Expression by Enhancement Medical Recalled by the FDA
On August 14, 2014, the FDA issued a class one recall for Expression, an intranasal splint. Expression is made by Enhancement Medical and is a hyaluronic acid gel to be used as an intranasal splint following nose surgery or trauma.
Hyaluronic acid, a naturally occurring compound, is used in many medical products and can be readily reversed with hyaluronidase. The FDA issues class one recalls when use of the recalled device may reasonably result in serious injury or death.
Expression Use Linked With Numerous Adverse Events
MassDevice reports that Enhancement Medical is unable to ensure that Expression is manufactured correctly and some lots might contain higher concentrations of hyaluronic acid while other lots of Expression where seen bubbling after sterilization, a potential sign of contamination.
The FDA is recalling all lots of Expression manufactured between September 2012 and June 2014, according to a release by the FDA. BioSpace reports that the recall covers all lots of Expression ever manufactured. Enhancement Medical reports that is has received complaints regarding the following adverse events in people treated with Expression.
- Bumps and Lumps
- Inflammatory reactions
Forbes reports that the FDA and Enhancement Medical have received complaints that Expression is not readily reversed using hyaluronidase, possibly due to the increased concentration of hyaluronic acid in Expression. The FDA reports that one person was left with an obvious deformity after reversal of Expression failed.
FDA Found Numerous Issues with Expression and Enhancement Medical
In a letter to Enhancement Medical, dated June 4, 2014, the FDA noted many problems were found during an inspection of the plant that manufactures Expression. The letter notes:
- Expression is not tested to ensure it contains the proper concentration of hyaluronic acid
- Enhancement Medical failed to handle and investigate complaints about adverse events associated with Expression in the proper manner
- Enhancement Medical had not performed any quality audits
- Multiple documents were found referring to Expression as an injectable filler, Expression has only been approved as an intranasal splint