Breast Implant Expert and Consumer Working Groups

We also continued discussions regarding our proposed breast implant risk assessment framework. The topics of discussion included the importance of access to quality and timely data; including data held by the Australian Breast Device Registry (ABDR), reviewing healthcare professional informed consent guidelines, and strengthening the focus on consumer consent processes.

26 October 2022 

We held a teleconference with the Breast Implant Expert Working Group on 26 October 2022 to discuss the emerging cases of squamous cell carcinoma and various lymphomas in the presence of breast implants. It was agreed that the occurrence is very rare worldwide and association with breast implants is yet to be determined. We sought advice from the working group regarding a risk framework to initiate future reviews of breast implants. In response to this discussion the working group provided initial input and considerations which will inform the initial drafting that will commence and provide back to the working group. We provided a further update to the working group regarding updates to the international standards for breast implant surface classification. The working group members acknowledged the progress that has been made and the ongoing work that is required in this standard.

3 May 2022 

We held a teleconference with the Breast Implant Expert Working Group on 3 May 2022 to discuss our updated clinical evidence guidelines on breast implants and tissue expanders and proposed updates to the TGA website and Breast Implant Hub, including data relating to the estimated risk of BIA-ALCL within Australia. Generally, the members acknowledged the importance of publishing this information but was mindful of appropriate messaging. It was suggested that further feedback be sought from consumer working groups. We provided updates on the international standards for breast implant surface classifications to which the working group viewed as appropriate.

July 2021 

We held a teleconference with the Breast Implant Expert Working Group on 12 July 2021 to discuss the status of our post-market review of breast implants, including regulatory actions taken and an update regarding the imposition of conditions of inclusion. The working group also discussed patient consent and patient information. We provided an update on the work of the International Technical Working Group Committee in updating the standards for breast implants and sought advice from the working group concerning the benefit and risk of acellular dermal matrix and mesh used in breast reconstruction.

22 October 2020 - Breast Implant Expert Working Group teleconference

The TGA held a teleconference with the Breast Implant Expert Working Group on 22 October 2020 to discuss the submissions received from sponsors in relation to the suspension of textured breast implants, and the sharing of matters of interest on breast implants, including recently published literature and clinical data requirements for new premarket applications.

Following input from the working group, further information in relation to the suspended implants was published by the TGA.

24 January 2020 - Breast Implant Expert Working Group nominations

The previously convened breast implant expert working group contributed extensively to the post-market review undertaken in 2019 of all breast implant devices supplied in Australia. As the group was initially convened in 2016, and as the member list was no longer current, the TGA decided to retire the existing group and seek a new nomination, or renewal of an existing representative, for the breast implant expert working group. Nominations for representatives from the expert working group stakeholder organisations was sought and the group members were updated in 2020.

4 December 2019  - Consumer working group teleconference

The TGA held a teleconference with its breast implant consumer working group on 4 December 2019 to seek feedback on the patient information leaflets that are being developed by manufacturers of breast implant devices. The patient information leaflets are required to be available to patients by 14 February 2020 as a result of regulatory action taken by the TGA. These leaflets are intended to assist in increased awareness of the risks associated with these devices.

Feedback from the consumer working group will be provided to sponsors of the breast implant devices to ensure the leaflets are fit for purpose with regard to the language being used and information included.

2 October 2019 - Consumer forum and expert working group meeting

The Breast Cancer Network Australia and Cancer Council Australia, together with the TGA hosted a breast implant consumer forum and Breast Implant Expert Working Group meeting on 2 October 2019.

The consumer forum was attended by a number of patients representing women with breast implants or supporting women with breast implants including patients who had experienced BIA-ALCL. Representatives from the Consumer Health Forum of Australia, Australian Breast Device Registry, Macquarie Research Group, Australian Society of Plastic Surgeons, Breast Surgeons of Australia and New Zealand, Australasian College of Cosmetic Surgery, and the Australian Commission on Safety and Quality in Health Care also attended.

The discussion focussed on the information available to consumers with an aim to identify the gaps in the information and where improvements are needed.

Issues identified by consumer advocates as being of major concern included:

• Inconsistent, or lack of, consent processes
• Indications for removal of breast implants
• Costs for removal of breast implants
• Identification of surgeons with qualifications and experience to perform explant surgery and
• Availability of accurate and consistent information on BIA-ALCL and patient options for both symptomatic and asymptomatic women.

Following this meeting, the Breast Implant Expert Working Group met to discuss the TGA's recent regulatory actions, identify future work required in the area of BIA-ALCL, an ongoing monitoring framework for breast implants, and provision of information to consumers.

The immediate action items for the TGA included:

• Consulting with consumer groups regarding Patient Information Leaflets
• Providing information about the Australian Breast Device Registry to the various consumer groups so they can to circulate to their members and include information about the registry on the TGA website
• Ensuring information relating to BIA-ALCL is circulated and made available via multiple methods
• Liaising with other areas within the Commonwealth Health Department regarding rebates for surgery
• Providing clear information particularly around legacy implants on the website and
• Considering an approach to lifelong surveillance.

15 August 2019  - Expert working group teleconference

The TGA held a teleconference with its breast implant expert working group on 15 August 2019 to facilitate input from consumer representatives and to table the identified risk and benefit factors for the breast implant devices available in Australia.

The immediate action items for the TGA included:

• Work with relevant stakeholders to organise and communicate details of a face to face consumer group workshop;
• Develop easy to understand information to be published on the TGA website (and provided to other organisations) regarding cancelled or legacy implants.

9 April 2019 - Expert working group convened

The TGA convened its breast implant expert working group on 8 April. This followed decisions taken by regulators in France and Canada to remove selected textured implants from their market.

The expert working group discussed the current data on BIA-ALCL rates and correlation with type of implant. The group identified gaps in the data currently available to inform an assessment of the true rate of BIA-ALCL in Australia, particularly with different grades of texture of the implants.

The TGA takes the potential risk to women's health seriously. We have today written to all Australian suppliers of textured breast implants with a formal request for information under section 42 of the Therapeutic Goods Act 1989.

This includes the provision of data on the date when particular implants were first supplied to the Australian market and how many have been supplied so as to develop a clearer understanding of the rates of BIA-ALCL in specific types of implant. Samples of particular products have also been requested by the TGA.

Suppliers have 10 working days to responds to the request for information. After receiving information from suppliers TGA will consider whether to suspend or cancel particular products from the Australian Register of Therapeutic Goods.

Other regulators, including the US FDA and several European regulators, have also deferred making a decision until more data is available.

The expert group confirmed that the breast implant associated cancer is rare. As of 8 April 2019 the TGA has received 76 reports for BIA-ALCL in Australian women, noting that between 13,000-17,000 breast implant procedures are performed in Australia each year.

The group also discussed the benefits of textured implants, particularly for reconstructive breast surgery and the need to:

• update the TGA website with accurate information about the benefits and risks of different types of implants
• strongly encourage the use of the Australian Breast Device Registry, including for recording details of removal of implants and of BIA-ALCL cases
• continue to support patients and surgeons to report all adverse events to the TGA.

Today, the TGA will also update its website with further information including information on signs and symptoms of BIA-ALCL and a range of questions that women considering a breast implant procedure should ask their surgeon.

Women with any concerns about their implants should contact their surgeon.

As part of the TGA's ongoing monitoring of BIA-ALCL, consumers and health professionals are advised that an advisory panel was convened to discuss the issue on 16 November 2016 and has been providing ongoing advice.

The expert advisory panel included representation from plastic surgeons, cosmetic surgeons, breast-cancer surgeons, cancer epidemiologists, data analysts and public-health practitioners. The panel's advice is outlined in the 'Information for consumers' and 'Information for health professionals' sections.

Breast implant-associated ALCL is a rare type of lymphoma that develops near breast implants. The TGA published safety communications regarding this issue on 27 January 2011 and 27 September 2016.

Since our last safety communication, the TGA has been provided with additional data and is advising that 46 cases of breast implant-associated ALCL have now been confirmed in Australia, including three that resulted in death. These cases have all occurred since 2007. Most cases of breast implant-associated ALCL are cured by removal of the implant and the capsule surrounding the implant, however a small number are more aggressive.

The TGA is also aware of a small number of unconfirmed cases. These are being investigated. Consumers and health professionals are asked to report any suspected cases to the TGA.