Product Liability

FDA warning letter for US breast implant manufacturers

The US Food and Drug Administration (FDA) has issued warning letters to two breast implant manufacturers for failure to comply with various regulatory requirements. The letter to California-based Allergan was for failing to comply with requirements, under two separate pre-market 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.