Secondary Logo

Journal Logo

Institutional members access full text with Ovid®

Novel Approach for Maximizing Follow-Up in Cosmetic Surgery Clinical Trials: The Ideal Implant Core Trial Experience

Mueller, Melissa A. M.D.; Nichter, Larry S. M.D.; Hamas, Robert S. M.D.

Plastic and Reconstructive Surgery: October 2017 - Volume 140 - Issue 4 - p 706-713
doi: 10.1097/PRS.0000000000003666
Cosmetic: Original Articles
Buy

Background: High follow-up rates are critical for robust research with minimal bias, and are particularly important for breast implant Core Studies seeking U.S. Food and Drug Administration approval. The Core Study for IDEAL IMPLANT, the most recently U.S. Food and Drug Administration–approved breast implant, used a novel incentive payment model to achieve higher follow-up rates than in previous breast implant trials.

Methods: At enrollment, $3500 was deposited into an independent, irrevocable trust for each of the 502 subjects and invested in a diversified portfolio. If a follow-up visit is missed, the subject is exited from the study and compensated for completed visits, but the remainder of her share of the funds stay in the trust. At the conclusion of the 10-year study, the trust will be divided among those subjects who completed all required follow-up visits. For primary and revision augmentation cohorts, the U.S. Food and Drug Administration published follow-up rates from Core Studies were compared for all currently available breast implants.

Results: Five-year follow-up rates for the IDEAL IMPLANT Core Study are higher for both primary augmentation and revision augmentation cohorts (94.9 percent and 96.7 percent, respectively) when compared to all other trials that have used U.S. Food and Drug Administration standardized follow-up reporting (MemoryShape, Allergan 410, and Sientra Core Studies).

Conclusions: This trial demonstrates the utility of a novel incentive strategy to maximize follow-up in cosmetic surgery patients. This strategy may benefit future cosmetic surgery trials and perhaps any prospective research trial by providing more complete data.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Orange and Newport Beach, Calif.; and Dallas, Texas

From the Department of Plastic Surgery, University of California, Irvine; the Pacific Center for Plastic Surgery; and Ideal Implant, Inc.

Received for publication December 4, 2016; accepted March 22, 2017.

This trial is registered under the name “Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants,” ClinicalTrials.gov identification number NCT00858052 (https://clinicaltrials.gov/ct2/show/NCT00858052).

Presented at Plastic Surgery The Meeting 2015, Annual Meeting of the American Society of Plastic Surgeons, in Boston, Massachusetts, October 16 through 20, 2015; and poster presentation at the American Association of Plastic Surgeons Annual Meeting, in Scottsdale, Arizona, April 11 through 14, 2015.

Disclosure:The authors have the following to disclose: Dr. Robert Hamas is the Medical Director, CEO, and President of Ideal Implant Incorporated. Dr. Larry Nichter is a paid clinical trial investigator for Ideal Implant Incorporated. Dr. Melissa Mueller has no financial interest to disclose. No funding was received for this article.

Melissa A. Mueller, M.D., Department of Plastic Surgery, University of California, Irvine, 200 South Manchester, Suite 650, Orange, Calif. 92686, mamuelle@uci.edu

Copyright © 2017 by the American Society of Plastic Surgeons