Sientra Inc – FDA Warning Letter, Mar 8, 2019

The FDA issued a Warning Letter to Sientra, Inc. concerning its Sientra Silicone Gel Breast Implants (PMA P070004), approved on March 9, 2012. A critical condition of this approval, mandated by 21 C.F.R. § 814.82(a), was the execution of a Post-Approval Study (US-PAS) to assess long-term device performance. The letter identifies Sientra's failure to comply with two key PAS requirements: evaluating the long-term clinical performance of the implants and following study subjects annually for 10 years. This non-compliance stems from the firm's inability to maintain the agreed-upon participant retention rate outlined in the approved study protocol. The 3-year overall follow-up rate is significantly below the target rates, thereby jeopardizing the adequate continuing evaluation of the device's safety, effectiveness, and reliability. This deficiency resulted in the study status being marked as 'Progress Inadequate' on the FDA website. Sientra must submit a corrective action plan or documentation of compliance within 15 working days, including a detailed timetable if corrections are ongoing. Failure to promptly address these issues may lead to the withdrawal of the PMA under 21 CFR 814.82(c), indicating severe regulatory and operational consequences for the company.