The regulator sent a letter to the company warning it for promoting the surgical mesh – which is approved to support and repair soft tissue and reinforce deficiencies – for breast surgery applications, which falls outside the scope of its approved indication.
A warning letter was sent to Allergan after the FDA reviewed the company’s www.seri.com website and found the SERI Surgical Scaffold was being marketed without an approved PMA or IDE application for the device “as described and marketed,” rendering it adulterated. The commercial distribution of the mesh with “major changes or modifications” to its intended use without the submission of new PMA notification also renders the SERI Surgical Scaffold misbranded, according to the letter.
The FDA specifies in its letter that the SERI Surgical Scaffold received clearance under K123128 with the 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.” Included is the reinforcement of soft tissue in plastic and reconstructive surgery, as well as general soft tissue reconstruction.
However, Allergan is promoting the SERI Surgical Scaffold as though it were intended for breast surgery applications, listing breast revision surgery, breast reductions, muscle flap reinforcement, and mastopexy with or without augmentation as procedures that “may benefit from using the SERI Surgical Scaffold.” The letter states this would constitute a “major change or modification to its intended use” for which Allergan doesn’t have approval or clearance.
The FDA wrote surgical mesh wasn’t cleared for use in breast reconstruction using a tissue expander or implant – which means the aforementioned indications aren’t included in the scope of the company’s intended use.
The letter also notes the specific breast reconstruction surgery indication changes the intended use of surgical mesh that’s cleared with a general soft tissue reinforcement indication.