Breast Augmentation - Predictors for Reoperation
Multisite Analysis of 177 Consecutive Primary Breast Augmentations: Predictors for Reoperation
McCafferty LR, Casas LA, Stinnett SS, Lin S, Rho J, Skiles M
Aesthetic Surgery Journal: May 2009;29;3.pp.213-222
Plastic surgeons and manufacturers of breast implants have been examining the complication and reoperation rates of primary breast augmentations for more than 18 years. The seemingly high rates reported by the manufacturers to the United States Food and Drug Administration (FDA) was the impetus for this multicenter study.
This paper reports on data pooled from three plastic surgery practices that were geographically distributed across the United States and examines the reoperation rate, time to reoperation, the reason for reoperation, and specific complications in 177 consecutive primary breast augmentation patients. These data are statistically compared to the manufacturers’ 2005 and 2008 FDA data. In addition, the significance of selected variables from our data is examined as predictors for reoperation.
Data were retrospectively collected from 177 consecutive primary breast augmentations performed between 2001 and 2004 from three surgical practices. Direct physician-to-patient follow-up periods ranged from 12 to 58 months, with 100% of patients having at least one year of follow-up. Each practice extracted chart data on variables and complications, including reoperations. These data were independently collated and sent to an independent biostatistician for analysis.
Our three-year Kaplan–Meier (KM) reoperation rate (8%) and capsular contracture rate (2%) were both lower than the manufacturers’ KM 3-year rates for reoperation (12%-21%) and capsular contracture (6%-9%). Logistic regression identified only simultaneous mastopexy and preexisting ptosis as predictors of reoperation.
In 2005 and again in 2008, both Inamed (Allergan) and Mentor Corporations reported seemingly high reoperation and complication rates in patients who underwent primary breast augmentation with their products.1,2 Then in 2012 Sientra submitted its data to the FDA. 41
Since these reports, other individual plastic surgeons have reported on reoperation and complication rates,3,4 but there has not been a multicenter study reporting a consecutive series with 100% follow-up. By analyzing 13 independent variables in this diverse patient group, we hoped to identify predictors of reoperation. In addition, we wanted to assess the pooled reoperation rates, complication rates, and time to reoperation for these three plastic surgery practices and compare them to those reported to the United States Food and Drug Administration (FDA) in 2005 and 2008 by the aforementioned implant manufacturers.
This is a retrospective study of 177 consecutive primary breast augmentations performed between 2001 and 2004, with follow-up periods ranging from 12 to 58 months and with all patients having at least one year of follow-up. The follow-up required at least one direct physician-to-patient visit, at which time the data were collected. The mean follow-up was 30.5 months (median 25 months). The 177 patients were from three practices; these practices averaged 20 years of experience. The first plastic surgeon was from the Northeast (LRM; 54 patients, 19 years in practice); the second was from the Midwest (LAC; 102 patients, 15 years in practice); and the third was from the West Coast (MS; 21 patients, 25 years in practice). The three surgeons collected data on complications including reoperation, capsular contracture (Baker grades III/IV), deflation, malposition, extrusion, and asymmetry. They also collected data on 13 variables including surgeon, implant type, incision location, implant pocket, drain usage, postoperative self-massage, use of vitamin E, use of shaping bras, days from initial consultation to surgery, number of preoperative visits, preexisting breast asymmetries, simultaneous mastopexy, and preexisting breast ptosis. After the data were compiled from the three surgeons’ charts, it was collated by an independent source (JR) and sent to an independent biostatistician (SSS) for analysis.
The data on these 177 patients were analyzed using SAS software (version 8.2; SAS Institute Inc., Cary, NC). Frequencies and percentages for categorical variables were obtained. The significance of the difference between groups (manufacturer data from Inamed/Mentor and the patient data) in these variables was assessed using the Fisher exact test. All relevant clinical descriptors were screened. Risk modeling with logistic regression was used to obtain and assess the significance of predictors of reoperation. Kaplan–Meier (KM) survival curves were produced for time to reoperation, both overall and separately by complication.
The patients’ ages ranged from 17 to 59 years (mean 35 years; median 36.5 years). The patients’ weights ranged from 94 to 180 pounds (median 124 pounds). Saline implants were used in 172 patients and silicone gel-filled implants were used in five patients. Smooth implants were placed in 176 patients and textured implants in one patient. One hundred forty-four patients had subpectoral and 33 patients subglandular implant placement. The volume ranged from 125 cc to 525 cc (mean 310 cc; median 325 cc). The median time from the first consult to surgery was 53 days and the median number of consults before surgery was two. One hundred twenty-two patients (70%) had preexisting asymmetries. One hundred forty-eight patients had an inframammary incision and 29 had either had a periareolar approach or had the implant placed through simultaneous mastopexy incision. All surgeons employed some form of dimensional analysis before surgery, used antibiotic irrigation, and recommended massage postoperatively.
The overall reoperation rate for any reason was 7.9%. The overall rates for the specific complications (capsular contracture [Baker grades III/IV], implant deflation, malposition, extrusion, and asymmetry) at one year of follow-up ranged from 0.5% to 1.7%. The reoperation rate, at 1 year with 100% follow-up of these 177 consecutive breast augmentation patients, was 4.5%. Three patients (1.6%) in the first year and five patients (2.8%) overall chose to have a reoperation specifically for size change.
Reasons and Predictors for Reoperation
Patient’s choice for size change was the reason for 35% of the reoperations and implant-related complications were responsible for 65% of reoperations. At one year with 100% follow-up, 37% of the reoperations were attributed to patient choice and 63% were attributed to implant-related complications.
The only significant predictors of reoperation after univariable analysis of 13 variables were simultaneous mastopexy (P = .025) and preexisting ptosis (P = .004). Surgeon, implant type (saline or silicone gel-filled), location of incision, implant placement location (submuscular or subglandular), drains, self-massage, vitamin E use, use of a shaping bra, and asymmetries were not predictors of reoperation. The odds of a reoperation for those patients who had a simultaneous mastopexy were 4.2 times greater than those without simultaneous mastopexy. The odds of a reoperation increased 2.04 times with each increase in degree of ptosis (from mild to moderate to severe).
Univariable analysis of predictors of reoperation
Reoperation Kaplan–Meier Survival Analysis
In our data set of 177 patients, 14 patients (7.9%) had a reoperation between zero and 54 months after primary breast augmentation. Eight patients had reoperations within the first year after surgery (four within the first six months) and six patients had reoperations at 13, 17, 22, 36, 40, and 54 months after their initial surgery, respectively. At six months post surgery, the expected survival rate of implants was 98%; at one year, 95%; at two years, 93%; at three years, 92%; and at four years, 90% .
Survival analysis for time to reoperation (for any reason) was analyzed. Of 177 patients in the combined data sets, 14 patients (7.9%) had a reoperation. Four patients had a reoperation within the first six months post surgery and eight had reoperations within the first year post surgery. The other patients had reoperations at 13, 17, 22, 36, 40, and 54 months post surgery. The KM analysis for time to surgery at different intervals (six months to four years) for capsular contracture (Baker grades III/IV), deflation, malposition, and size change revealed high survival rates, ranging from 96% to 99%. For example, at three years post surgery, 2% of this patient population would be expected to have another operation for Baker grade III/IV capsular contracture, 1% for deflation, 2% for malposition, and 4% for a desired size change. The Inamed/Mentor three-year KM rates for each complication, with the exception of size change, were higher. Specifically, the KM three-year rates were 8.2% to 9% for capsular contracture, 3.3% to 5% for deflation, and 8.2% for malposition
Kaplan–Meier survival analysis for time to surgery for each complication was analyzed. The asterisk denotes the Kaplan–Meier rates in our study at years one, two, three, and four. The figure lists probabilities of survival when time to a specific complication is analyzed in separate models. The risk of failure is one minus the survival probability. These data should be interpreted cautiously because of the small sample sizes. The double asterisks denote the Inamed/Mentor Kaplan–Meier rates at three years post surgery.
Manufacturers’ Data (Inamed/Mentor)
The manufacturers’ three-year KM complication rates for silicone and saline implants presented to the FDA in 2005 reported reoperation rates of 13% to 21% and listed patient desire for size change as a reason for reoperation 30% to 40% of the time. 1,5 Lists a summary of the updated manufacturers’ data available as of October 2008.1,2,6,7 The KM complication rates were updated, revealing an increase in the percentage for each specific complication.
Kaplan–Meier complication rates
The data from the 177 consecutive breast augmentation patients showed a 0.92 KM survival rate or an 8% risk of reoperation after three years, compared to the implant manufacturers’ overall KM rate of 13% to 21%. After four years, our study patients showed a 10% risk of reoperation (KM survival rate of 0.90). The manufacturers’ data available for silicone implants after four years showed a 16% to 23.5% reoperation rate. The manufacturers’ data for saline implant reoperation is available after five years and shows a 20% to 26% reoperation rate.
Three-year Kaplan–Meier complication rate comparison for specific complications
The comparison between this study group and the two manufacturers’ study data of the three-year KM survival analysis for specific complications clearly shows that the rates are lower in this study group for every complication. It is not possible to compare the complication rate between our study patients and the manufacturers’ study groups for size change data because the manufacturer does not report a KM complication rate, but rather lists it as a percentage of the reoperations. Nonetheless, the only data point that was consistent between all 3 study groups was reoperation for implant size change, which occurred approximately 35% of the time.
The data from the manufacturers listing reasons for reoperation was updated in October 2008. Reoperation for size change (patient choice) continues to be a significant reason in this updated data; however, the range is wider than in the 2006 data1, 2,6,7. The new form-stable silicone gel-filled device data, when compared to our data, shows a higher reoperation rate both at three years (Inamed 410; 12.5% vs. 8%) and two years (Mentor; 9.4% vs. 8%). 8,9 However, patient choice as a reason for reoperation is lower (Mentor, 13%; Inamed, 15.1%) than in our study (35%). 8,9
Form-stable Kaplan–Meier complication rates
We compared the Inamed and Mentor one-year saline data1 to our one-year saline data. Our subset of 172 consecutive saline augmentation patients had 100% follow-up at one year, compared to Inamed’s 67% follow-up of 2875 patients and Mentor’s 47% follow-up of 2385 patients. After statistical analysis of the combined manufacturers’ one-year saline data to ours, we found our capsular contracture rate to be significantly smaller and our deflation rate to be borderline significantly lower.
The overall proportion of patients having a reoperation in our study was small (7.9%). The analysis of all variables showed that a simultaneous mastopexy (significant) and preexisting ptosis (highly significant) were the only predictors of reoperation. A higher percentage of patients in our study with simultaneous mastopexy had a reoperation (20%) compared to those who did not have this procedure (5.6%). An increased severity of ptosis was associated with an increased risk of reoperation. This is consistent with other findings.10,11 The three-year KM survival rate was 0.92, indicating an 8% risk of reoperation during the first three years. This was less than the manufacturers’ 13% to 21.4% 3-year KM reoperation rate. Our four-year survival rate was 0.90, indicating a 10% risk of reoperation during the first four years post surgery. Our KM survival analysis for individual complications (capsular contracture, deflation, and malposition) at the completion of one year and over the entire study indicates a much lower risk of reoperation for these complications than the manufacturers’ data indicates, but because our sample size was small, these results should be interpreted cautiously.
Along with other researchers, we feel that antibiotic irrigation, massage, and meticulous hemostasis can help decrease the capsular contracture rate and therefore the reoperation rate.11–26 All but one of our patients received smooth implants. Reports comparing smooth and textured implants offer conflicting results27–30; some evidence indicates that smooth implants wrinkle less and are perhaps less prone to rupture and deflation, but do not significantly protect against capsular contracture.21,25–27,31–33
Our study is in agreement with others that the revision rate is higher in patients with ptosis and/or patients undergoing simultaneous mastopexy with primary augmentation.10,11 Most striking when evaluating all statistics is that the reoperation rate for size change remained relatively high. Some of this is beyond the patient’s or surgeon’s control.34,35 For example, neither can control the aging process, nor the changes of the breast around existing implants in response to pregnancy and breastfeeding. However, we agree with others that better management of patient expectations and the use of dimensional analysis before surgery can help decrease the reoperation rate.2,20,36–40 In our study, five patients had a reoperation as a matter of choice for an increase in size. Three patients simply wanted a larger size within the first year, indicating a breakdown in the preoperative consultation and education process. One patient had a simultaneous mastopexy (predictor) with her primary augmentation and requested larger implants 33 months later. Finally, our fifth patient—three years later and after postpartum involution—requested an increase in size. We identified no predictors.
The strengths of this study include the fact that our data were obtained from a consecutive series of patients from three separate surgical practices located in different geographic areas of the United States. Also, our follow-up was direct physician-to-patient examination without the involvement of intermediary mailings or surveys. In addition, an independent biostatistician analyzed our data.
The weaknesses include the small sample size and the fact that there were too few complications for individual comparative analysis.
However, because our study identified potential predictors of reoperation and suggests a lower complication and reoperation rate than reported to the FDA by the manufacturers, we feel that a similar large, multicenter study would be beneficial.
This multisite study showed that preexisting ptosis and simultaneous mastopexy were significant predictors for reoperation. Our KM complication rates were lower than the rates reported to the FDA by the manufacturers.
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- U.S. Food and Drug Administration Web site. Center for Devices and Radiological Health. Product labeling data for Mentor and Allergan (formerly Inamed) saline-filled and silicone gel-filled implants.
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