Cohesive Implants Research Articles

Silicone Leakage from Breast Implants Is Determined by Silicone Cohesiveness: A Histological Study of 493 Patients.

Silicone leakage from breast implants is a concern with potential implications for patient health. This study aimed to quantify and model silicone leakage from implants to the breast implant capsule and to investigate whether silicone cohesiveness affected the silicone leakage rate. Silicone content in the breast implant capsule was quantified histologically by measuring the area of silicone deposits. This was used to model silicone leakage over time based on the time of implantation. The effect of cohesiveness on silicone leakage was investigated across all implant brands with declared cohesiveness and in a subanalysis comparing only Mentor cohesive I implants with cohesive II and III implants. The study included 493 patients with 872 breasts and a median time of implantation of 13.0 years (range 0.4 to 51 years). The modeling of silicone leakage from intact implants showed that leakage and the acceleration of the leakage rate were significantly higher in low-cohesive implants than in highly cohesive implants (p<0.05). This was confirmed when analyzing only Mentor implants (p<0.05) and in the case of implant rupture (p<0.01) where low-cohesive implants also leaked significantly more than highly cohesive implants. Our results suggest that highly cohesive implants are superior to low-cohesive implants in preventing silicone leakage. Due to the accelerating rate of silicone leakage especially found in low-cohesive implants, we propose that exchange of low-cohesive implants could be discussed with patients 10 to 15 years after implantation to minimize silicone leakage even in the absence of implant rupture.

The Impact of Breast Implant Cohesivity on Rippling and Revision Procedures in 2-Stage Prepectoral Breast Reconstruction

Abstract Background Rippling remains one of the most common complications following prepectoral implant-based reconstruction (IBR). Objectives The purpose of this study was to assess how implant cohesivity, a measure of elasticity and form stability, affects the incidence of rippling in prepectoral IBR. Methods We performed a retrospective cohort study of 2-stage prepectoral IBR performed between January 2020 and June 2022 at the Brigham and Women's Hospital and Dana-Farber Cancer Institute, comparing outcomes in patients who received Allergan Natrelle least cohesive, moderately cohesive, and most cohesive silicone gel implants. Outcomes of interest were rippling and reoperation for fat grafting. Results A total of 129 patients were identified, of whom 52 had the least cohesive implants, 24 had the moderately cohesive implants, and 53 patients had the most cohesive implants. The mean follow-up time was 463 (±220) days. A decreased incidence of rippling was seen with moderately cohesive (odds ratio [OR] 0.30, P &amp;lt; .05) and most cohesive (OR 0.39, P &amp;lt; .05) implants. Third stage reoperation for fat grafting was less frequent in patients with the most cohesive implant (OR 0.07, P &amp;lt; .05). In subgroup analyses, the patients with the most cohesive implant, who did not receive fat grafting at the time of initial implant placement, did not require reoperation for fat grafting (0%). Conclusions The use of highly cohesive implants in prepectoral IBR is associated with decreased rippling and fewer reoperations for fat grafting. Level of Evidence: 3

A Critical Analysis of Factors Associated With Anteroposterior Implant Flipping in Immediate Breast Reconstruction.

Implant-based reconstruction remains the most common form of postmastectomy breast reconstruction. With ever-evolving device characteristics, including the advent of high-profile, cohesive, fifth-generation implants, the incidence of anterior-posterior flipping of implants is presenting a new challenge. Patient and device characteristics associated with this phenomenon have yet to be fully elucidated. Patients who underwent nipple- or skin-sparing mastectomy with subsequent 2-stage or direct-to-implant reconstruction with smooth implants between 2015 and 2021 were retrospectively identified and stratified by incidence of implant flipping. Patient, procedural, and device characteristics were evaluated. Within 165 patients (255 reconstructed breasts), 14 cases of implant flipping were identified (flip rate 5.5%). All flips occurred in patients with cohesive implants (odds ratio [OR], 87.0; P = 0.002). On univariate analysis, extra full implant profile (OR, 11.2; P < 0.001) and use of a smooth tissue expander for 2-stage reconstruction (OR, 4.1; P = 0.03) were associated with flipping. Implants that flipped were larger than those that did not (652.5 ± 117.8 vs 540.1 ± 171.0 mL, P = 0.0004). Prepectoral implant placement (OR, 2.7; P = 0.08) and direct-to-implant method (OR, 3.17; P = 0.07) trended toward association, but this effect was not significant. Patient BMI, weight fluctuation during the reconstructive course, mastectomy weight, AlloDerm use, and history of seroma or periprosthetic infection were not associated with flipping. Patients who receive a highly cohesive, high profile, larger implant are at increased risk for implant flipping. In addition, patients who receive a smooth tissue expander are more likely to experience flipping of their subsequent implant, compared with those who had textured tissue expanders. These characteristics warrant consideration during device selection to minimize discomfort, aesthetic deformity, and the need for reoperation.

Implant Malposition in Prepectoral Breast Reconstruction: Experience with Natrelle® Cohesive Implants over 6.5 Years

Implant malposition has been reported to be a common reason for revision surgery after implant-based breast reconstruction (IBR). With the recent increase in the use of smooth implants due to concerns for breast implant-associated anaplastic large-cell lymphoma with textured implants, we compared and reported the rates of malposition in prepectoral IBR and identified risk factors. A retrospective review of patients who underwent prepectoral IBR with Natrelle® (Allergan, Inc., Irvine, CA) implants at our institution between January 2014 and May 2020 was performed. Clinical characteristics, implant types, and the rate of malposition, defined as implant flipping or rotation, were recorded. Univariate and multivariable time-to-event analyses using the Cox proportional-hazards model were performed to identify predictors of malposition. Three hundred seventy-five patients (660 breasts) were included. Four hundred forty-one (66.8%) breasts had smooth round implants whereas 219 (33.2%) had textured anatomical devices. Malposition requiring either a manual correction or surgical intervention occurred in 26 (5.9%) smooth round implants versus 3 (1.4%) textured anatomical. Multivariable analysis showed that having a smooth round implant (aHR: 7.19, 95% CI: [2.04 - 25.4]) and an increase in implant volume (aHR: 1.003, 95% CI: [1.001 - 1.006]) were associated with having a malposition requiring intervention. Among smooth round implants; INSPIRA® Cohesive implants were more likely to result in a malposition requiring intervention (p<0.0001) compared to other smooth round implants. Overall, malposition requiring intervention occurred in 5.9% of smooth round implants and 1.4% of textured anatomical implants. Statistical analysis demonstrates that smooth round implants and an increase in implant volume both are associated with a malposition requiring intervention.

Risk Factors for Anteroposterior Implant Malposition in Postmastectomy Patients with Cohesive Round Implants

BACKGROUND: Round cohesive implants are increasingly popular due to their ability to maintain shape, higher fill volume, and projection. However, they have also been associated with a higher risk of implant flipping. The current literature on risk factors of anteroposterior implant malposition in patients with two-stage implant-based reconstruction (IBR) is scarce. We identified predisposing factors of implant anteroposterior malposition in postmastectomy patients with prepectoral round, cohesive, smooth implants. METHODS: A retrospective review of patients who underwent postmastectomy two-stage IBR with prepectoral Natrelle Inspira Cohesivity Level 3 implants, from 2013 to 2020 at our institution, was conducted. Inclusion criterion was patients 18 years or older who had a prepectoral tissue expander and prepectoral breast implant. Patients who had prior breast reconstruction or aesthetic surgeries were excluded. RESULTS: A total of 214 implants (84.9% bilateral) in 106 patients were included. The mean age at surgery was 51.1 ± 11.4 years, and the mean body mass index was 27.0 ± 4.8 kg/m2. In total, 22.35% had a history of radiation to the chest wall, and 46.3% had chemotherapy. Of all breasts, 79.4% had prior MX tissue expanders, the median implant volume was 485 cm3 (Q1-3: 385–580), and acellular dermal matrix was placed in 65.4% of breasts. Anteroposterior malposition was reported in 19 (8.9%) breasts, 50% of which underwent surgery to correct the flipping. The mean time to implant flipping was 6.1 months (Q1-3: 3.5–16.8), and the mean follow-up time was 12.2 months (5.0–17.5). On univariate analysis, SCX implants [OR= 3.4 (1.3–8.7), P = 0.01], implant volume > 400 cm3 [OR 8.9 (1.2–68.2), P = 0.011], older age at surgery (OR = 1.1 P = 0.022), and BMI (OR=1.1, P = 0.005) were correlated with a higher risk of anteroposterior malposition. CONCLUSIONS: Use of SCX implants, implants with a volume > 400 cm3, older age at surgery, and high BMI increase the risk of anteroposterior malposition in Natrelle Inspira Cohesivity Level 3 implants. These results can be useful for patient counseling, better surgical planning, and improving clinical practice.

Splitting the Difference: Using Synthetic and Biologic Mesh to Decrease Cost in Prepectoral Immediate Implant Breast Reconstruction.

Prepectoral breast reconstruction has minimized morbidity and dynamic deformities associated with submuscular implant-based breast reconstruction. However, reliance on implant coverage with acellular dermal matrix in immediate implant reconstruction remains limited by high material costs. The authors describe a technique in which anterior implant coverage in prepectoral reconstruction is split into acellular dermal matrix inferolaterally and synthetic, absorbable mesh superiorly. Use of acellular dermal matrix inferiorly provides coverage and reinforces the inframammary fold, whereas the absorbable mesh is trimmed and sutured to the acellular dermal matrix at the appropriate tension to support the implant and relieve pressure on mastectomy flaps. A retrospective review was performed on all consecutive prepectoral one-stage breast reconstructions using this technique at a single institution. Patient demographics, mastectomy and reconstruction characteristics, reconstructive outcomes, and cost of support materials were queried and analyzed. Eleven patients (21 breasts) underwent prepectoral immediate implant reconstruction with Vicryl and acellular dermal matrix anterior coverage. Average mastectomy weight was 775.8 g. Smooth, round cohesive implants were used in all cases and average implant size was 514.5 ml. Overall complication rates were low and included one minor infection (4.8 percent) and one case of minor mastectomy flap and partial nipple necrosis each (4.8 percent). Calculated cost savings of Vicryl and acellular dermal matrix anterior coverage was up to $3415 in unilateral and $6830 in bilateral cases. Prepectoral breast reconstruction using acellular dermal matrix inferiorly and Vicryl mesh superiorly is a safe technique that decreases material costs associated with support materials and allows the surgeon to precisely control the implant pocket and position. Therapeutic, IV.

Cohesive implants in revisionary breast reconstruction: strategies for optimizing aesthetic outcomes

Cohesive implants in revisionary breast reconstruction: strategies for optimizing aesthetic outcomes

Cohesive Round Implants and the Risk of Implant Flipping.

Background:Fifth-generation, round, form-stable implants have a higher cohesive gel, a higher fill volume, and distinct anterior and posterior profiles. Due to these implant features, anterior-posterior (AP) flipping of round, form-stable implants is discernible, but little is known of this complication of implant reconstruction.Methods:Patients who underwent skin- or nipple-sparing mastectomy followed by direct-to-implant reconstruction with round, cohesive, smooth implants were included in this retrospective study. Implants were placed submuscularly or prepectorally. Incidence of flipping was retrieved from patient records. Patients were stratified by presence or absence of flipping; data on patient demographic characteristics, neoadjuvant/adjuvant treatment, mastectomy characteristics, and acellular dermal matrix (ADM) type (AlloDerm or FlexHD) and coverage technique (inferior pole, tenting, or wrapping) were compared between the groups to identify risk factors associated with flipping.Results:A total of 117 patients (230 breasts) were evaluated. Sixteen cases of implant flipping were documented for a flip rate of 7.0%, all occurring in patients with prepectoral implants. On univariate analysis, prepectoral implant placement, highly cohesive implants, use of AlloDerm, and ADM wrapping/tenting were found to be significantly associated with AP flipping. On logistic regression analyses, ADM type and ADM coverage technique were no longer significant predictors of AP flipping.Conclusions:Patients who undergo prepectoral implant reconstruction with highly cohesive round implants appear to be at an increased risk of AP flipping. Subpectoral reconstruction is not associated with AP flipping.

Safety and Efficacy of Combined Gluteal Lipofilling with Silicone Cohesive Implants for Gluteal Enhancement in an Egyptian Population

Background: Buttock augmentation surgery is on the risein the recent years. Different approaches exist with differentadvantages and complication rates. Furthermore, ethnic groupsmight have different aesthetic demands.Material and Methods: Here, we describe our experiencewith a combined lipofilling and silicone implant approach in20 female Egyptian patients.Results: Our results reveal both an objective success withan average achieved waist-to-hip ratio of 0.78 after 6 monthspost-operatively, together with a subjective success withstatistically-significantly higher scores reported by both thepatients and two independent aesthetic surgeons. Our complicationrates were minimal and planned for.Conclusion: Gluteal lipofilling can thus safely and effectivelybe combined with silicone implants for gluteal enhancement,giving better shape and projection and avoiding implantdissatisfaction.

Optimizing Outcomes in 2-Stage Prepectoral Breast Reconstruction Utilizing Round Form-Stable Implants.

Prepectoral breast reconstruction carries many benefits to patients, including its minimally invasive (muscle-sparing) nature, and its reduction in symptoms such as pain and animation deformity, relative to subpectoral reconstruction. However, without the traditional use of the pectoralis major muscle to mask the upper pole of the implant, and dictate the shape of the upper pole, certain steps must be taken to ensure the optimal aesthetic outcome in prepectoral reconstruction. Surgeons have utilized acellular dermal matrices, fat grafting, and highly cohesive implants to improve outcomes. Among the most important steps is the proper implant selection. To this end, the authors routinely utilize round form-stable gel implants, when performing prepectoral breast reconstruction. These implants offer improved aesthetic outcomes, given their ability to reduce rates of rippling and edge visibility. Furthermore, the characteristics of a soft and naturally shaped breast are achieved despite the lack of muscle coverage. The authors believe that reproducibly successful prepectoral reconstruction is dependent on proper technique. In this article, we present the proper techniques necessary for optimizing outcomes when using these implants in 2-stage prepectoral breast reconstruction.

Financial Disclosure Appendix for "Utilizing a Spectrum of Cohesive Implants in Aesthetic and Reconstructive Breast Surgery".

Financial Disclosure Appendix for "Utilizing a Spectrum of Cohesive Implants in Aesthetic and Reconstructive Breast Surgery".

Folded breast implant’s pointed edge causing thinning of the skin

Sir, Aesthetic breast augmentation can be fraught with postoperative complications, particularly capsular contracture, malrotation, skin surface irregularities, and implant or inframammary fold malposition. However, we found only one report from 1972, 6 years after introduction of silicone breast implants, which describes Bthe folded breast sign^ as a radiological appearance rather than a clinical sign of a pointed Silastic shell [1]. Since we have corrected this late complication with conspicuous skin thinning several times in the past, we present today on two patients, both slim and tall and without any detectable thorax asymmetry. Two smooth-walled, soft, round, and lowprofile implants had been inserted into the sub-mammary space through the trans-axillary approach [2] in both patients 6 and 5 years prior. Both patients showed absolutely soft breast and had never developed a Baker II–IV capsule. One patient, a 24-year old student received 240 cm smoothwalled implants 5 years ago and recognized the pointed edge in the upper outer quadrant of the right breast (Fig. 1a) about 1 year after augmentation. The implant appeared vertically folded, and its protruding tip could be hidden behind the vertical bra strip. When the tip slowly thinned out the covering dermis, the patient asked for treatment. The implant pocket was so wide that a turning maneuver of the implant counter-clockwise from outside was successful. No pointed tip was palpable, and the implant appeared to be unfolded for over 9 months by now (Fig. 1b). The thinned out skin area recovered by itself after the pressure and rubbing from the inside subsided. The other patient, a 36 year-old riding instructor received two smooth-walled implants of 320 cm 6 years ago and developed a palpable and visible pointed implant tip also approximately 1 year later in the inner lower quadrant of her left breast. Under the impression of a capsule contracture as the cause for folding, she had been re-operated in the meantime three times by widening the pocket but leaving the implant. Early reoccurrence of the implant folding created the same pointed tip each time. Within a few weeks, the subcutaneous fat disappeared under pressure and slight rubbing and the implant edge shined through the skin in an area of about 2 cm in diameter (Fig. 2a). Both smooth implants could be moved easily upwards within their normal wide pockets, but the horizontally folded implant could not be kept unfolded by external maneuvers. Breast sonography [3] showed a clear fold with a pointed tip of the shell in front of the lower edge of the sternum. Checking all available implants on aesthetic surgery meetings, folding was possible in all presently available textured or smooth cohesive implants from all manufacturers (Fig. 3a, b). The only implant which could not be folded was Allergan’s cohesive textured high-profile implant Natrelle (Allergan, Irvine, California, USA) CHP-345 with 12 cm in diameter. Consequently, we inserted this implant in both breasts through a new inframammary incision. The thinned out skin area on the left breast was supported with a triangle-shaped capsular-fascial flap of 6 cm in length, raised from the pectoral muscle [4, 5]. An alternative solution would have been subpectoral implantation, which will support the recovery of thinned out skin in the upper but not in lower quadrants. Twelve months after corrective surgery, both breasts looked perfect without any signs of unevenness or skin thinning (Fig. 2b). Both breasts were firmer than before revision but did not bother the happy patient. * Gottfried Lemperle lemperle8@aol.com

Algorithm and techniques for using Sientra's silicone gel shaped implants in primary and revision breast augmentation.

With the 2006 Food and Drug Administration approval of round silicone gel breast implants in the United States, there still remained a lack of versatility in implant options. The approval of Sientra's shaped cohesive implants in 2012 brought with it the innovations needed to address varying patient needs. Because access to shaped devices is still fairly recent in the United States, some surgeons remain uncomfortable with implementing shaped cohesive gel implants into their practice. The author outlines surgical techniques and algorithms from experience with the Sientra shaped device, covering the preoperative stage, measurements (base diameter, sternal notch to nipple, tissue pinch, and nipple to inframammary fold), ideal first candidates, operative techniques, and complication avoidance, as well as important factors for shaped-implant selection, including chest base diameter, implant height, implant volume, and implant projection for the patient's desired outcome. With experience, surgeons will find new utility with shaped implants for a variety of patients in their practices.

Failure of a “Highly Cohesive Implant”: What Does It Really Mean?

Failure of a “Highly Cohesive Implant”: What Does It Really Mean?

Soft cohesive silicone gel breast prostheses: a comparative prospective study of aesthetic results versus lower cohesivity silicone gel prostheses

The flexibility of lower cohesivity silicone prostheses is the main reason for wrinkling, rippling and evidence of implant edges. The soft cohesive silicone implants promise to minimize such effects with minimal softness reduction. Forty consecutive patients received soft cohesive prostheses (INAMED Style 110 ST) and were studied prospectively. A historical group, made up by the 40 consecutive patients who received lower cohesivity silicone implants (INAMED Style 110) in the immediately preceding months, was used as a control. Wrinkling, prosthetic edge perceptibility and capsular contracture degree were assessed six months after surgery. The tissue coverage thickness was measured using ultrasonography. The patients were then asked to evaluate the breast softness by means of an anonymous questionnaire, where they also expressed their overall satisfaction by means of the five-steps linear analogical scales. The wrinkling prevalence was 9.2% in the soft cohesive group vs. 55% in the lower cohesivity one (p<0.01). The edge perceptibility was 14% in the soft cohesive group vs. 22% in the lower cohesivity one (no statistical significance). The coverage tissue thickness was not found to be significantly related to the wrinkling prevalence or to the edge perceptibility. The capsular contracture rate was almost identical in the two groups (Baker II: 2.6% vs. 2.7%, no Baker III or IV). A higher stiffness was noted in the soft cohesive group (average score: 4.2 vs. 4.4 in the control group, p<0.05), but the overall satisfaction degree was higher for soft cohesive implants (average score: 4.5 vs. 3.8, p<0.01). The soft cohesive prostheses offered better overall results than the lower cohesivity silicone prostheses, even if a longer term follow-up should be advised. The soft cohesive prostheses showed a higher firmness, but this seemed not to have any influence on the overall satisfaction degree.