The FDA warned Allergan last month about marketing the Seri surgical scaffold in the U.S. for breast surgery indications without marketing clearance or approval.
An FDA review of Allergan’s Seri website reported the scaffold was being marketted for breast surgery applications, which the federal watchdog says “would constitute a major change or modification to its intended use, for which your firm lacks clearance or approval.”
The Seri Scaffold had indications for “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 letter. The indications include general soft tissue reconstruction and soft tissue reinforcement in plastic and reconstructive surgery.
The FDA stated the breast surgery indication was outside Seri’s intended use because “surgical mesh has not been cleared or approved for use in breast reconstruction using a tissue expander or implant.”
Allergan bought Serica, initial developers of the Seri surgical scaffold, in 2010 for an undisclosed amount.
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