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.

$10 Microchip by Duke and Stanford turns 2-D Ultrasound Machines to 3-D Imaging Devices

Researchers from Duke University and Stanford University have designed a $10 microchip to make a simple 3D ultrasound imaging device that produces 3D scans similar in quality to CT or MRI scans using your regular 2D ultrasound machine.

The researchers and physicians from Duke demonstrated their device on Oct. 31 at the American College of Emergency Physicians (ACEP) Research Forum in Washington, D.C. 

The budget microchip is roughly the size of a fingernail, and like a Nintendo Wii video game controller, the chip registers the probe’s orientation, then uses software to seamlessly stitch hundreds of individual slices of the anatomy together in three dimensions to give an instant 3-D model similar in quality to a CT scan or MRI. And the better the ultrasound machine being used, the higher the quality of the generated 3D image.

The chip can be added to your regular 2D ultrasound armament by using a 3D printed clip on attachment. 3D ultrasound machines can cost around $250,000, around five times more than their 2D counterparts.

 Joshua Broder, M.D., an emergency physician and associate professor of surgery at Duke Health and one of the creators of the technology got the idea behind the chip while playing Nintendo games with his son.

 After working on the chip for a year, he took sketches to Duke’s Pratt School of Engineering, connecting with then-undergraduate Matt Morgan, and biomedical engineering instructors and professors Carl Herickhoff and Jeremy Dahl, who have since taken positions at Stanford where they continue to develop the device.

The team has used Duke’s own 3-D printing labs to create a prototype, in the form of a streamlined plastic holster that slips onto the ultrasound probe. A physician can use the probe as a regular 2D probe or add the 3-D capability by simply snapping on a plastic attachment containing the location-sensing microchip. To get the best 3-D images, the team also devised a plastic stand to help steady the probe as the user hones in on one part of the anatomy.

The microchip and the ultrasound probe connect via computer cables to a laptop programmed for the device. As the user scans, the computer program whips up a 3-D model in seconds.

Both Duke and Stanford are testing the technology in clinical trials to determine how it fits in the flow of patient care. The creators believe some of the most promising uses could be when CT scans or MRIs are not available, in rural or developing areas, or when they are too risky.

“Instead of looking through a keyhole to understand what’s in the room, we can open a door and see everything in front of us.”

This upgrade is especially important for babies and trauma patients who cannot be moved. The team has already received a grant from Emergency Medicine Foundation and General Electric to conduct clinical trials for application of the device to located bleeding vessels in trauma patients.

The quality of resulting 3D model is comparable to images produced by a 3D sonography machine, CT scan or MRI scan.”

Clinical trials are already on the way to test the technology in real life applications and emergency scenarios.

Here is a video in which Dr.Broder demonstrate the device.

3D printed fetus to hold and love: Brazilian obstetrician prints ultrasound fetal model for visually impaired couple

Ana Paula and Alvaro with the baby's model

Ana Paula and Alvaro with the baby's model

A team of doctors from Brazil printed a 3D life like model of  baby in utero from images obtained from GE Voluson10 ultrasound  for a legally blind couple, so that they can feel their baby, because they were unable to see the ultrasound images.

Ana Paula Silveira and her husband, Alvaro Zermiani, live in São Paulo, Brazil, and are legally blind. Like other normal couples they also wanted to enjoy the grainy glimpses of their son, Davi Lucas and see him growing and developing well inside the uterus.

They consulted Dr. Heron Werner, a gynecologist and obstetrician working atthe DASA clinic in Rio de Janeiro, who is well into 3D printing and is known for printing 3D fetus models through high-quality ultrasound exams.

So, they printed the first fetus model for the couple at 12 weeks of pregnancy. Ana and Alvaro were thrilled. “Holding the small fetus at 12 weeks is an indescribable feeling,” she says. “Following up on our son’s evolution allowed us to have this feeling of being whole, because we feel with our hands.”

Ana Paula and Alvaro with Dr. Werner (left) in his office in Rio. 

Images credit: Ana Paula and Alvaro Zermiani.

Dr. Werner got the idea of 3D printing babies during a visit to Rio’s National Museum, which was using a tomography machine to digitize its ancient Egyptian exhibits.

“From the moment we got to the high-quality ultrasound exam, through the possibility of 3D printing it, I realized that it could also serve to enhance the prenatal experience of visually impaired pregnant women,” Dr. Werner said.

A second model has also been printed, in which they could feel Davi’s face and appreciate the close resemblance he shared with them. “Thanks to the exams and printing, we were able to not only know that our baby was growing healthy but also to have a very real contact and establish a very strong involvement with our son,” she says.

The ultrasound machine, Voluson E10 is GE’s newest and most advanced Voluson system to date. The Voluson E10’s Radiance System Architecture sets a new standard in imaging technology and gives the more clarity because of 4X ultrasound pathways for spectacular 2D and 3D/4D images with increased penetration, transfer the data at 10x speed providing higher resolution and very fast frame rates and it processes the information 4X times faster to streamline the workflow.

A real-time ultrasound GIF of a baby’s face taken by the GE’s Voluson 10 machine.

 Image credit: GE Healthcare

All images: Courtesy GE

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