Trilucent Care Centre

In 2000 the Medical Devices Agency released a notice recommending that all patients with Trilucent breast implants should have them removed. This affected patients in the UK, Spain and the Rest of the World.

We were involved in the programme and the Trilucent Care Centre from the start.

The initial task was to discuss the Implantation, Explantation and Post Operative Review Form data requirements.

We used the knowledge from the CHCC programme to recommend the type of information to be captured and the format this should be documented in.

Following extremely tight deadlines we created 3 similar databases to capture the information from the UK, Spain and the Rest of the World.

Data validation and input mask rules were implemented at table design level, e.g. product produced after 1994, system would not allow dates prior to 01/01/1995 unless over ruled by administrator as a trial component.

Mandatory fields were implemented to ensure the patient consent data fields were completed before the clinical information could be submitted to the database.

The 3 databases were installed and tested; training and documentation was provided to all users.

Reports were created from the databases to be distributed to all key stakeholders, these included financial reports for the TCC finance department, legal reports for the solicitors representing the patients, KPI and call statistics reports for the TCC management, Gap Analysis and clinical update reports for the Trilucent manufacturer.