The FDA issued a warning on Wednesday that several lots of Other-Sonic Generic Ultrasound Transmission Gel, used in a variety of ultrasound procedures, were contaminated with two kinds of bacteria: Pseudomonas aeruginosa and Klebsiella oxytoca. Sixteen people have gotten sick as a result. They all received transesophageal ultrasounds, a procedure used to scan the heart through the throat. But transvaginal ultrasounds have been in the news a lot lately, with several states proposing laws that would mandate them before any abortion. And such laws are already on the books in North Carolina and Texas. So, we wondered, how dangerous would getting a transvaginal ultrasound with the contaminated gel be?
According to FDA spokesperson Sarah Clark-Lynn, yes. She told us that while not every patient exposed to the gel would get sick, "the risk remains present."
Others said that risk was likely small. Dr. Kevin Ault, a professor of gynecology and infectious diseases at Emory University, told us that the first bacteria, Pseudomonas, was "not a common cause of gynecological infections." Klebsiella, he said, "can cause problems" if introduced into the vagina — he said an infection caused by this bacteria in the gel was possible, but not likely.
Dr. Steven Goldstein, professor of obstetrics and gynecology at New York Medical Center and the author of several textbooks on gynecological ultrasounds, says doctors usually use procedures that would make infection from gel less likely. They typically place a fresh condom over the ultrasound probe, and any gel goes inside the condom. It's possible that a doctor might use the gel on the outside of the condom, but in a woman with a healthy immune system, the bacteria in question would be "unlikely to cause a clinically relevant infection."
Women with compromised immune systems might be in more danger, though — FDA associate commissioner for regulatory affairs Dara Corrigan said in a statement, "this ultrasound gel presented serious health risks to patients, particularly vulnerable ones."
Ault stressed that women shouldn't specifically avoid transvaginal ultrasounds because of the recall. Instead, he said, the FDA warning was really a message to doctors to avoid using the contaminated gels. He added that even non-sterile gels, like Other-Sonic, aren't supposed to contain "significant" amounts of bacteria. A "large bolus," like that found in the contaminated lots, is a problem.
The FDA, for their part, remains cautious. They're recommending that all patients potentially exposed to the gel receive extra monitoring, and that all containers of it be disposed of as bio-hazards.