FACT CHECK: The Truth About Gummy Bear Clinical Studies
Dr. Capizzi and Stillwater are fully committed to helping patients make informed decisions. The Internet and personal consultations with surgeons are your most important resources for information – and sadly – sometimes misinformation.
Today, we’d like to take a moment and clarify FDA studies and ongoing clinical studies relating the Gummy Bear implants. We promise we’ll keep it simple AND factual. Let’s go.
- Gummy Bears represent the most advanced silicone gel breast implant available today. As of early last year, Gummy Bears from three medical manufacturers – Sientra, Allergan and Mentor – are fully FDA approved.
- For nearly a decade in advance of the approvals, Dr. Capizzi was among an elite group of surgeons – and the only in North Carolina – asked to participate in an Gummy Bear FDA clinical trial for the Allergan implant, which ultimately led to the approval.
- Dr. Capizzi is often called Charlotte’s Gummy Bear doctor because he has mastered Gummy Bear surgical technique in a decade of experience. To date, Dr. Capizzi has placed nearly 700 Gummy Bear implants.
- The makers of Gummy Bears – like Sientra and others – continue to monitor the performance of Gummy Bear implants with on-going clinical studies. ALL surgeons qualified to operate with the Gummy Bear implant – Dr. Capizzi as well as others with less experience and understanding of the Gummy Bear – are invited to participate in these studies. Patients need only meet basic requirements, such as good health and a minimum age threshold.
The mark of excellence and mastery in breast implant surgery is not participation in a medical manufacturer’s clinical study, as these studies are essentially open to all surgeons. As you’re considering Gummy Bear breast implant surgery, the question to ask is “How many Gummy Bears have you placed?”
The response we offer at Stillwater is this: Dr. Capizzi has placed nearly 700 Gummy Bears over the course of a decade. He conducts national preceptorships – surgical training seminars – for Sientra, the leading maker of Gummy Bears. And nationally, Dr. Capizzi ranks among the top-echelon of surgeons with the most Sientra Gummy Bear experience.
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