The U.S. Food and Drug Administration (FDA) believes the consumer product for infant children called SimplyThick might cause necrotizing enterocolitis (NEC).
What Is SimplyThick?
Infants, particularly those born prematurely, often have difficulty swallowing food. Moreover—as parents know—infants spit up their food. SimplyThick, created by SimplyThick, LLC, and manufactured by Thermo Pac, LLC, in Stone Mountain, Georgia, is a thickening agent in the form of a gel that parents can mix with breast milk or formula. It’s intended to ease infants’ swallowing difficulties and help them keep their food down. Older children and adults who have swallowing difficulties due to throat injuries can also use it.
On May 20, 2011, the FDA issued a Public Health Notification because the agency had received 15 reports of NEC occurring to infants fed SimplyThick. Two of the 15 infants died. At the time, the FDA only advised consumers not to give SimplyThick to infants born at 37 weeks of gestation or earlier.
In June 2011 SimplyThick initiated a voluntary recall of its product manufactured at Thermo Pac’s Stone Mountain facility because Stone Mountain failed to file a form with the FDA detailing its process for destroying bacterial pathogens in the SimplyThick manufacturing process. The FDA did not say if the SimplyThick recall was related to its alleged tendency to cause NEC.
After the May 2011 SimplyThick warning, the FDA began investigating the possible relationship between SimplyThick and NEC in all cases reported between 2008 and 2011. The FDA’s researchers found that of the 22 infants who ingested SimplyThick, 21 were born prematurely while one was born at term. Fourteen infants required surgery and seven died. In light of these findings, the FDA updated the Public Health Notification advising consumers not to give SimplyThick to infants of any age. The FDA’s findings appear in the August 2012 issue of the Journal of Pediatrics (PDF).
SimplyThick Might Cause Necrotizing Enterocolitis Side Effects
Necrotizing enterocolitis is a life-threatening condition that occurs when intestinal tissue becomes inflamed and then dies. According to the FDA, parents who have given their children SimplyThick should be on the lookout for the following symptoms that indicate NEC:
- Bloated stomach
- Greenish-tinged vomit
- Bloody stools
The FDA recommends contacting a health care professional immediately if these symptoms appear in infants who have consumed SimplyThick.
RLG’s SimplyThick Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The SimplyThick lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed your child shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a SimplyThick lawsuit on your behalf if necessary. RLG will also keep you up to date on any SimplyThick class action lawsuits, FDA SimplyThick warnings, and additional SimplyThick FDA recall announcements. If you believe SimplyThick harmed your baby, contact RLG today.