Johnson & Johnson and Sientra Inc. received warning letters from the U.S. Food and Drug Administration for failing to comply with requirements of certain approvals for their silicone gel-filled breast implants.
According to the FDA, J&J unit Mentor Worldwide LLC failed to enroll the required number of patients in the post-approval study for its MemoryShape breast implant. Further, the study had "significant data inconsistencies," and Mentor did not have sufficient follow-up rates with patients in the study.
Meanwhile, Sientra's post-approval study for its silicone gel breast implants had a "serious deficiency," with the company reporting a follow-up rate of 61%, which is below the target.
Mentor's and Sientra's implants were approved in 2013.
In the U.S., manufacturers of silicone gel-filled breast implants are required to conduct post-approval studies to evaluate long-term safety and effectiveness of the products. The regulator said failure to meet post-approval study requirements is a violation of the premarket approval order.
The FDA requested Mentor and Sientra, both based in Santa Barbara, Calif., to submit responses detailing corrective actions within 15 days.