Dataset Information

Prospective Study of Saline versus Silicone Gel Implants for Subpectoral Breast Augmentation.

ABSTRACT:

Background

Silicone gel implants are regarded as esthetically superior to saline implants, offering a more natural consistency. They are also considered less susceptible to rippling. However, objective measurements and patient-reported outcome studies are lacking. Similarly, minimal data are available quantitating animation deformity.

Methods

A 3-year prospective study was undertaken among 223 women undergoing primary subpectoral breast augmentation using either saline (n = 145) or silicone gel (n = 78) implants. Photographs obtained included frontal views with the patient flexing the pectoral muscles. Images were matched, and vertical differences in nipple position were measured. Breast implants were evaluated using high-resolution ultrasound to detect any ripples or folds at least 3 months after surgery. Outcome surveys were administered. Statistical analysis included the χ² test, point-biserial correlations, and a power analysis.

Results

Respondents reported visible rippling in 18% of women and palpable rippling in 32% of patients, with no significant difference between women treated with saline and silicone gel implants. Ripples were detected on ultrasound scans in 24% of women with saline implants and in 27% of women with silicone gel implants (difference not significant). Ripples were more common in women with lower body mass indices. Fifty percent of patients demonstrated nipple displacement <1 cm on animation. Nipple displacement occurred either up or down with equal frequency and a mean overall nipple displacement of zero.

Conclusions

Saline and silicone breast implants produce similar degrees of rippling, as determined on outcome surveys and ultrasound examination. Animation deformities tend to be minor and well-tolerated.

SUBMITTER: Swanson E

PROVIDER: S-EPMC7339341 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Publications

Prospective Study of Saline versus Silicone Gel Implants for Subpectoral Breast Augmentation.

Swanson Eric E

Plastic and reconstructive surgery. Global open 20200604 6

<h4>Background</h4>Silicone gel implants are regarded as esthetically superior to saline implants, offering a more natural consistency. They are also considered less susceptible to rippling. However, objective measurements and patient-reported outcome studies are lacking. Similarly, minimal data are available quantitating animation deformity.<h4>Methods</h4>A 3-year prospective study was undertaken among 223 women undergoing primary subpectoral breast augmentation using either saline (n = 145) o ...[more]

PMID: 32766047

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Project description:BackgroundSilicone breast implant design has evolved over the last 50 years. Regulatory bodies including the FDA require data to support the modifications designed to improve the safety, efficacy, longevity, and biocompatibility of breast implants.ObjectivesThe authors reviewed the 3-year data on the safety and effectiveness of Motiva (Establishment Labs Holdings, Inc., Alajuela, Costa Rica) SmoothSilk silicone gel-filled breast implants submitted to the FDA. The current submitted data include the primary breast augmentation and revisional augmentation cohorts.MethodsThe Motiva IDE is a prospective, single-arm, multicenter, 10-year pivotal study in which data are collected on breast augmentation, reconstruction, and revisional surgery. Three-year data were submitted to the FDA on adverse events, reoperations, patient and physician satisfaction, connective tissue diseases, and quality of life validated instruments. A subset of the patients underwent annual magnetic resonance imaging (MRI) at years 1, 2, and 3 to screen for implant rupture.ResultsA total of 451 patients were implanted in the primary augmentation cohort and 109 patients in the revisional augmentation cohort. There were 218 patients enrolled in the MRI cohort. Reported rates for reoperation for any reason were 6.1% in the primary augmentation cohort (92.4% follow-up) and 25.8% in the revisional augmentation cohort (88.7% follow-up).DiscussionMotiva implants were first introduced in 2010. The 3-year Motiva data suggests that the leading cause of revisional surgery has shifted from capsular contracture and rupture to more subjective indications for reoperation such as malposition and size change.ConclusionsThree-year data from the primary augmentation and revisional augmentation cohorts submitted to the FDA demonstrate the safety and efficacy of the Motiva implants. There were low complication rates for implant-related complications and high surgeon and patient satisfaction.Level of evidence: 2

Project description:BackgroundRecently, old concerns linking silicone breast implants (SBIs) with breast cancer have resurfaced. These concerns apply specifically to the risk of breast cancer recurrence in patients who received breast reconstructions with macro-textured SBIs. In this study, we investigated the effect of breast reconstruction with macro-textured SBIs on long-term oncologic outcomes of breast cancer patients.Materials and methodsWe conducted a retrospective cohort study in two large cancer centres in the Netherlands. Patients who had been treated for primary breast cancer between January 1st 2000 and December 31st 2015 were included. Data on treatment and oncologic outcomes were obtained from prospectively maintained institutional and nationwide registries. Patient files were reviewed manually to complement missing information. Missing data was accounted for by multiple imputation by chained equations (MICE). Reconstruction with a macro-textured SBI was analysed as a time-dependent variable. The main outcomes of interest were locoregional recurrence-free survival (LRRFS) and distant metastasis-free survival (DMFS). Hazard Ratios (HRs) were estimated using multivariable Cox proportional hazard models.ResultsOf the 4,695 women who were eligible for inclusion, 2,393 had undergone mastectomy. Of these women, 1,187 (25%) had received breast reconstruction with a macro-textured SBI. Mean follow-up time was 11.5 (SD, 5.0) years. Compared with women who had undergone a simple mastectomy or autologous breast reconstruction, women with an implant-based reconstruction did not differ significantly in LRRFS or DMFS after accounting for various confounding factors (HR 1.27 [95% CI 0.93 - 1.72] and HR 0.94 [95% CI 0.74 - 1.20], respectively). Sensitivity analysis in complete cases of patients and varies subgroup analyses yielded similar results.ConclusionReassuringly, in this multi-centre cohort study no difference was found in long-term oncologic outcomes between women who had received breast reconstruction with a macro-textured SBI and women who had undergone a simple mastectomy or autologous breast reconstruction.

Dataset Information

Prospective Study of Saline versus Silicone Gel Implants for Subpectoral Breast Augmentation.

Background

Methods

Results

Conclusions

Publications

Prospective Study of Saline versus Silicone Gel Implants for Subpectoral Breast Augmentation.

Similar Datasets

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