Thursday, 31 May 2018

Breast implant registry on track to protect patient health

The first comprehensive report on breast implant surgeries captured by the Australian Breast Device Registry (ABDR) between 2012 - 2016, marks a significant milestone in the development of registry's potential to safeguard patient health.

Funded by the Australian Government Department of Health, the ABDR monitors the performance of breast implants, as well as tissue expanders and dermal matrices that may be used in the reconstruction of breast tissue, such as after mastectomies.

Project lead, Dr Ingrid Hopper, said the registry, which is expected to have national coverage later this year, will have the capacity to track complication rates back to a particular type of implant or surgical technique.

The ABDR was set up in 2012 following a reported high rupture rate internationally, in 2010, of the French made Poly Implant Prosthese (PIP). Attempts at the time to track Australian women who had had the PIP implant through a breast implant registry which required participants to pay and to opt in, captured only 3% of the Australian women with the French device.

Last year, the Therapeutic Goods Administration announced a likely causal link between breast implants and a rare form of cancer called Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), further underscoring the need for the national ABDR.

The ABDR is still enrolling surgeons and
 their patients into the registry.  
Future reports will give nation-wide

More than 27,000 Australians are currently enrolled in the opt-out registry which is unique in the world for having surgeons from all three of the medical professional groups (plastic, cosmetic and general breast surgeons) contributing to the program.

The report found that between January 2012 - December 2016:

  • 67% of 321 sites where breast surgery is performed were participating in the ABDR
  • 61% of the 552 surgeons were participating
  • Patient opt out rate is < 1%
  • 71% of breast device surgery took place in a
  • private overnight facility, and 26% in a private same day facility - Of the 26,505 breast level procedures registered, 72% were for cosmetic augmentation, 21% for breast reconstruction (post cancer or benign/risk reducing) and 3% to correct developmental deformity - The median age of patients undergoing cosmetic augmentation was 33 years; breast reconstruction 50 years and correction of a deformity 26 years - The most common issues identified at revision were device malposition and capsular contracture
  • Based on 17,987 primary implant breasts, 2.2 % of primary breast devices were revised within one year of insertion and 3.5% within two years of the initial surgery (not risk adjusted).
The report and infographic can be downloaded here.