A Comparison of Revision Surgery after Implant-Based Breast Reconstruction Between Smooth, Textured and Polyurethane-Covered Implants: Results from the Dutch Breast Implant Registry

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00033421

Enrollment

4000

Registered

2024-01-18

Start date

2024-02-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implant-based breast reconstruction after mastectomy

Interventions

Group 1: Patients receiving a breast reconstruction after mastectomy using textured breast implants Group 2: Patients receiving a breast reconstruction after mastectomy using smooth breast implants Gr

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: All permanent breast implants inserted for immediate direct-to-implant or two-stage IBBR after therapeutic or prophylactic mastectomy from September 2017 to November 2022

Exclusion criteria

Exclusion criteria: Delayed reconstructions, reconstructions involving additional surgical techniques (fat grafting, autologous flaps, mastopexy), reconstructions that were preceded by any previous breast implant surgery (excluding TE insertion as part of a two-stage reconstruction), or non-silicone-filled implants

Design outcomes

Primary

Measure	Time frame
The primary outcome was surface-related revision surgery defined as reoperation after insertion of the permanent implant during which the implant was repositioned, replaced or explanted for an indication that might have been the result from the implant surface, i.e., asymmetry, Breast Implant-Associated Illness (BII), breast pain, capsular contracture, deep wound infection, device malposition, device rupture, newly diagnosed breast cancer, seroma or hematoma, suspicion of or pathology-confirmed BIA-ALCL, silicone extravasation or a recall. In the Netherlands, it is mandatory to register all revisions of a breast implant in the Dutch Breast Implant Registry and therefore all data necessary for this study is available in there.	—

Measure

Time frame

The primary outcome was surface-related revision surgery defined as reoperation after insertion of the permanent implant during which the implant was repositioned, replaced or explanted for an indication that might have been the result from the implant surface, i.e., asymmetry, Breast Implant-Associated Illness (BII), breast pain, capsular contracture, deep wound infection, device malposition, device rupture, newly diagnosed breast cancer, seroma or hematoma, suspicion of or pathology-confirmed BIA-ALCL, silicone extravasation or a recall. In the Netherlands, it is mandatory to register all revisions of a breast implant in the Dutch Breast Implant Registry and therefore all data necessary for this study is available in there.

—

Secondary

Measure	Time frame
Subgroup analyses will focus on revision surgery due to capsular contracture, asymmetry, malposition, and breast pain.	—

Countries

Netherlands

Contacts

Public ContactMarc Mureau

Department of Plastic and Reconstructive Surgery, Erasmus MC Cancer Institute, University Medical Centre Rotterdam, Rotterdam, The Netherlands

m.mureau@erasmusmc.nl+31 10 704 01 37

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026