Current state of evidence-based long-term monitoring protocols for breast plastic surgery patients

HIGHLIGHTS

• What: As a condition of their approval, the FDA now requires implant companies to conduct post-approval studies to monitor long-term performance and safety of silicone breast implants, specifically core post-approval studies, large post-approval studies, device failure studies, focus group studies, annual physician-informed decision survey, and adjunct studies . Device failure studies further characterize the failure of explanted devices, and focus group studies aim to improve patient labeling. Because the moratorium on cosmetic implants was lifted in 2006, adjunct studies aim to assess the performance and safety of silicone gel implants implanted for reconstruction . . .
  

   

  

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