ISSUE #11 ABDR NEWSLETTER OUT NOW

October 7, 2019

Welcome to the latest issue of the Australian Breast Device Registry (ABDR) newsletter. In addition to an update on the registry’s progress, we’ve compiled links to important safety information about breast devices (implants) issued by the TGA, including how to find out what implant you have.

National recruitment

 

 

 

We’ve welcomed more than 4,500 patients to the ABDR since our last e-news!

Our sincere thanks to over 43,000 patients and 512 Australian surgeons contributing data about breast device procedures.  View the 280 participating sites here 

 

 

How to stay up to date on TGA announcements about breast device safety

Regulatory Action

Recently the TGA announced regulatory action on all breast implants and tissue expanders sold in Australia, including the suspension of eight models from the market for six months.

The TGA has a dedicated Breast Implant Hub providing easy to read information to support people with concerns about their implants or considering implants (including where to go for help and for information about their device).

Developments relating to BIA-ALCL (Breast implant associated anaplastic large cell lymphoma) and/or breast devices are updated on the TGA website for consumers here and for health professionals here.

Allergan Voluntary Recall

Following Allergan’s voluntary withdrawal of Biocell textured implants and tissue expanders in August, the TGA released these easy to read brochures:

 

For any concerns about breast devices, or your health following breast device surgery, please see your surgeon or your GP. 

Why details of removed (explanted) devices are important

Explant data is critical to learn about the lifespan and performance of a device following insertion, and to help identify issues associated with their removal.
Information about explant surgeries (with or without a replacement), is completed by surgeons in the pink and blue sections of the Data Collection Form (DCF).

News in Brief:

  • ABDR 2018 Annual Report – We are in the final stages of preparing this report for print. Electronic versions will be available to view and download here.
  • ABDR surgeon reports –  New individual surgeon reports, based on feedback from last year, are under development.
  • New surgeons –  If a new surgeon joins a health service, please advise them that your facility supports the ABDR and notify our team, who will follow up with the surgeon directly.
  • ABDR PROMs SMS –  SMS continues to be the most popular way for patients to complete the PROMs (Patient Reported Outcome Measures) questionnaire. Find out more about this sub-study here.

Recent publications:

Begum H, Vishwanath S, Merenda M, Tacey M, Dean N, Elder E, Mureau M, Bezic R, Carter P, Cooter R, Deva A, Earnest A, Higgs M, Klein H, Magnusson M, Moore C, Rakhorst H, Saunders C, Stark B, Hopper I. “Defining Quality Indicators for Breast Device Surgery Using Registries for Global Benchmarking”. Plastic and Reconstructive Surgery – Global Open. 2019 August 19. doi: 10.1097/GOX.0000000000002348

Vishwanath S, Ng S, Pusic A, Parker E, Cooter RD, Elder E, Moore C, McNeil J, Hopper I. Response to “Comments on ‘Patient-Reported Outcome Measures for Breast Implant Surgery: A Pilot Study”. Aesthet Surg J. 2019 Jul 17. pii: sjz178. doi: 10.1093/asj/sjz178. [Epub ahead of print]
All publications are listed on abdr.org.au/publications

Presentations:

Our sincere thanks to these organisations for the opportunity to increase awareness of this important registry.

  • BreastSurgANZ Post Fellowship Trainees Day Adelaide, August
  • The VPNG (Victorian Perioperative Nurses Group) State conference Melbourne, August
  • Pink Hope Information Day Melbourne, August
  • St. Vincent’s Advanced Plastic Surgery Symposium (VAPS) Sydney, September
Pictured below- Left: ABDR research officers, Judy and Eva’s presentation at the VPNG state conference in Melbourne attracted a lot of delegate interest and support for the registry.  Right: Special thanks to Dr Ginnie Ip for co-presenting an update on the ABDR at the BreastSurgANZ’s Post Fellowship Trainees Day in July.