Research ArticleClinical Studies
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A Retrospective Multicenter Analysis of Diagon/Gel® 4Two Implant in 209 Cases of Reconstructive Breast Surgery

JENS HACHENBERG, JOHANNA GUNDERMANN, HANNAH FRITSCH, WOLFRAM MALTER, LENA STEINKASSSERER, PETER HILLEMANNS and CHRISTIAN EICHLER
In Vivo January 2024, 38 (1) 380-384; DOI: https://doi.org/10.21873/invivo.13449

Abstract

Background/Aim: Breast cancer was the most common cancer in women in 2020. Breast reconstruction is an elementary component of modern breast surgery. This is especially important after oncological treatments. This is a retrospective multicenter study comparing Diagon\Gel® 4Two implants with different implants chosen by the treating surgeon. Diagon\Gel® 4Two (Polytech Health & Aesthetics, Germany) are anatomical silicone implants. Patients and Methods: A total of 209 patients underwent surgery. All patients were treated in the period from 2001 to 2019. All procedures were subcutaneous mastectomies. The surgical techniques used were either skin-sparing mastectomies or nipple-sparing mastectomies. Surgery was performed with Diagon/Gel® 4Two implant or treatment of choice implant by the treating physician. Endpoints were major and minor complication rates. The average follow-up time was 5 years. In total, 110 subjects were asked about their satisfaction with the treatment. Results: A total of 155 procedures were performed in the Diagon/Gel® 4Two implant group. One hundred and sixty procedures were done in the comparison group. Concerning either minor or major complications, there were no significant differences between both groups. The postoperative patient survey showed high satisfaction scores for both. There was significantly higher patient satisfaction among the study participants in the Diagon/Gel® 4Two implant group compared to the comparison group (p<0.01). Conclusion: The Diagon/Gel® 4Two implants are safe alternatives in direct comparison to previously used breast implants. Our study even demonstrated a slight superiority concerning patient satisfaction. Based on this study, further implants can be compared concerning both the direct perioperative complication rate and patient satisfaction.

Key Words:

Breast cancer was the most common cancer in women in 2020. Worldwide, 2,261,419 women developed the disease and 684,996 died from it (1). Most patients who develop breast cancer undergo surgery. In addition to mastectomy, i.e., removal of the entire breast, lumpectomy or segmental mastectomy, in which only part of the breast is removed, can be performed. Partial breast removal is generally followed by a recommendation for radiation. Mastectomy is generally not followed by radiation. Exceptions are, for example, the involvement of axillary lymph nodes, residual tumor after systemic therapy, or pronounced tumor disease of stage T3 (2). Breast reconstruction is an elementary component of modern breast surgery. This is especially important after oncological treatments. The procedure can also be performed for aesthetic reasons or to adjust the breast after treatment on the opposite side. Reconstruction of the breast can be done either with autologous tissue or implant-based. Data from the United States show that implant-based breast reconstruction (IR) of breast cancer patients has increased from 20% in 2005 to 40% in 2016 (3). One of the most important differences between the two procedures is the less invasive nature of implant surgery. Autologous reconstruction (AR) poses a greater risk of deep vein thrombosis or pulmonary embolism. Against the background of an older patient population and sometimes strenuous oncological treatments this is an important factor in the increased overall morbidity of patients. On the other hand, AR is associated with better patient satisfaction with breasts and sexual well-being. Regarding the general quality of life and psychosocial well-being, however, there are no differences. Disadvantages of IR include a higher risk of long-term reconstruction failure and a greater risk of breast seroma (4). A distinction is made between the two implant constructions. These are silicone- or saline-based. This is a retrospective multicenter study comparing Diagon\Gel® 4Two implants with different implants chosen by the treating surgeon. Diagon\Gel® 4Two (Polytech Health & Aesthetics, Dieburg, Germany) are anatomical silicone implants. They are characterized by the combination of a softer gel (EasyFit Gel™) and a firmer gel (Shapar Gel™).

Patients and Methods

A total of 209 patients underwent surgery (Table I). All patients were treated in the period from 2001 to 2019. All procedures were subcutaneous mastectomies. The surgical techniques used were either skin-sparing mastectomies (SSM) or nipple-sparing mastectomies (NSM). Indications for surgery included oncologic, aesthetic, and prophylactic indications. After informed and written consent of the patient, surgery was performed either with Diagon/Gel® 4Two implant or treatment of choice implant by the treating physician. If mastectomy was performed, the contralateral side, if operated to create symmetry, was considered an aesthetic procedure. This classification is analogous to the definition of the German healthcare reimbursement system. In the case of oncologic indication, prior radiation treatment or reduction mastopexy could have been performed as part of the treatment.

View this table:
Table I.

Patient characteristics for both cohorts.

Surgical technique. All surgeries were performed according to the current gold standard for immediate or secondary implant-based SSM/NSM reconstruction or reduction mastopexy procedures. Surgery was performed by an experienced senologic surgeon. Materials were handled according to the instructions of the corresponding manufacturers. Perioperative antibiotic treatment was given as standard. After surgery, antibiotics were not administered unless the patient’s clinical symptoms necessitated it. Drains were not removed within the first 24 h after surgery. Drains were removed if less than 30 ml/24 h fluid delivery was noted. Surgical compression bras were applied immediately after surgery and worn by the patient for at least 6 weeks.

Ethics Committee approval. This study was conducted in accordance with institutional review board standard operating procedures. An ethics committee vote was procured. A written statement to this extent is available.

Statistical analysis. Statistical Package for Social Sciences (SPSS) version 28 was used for statistical analysis of the data. For comparing categorical variables absolute and relative frequencies are presented for each group separately. Continuous variables are shown as means and standard deviations for each group. Statistical significance was tested for continuous baseline variables by using independent t-tests and for outcomes by univariate analysis of covariance. Significance was defined as p<0.05.

Endpoints. The endpoints of this analysis were major and minor complication rates (Table II). Minor complications included seroma with puncture or hematoma, infection with antibiotics, red breast syndrome/RASH, cosmetically unsatisfactory outcome, wound healing disturbance, and capsular contracture. Major complications were defined as breast implant infection, implant loss due to impaired wound healing or necrosis, implant loss due to dislocation (rotation, biasing, edging), implant loss due to other factors, implant loss due to thinning of the cover, and capsulitis due to RTX. The average follow-up time was 5 years. A total of 110 subjects were asked about their satisfaction with the treatment. The patients were able to give a score of 1 (very satisfied) to 6 (very dissatisfied) (Table III).

View this table:
Table II.

Complication rates for both types of implants.

View this table:
Table III.

Postoperative survey of patients. The patients were able to give a score of 1 (very satisfied) to 6 (very dissatisfied).

Results

Most of the procedures were oncologic procedures for both groups; 86 for Diagon/Gel® 4Two implants and 75 in the treatment of choice group (Table I). A total of 155 procedures were performed in the Diagon/Gel® 4Two implant group and 160 procedures in the comparison group. The median age of the Diagon/Gel® 4Two implant group was 47.66 years (range=23-74 years). The median age of the comparison group was 52.19 years (range=18-78 years) (p=0.000476). The median BMI of the Diagon/Gel® 4Two implant group was 22.88 (range=17.47-37.34). The BMI of the comparison group was 23.62 (range=17.8-36.2) (p>0.05). There were no significant differences between the two groups regarding smoking, chemotherapy, and radiotherapy. Concerning either minor or major complications, there were no significant differences between the Diagon/Gel® 4Two implant group and the comparison group. In the Diagon/Gel® 4Two implant group, 52 minor complications occurred. In the comparison group, 53 minor complications were seen (p>0.05). In both groups, the most frequent minor complication was a cosmetically unsatisfactory finding. This occurred in 29 cases (18.7%) of the Diagon/Gel® 4Two implant group and thus slightly less frequently than in the comparison group with 34 cases (21.3%, p>0.05). In 6 cases in the Diagon/Gel® 4Two implant group major complications occurred. This was mainly a loss of implant due to wound dehiscence, which affected four patients. In the comparison group, major complications occurred in 13 cases (p>0.05). The most frequent reason for a major complication in this case was a loss of implant due to dislocation, which was observed four times. In addition, four patients had a loss of implant due to other reasons. The patient satisfaction survey showed a slight tendency towards the Diagon/Gel® 4Two implant group. While 49 patients (84.5%) in the Diagon/Gel® 4Two implant group gave good to very good grades for satisfaction, only 37 patients (72.5%) in the comparison group did so (Table III). The grades 3 to 4 were given five times (8.6%) in the Diagon/Gel® 4Two implant group and 11 times (21.6%) in the comparison group. Grades 5 to 6 were given only four times (6.9%) in the Diagon/Gel® 4Two implant group and four times (7.8%) in the comparison group. The postoperative patient survey showed high satisfaction scores in both groups (mean 1.98 vs. 2.13). There was a significantly higher satisfaction among the study participants in the Diagon/Gel® 4Two implant group compared to the comparison group (p<0.01).

Discussion

In this multicenter, single-surgeon, retrospective nonrandomized study, we demonstrated that Diagon/Gel® 4Two implants are equivalent to the treatment of physicians’ choice implants in terms of minor and major perioperative complications. In addition, patient satisfaction scores were significantly better in favor of Diagon/Gel® 4Two implants. However, both groups showed high overall patient satisfaction scores with their treatment. The data situation regarding the comparison of different implants is thin. A Cochrane analysis from 2016 identified only five randomized controlled trials. In total, only 202 participants were included in the analysis (5). The quality of the included studies was rated as low. The included studies were conducted between 1990 and 2012 (6-10). Saline implants showed slight superiority over silicone implants in these small cohorts. Severe capsular contracture occurred significantly less frequently in saline-implanted patients (RR=3.25, 95%CI=1.24-8.51; 1 study, 60 participants). In addition, increased patient satisfaction was shown (RR=0.60, 95%CI=0.41-0.88; 1 study, 58 participants). However, disadvantages could also be demonstrated. Re-intervention was significantly more likely in saline-implanted than in silicone-implanted patients (OR=0.08, 95%CI=0.01-0.43; 1 study, 60 participants). A large meta-analysis by Saldanha et al. in 2021 titled Breast Reconstruction After Mastectomy: A Systematic Review and Meta-Analysis identified five nonrandomized controlled retrospective studies from 15,936 publications reviewed (11-15). In total, these studies examined 2,929 patients (between 143 and 1,143 patients each). A distinction was made between silicone and saline implants. These studies showed comparable patients’ satisfaction with their breast implants. Due to sparse data statements regarding clinical outcomes or complication rates could not be made. Overall, studies comparing different implant designs are lacking. With 209 patients operated on, this retrospective multicenter study provides a comparatively large and modern patient population. The physician’s choice implants comparison group represents the average complication and satisfaction rate. The only difference between the two comparison groups was the slightly younger age of the patients. The lack of randomization of the study is certainly a limitation.

Complication rate. There were no significant differences between the Diagon/Gel® 4Two implant group and the comparison group concerning either minor or major perioperative complications. There are little data examining perioperative risk concerning different breast implants. In a 2007 study, Araco et al. examined 3,002 reconstructive breast procedures performed by two surgeons between 1996 and 2001 in England. The described perioperative risk for complications was 4.6% (16). In the non-randomized controlled study by Corderiso et al., it was shown that the risk for implant failure/loss occurred less frequently among patients with silicone implants than among patients with saline implants. However, no statistical significance could be demonstrated here (15). Antony et al. reported that no differences were found between silicone or saline implants concerning capsular contractures (of Baker Classification Grades 3 or 4) (13). In the Diagon/Gel® 4Two implant group, 52 minor complications occurred. In the comparison group, 53 minor complications were seen (p>0.05). In both groups, the most frequent minor complication was a cosmetically unsatisfactory finding (p>0.05). In six cases, major complications occurred in the Diagon/Gel® 4Two implant group versus 13 cases in the comparison group (p>0.05). Overall, no significant differences in complication rates were identified between the two study groups. Compared with the major complication rates described in the literature, there was no difference in our study either.

Patient satisfaction. Forty-nine patients (84.5%) in the Diagon/Gel® 4Two implant group gave a good to very good grade for satisfaction. The postoperative patient survey showed high satisfaction scores in both groups (mean 1.98 vs. 2.13). There was a significantly higher satisfaction among the study participants in the Diagon/Gel® 4Two implant group compared to the comparison group (p<0.01). In non-randomized controlled studies, both Macadam et al. and McCarthy et al. found equal patient satisfaction with both saline and silicone implants (11, 14). A limitation is that both studies used the BREAST-Q questionnaire and therefore the results of our studies are only comparable to a limited extent due to different survey techniques.

Conclusion

The Diagon/Gel® 4Two implants are safe alternatives in direct comparison to previously used breast implants. Our study even demonstrated a slight superiority concerning patient satisfaction. Based on this study, further implants can be compared concerning both the direct perioperative complication rate and patient satisfaction.

Footnotes

  • Authors’ Contributions

    JH: Writing, editing, data collection, statistical analysis, trial development; CE: Writing, editing, data collection, statistical analysis, trial development; JG: Writing, editing, data collection, statistical analysis, trial development; HF, WM, LS, PH: writing, editing.

  • Conflicts of Interest

    The Authors declare no conflicts of interest in this investigator-driven study.

  • Received September 3, 2023.
  • Revision received September 21, 2023.
  • Accepted September 22, 2023.

This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY-NC-ND) 4.0 international license (https://creativecommons.org/licenses/by-nc-nd/4.0).

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A Retrospective Multicenter Analysis of Diagon/Gel® 4Two Implant in 209 Cases of Reconstructive Breast Surgery
JENS HACHENBERG, JOHANNA GUNDERMANN, HANNAH FRITSCH, WOLFRAM MALTER, LENA STEINKASSSERER, PETER HILLEMANNS, CHRISTIAN EICHLER
In Vivo Jan 2024, 38 (1) 380-384; DOI: 10.21873/invivo.13449
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