Establishment of an algorithm to evaluate quality and function of silicone breast implants (in the context of the PIP-/Rofil-affair)

Establishment of an algorithm to evaluate quality and function of silicone breast implants (in the context of the PIP-/Rofil-affair) - Silicone-breast-implant-study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00004924

Enrollment

Registered

2013-08-08

Start date

2013-08-02

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

T85.88

Interventions

Group 1: One arm only. Participating are women of at least 18years age with medical indication for exchange or removal of silicone breast implants. Measurement of silicone-content in blood (preoperati

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Indication for exchange or removal of silicone breast implants.

Exclusion criteria

Exclusion criteria: less than 18 years old, not able to agree

Design outcomes

Primary

Measure	Time frame
Measurement of silicone-content in blood and tissue of the breast by means of gas-chromatography (Agilent Technologies 5973 Network: GC-distinction-column Restek Rxi-5sil MS30m x 250um x0,25um) and comparison with findings in medical imaging and clinical evidence.	—

Secondary

Measure	Time frame
- establishment of an algorithm to evaluate quality of silicone-breast-implants - definition of a threshold value for blood-silicone-measured value - testing of the options to avoid unneccessary implant-explantations	—

Countries

Germany

Contacts

Public ContactPeter Rusch

UFK Essen

Peter.Rusch@uk-essen.de0201-723-85288

Outcome results

None listed

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