Breast implants are in the news again, with the US Food and Drug Administration having issued warning letters to two manufacturers, and hearings on renewed safety concerns are set. But before getting too caught up in the controversies of the moment, it’s worth looking at how we got here. Let me add at the outset that as a board certified plastic surgeon, I am first and foremost a physician dedicated to the healing arts. The safety and well-being of my patients is always a top priority.
Breast implants and I go back a long way. What is now known as the FDA moratorium on silicone implants hit soon after I entered private practice. Controversy prevailed back then, manifest by class action lawsuits against the manufacturers and a sense of panic among breast implant recipients. All of this was fueled by a lack of adequate information on the safety of silicone implants, so during the 14 years of restriction an enormous amount of research was done. In fact no medical implant of any type has undergone more intensive scrutiny. In 2006, they were approved by the FDA, with the requirement that manufacturers participate in ongoing surveillance, what is called a post-marketing study. The March 2019 FDA Warning Letters to Mentor and Sientra were based on criticism that the numbers of patients in long term follow up were inadequate. (I’ll get back to that.)
