IDEAL IMPLANT Structured Breast Implants

Core Study Results at 6 Years

Larry S. Nichter, M.D.; Robert A. Hardesty, M.D.; Gregg M. Anigian, M.D.

Disclosures

Plast Reconstr Surg. 2018;142(1):66-75. 

In This Article

Patients and Methods

Study Design

This study was a prospective, multicenter, clinical trial to document the safety and effectiveness of the IDEAL IMPLANT in two patient cohorts: bilateral primary breast augmentation and bilateral revision of existing saline or silicone gel augmentation implants. If a primary augmentation cohort patient had a study implant or implants replaced, she remained in the primary augmentation cohort. The protocol specified that patients were required to return for follow-up visits at 2 months; 6 months; and 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 years after implantation. Safety was assessed by means of the incidence and timing of all adverse events and subsequent breast operations reported by the investigator. Effectiveness was assessed by change in breast size (for augmentation patients), quality-of-life assessments by the patient, and outcome satisfaction assessments by the patient and surgeon.

The study was approved by a central investigational review board (RCRC IRB, now Salus IRB, Austin, Texas) because all investigators conducted study procedures in their offices or a site without an investigational review board, such as a free-standing surgical center. To encourage high rates of patient follow-up, a unique financial incentive plan was devised. Instead of making payments for each follow-up visit over 10 years, Ideal Implant Incorporated placed $3500 for each trial patient into an independent, irrevocable study participants' trust fund. Patients who complete all of the required follow-up visits during the 10 years of the study will receive a lump sum payment from the trust fund. If a patient misses any required follow-up visit, she is discontinued from the study and loses her share of the trust fund, but her share remains in the trust fund to be divided among those who remain in the study through 10 years. Details of this incentive plan have been reported elsewhere.[3] Investigators receive nominal financial incentives for completing case report forms and study administration.

Subjects

Women 18 years or older were eligible to enroll. They had to agree to comply with their surgeon's postoperative instructions and follow-up visit requirements. Exclusion criteria were pregnancy or planning to become pregnant within 6 months of implantation, nursed within the previous 3 months, cancer or premalignant breast disease, an infection or abscess, a condition that could compromise healing, inadequate tissue cover or compromised vascularity, any condition that constituted an unwarranted surgical risk, or unrealistic expectations of the results.

Statistical Analysis

Data were collected on standardized case report forms before the procedure and at each required follow-up visit, other follow-up visits, and subsequent breast operations. The forms were sent to a data management center (NAMSA, Inc., Minneapolis, Minn.) for statistical analysis.

All adverse events reported by the investigator were included in the statistical analysis, except for capsular contracture (only Baker grade III or IV capsular contractures were included) and palpable wrinkling/scalloping (only moderate or severe were included), because mild and very mild occurrences were not considered clinically significant problems. Kaplan-Meier analyses of individual adverse events were performed on a per-subject basis for each cohort. To avoid the problem of competing risks, a subject who experienced one adverse event was still considered a candidate to experience any other potential adverse event.

Breast size was defined as the difference between chest circumference measurements at the inframammary fold and at the nipple line. Baseline measurements and 1-year measurements were collected to assess effectiveness for primary augmentation patients only.

The Breast Evaluation Questionnaire[4] is a 55-item assessment specifically designed to evaluate breast satisfaction (both self-esteem and body image) among breast surgery patients, including three domains: (1) comfort not fully dressed, (2) comfort fully dressed, and (3) satisfaction with breast attributes. Scoring is a simple summation of the rating responses provided within a domain. Changes from baseline in all three domains are presented as mean, standard deviation, number of patients, and range, and are tested for significance using a paired t test. The Breast Evaluation Questionnaire is used to assess subjects' satisfaction with their breasts before and after implant surgery at 1, 2, 4, 6, 8, and 10 years.

Both patients and investigators were asked at each required follow-up visit to assess their satisfaction with the outcome achieved in each breast on a five-point scale that ranges from definitely satisfied to definitely dissatisfied. To be conservative, a per-subject analysis was performed by taking the worst assessment between the two breasts as the score.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....