SALINE-FILLED BREAST IMPLANT CONTINUED AVAILABILITY
This article was originally published in The Gray Sheet
Executive Summary
SALINE-FILLED BREAST IMPLANT CONTINUED AVAILABILITY pending completion of ongoing research will be urged by the American Society for Aesthetic Plastic Surgery at a June 2 public hearing on the devices. "Given the current status of ongoing research into the safety and efficacy of silicone inflatable [saline filled] breast implants, FDA should allow additional time for the results of this research to be completed and evaluated prior to the agency issuing a final rule to require the filing of a [premarket approval application] for the device," the group says in a request to appear at the hearing.