U.S. Food and Drug Administration Simply Thick Warning
On May 20, 2011 the FDA issued a warning to all citizens urging them not to feed the gel known as SimplyThick to their premature infants. The administration explained how the product was under investigation for causing the potentially fatal intestinal disease known as necrotizing enterocolitis (NEC). The FDA noted that the product was capable of harming prematurely born infants who were currently receiving hospital care as well as those who had been discharged from the hospital.
The Problem with SimplyThick
The Food and Drug Administration issued the warning after learning of a potential link between NEC and use of SimplyThick gel. Specifically, they discovered at least 15 cases of NEC development in premature infants—at least two of those infants died. The problem was identified in infants who had been given the gel for various amounts of time and in different forms—it was usually mixed with breast milk or infant formulas. The product was provided to the infants to help with swallowing problems that resulted from their premature birth.
The risk of developing the intestinal problem does not appear isolated to any single part of the country. At least four different medical centers around the nation have been the site of necrotizing enterocolitis development. All of the complications have been reported in the last six months.
Necrotizing enterocolitis is a life-threatening condition that causes inflammation and death of tissues on the infant’s intestine. Decrease in blood flow to the area may be one of the causes of the problem. Bacteria build-up is also considered a potential factor leading to the condition. Signs that your child may have NEC include a bloated abdomen, ill appearance, feeding intolerance, vomiting, and bloody stool.
Simply Thick Voluntary Recall
Two weeks after the FDA warning, Simply Thick, LLC announced a voluntary recall of its SimplyThick thickening gel manufactured at a processing plant in Stone Mountain, Georgia. The recall affects all products made at the plant in the last two years. The drastic step was initiated at the FDA’s advisement of the company’s failure to file a proper schedule to ensure that harmful bacteria were properly destroyed through the manufacturing process. This failure may have significant public health consequences.
Simply Thick lawsuits can be brought against the company that created the dangerous substance. Product liability suits allow individuals to seek recovery against those who sell goods that harm consumers. Our Simply Thick lawyer is working with families whose infants have been injured by this product. If you or someone you know may have been harmed by this gel, please contact our SimplyThick attorney at the Law Office of Eric H. Luckman to share your story and learn of your legal rights.