Transforming Australia's Breast Implant Registry

Jeeves, Amy; Cooter, Rodney D.

doi:10.5694/mja12.10117

Cited by 15 publications

(13 citation statements)

References 17 publications

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“…The Department of Health has contracted Monash University to operate the Australian registry — an opt‐out clinical quality registry for all recipients of breast devices, including breast implants for cosmetic or reconstructive purposes, tissue expanders and acellular dermal matrices. The registry was established following an Australian Senate inquiry recognising the need for a better audit trail in light of the Poly Implant Prothèse crisis, 1 and the design of the registry has addressed many of the weaknesses of its predecessor 10 …”

Section: The Australian Breast Device Registrymentioning

confidence: 99%

“…Previous implant‐related health scares escalated rapidly because of a lack of data 1 . The existence of the Australian Breast Device Registry has meant that BIA‐ALCL is the first implant‐related concern to be dealt with prospectively, and international collaborations have the potential to rapidly amplify the datasets.…”

Section: The Urgent Need For Collaborationmentioning

confidence: 99%

“…Breast devices, including implants and tissue expanders, are classified as class III (high risk) medical devices by the Therapeutic Goods Administration, and are subject to the highest level of regulatory control. They have been associated with highly publicised health scares in the past, particularly, the Poly Implant Prothèse crisis 1 . More recently, breast implants have again created national concern, with the Therapeutic Goods Administration confirming in late 2016 that there were 46 reports of breast implant‐associated anaplastic large cell lymphoma (BIA‐ALCL) in Australia, including three cases that resulted in death.…”

mentioning

confidence: 99%

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Improving the safety of breast implants: implant‐associated lymphoma

Hopper

Ahern

McNeil

et al. 2017

Medical Journal of Australia

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Section: The Australian Breast Device Registrymentioning

confidence: 99%

Section: The Urgent Need For Collaborationmentioning

confidence: 99%

mentioning

confidence: 99%

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Improving the safety of breast implants: implant‐associated lymphoma

Hopper

Ahern

McNeil

et al. 2017

Medical Journal of Australia

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“…Heightening the scare, Poly Implant Prothèse implants were suspected to have had a higher rupture rate than other implants. 3 In the absence of robust registry data, it took concerted scientific efforts to determine the relative risk of these devices. 1), and many had a milky suspension of uncertain composition (Fig.…”

Section: History Of Global Implant Crisesmentioning

confidence: 99%

International Importance of Robust Breast Device Registries

Cooter

Barker

Carroll

et al. 2015

Plastic and Reconstructive Surgery

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Recent implant crises have highlighted the need for robust registries. This article argues the importance of securing at least 90 percent data capture, which is achievable through the opt-out consent model. Since adopting this model, the Australian Breast Device Registry has increased data capture from 4 percent to over 97 percent. Simultaneously, it is important to foster international collaboration from the outset to avoid duplication of efforts and enable the development of effective international early warning systems.

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“…The Australian breast implant registry revealed that less than 4% of these implants were captured in an opt-in (voluntary type of data entry), triggering a revision of the system [6].…”

Section: List Of Questionsmentioning

confidence: 99%

Medical device registries for breast implants - where to?

Lumenta

Cooter

2015

Saf Health

Self Cite

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This comment discusses the requirements, challenges and limitations for setting up medical device registries for breast implants. Previous experiences, notably the PIP implant scandal in 2010, revealed the inaccuracy and inefficiency of the majority of breast registers in place, and resulted in a rethinking of how registries should work. Quality registries monitor the three Ps: person (eg. patient, surgeon), part (eg. device) and place (eg. hospital). Setting up a register requires a minimum agreed dataset and clearly defined endpoints (eg. revision) of a permanently implanted medical device (eg. breast implant) by means of a medical intervention (operation) readily recorded in a routine procedure, where a direct causal and logical relationship between the malfunction of the device and revision operation exist. Apart from the technical realization, the hurdles for setting up a registry are predominantly found in the political, ethical, financial, and governing spheres. The possible benefits of a working registry for the stakeholders might be evident, and include a market overview (industry), recall mechanism (surgeons, industry, and patients), benchmarking (surgeons, hospitals) legal, quality management (governing body), (eg. national vs. international) of and participation (opt-in vs. opt-out) in a given registry. Future efforts should take into account past experiences and build upon international collaborations to develop optimal solutions for improving patient safety.

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Transforming Australia's Breast Implant Registry

Cited by 15 publications

References 17 publications

Improving the safety of breast implants: implant‐associated lymphoma

Improving the safety of breast implants: implant‐associated lymphoma

International Importance of Robust Breast Device Registries

Medical device registries for breast implants - where to?

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