Federal officials, responding to concerns that an unltrasound gel presents serious risks to patients, raided the offices of the gel's New Jersey-based manufacturer, Pharmaceutical Innovations, on Wednesday. According to the Food and Drug Administration, the gel contains dangerous amounts of bacteria which has caused 16 patients to become sick.
The FDA has apparently not commented on how widely the gel had been distributed, but health care professionals were ordered to stop using the product immediately. The agency did say that patients exposed to the bacteria develop severe skin inflammations. For those undergoing invasive biopsy procedures, the bacteria could be carried into tissues, causing abscesses or blood poisoning.
The FDA also found that the bacteria could make its way into the digestive tract, potentially causing pneumonia or other infections if exposed to the lungs and other tissues.
Ultrasound gel is widely used to capture images of a child in utero, but it isn't clear whether the product in question had been used for this purpose. The FDA commented that the risks presented in abdominal ultrasounds by the gel were remote unless the patient has open cuts on her skin, though the risks in a transvaginal ultrasound are greater.
As with dangerous pharmaceutical drugs, patients receive treatment expecting that any pharmaceutical device or product they use is safe for the purpose intended. When patients are made ill or injured by such products, they often feel like they have nowhere to turn. Those who've suffered because of a pharmaceutical drug or other product may be entitled to compensation for injuries, medical expenses and other costs.
Source: CNN Health, "U.S. marshals seize ultrasound gel that allegedly sickened 16 patients," Todd Sperry, April 18, 2012.
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