The options in breast augmentation have recently increased due to the emergence of a third breast implant manufacturer, Sientra. Sientra offers an extensive line of silicone gel breast implants with round and anatomic shapes and volumes up to 800ccs. They offer one type of silicone gel which is very cohesive and has often been described as being of ‘gummy bear-like’ consistency.
As an obligation of every silicone gel breast implant manufacturer once they are approved for commercial sale, Sientra is required by the FDA to conduct long-term studies of patients that have been implanted. Known as a post-approval study, patients must be followed for up to ten years after their surgery. This is an excellent way to see how well their implants perform, patient satisfaction and outcomes and reasons that revisional surgery may have been done. Sientra has called their post-approval study, OASIS. (Online Annual Sientra Implant Study)
To accumulate the number of patients that are needed for this long-term study, Sientra has enlisted numerous board-certified plastic surgeons across the U.S. to participate in this study. Plastic surgeons will enroll patients from their practice and follow them over the course of ten years after surgery. Patients will be compensated for their participation and will be able to report their experiences online.
Patient requirements, after having the implant surgery, include 10 annual online questionnaires and three office visits at years 1, 5 and 9 after surgery. Patients receive $50 for a baseline questionnaire filled out when signing up for surgery, $50 for each of the three annual follow-up visits, and $20 for each annual questionnaire filled out from years one through ten. These compensations for participating in the study could amount to a total of $400 over the course of the study. Payment can be received by check or gift cards from Amazon, Starbucks or Target. (fyi – these merchants are not sponsors or are affiliated with the Sientra Oasis study) Payments will arrive six to eight weeks following the completion of the patient’s questionnaire or office visit.
The OASIS study allows patients to participate and provide valuable personal information on their breast augmentation experience and will benefit all women considering Sientra breast implants. Most patients should be able to find a participating plastic surgeon in their geographic area and, if not, they should contact the company directly for assistance in finding one.
Breast implants are not permanent or lifelong devices, regardless of the manufacturer. They will eventually fail and will need to be replaced in most patients. Sientra is well aware of this expected phenomenon which is why they offer lifelong implant replacement and financial compensation for surgery (up to $3600) and dual implant replacement if failure should occur in the first ten years after surgery. The OASIS study will help gather implant performance information that will enable improved implant designs and durability as breast device science continues to improve into the future.
Dr. Barry Eppley
Indianapolis, Indiana