When the FDA issued its final guidance for recommendations on breast implants at the end of last month, it left some plastic surgeons scratching their heads.
While the original guidance was drafted back in 2019, this latest version “provides recommendations for manufacturers to incorporate a boxed warning and a patient-decision checklist into the labeling for breast implants to better ensure certain information is received and understood by patients.” In addition, the new guidance recommends additional labeling information, including updates to the silicone gel-filled breast implant rupture screening recommendations.
While La Jolla, CA plastic surgeon Robert Singer, MD explains that professional surgical societies such as The Aesthetic Society, Aesthetic Surgery Education and Research Foundation and the American Society of Plastic Surgeons gave testimony at prior FDA hearings that led up to this draft guidance document, it didn’t deliver any significant new information “except modification of recommendation of ongoing screening of patients with gel implants and the role and frequency of ultrasound and MRIs.”
“All of these societies represent fully trained, ethical plastic surgeons who are concerned about the safety and welfare of our patients,” Dr. Singer stresses. “And they have all advocated fully informed consent—which includes not only the benefits, but potential problems of the surgical procedures as well.”
It’s the training part of the equation that University Park, TX plastic surgeon William P. Adams, MD, who is a member of Breast Device Collaborative Community (BDCC), an advocacy organization that submitted information on the subject to the FDA earlier in the year, says was the biggest miss.
“The guidance document doesn’t have anything on the importance of seeking out a properly board-certified plastic surgeon for your procedure,” he says. “The truth is, it is very clear that good outcomes are directly affected by proper technique. The complications are much, much lower when you go to the right surgeon, and not someone who took a weekend course. Technique and expertise are—and always will be—key to a good and safe outcome.”
Dr. Adams also points out that the average patient rarely takes the time to read and fully comprehend a big checklist, and the guidance is rather long. More importantly, he stresses, is that “the list of symptoms also occurs in patients with and without implants, and only scientific studies will show whether they are in fact related or associated to implants and subgroups of patients who are at greater risk for developing them.”
Statistically speaking, Eugene, OR plastic surgeon Mark Jewell attests that the actual percentages of satisfaction for patients who have breast implants is consistently high: “In 10-year studies, we see in the mid-90 percent of patients are satisfied and glad they had the procedures, according to published studies,” he says.
Regardless of the numbers, all doctors we interviewed for this story reiterated that the societies are still actively engaged in communication with the FDA about patient safety and options for greater patient education, and recommend that anyone who has breast implants download the public-facing app, AestheticOne, which allows patients to securely save their implant information, communicate with their surgeon, get updates on implant information and participate in research surveys, which aim to gather more valid data about long-term results and any possible side effects.
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