Last month, U.S. Food and Drug Administration (FDA) warned Allergan about marketing the Seri surgical scaffold in the U.S. without receiving FDA marketing approval or clearance.
About the FDA Warning
According to MassDevice, the FDA has reviewed Allergan’s Seri website and found that it was marketing the Seri scaffold for breast surgery applications.
This reportedly is a significant difference from the Seri scaffold’s actual intended use, and more-so Allergan lacks the approval or clearance of the FDA to market the product in such a way.
In the warning letter the FDA states that the implicated use for breast surgery on Allergan’s website was invalid and not the scaffold’s intended use.
Why Allergan’s Claim is Not Approved
Allergan claimed that the use of the Seri scaffold is to “use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome,” according to the FDA’s warning letter.
Overall, this indicates that the scaffold could be used for general soft tissue reconstruction and tissue reinforcement in plastic or reconstructive surgery.
Currently surgical mesh has not been cleared or approved by the FDA for the use of reconstructive or plastic breast surgeries; therefore the Seri scaffold cannot be marketed for use in such surgeries.