalence of cases whose occult malignancy was dispersed following the use of morcellator.

The researchers, however, stressed the need for informed and shared decision making between patients, providers and governing bodies till additional larger studies are conducted or preoperative diagnostic techniques are refined.

The researchers concluded that “Further research is warranted focusing on the refinement of these alternative techniques of uterine morcellation and on the identification of women who would benefit from MIS.”

Full text

More on Power Morcellators:

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

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

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

Debate escalates over morcellation of uterine and fibroid specimens in Minimal Invasive Surgeries after FDA permits the marketing of PneumoLiner!

Power Morcellator: A Boon or Curse? Dr. Amy Reed, a staunch opponent of power morcellator loses the battle to uterine cancer

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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.

Abstract

Media courtesy:  https://injuryrecoveryinstitute.com, https://www.dashdc.org, https://www.medpagetoday.com

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. 

FDA guidance PDF

Related articles:

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

Debate escalates over morcellation ofuterine and fibroid specimens in Minimal Invasive Surgeries after FDA permits the marketing of PneumoLiner!

Power Morcellator: A Boon or Curse?Dr. Amy Reed, a staunch opponent of power morcellator loses battle to uterine cancer.

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. 

ACOG statement on power morcellator 

Abstract

ACOG updates it recommendations for selecting the best route of hysterectomy for benign diseases

ACOG updates its committee opinion for choosing the best route for Hysterectomy in Benign Disease. It replaces the Committee Opinion Number 444, issued November 2009.

In the United States, approximately 600,000 hysterectomies are performed each year, and the procedure is the second most frequently performed major surgical procedure among reproductive-aged women.

More than 50% of benign hysterectomies are performed for uterine fibroids followed by Abnormal uterine bleeding (42%), endometriosis (30%) and prolapse (18%), although some indications are overlapping.

Hysterectomies are performed vaginally, abdominally or laparoscopically (total laparoscopic hysterectomy [with or without robotic assistance] or laparoscopically assisted vaginal hysterectomy).

An analysis of data in between 1998 – 2010 shows a decreasing trend of abdominal route (65% to 54%) in favor of Minimal Invasive Surgery. But, the vaginal approach has shown a consistent decline in use from 1998-2010 (25% to 17%).

The recommendations and conclusions are as follows:

Vaginal Hysterectomy should be the route of choice when feasible. Evidence supports that it is associated with shorter operation time, better outcome and it is also the most cost effective of all procedures. Society of Pelvic Reconstructive Surgeons has issued its own guidelines incorporating the uterine size, mobility, and accessibility of uterus to determine the best route of hysterectomy for a patient.

In patient with adnexal pathology, adhesions or endometriosis vaginal hysterectomy is not feasible, in such patient’s laparoscopic hysterectomy is the alternative of choice over open surgery.

Each patient should be evaluated for the route of hysterectomy based on clinical factors, anatomical characteristics and patient’s individual choice combined with surgeon’s training and experience.

The healthcare provider should discuss with each patient the best possible route for her, and she should be informed the pros and cons of each route based on her clinical situation.

Opportunistic salpingectomy can safely be performed at the time of vaginal hysterectomy.  A 2015 study showed that the procedure can be accomplished in 88% of planned cases by vaginal route.

Prophylactic bilateral salpingo-oophorectomy in cases of genetic mutation represents a total different clinical scenario. The procedure should be performed by laparoscopic or open abdominal approach to get proper tissue margins and inspect the peritoneal surface.

If patient choose to have a supracervical hysterectomy, laparoscopic or abdominal approach is best suited.

In case a laparoscopic approach is decided upon, the uterus can be removed intact or scalpel morcellation. Power morcellation is under scrutiny after Dr Amy Reed and her husband lobbied against its use in Minimal Invasive Surgery. The dangers of power morcellation, contained power morcellation should be discussed with patient and she should be explained about presence of an occult malignancy that may worsen the cancer prognosis.

The committee opinion can be accessed here. 

ACOG statement on power morcellator use in gynecological surgery can be accessed here.

Power Morcellator: A Boon or Curse ? Dr. Amy Reed, a staunch opponent of power morcellator loses battle to uterine cancer.

Amy Reed, MD, PhD, an anesthesiologist died because of uterine leiomyosarcoma on Wednesday, May 24 at age of 44.

She underwent a laproscopic 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 surgery took place at the Harvard-affiliated Brigham and Women’s Hospital in Boston where both Reed and her husband Noorchashm worked.

She came to know about the diagnosis only after the histopathology reports came in after the surgery. To date, there isn’t a reliable method to determine whether or not a uterine tumor is malignant before it has been removed and fully examined. The estimated incidence of leiomyosarcoma is 0.64 per 100,000 women.

The couple immediately knew they were in trouble and it was just a race against time. 

She turned her calamity into advocacy against the use of power morcellator and have fought an uphill battle to ban morcellation.  

Introduced to the United States in 1993 and approved by the FDA in 1995, the device gained rapid popularity among gynecologists particularly for the removal of fibroids and in hysterectomies.

It is estimated that Power Morcellator is used in about 600,000 minimally invasive hysterectomies and myomectomies annually.

Traditional cancer therapies were all ineffective as the morcellation has already advanced the cancer to stage IV. She fought an epic battle against the deadly disease along with a campaign to ban morcellation. She and her husband wrote numerous emails to FDA, along with device makers and hospitals and legislators. They also waged the war on social media and other traditional medias.

It is because of her efforts that FDA revisited the literature and made an announcement on April 17, 2014 “Importantly, based on an FDA analysis of currently available data, it is estimated that 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.”

“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 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.”

Soon, after this FDA newsletter, Johnson & Johnson pulled its device off the market.

Morcellator use dropped after this, but was not completely banned. By September 2016, the FDA received 285 additional reports of cancer spread by morcellation.

Many gynecologist surgeons however, continue to use the morcellator. In 2014, ACOG issued a position statement on Power Morcellation quoting that while it supports FDA commitment to women’s health, but believe that power morcellation has a role in gynecologic surgery. A careful selection of cases and evaluation of woman’s risk for leiomyosarcoma plus informed consent can protect women against the negative outcome. 

Following the ongoing controversy, on April 7, 2016, FDA granted permission to an Irish company to market the “PneumoLiner,” a first-of-its-kind containment system indicated for isolating and containing uterine tissue during a minimally invasive hysterectomy or myomectomy.

However, FDA requires the manufacturer to warn patients and health care providers that the containment system has not been proven to reduce the risk of spreading cancer during power morcellation.

FDA recommendation can be accessed here.

ACOG full statement can be accessed here.

Drs. Noorchashm and Reed make a joint presentation at a symposium focused on FDA law and law enforcement at Widener University Law School.