Gummy Bear – it’s quirky name for the latest advancement in breast implants for cosmetic and reconstructive breast surgery. Late in 2012 the FDA approved the fifth-generation, form-stable silicone breast implant (AKA Gummy Bear) from Sientra and Allergan. While the Gummy Bear is new, it’s not new to Dr. Capizzi. For the past nine years, Dr. Capizzi has been among an elite group of American surgeons participating in an FDA-study of the Allergan Natrelle 410 or Gummy Bear. Dr. Capizzi is the only surgeon in the area engaged in the study and hence, the expert. The number’s rising every day, but as of now, Dr. Dr. Capizzi placed 400 Gummy Bear implants for cosmetic and reconstructive breast surgeries. For today’s blog, we snagged Dr. Capizzi for a Gummy Bear Q&A.
Q. You were part of the FDA-study that lead to the Gummy Bear approval. What does that mean to patients?
A: “It means nearly a decade of experience and specifically 200 surgeries, placing 400 Gummy Bears. The FDA-study is controlled and rigorous. After all, the agency makes decisions that support the well being of the populace. My Gummy Bear surgeries and results have been carefully monitored and scrutinized. And, my work contributed to the recent approvals.” Dr. Capizzi
Q. Now that this new implant is approved, presumably other surgeons can access and operate with Gummy Bears, correct?
A: “The answer is yes and no. Surgeons are human (you heard it here first!). It’s natural to gravitate toward what you know. I have ten years of experience with Gummy Bears as well as all other silicone and saline implants. Additionally, because I was part of the FDA-coinvestigation, today I have access to a broader range of Gummy Bear styles that goes well beyond what’s available to practices where the Gummy Bear is new.” Dr. Capizzi
Q. Back up…so, there’s not one Gummy Bear?
A: “Gummy Bears are highly customizable. There are many, many options – size, shape, and texture. My implant recommendations are personalized for every woman. Gummy Bears afford me the opportunity to do this. Let me be specific. Because of my FDA-coinvestigator status with the Allergan Natrelle 410 Gummy Bear, I am permitted access to the entire portfolio of 120 Gummy Bear implant choices, compared to a selection of 25 at other practices. This wide selection allows me to craft the best, most natural solution for my patients.” Dr. Capizzi
Q. If the Gummy Bear is a superior implant, it seems like it ought to become the standard. Are you saying surgeon resistance to change may prevent this?
“Absolutely not. I did note that it is natural to gravitate toward known successful products and procedures. But, on whole, plastic surgeons are a highly intelligent and progressive group. Sientra is one of the makers of the Gummy Bear. On a weekly basis, I get Sientra-referred calls from plastic surgeons seeking consults and advice on Gummy Bear protocol for their own patients. I am happy to share. Additionally, I’m serving on a Sientra advisory committee to help train and educate surgeons on the merits of the Gummy Bear. I need to note this is not a paid endorsement of any sort. I am doing this to support my profession and patients.” Dr. Capizzi
Q. Okay, in layman’s terms – so keep it simple – can you tell us more about Gummy Bear surgical technique? What new skill set or approach is involved. Why is technique important?
A: “Let me give you a few specifics. First, the surgeon first must artfully match one of the hundreds of Gummy Bear styles and shapes to the patient’s anatomy. And, each breast can be different. Gummy Bear results, I believe, are superior, but it’s not a one-size-fits-all proposition. Matching or planning is one of the most difficult aspects for a neophyte. Moving forward to the actual surgery, Gummy Bear incision technique is absolutely critical. Inframammary incision is optimum; the underarm incision will not result in the best outcome. During surgery it’s critical that the surgeon creates a pocket that mirrors the implant. This is not rote. Because the Gummy Bears are so customizable, each surgery is unique. The ability to assess, modify and, of course, execute with precision is so important; it is a learned technique. That’s an overview. Maybe this should be the topic of a deeper dive in an upcoming blog.” Dr. Capizzi