Federal Registry Set Up for Silicone Breast Implant Users
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
Women who have gotten silicone implants in the past decade are now being encouraged by a federal advisory board to follow up on their implant experience. In order for the FDA to rule out the connection between breast implants and rare lymphoma, they need to complete yearly follow-up studies from the manufacturers. The 25-page questionnaire has a very low follow-up rate.
Having a database helps the FDA gather information about the safety of the breast implants and possibly detect any future issues. Particular answers researchers want to find out are how long the lifespan of breast implants are, and what percentage of silicone implants leak. The best way for women to find out how their own individual implants are doing is to get an MRI three years after getting the implants, and then every two years after to screen for ruptures and leaks. FDA reports that out of the five to ten million women in the world who have breast implants, most are satisfied with their product.