Observational study on Allergan Natrelle Breast Implants

• Research type

  Research Study

• Full title

  Retrospective multi-centre, post-marketing study to evaluate the incidence and aetiology of reoperations with Allergan Natrelle Breast Implants in primary augmentation (RANBI)

• IRAS ID

  148064

• Contact name

  Paul Banwell

• Contact email

  paul@paulebanwell.com

• Sponsor organisation

  Allergan Pharmaceutical Ireland

• Research summary

  This is a non-interventional retrospective, multi-centre, international study. The aim of this study is to evaluate the number and cause of re-operations in patients who have previously undergone surgery for breast augmentation with Allergan Natrelle® 410 implants. The surface of an implant can either be smooth or come with BIOCELL™ texturisation. The study will involve a retrospective medical records review of approximately 500 adult patients, who received Natrelle® 410 implants three to ten years ago. Data collection in this study is expected to last for up to 6 months.

• REC name

  North East - York Research Ethics Committee

• REC reference

  14/NE/0095

• Date of REC Opinion

  26 Mar 2014

• REC opinion

  Favourable Opinion