Goals/Purpose:
Understanding physician and patient satisfaction after breast augmentation will contribute to improved quality of counseling for patients considering breast augmentation and better device selection by physicians and patients.
Methods/Technique:
A 10-year, prospective, open-label, multi-center clinical study on Mentor contour profile gel breast implants (manufactured by Mentor Worldwide LLC, Irving, Texas) is underway and data through 8 years are available. The study began in 2002 and includes 57 investigators, at 68 US sites, and 955 patients (572 primary augmentation, 124 revision-augmentation, 191 primary reconstruction, and 68 revision-reconstruction). Safety is assessed and the cumulative incidences of complications and reoperations are estimated using the Kaplan-Meier (KM) method. The effectiveness endpoints of the study are the overall increase in bra cup size following implantation (primary augmentation only), the overall mean change in chest circumference, global patient satisfaction, and changes in self-reported responses to quality of life questionnaires, such as the Breast Evaluation Questionnaire (BEQ). Investigator satisfaction is assessed (at 1, 2, and 3 years post implantation) by asking the investigator whether he/she was satisfied with the implant results and, if so, the reasons (shape similar to natural breast, feel similar to natural breast, desired level of ptosis, tapered superior edge provides transition).
Results/Complications:
The overall mean change from baseline through 8 years in circumferential chest size was 2.1 inches (P< .001) for primary augmentation and 0.7 inches (P< .001) for revision-augmentation (Table 1). The overall mean bra cup size increase from baseline, captured for primary augmentation only, across all follow-up visits was 2.2 cup sizes (P< .001).
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Table 1. Circumferential Breast Measurements |
Of the 320 (56%) primary augmentation patients who answered the global patient satisfaction question at the 8-year follow-up visit, 313 (98%) indicated they would make the same decision to have the breast implant surgery. The results were similar for revision-augmentation (68 of 72 patients, 94%). Among the primary augmentation patients who had any type of reoperation, 96% (51 of 53) at year 4 and 100% (45 of 45) at year 8 indicated that they would make the same decision to have the breast implant surgery again. The response was similar for revision-augmentation patients, 100% (12 of 12) at year 4 and 86% (12 of 14) at year 8.
For the implant level analysis of satisfaction, investigators reported satisfaction levels of 99% (1121 of 1131) for primary augmentation and 96% (231 of 242) for revision-augmentation. The investigators selected up to 4 reasons for satisfaction including shape similar to natural breast, feel similar to natural breast, desired level of ptosis, and tapered superior edge provides transition. Selection across the options ranged from 84% to 98%.
Quality of Life Assessments
The BEQ was developed to assess breast satisfaction and quality of life outcomes among breast surgery patients. Overall 94% (288 of 308) of primary augmentation patients were satisfied with the general appearance of her breasts at 8 years compared to 9% (53 of 569) at baseline, and for revision-augmentation, 69% (47 of 68) were satisfied at 8 years compared to 36% (45 of 124) at baseline (Figure 1).
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Figure 1. BEQ Assessment of Patient Satisfaction at Baseline and 8 Years | |
When asked to describe satisfaction levels with breast size, shape, and firmness in intimate or sexual activities, leisure or social activities, and professional or job-related activities, the majority of primary augmentation (>84%) and revision-augmentation (>70%) patients were satisfied (Figure 2).
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Figure 2. BEQ Overall Assessment of Patient Satisfaction with the Size, Shape, and Firmness of the Breasts | |
Safety Assessments
For the augmentation cohorts, the KM estimated 8-year cumulative incidence rates for the key complications are presented in Table 2.
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Table 2. Kaplan-Meier Estimated Rates for Key Complications |
Comparisons of KM rates for any reoperation, capsular contracture, implant removal, and infection were done for patients who answered “No” versus those who answered “Yes” to whether they would make the same decision to have breast implant surgery again. “No” responders' KM rates were higher for implant removal with or without replacement (39% vs. 6%, P< .001) and for any reoperation (41% vs. 19%, P< .05) in primary augmentation. For revision-augmentation, “No' responders had higher KM rates for capsular contracture Baker Grade III/IV (50% vs. 13%, P< .01) and for any reoperation (56% vs. 26%, P< .05)
Conclusion:
Breast augmentation with Mentor contour profile gel breast implants led to high patient and investigator satisfaction rates. As expected, the satisfaction assessments suggest the occurrence of particular complications and reoperations, such as severe capsular contracture and implant removal, can impact patient satisfaction. In addition, even though the primary augmentation and revision-augmentation populations show a different distribution of satisfaction before and after implant surgery, the vast majority of patients in both populations would choose to have the breast implant surgery again.