New Silicone Breast Implant Approved — Physician’s First Watch
New Silicone Breast Implant Approved
By Kristin J. Kelley
The FDA has approved a new silicone gel-filled breast implant — the agency's fifth such approval — for reconstruction in women of any age and for augmentation in women aged 22 and older.
The most frequently observed adverse outcomes for the new implant, marketed as MemoryShape, included asymmetry, capsular contracture, implant removal, and wrinkling. Fissures in the gel were also seen in some of the implants. Approval was based on 6 years' worth of data from nearly 1000 women.
The manufacturer will be required to conduct postapproval studies to assess long-term safety and efficacy and a 10-year follow-up on the women in the core study. The agency stressed that breast implants "are not lifetime devices" and require long-term monitoring.