FDA WARNING_LETTER - Allergan - August 31, 2011

The FDA issued a Warning Letter to Allergan for non-compliance with post-approval study (PAS) requirements for their NATRELLE Silicone-Filled Breast Implants (Round Responsive) and NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Style 410). These PASs were conditions of device approval under 21 C.F.R. § 814.82(a) to ensure continued safety and effectiveness.

For Round Responsive implants, Allergan failed to collect local complication and safety endpoint data during year 4 physician evaluations at a sufficient follow-up rate, which is critical for meeting the year 10 target. This deficiency, coupled with a decrease in participating IRB-approved sites, prevents adequate evaluation of the device's long-term safety and effectiveness.

For Style 410 implants, the firm failed to enroll the required 530 subjects in the redesigned study, having only enrolled (b)(4) subjects by August 2019, 30 months past the enrollment deadline, with enrollment subsequently halted due to a worldwide recall. This failure also impedes the adequate continuing evaluation of the device's safety and effectiveness.

Both failures violate 21 C.F.R. § 814.82(a)(2) and (9). The FDA warned that failure to promptly correct these issues could lead to the withdrawal of the Premarket Approval (PMA) under 21 C.F.R. § 814.82(c). Allergan is required to submit a corrective action plan or documentation of compliance within 15 working days, detailing steps taken, supporting evidence, and a timetable for ongoing corrections. The FDA also suggested considering alternative strategies to fulfill the PAS requirements.