Biological Matrices and Synthetic Meshes Used in Implant-based Breast Reconstruction - a Review of Products Available in Germany.
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ABSTRACT:
SUBMITTER: Dieterich M
PROVIDER: S-EPMC3862049 | biostudies-other | 2013 Nov
REPOSITORIES: biostudies-other
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Project description:Acellular dermal matrices (ADMs) entered the market in the early 2000s and their use has increased thereafter. Several retrospective cohort studies and single surgeon series reported benefits with the use of ADMs. However, robust evidence supporting these advantages is lacking. There is the need to define the role for ADMs in implant-based breast reconstruction (IBBR) after mastectomy.MethodsA panel of world-renowned breast specialists was convened to evaluate evidence, express personal viewpoints, and establish recommendation for the use of ADMs for subpectoral one-/two-stage IBBR (compared with no ADM use) for adult women undergoing mastectomy for breast cancer treatment or risk reduction using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach.ResultsBased on the voting outcome, the following recommendation emerged as a consensus statement: the panel members suggest subpectoral one- or two-stage IBBR either with ADMs or without ADMs for adult women undergoing mastectomy for breast cancer treatment or risk reduction (with very low certainty of evidence).ConclusionsThe systematic review has revealed a very low certainty of evidence for most of the important outcomes in ADM-assisted IBBR and the absence of standard tools for evaluating clinical outcomes. Forty-five percent of panel members expressed a conditional recommendation either in favor of or against the use of ADMs in subpectoral one- or two-stages IBBR for adult women undergoing mastectomy for breast cancer treatment or risk reduction. Future subgroup analyses could help identify relevant clinical and pathological factors to select patients for whom one technique could be preferable to another.
| S-EPMC9946425 | biostudies-literature
Project description:Biological and synthetic meshes may improve the outcomes of immediate implant-based breast reconstruction (IBBR) by facilitating single-stage procedures and improving cosmesis. Supporting evidence is, however, limited. The aim of this study was to explore the impact of biological and synthetic mesh on patient-reported outcomes (PROs) of IBBR 18 months after surgery. Consecutive women undergoing immediate IBBR between February 2014 and June 2016 were recruited to the study. Demographic, operative, oncological and 3-month complication data were collected, and patients received validated BREAST-Q questionnaires at 18 months. The impact of different IBBR techniques on PROs were explored using mixed-effects regression models adjusted for clinically relevant confounders, and including a random effect to account for clustering by centre. A total of 1470 participants consented to receive the questionnaire and 891 completed it. Of these, 67 women underwent two-stage submuscular reconstructions. Some 764 patients had a submuscular reconstruction with biological mesh (495 women), synthetic mesh (95) or dermal sling (174). Fourteen patients had a prepectoral reconstruction. Compared with two-stage submuscular reconstructions, no significant differences in PROs were seen in biological or synthetic mesh-assisted or dermal sling procedures. However, patients undergoing prepectoral IBBR reported better satisfaction with breasts (adjusted mean difference +6.63, 95 per cent c.i. 1.65 to11.61; P = 0.009). PROs were similar to those in the National Mastectomy and Breast Reconstruction Audit 2008-2009 cohort, which included two-stage submuscular procedures only. This study found no difference in PROs of subpectoral IBBR with or without biological or synthetic mesh, but provides early data to suggest improved satisfaction with breasts following prepectoral reconstruction. Robust evaluation is required before this approach can be adopted as standard practice.
| S-EPMC7896806 | biostudies-literature
Project description:ImportanceThe potential association between breast implant-related anaplastic large cell lymphoma (BIA-ALCL) and implant texture has raised concerns about the additional unexpected adverse effects of textured implants, including potentially adverse outcomes for other cancers. In addition to the risk of developing BIA-ALCL, breast cancer survivors may worry about whether the type of implant inserted is associated with recurrence of their original cancer-an issue for which little evidence currently exists.ObjectiveTo evaluate the oncologic outcomes of breast cancer according to the surface type of implants used for reconstruction and to identify the independent factors associated with breast cancer recurrence and survival, including implant surface type.Design, setting, and participantsThis cohort study was conducted at Samsung Medical Center, a single tertiary referral center in Seoul, South Korea. Patients with breast cancer who underwent total mastectomy and immediate 2-stage tissue expander/implant reconstruction between January 1, 2011, and December 31, 2016, were identified from a prospectively maintained database. Patients were categorized into 2 groups according to the surface type of implant used for their reconstruction (smooth or textured implant). These patients were followed up for at least 2 years after insertion of the implant. Data analysis was performed from February 15, 2020, to March 5, 2020.ExposuresUse of smooth implants vs textured implants at the second-stage operation.Main outcomes and measuresThe main outcomes of interest were local and regional recurrence-free survival (LRRFS) and disease-free survival (DFS) rates. Cumulative incidence of oncologic events in the smooth implant and textured implant groups and their respective hazard ratios (HRs) were collected and updated regularly.ResultsIn total, 650 patients (all women, with a mean [SD] age of 43.5 [7.4] years), representing 687 cases, met the inclusion criteria and were followed up for a median (range) duration of 52 (31-106) months. Of the 687 cases, 274 (39.9%) received a smooth implant and 413 (60.1%) received a textured implant. Patients in these 2 surface texture groups had similar characteristics, including tumor staging (stage I: 102 [37.2%] vs 173 [41.9%]; stage II: 93 [33.9%] vs 119 [28.8%]; stage III: 14 [5.1%] vs 20 [4.8%]; P = .50) and rates of adjuvant radiotherapy (42 [15.3%] vs 49 [11.9%]; P = .19) and chemotherapy (113 [41.2%] vs 171 [41.4%]; P = .97). The 5-year LRRFS was 96.7%, and the 5-year DFS was 95.2%. Compared with the use of a smooth implant, textured implant use was statistically significantly associated with lower DFS, and this difference remained significant after adjusting for estrogen receptor (ER) status and tumor stage (HR, 3.054; 95% CI, 1.158-8.051; P = .02). Similar statistically significant associations were observed on multivariable analysis of patients with ER-positive cancer (HR, 3.130; 95% CI, 1.053-9.307; P = .04) and those with invasive cancer (HR, 3.044; 95% CI, 1.152-8.039; P = .03). The association of textured implant use with recurrence (lower DFS) was more prominent in cases with late-stage (stage II or III) tumor (HR, 8.874; 95% CI, 1.146-68.748; P = .04). The LRRFS did not differ statistically significantly according to implant surface texture.Conclusions and relevanceThis cohort study found that use of textured implants in reconstruction appears to be associated with recurrence of breast cancer. Further investigation is required to verify these results.
| S-EPMC7542523 | biostudies-literature
Project description:With increasing acceptance of prepectoral implant breast reconstruction, there has been a requirement for biological acellular dermal matrices with conformational properties, high tensile strength, and rapid integration. SurgiMendPRS Meshed is a biological acellular dermal matrix derived from fetal calf with these specific characteristics for prepectoral implant breast reconstruction. The aim of this study was to test the performance of this mesh by recreating its surgical use ex-vivo using a variety of implants in an effort to define its physical properties. The mesh is usually attached with a number of interrupted sutures to the implant periphery, the variable being at the inferior border, where it can be attached as a snug fit at the level of the inframammary crease ("tent" technique) or sewn behind the implant, cradling the lower pole ("hammock" technique). The results show mesh elasticity to stretch with increasing implant weight. When used as a "hammock," greater stretch was demonstrated compared with the "tent" technique, allowing greater degrees of ptosis to be achieved. The suture points demonstrated lines of tension that progress evenly over the anterior implant surface. The mesh performed better when used at maximum stretch, but should not be forcibly stretched over an implant as the lines of stress show uneven distribution of lines of tension. These data provide a structural basis on optimum clinical use of this acellular dermal matrix in prepectoral implant breast reconstruction.
| S-EPMC9177243 | biostudies-literature
Project description:The aim of the present study was to monitor implant stability after sinus floor elevation with two biomaterials during the first six months of healing by resonance frequency analysis (RFA), and how physico-chemical properties affect the implant stability quotient (ISQ) at the placement and healing sites. Bilateral maxillary sinus augmentation was performed in 10 patients in a split-mouth design using a bobine HA (BBM) as a control and porcine HA (PBM). Six months after sinus lifting, 60 implants were placed in the posterior maxilla. The ISQ was recorded on the day of surgery from RFA at T1 (baseline), T2 (three months), and T3 (six months). Statistically significant differences were found in the ISQ values during the evaluation period. The ISQ (baseline) was 63.8 ± 2.97 for BBM and 62.6 ± 2.11 for PBM. The ISQ (T2) was ~73.5 ± 4.21 and 67 ± 4.99, respectively. The ISQ (T3) was ~74.65 ± 2.93 and 72.9 ± 2.63, respectively. All of the used HAs provide osseointegration and statistical increases in the ISQ at baseline, T2 and T3 (follow-up), respectively. The BBM, sintered at high temperature with high crystallinity and low porosity, presented higher stability, which demonstrates that variations in the physico-chemical properties of a bone substitute material clearly influence implant stability.
| S-EPMC5554025 | biostudies-other
Project description:PurposeThe aim of the study is to evaluate the level of sensible impairment after mastectomy or implant-based breast reconstruction (IBBR). In addition, factors influencing breast sensibility were evaluated.MethodsA cross-sectional study was performed in Maastricht University Medical Center between July 2016 and August 2018. Women with unilateral mastectomy with or without IBBR were included. Objective sensory measurements were performed using Semmes-Weinstein monofilaments. Their healthy breast served as control, using a paired t test. Differences between mastectomy with and without IBBR were evaluated using the independent t test. Linear regression was performed to evaluate the association between patient characteristics on breast sensibility. The paired t test was used to evaluate in which part of the breast the sensibility is best preserved.ResultsFifty-one patients were eligible for inclusion. Sixteen patients underwent IBBR after mastectomy. Twenty-three patients received radiotherapy and 35 patients received chemotherapy. Monofilament values were significantly higher in the operated group compared to the reference group (p?<?0.001). Linear regression showed a statistically significant association between IBBR and objectively measured impaired sensation (p?=?0.008). After mastectomy, the cutaneous protective sensation is only diminished. After IBBR, it is lost in the majority of the breast. The medial part of the breast was significantly more sensitive than the lateral part in all operated breasts (p?<?0.001).ConclusionIBBR has a significantly negative impact on the breast sensibility compared to mastectomy alone. This study shows that the protective sensation of the skin in the breast is lost after IBBR. To our knowledge, this is the first study to evaluate the level of sensible impairment after mastectomy or IBBR. More research is necessary to confirm these results.
| S-EPMC6533215 | biostudies-literature
Project description:Introduction While many authors have reported their experience in immediate prepectoral breast reconstruction (BR), implant pocket conversion from a submuscular to a prepectoral plane is less well described. The aim of this study is to provide a comprehensive review on plane conversion in implant-based BR, including the indications, surgical techniques, functional, and esthetic results. Materials and Methods A literature search via PubMed, Medline, Google Scholar, and Cochrane databases was performed using the following MeSH terms: “prepectoral pocket conversion”, “subcutaneous pocket conversion”, “prepectoral plane conversion”, “subcutaneous plane conversion”, and “prepectoral breast reconstruction”. Results Ten articles in which 504 breasts were studied were deemed eligible for inclusion. The indications to perform plane conversion were animation deformity (AD), chronic pain, and implant malposition. Seven studies described complete or partial capsulectomy. The use of acellular dermal matrices (ADM) was reported in all cases except for three studies. The mean follow-up was 10.64 months. There was resolution of AD in 100% of cases. Three studies reported complete resolution of chronic pain. The overall complication rate was 12.102% and capsular contracture (CC) was the most frequent complication. Cosmetic revisions were reported in six studies (9.52%). The use of ADMs and fat grafting appeared to decrease the rate of subsequent CC formation and cosmetic revisions. Conclusions The current article represents the first review about implant pocket conversion from a submuscular to a prepectoral plane, delineating its indications, surgical technique, postoperative complications, and functional and esthetic outcomes.
| S-EPMC7502407 | biostudies-literature
Project description:BackgroundOver half of immediate implant-based breast reconstructions (IBBR) are performed with an acellular dermal matrix, despite limited long-term outcome data.MethodsThe Breast Reconstruction Outcomes with and without Strattice, or BROWSE, study was a retrospective multicenter cohort study comparing consecutive patients who had undergone immediate Strattice IBBR with those who had undergone immediate IBBR with a submuscular technique between January of 2009 and December of 2015.ResultsThis study compared 553 Strattice reconstructions with 242 submuscular reconstructions, with a median follow-up of 4.3 years (range, 2 to 9.3 years) and 5.7 years (range, 2 to 8.1 years), respectively, demonstrating an equivalent total complication rate [Strattice, n = 204 (36.9%); submuscular, n = 77 (31.8%); P = 0.17] and implant loss rate (8.5% versus 5.4%, respectively; P = 0.12). Infection rates and wound dehiscence rates were higher in the Strattice cohort [ n = 114 (20.6%) versus n = 31 (12.8%), P = 0.009; and n = 90 (16.3%) versus n = 25 (10.4%), P = 0.03, respectively]. Overall revision rates were comparable [ n = 226 (46.7%) versus n = 79 (41.1%); P = 0.2], but significantly fewer Strattice reconstructions required revision surgery for capsular contracture (5.3% versus 15.6%; P < 0.001).ConclusionAlthough the risk of complications associated with Strattice reconstruction is numerically higher than that for submuscular coverage, the difference is small and not statistically significant, and likely outweighed by the clear reduced rate of revision surgery because of capsular contracture when Strattice is used.Clinical question/level of evidenceTherapeutic, III.
| S-EPMC10298128 | biostudies-literature
Project description:BACKGROUND:Immediate implant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure in the UK, but almost one in ten women experience implant loss and reconstructive failure after this technique. Little is known about how implant loss impacts on patients' quality of life. The first phase of the Loss of implant Breast Reconstruction (LiBRA) study aimed to use qualitative methods to explore women's experiences of implant loss and develop recommendations to improve care. METHODS:Semistructured interviews were conducted with a purposive sample of women who experienced implant loss after immediate IBBR, performed for malignancy or risk reduction across six centres. Interviews explored decision-making regarding IBBR, and experiences of implant loss and support received. Thematic analysis was used to explore the qualitative interview data. Sampling, data collection and analysis were undertaken concurrently and iteratively until data saturation was achieved. RESULTS:Twenty-four women were interviewed; 19 had surgery for malignancy and five for risk reduction. The median time between implant loss and interview was 42 (range 22-74) months. Ten women had undergone secondary reconstruction, two were awaiting surgery, and 12 had declined further reconstruction. Three key themes were identified: the need for accurate information about the risks and benefits of IBBR; the need for more information about 'early-warning' signs of postoperative problems, to empower women to seek help; and better support following implant loss. CONCLUSION:Implant loss is a devastating event for many women. Better preoperative information and support, along with holistic patient-centred care when complications occur, may significantly improve the experience and outcome of care.
| S-EPMC7260419 | biostudies-literature
Project description:Acellular dermal matrices are commonly used in prepectoral breast reconstruction for implant coverage and support, but they are associated with significant costs. The authors describe a technique for prepectoral breast reconstruction in which the implant is completely wrapped in a knitted Vicryl mesh and then positioned on the chest, without the need for any tacking sutures. A retrospective review was performed on all consecutive prepectoral breast reconstructions, using this technique at a single institution. A separate cohort undergoing prepectoral reconstruction with a conventional acellular dermal matrix technique was also reviewed for comparison. Patient demographics, oncologic and reconstruction characteristics, outcomes, complications, and materials cost were analyzed. Twelve patients (23 breasts) underwent prepectoral reconstruction with Vicryl mesh, and 34 patients (55 breasts) underwent prepectoral reconstruction with acellular dermal matrices. Overall complication rates in the Vicryl group were low (two infections, one case of skin necrosis, one hematoma) and did not differ statistically from the acellular dermal matrix group. Operative time per breast was nearly twice as fast (35.7 versus 68.0 min, P < 0.01). Calculated materials cost savings was $8273 per breast. Prepectoral breast reconstruction with Vicryl mesh only is a safe technique that is much faster and significantly cheaper compared with conventional reconstructive techniques utilizing acellular dermal matrices.
| S-EPMC10259646 | biostudies-literature