FDA WARNING_LETTER - Mentor Worldwide LLC & Acclarent - March 19, 2019

The FDA issued a Warning Letter to Mentor Worldwide LLC regarding their MemoryShape breast implant (PMA P060028) due to non-compliance with post-approval study (PAS) requirements. The FDA approved MemoryShape on June 14, 2013, with a condition to conduct a PAS per 21 C.F.R. § 814.82(a) to evaluate long-term performance and safety.

The original PAS required enrolling 2,518 women with MemoryShape and 300 controls, with 10-year annual follow-up for safety and effectiveness data. A revised protocol, approved February 12, 2016, combined MemoryShape and MemoryGel devices into the "MemoryGel and Shape Glow Study," requiring 2,518 total subjects (minimum 750 per device family) across up to 100 sites, plus 300 controls. Enrollment was to be completed by a specific date.

The firm failed to enroll the required number of MemoryShape subjects. As of December 13, 2018, only 102 MemoryShape subjects were enrolled, significantly below the target, despite 1,930 MemoryGel subjects and 319 controls being enrolled. The FDA noted that the firm's rationale of slow MemoryShape device implantation was not supported by their own data showing 1