Food and Drug Administration (FDA) Alert To Stop Using Bacteria Contaminated Ultrasound Gel
On April 18, 2012, the Food and Drug Administration (FDA) issued an alert to doctors, hospitals, radiologists, urologists, gastroenterologists, obstetricians/gynecologists, internists, chiropractors, nurses, physical therapists and ultrasound sonographers to stop using certain lots of Other-Sonic Generic Ultrasound transmission gel manufactured by Pharmaceutical Innovations.
The FDA is concerned about bacterial contamination in lot numbers 060111 through 120111. To date, the FDA received 16 reports of patients that were colonized or infected with Pseudomonas aeruginosa after examination with transesophageal ultrasound probes that were lubricated with the contaminated gel. Upon further investigation, the gel was also found to be contaminated with Klebsiella oxytoca.
Pseudomonas aeruginosa is usually found in water and soil. If the bacteria gets on the skin it could cause an inflammatory dermatitis. However, if it gets into the upper airway, lungs, lower GI tract, vagina, or female genital tract it could lead to pneumonia, urinary tract infections or more severe pelvic or uterine infections. Klebsiella bacteria is often found in the digestive tract where it does not cause any problems. However, if Klebsiella is introduced into the lungs, vaginal tract or other tissues, it could lead to pneumonia, infections or sepsis.
Since many women undergo transvaginal ultrasounds while pregnant, any contamination or infection in the vaginal tract can lead to an infection of the uterus, placenta, or unborn baby. Undiagnosed or untreated infections during pregnancy can lead to premature labor, neonatal sepsis, infant brain damage, cerebral palsy or a still born birth.
If you or a loved one developed an infection after an ultrasound or procedure, please feel free to contact one of our experienced pharmaceutical lawyers, doctors or nurses at (215) 866-2424 or online, for a strictly confidential and free consultation.