The FDA issued warning letters today to two breast implant manufacturers for failure to comply with regulatory requirements.
One letter went to Allergan (now part of AbbVie) for failing to comply with requirements — under two separate premarket approval orders — to conduct post-approval studies to assess the long-term safety and risks of two models of breast implants, both of which were voluntarily recalled from the market last year. The FDA also issued a warning letter to Ideal Implant (Dallas, Texas) for failure to comply with current good manufacturing practice requirements and adverse event reporting requirements following an inspection conducted earlier this year.
Every manufacturer of FDA-approved silicone gel-filled breast implants must conduct post-approval studies to further evaluate the implants’ safety and effectiveness and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their pre…