Unnecessary Risk

This is a good example of why we need an FDA, and why nothing is risk-free…

New Jersey-based Pharmaceutical Innovations Inc. manufactures Other-Sonic Generic Ultrasound Transmission Gel. The gel is used by medical professionals in ultrasounds, a procedure involving high-frequency sound waves to look at patients’ organs. Samples of the gel taken by the FDA in February contained two strains of bacteria.

“This ultrasound gel presented serious health risks to patients, particularly vulnerable ones,” the FDA’s Dara Corrigan said in a statement. Additionally, the FDA issued a safety alert to health care providers about the bacteria risk and possibility of dangerous infections from the gel.

We have politicians playing doctor, demanding that women get unnecessary vaginal ultrasounds before an early abortion. This is based on two faulty assumptions– that women don’t know what they are doing, and that any medical procedure is risk-free. Not least is taking medical resources from where an ultrasound is needed and beneficial, and applying those scarce resources with the intent of causing emotional harm. It’s unexpected that the contaminated gel has caused patients physical harm, but medicine is all about the unexpected.

We have politicians calling for deregulation. A government agency like the Food and Drug Administration is our line of defense against negligent manufacturers who sell a dangerous product to the public.

So, this morning, two thoughts that came to my mind reading about the 16 people who got sick from contaminated ultrasound gel.

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