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

doi:10.21873/invivo.13449

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

In Vivo. 2024 Jan-Feb;38(1):380-384. doi: 10.21873/invivo.13449.

Authors

Jens Hachenberg^#¹, Johanna Gundermann², Hannah Fritsch³, Wolfram Malter², Lena Steinkassserer⁴, Peter Hillemanns⁴, Christian Eichler^#^{2

3

5}

Affiliations

¹ Department of Gynecology and Obstetrics, Hannover Medical School, Hannover, Germany; Hachenberg.Jens@mh-hannover.de.
² Department of Gynecology and Obstetrics, University of Cologne, Cologne, Germany.
³ Breast Center, St. Franziskus-Hospital, Münster, Germany.
⁴ Department of Gynecology and Obstetrics, Hannover Medical School, Hannover, Germany.
⁵ Department of Gynecology and Obstetrics, Frauenklinik Holweide, Kliniken der Stadt Köln, Cologne, Germany.

^# Contributed equally.

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.

Keywords: Breast surgery; breast implants; patient satisfaction; perioperative complications; reconstructive surgery; retrospective multicenter study.

Publication types

Multicenter Study

MeSH terms

Breast Implantation* / adverse effects
Breast Implantation* / methods
Breast Implants*
Breast Neoplasms* / etiology
Breast Neoplasms* / surgery
Female
Humans
Mammaplasty* / adverse effects
Mammaplasty* / methods
Patient Satisfaction
Plastic Surgery Procedures*
Retrospective Studies