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TGA WEBSITE AND LINKS- https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma

Update – Outcomes from the TGA’s review of breast implants and breast tissue expanders

17 October 2019

The TGA has decided to take regulatory action in relation to all un-implanted breast implants and tissue expanders sold in Australia. However, even if your breast implants are being cancelled, suspended or recalled, medical experts do not recommend removing them if you do not have symptoms of BIA-ALCL. This is because BIA-ALCL is very rare, and the risk of undergoing surgery could be higher than the risk of developing BIA-ALCL.

If you have a breast implant and detect any change in the breast or armpit such as swelling, a lump or pain, you should consult your doctor.

The breast implant hub has information to support people with any concerns about their implants, or those considering implants.

TGA review of breast implants

What action has the TGA taken?

The TGA has decided to take regulatory action in relation to all un-implanted breast implants and tissue expanders sold in Australia.

The TGA has reviewed a range of inputs to inform decisions about the quality and performance of breast implant and tissue expander devices, and their compliance with the Essential Principles for Medical Devices that require that the benefits of devices outweigh risks. Evidence considered includes:

  • results of extensive laboratory testing on surface texture and analysis of manufacturing processes
  • statistical review of BIA-ALCL cases in Australia
  • advice from the Breast Implant Expert Working Group
  • submissions and information from other stakeholders and patients
  • evidence submitted by the sponsors and manufacturers of breast implants and tissue expanders including:
    • clinical evidence reports
    • biocapatibility testing
    • risk management frameworks
    • vigilance data
    • quality management systems for manufacturing processes

Consumers should speak with their medical practitioner if they have any concerns about their breast implants.

Further information can be found in our consumer information or on the breast implant hub.

Affected brands of breast implant devices and the regulatory actions to be imposed are as follows.

Un-implanted stock removed from market

In some cases, the sponsor has chosen to cancel the inclusion of their implant devices in the Australian Register of Therapeutic Goods (ARTG) during the course of this review. The Allergan Biocell macro-textured breast implants and tissue expanders and the Emergo Airxpanders Aeroform tissue expanders are no longer available on the Australian market. This means no new patients will receive these implants.

Suspension of un-implanted devices

Some breast implant devices have been suspended. This means that these implants will not be able to be implanted into new patients over the next six months. During this period, the sponsor will have the opportunity to provide additional information to the TGA about the safety and performance of their products.

Suspended implants are those that are “macrotextured” – grade 3 and 4 and some “microtextured” implants associated with higher incidences of BIA-ALCL and other clinical concerns.

Sponsor (Manufacturer) ARTG/Device Number Product Name
Allied Scientific Products Pty Ltd (Nagor) 142863 Nagor Mammary Implants Gel-filled-TEXTURED
277757 9-cell CoGel gel-filled Nagor mammary implant range – textured
277758 Impleo gel-filled Nagor mammary implant range – textured
Emagin Pty Ltd (Groupe Sebbin SAS) 309613 Anatomical Breast Implants – Textured – High Cohesive Gel
Euro Implants Pty Ltd (Eurosilicone SAS) 132040 Cristaline I Aptex/Vertex Paragel Natural Cohesive Gel Implant
132037 Cristaline Paragel Cohesive Gel Implant
JT Medical Pty Ltd (Polytech Health & Aesthetics GmbH) 171782 Sublime Line, Microthane, Silicone gel filled Mammary Implants
185060 4Two Line, Single Lumen, Micro Polyurethane, Silicone gel filled Mammary Implants

To recap:

  • The above breast implant devices have been suspended.
  • The devices will not be able to be supplied, imported, or exported from Australia for the duration of the suspension (6 months), effective 25 October 2019.
  • A suspension can be withdrawn early if the sponsor can address concerns to the TGA’s satisfaction.
  • If concerns persist, the suspension may be extended or the entries of the devices may be cancelled.
  • All un-implanted products will be subject to recall to remove them from the market (i.e. on hospital shelves).
  • If a decision is made to recall the above breast implants, this will only apply to un-implanted stock, not devices that have already been implanted.

New conditions for breast implant devices

To ensure the highest level of patient safety possible, the TGA has imposed ‘conditions’ on all breast implant devices that remain available in Australia. This means that for a sponsor to supply a breast implant device in Australia, they must meet a range of new requirements. If a sponsor fails to comply with any condition of inclusion, the device may be removed from the ARTG.

What are the conditions?

  1. Reporting of BIA-ALCL: To support the on-going monitoring of BIA-ALCL, all cases of BIA-ALCL must be reported to the TGA by the sponsors within 10 working days of becoming aware of the adverse event.
  2. Six monthly reporting: To support greater vigilance and increased awareness and data collection on this issue, the TGA is requiring reports to be provided every six months from the sponsors. The reports must include supply data and detail all adverse events and complaints received regarding breast implant and tissue expander devices, both in Australia and worldwide, including BIA-ALCL, capsular contracture, or rupture of the implant.
  3. Instructions for use: To promote clinicians’ awareness, the risk of BIA-ALCL must be included in the Instructions for Use of all breast implant and tissue expander devices.
  4. Patient information leaflet: To support informed patient choices, all breast implant and tissue expander devices must have access to a patient information leaflet that includes information about warnings and risks associated with the product. Information relating to the Australian Breast Device Registry must also be included, to support on-going reporting and monitoring.

** Additional conditions relating to clinical data have been applied to these micro-textured implants and tissue expanders

Sponsor (Manufacturer) Device Number Product Name
Allied Scientific Products Pty Ltd (Nagor) 142860 Gel Filled Mammary Implant
277759 Impleo gel-filled Nagor mammary implant range
Allergan Australia Pty Ltd (Allergan) 218869 BRST Round Microcell Textured Responsive gel filled breast implant
220900 BRST Round Microcell Textured Cohesive gel filled breast implants
171393 Natrelle Truform1 Gel, Smooth Single Lumen Breast Implants
175421 Natrelle INSPIRA, Truform 1 gel, Smooth, Single Lumen Breast Implants
175426 Natrelle INSPIRA Truform 2 gel, Smooth, Single Lumen Breast Implants
220696 BRST Round Smooth Responsive gel filled breast implants
Emagin Pty Ltd (Groupe Sebbin SAS) 309613 Microtextured, Round, Firm High Cohesive Gel, Mammary Implants
309617 Microtextured, Round, Classic, Cohesive Gel, Mammary Implants
309618 Smooth, Round, Firm High Cohesive Gel, Mammary Implants
309619 Smooth, Round, Classic, Cohesive Gel, Mammary Implants
309614 Textured, Round, Firm, High Cohesive Gel Mammary Implant
309615 Textured, Round, Soft Classic, Cohesive Gel, Mammary Implants
Euro Implants Pty Ltd (Eurosilicone SAS) 132036 Paragel Cohesive Gel Implant
Johnson & Johnson Medical Pty Ltd (Mentor Medical Systems BV)** 110588 Siltex Round Cohesive I
110589 Siltex Round Cohesive II
110592 Siltex Round Becker Cohesive I
119809 Siltex Contour Becker Cohesive II
130678 Siltex Contour Gel Breast Implants Cohesive III
226977 Mentor® CPX™4 Breast Tissue Expander
226982 Mentor® CPX™4 with Suture Tabs Breast Tissue Expander
110587 Smooth Round Cohesive I
119646 Smooth Saline Mammary Prostheses with Diaphragm Valve
319150 Smooth Round XTRA Gel Breast Implants
JT Medical Pty Ltd (Polytech Health & Aesthetics GmbH) 171783 Sublime Line, Textured, silicone gel filled Mammary Implants
185059 4Two Line, Single Lumen, Textured, Silicone gel filled Mammary Implants
171781 Sublime Line, Smooth, Silicone gel filled Mammary Implants
Spiran Pty Ltd (Establishement Labs SA) 282776 Sterile Silicone Breast Implants Motiva Implant Matrix SilkSurface PLUS with Qid
282777 Sterile Silicone Breast Implants Motiva Implant Matrix Ergonomix Round SilkSurface with Qid
282778 Sterile Silicone Breast Implants Motiva Implant Matrix SilkSurface PLUS

Next steps

If you have any of the above breast implants, you do not need to do anything except be aware of the symptoms of BIA-ALCL and seek advice from a health professional if you notice any changes.

The sponsors of suspended implants have an opportunity to make submissions at any time during the period of suspension to demonstrate that the safety and performance concerns raised by the TGA have been addressed.

The TGA will take into consideration each sponsor’s submission when deciding what, if any, further regulatory action should be taken in relation to particular sponsor’s device(s).

Background

The evidence available at present indicates that while causes are likely to be multi-factoral BIA-ALCL is more likely to occur in implants with a greater surface area and roughness of their wall. The degree of texturing in the surface is a result of the materials used in the production of the device or the manufacturing processes.

The TGA is taking a precautionary approach and suspending particular breast implant devices which have a higher degree of texturing, or a higher risk of BIA-ALCL, or deficiencies in evidence to demonstrate the manufacturer has adequate risk detection and mitigation measures in place.

Over the past few years there has been a change in the type of breast implants used in Australia with a decrease in macro-textured implants and an increase in supply of micro-textured and smooth implants. The suspensions imposed by the TGA do not impact on the supply of the smooth implants available and to date there are no known cases of BIA-ALCL in Australia where only smooth devices were implanted.

References

  1. Knight R et al. Epidemiology and risk factors for Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in Australia & New Zealand. Plastic & Reconstructive Surgery Global Open 2016;4(9S):82-83.
  2. Swerdlow SH, Campo E, Pileri SA et al. The 2016 revision of the World Health Organisation classification of lymphoid neoplasms. Blood 2016; 127(2):2375-2390
  3. Rothman KJ, Greenland S. Causation and causal inference in epidemiology. Am J Public Health. 2005;95(Suppl 1):S144-S151.
  4. Deva AK, Adams WP, Jr., Vickery K. The role of bacterial biofilms in device-associated infection. Plast Reconstr Surg 2013;132(5):1319-1328.
  5. American Society of Plastic Surgeons FAQ. www.thepsf.org/Documents/Clinical/PROFILE/profile-faq.pdf (pdf,2.46Mb).

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA’s monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual’s medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.