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Reconstructive breast surgery with partially absorbable bi-component Seragyn® BR soft mesh: an outcome analysis

  • General Gynecology
  • Published:
Archives of Gynecology and Obstetrics Aims and scope Submit manuscript

Abstract

Objective

Synthetic meshes and acellular dermal matrices are increasingly used in implant-based breast reconstruction. The objective of this study was to determine the incidence and severity of complications following the implantation of the partially absorbable bi-component soft mesh SERAGYN® BR and assess risk factors for adverse operative outcomes.

Methods

A retrospective clinical study was performed: The SERAGYN® BR soft mesh was utilized in 148 operations (skin-sparing mastectomy, nipple-sparing mastectomy, breast-conserving surgery, and secondary reconstruction after mastectomy) in four different institutions in Germany from June 2012 to February 2014. We analyzed whether the results were affected by tumor morphology (e.g., grading), patient characteristics and comorbidities, previous surgery or therapies, and use of alloplastic materials.

Results

The SERAGYN® BR soft mesh was successfully implanted in 131 of 148 operations. The rate of reconstructive failure was 11.5%. The most common complication was seroma (25.7%), followed by hematoma and skin infection (each 14.2%). Wound-healing issues were detected in 13.5% cases, secondary wound infections in 10.8%. 83.8% of operations had no severe complications. Independent predictors for reconstructive failure were wound-healing issues, nipple- or skin necrosis, wound- or skin infections, a high volume of excised tissue, hematomas, seromas, and sentinel lymph node excisions. A higher body mass index was correlated with a higher rate of infection.

Conclusion

SERAGYN® BR mesh can be used successfully in breast reconstructive surgery. Rates of major complications or reconstructive failure are comparable to the use of other synthetic or biological meshes.

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Abbreviations

DIEP:

Deep inferior epigastric perforators

ADM:

Acellular dermal matrix

TRAM:

Transverse rectus abdominis muscle

GCP:

Good clinical practice

SLNE:

Sentinel lymph node excision

LNE:

Lymph node excision

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Acknowledgements

We would like to thank all patients and investigators for the support.

Funding

Unrestricted financial grant by SERAG-WIESSNER.

Author information

Authors and Affiliations

  1. Breast Center, Charité-Universitätsmedizin, Charitéplatz 1, 10117, Berlin, Germany

    Anna Machleidt, Jens-Uwe Blohmer, Janina Kueper & Gabriel von Waldenfels

  2. Martin-Luther-Krankenhaus, Caspar-Theiß-Straße 27-31, 14193, Berlin, Germany

    Nora Schmidt-Feuerheerd

  3. Universitätsmedizin Greifswald, Ferdinand-Sauerbruch Straße, 17475, Greifswald, Germany

    Ralf Ohlinger

  4. Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany

    Sissi Dittmer, Stefan Paepke & Evelyn Klein

Authors
  1. Anna Machleidt
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  4. Ralf Ohlinger
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Contributions

Protocol/project development: S-FN, BJU, KE, and PS; data collection and management: S-FN and DS; data analysis: MA, S-FN, KJ, WG, DS, OR, KE, and PS; manuscript writing/editing: MA, S-FN, WG, BJU, KJ, DS, and OR.

Corresponding author

Correspondence to Gabriel von Waldenfels.

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Conflict of interest

JU Blohmer, A Machleidt, J Kueper, N Schmidt-Feuerheerd, G von Waldenfels, S Dittmer, and E Klein no conflict of interest. Ohlinger S and Paepke S Honoraria and support for traveling expenses and training until 2015 by SERAG-WIESSNER GmbH & Co. KG, Naila, Germany.

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No parts of this article were published previously.

Anna Machleidt and Nora Schmidt-Feuerheerd are both first authors.

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Machleidt, A., Schmidt-Feuerheerd, N., Blohmer, JU. et al. Reconstructive breast surgery with partially absorbable bi-component Seragyn® BR soft mesh: an outcome analysis. Arch Gynecol Obstet 298, 755–761 (2018). https://doi.org/10.1007/s00404-018-4859-5

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  • DOI: https://doi.org/10.1007/s00404-018-4859-5

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