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Simply Thick Recall & Necrotizing Enterocolitis (NEC) Connection

Parents of premature babies who were fed formula or breast milk that was mixed with a thickening gel known as SimplyThick should contact a lawyer who is taking Simply Thick product liability cases as soon as possible.

Your child’s life may have been jeopardized as part of a public health risk created by sloppy manufacturing practices that violated U.S. Federal Drug Administration rules and resulted in a Simply Thick recall.

For families suffering the outcome, the results are devastating: disease, disability and death.

As part of their treatment, premature infants with swallowing problems are sometimes fed a mixture of breast milk or infant formula with a thickening gel that makes it easier for the child to swallow, thus ensuring that it can take in vital nutritional calories. One thickening gel, SimplyThick, a product of Simply Thick, LLC may be the cause of a rash of the life-threatening illness, necrotizing enterocolitis (NEC).

As of May 13, 2011, The Federal Drug Administration or FDA reported 15 known cases of NEC that could be linked to Simply Thick products manufactured by Thermo Pac, LLC in Stone Mountain, Georgia. The cases were reported by hospitals scattered around the country. After the initial stages of an FDA investigation that is still ongoing, Simply Thick voluntarily issued a recall of those products — however, two of the cases have already resulted in heartbreaking deaths. Surviving babies have had to undergo abdominal surgery in which part of their bowels were removed to stop the disease. When the intestine cannot be rejoined, the babies also have to have a portion of their intestine rerouted to an opening in their belly. The opening, known as an ostomy, is connected to a bag that collects bodily waste.

Later complications of NEC can include malabsorption — in which the body cannot absorb enough nutrients — and scarring of the intestine which may result in intestinal blockage.

In its statement concerning the recall, the FDA explained the Simply Thick recall as “a result of the company’s failure to ensure that harmful bacteria…were destroyed in the manufacturing process at that manufacturing plant.”

As necrotizing enterocolitis (NEC) develops, the lining of the intestinal wall dies and the tissue falls away. The medical community considers premature babies to be at risk for NEC, and bacteria may be the cause of NEC. The FDA discovered, upon an inspection of the Stone Mountain plant, that Thermo Pac had never filed a plan that was supposed to be in place to ensure the hygienic standards and manufacturing processes that would destroy harmful bacteria.

In addition to the Thermo Pac Simply Thick recall, the FDA has issued a public alert to warn parents of the possibility of NEC if their child consumed SimplyThick, was premature, and is less than 37 weeks old.
Some of the affected infants developed NEC while still in the hospital. Others who were prescribed a diet that included SimplyThick fell ill after going home.

Symptoms of NEC include:

-A bloated belly
-Vomiting bile — a greenish digestive fluid
-Bloody stools
-An intolerance of feeding
-A red or bluish belly
-A slow heart rate
-Troubled breathing

If parents see these symptoms in their baby, especially a premature baby, they should seek immediate medical attention at a hospital emergency room.

Babies have needlessly died, and their deaths could have been prevented. Other babies have become tragically ill. Some now have a bag attached to their little bodies, collecting bodily waste. And some of them may face more life-threatening complications down the road. Don’t wait if your child consumed SimplyThick. Take immediate action. Hold Simply Thick accountable. Contact a Simply Thick recall lawyer as soon as possible.


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