FDA WARNING_LETTER - Allergen Medical

On May 29, 2015, the FDA issued a Warning Letter to Allergan's Quality Assurance Director, Samir Paliwal, regarding the marketing of SERI Surgical Scaffold. The FDA determined the device is adulterated under section 501(f)(1)(B) of the Act because Allergan lacks an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) for the device as marketed.

The device is also misbranded under section 502(o) of the Act, as Allergan introduced it into interstate commerce with major changes to its intended use without submitting a new premarket notification (510(k)). Specifically, the SERI Surgical Scaffold was cleared under K123128 for general soft tissue support and repair. However, Allergan's website promotes the device for breast surgery applications, including "Breast revision surgery," "Mastopexy with or without augmentation," and "Breast reductions," which constitute a major change in intended use. Surgical mesh has not been cleared or approved for breast reconstruction using a tissue expander or implant, and this specific indication changes the intended use of a surgical mesh cleared for general soft tissue reinforcement (21 CFR 878.3300).

The FDA requested Allergan immediately cease activities resulting in the misbranding or adulteration of the SERI Surgical Scaffold, including commercial distribution for the unapproved uses. Allergan was required to respond