As part of ongoing work regarding breast implant associated anaplastic large cell lymphoma (BIA-ALCL), the Therapeutic Goods Administration (TGA) has completed its review and laboratory assessment of textured breast implants on the Australian market. The review was announced on 3 May 2019 and involved both laboratory testing and statistical analysis of supply information and the known cases of BIA-ALCL to estimate the risks associated for each type of implant.

What is BIA-ALCL and what should you do if you have concerns?

BIA-ALCL usually involves a swelling of the breast, typically 3 to 14 years after the operation to insert the breast implant. This swelling is due to an accumulation of fluid. Less commonly, BIA-ALCL can take the form of a lump in the breast or a lump in the armpit.
It is a rare condition, with expert opinions estimating the published risk of BIA-ALCL at between 1-in-1,000 and 1-in-10,000.

TGA’s proposed regulatory action – textured implants only

Based on the laboratory and statistical review, the TGA has proposed regulatory action in relation to a number of textured implants only. Those proposed regulatory actions are either a proposal to cancel or a proposal to suspend. The TGA has also imposed new conditions on the inclusion of a number of other textured implants in the Register.
The TGA has notified each of the sponsors of the relevant proposed regulatory action (or imposition of conditions, where conditions have been imposed) on 9 July 2019.

It is important to understand that the proposed cancellations and suspensions set out below are proposed. No decision has been made to suspend or cancel the relevant products at this time.

The next steps are for the sponsors to respond to the TGA’s notification and invitation to comment by 24 July 2019. The TGA will, as a matter of priority, consider the sponsor’s submissions before reaching any decision on whether to proceed to the proposed regulatory action.


 

Proposed Cancellation

Sponsor (Manufacturer)

Allergan Australia Pty Ltd

ARTG Number: 169956
Product Name: Natrelle Double Lumen Gel/Saline Breast Implants

ARTG Number: 171387
Product Name: Natrelle Truform Dual gel, Textured Single Lumen Breast

ARTG Number: 171388
Product Name: Natrelle Saline-filled, Textured Breast Implants

ARTG Number: 171475
Product Name: Natrelle Soft Touch, Truform 2 gel, Textured, Single Lumen Breast Implants

ARTG Number: 171512
Product Name: Natrelle Truform 3 gel, Textured Single Lumen Breast Implants

ARTG Number: 175420
Product Name: Natrelle Truform1 gel, Textured, Single Lumen Breast Implants

ARTG Number:175422
Product Name: Natrelle INSPIRA Truform 1 gel, Textured, Single Lumen Breast implants

ARTG Number:175425
Product Name: Natrelle INSPIRA Truform 2 gel, Textured Single lumen Breast Implants

ARTG Number:175797
Product Name: Natrelle Tissue Expanders

If the entries of the above products are cancelled, the products would no longer be able to be imported, manufactured or exported from Australia by the sponsor. The TGA is also proposing to require the sponsor to recall the products to remove all remaining products from the market.  The recall would only apply to product that is waiting to be implanted.

There is not a recommendation to surgeons to remove implants in the absence of a BIA-ALCL diagnosis.

Proposed Suspension (on the basis that it is likely that there are grounds for cancelling the entries of the products)

Sponsor (Manufacturer)

Adirel Consolidated Pty Ltd T/A Surgiplas Medical
(Nagor)

ARTG Number:142863
Product Name: Nagor Mammary Implants Gel-filled-TEXTURED

ARTG Number:277757
Product Name: 9-cell CoGel gel-filled Nagor mammary implant range – textured

ARTG Number:277758
Product Name: Impleo gel-filled Nagor mammary implant range – textured

ARTG Number:277758
Product Name: Impleo gel-filled Nagor mammary implant range – textured

Sponsor (Manufacturer)

Emagin Pty Ltd (Groupe Sebbin SAS)

ARTG Number:309613
Product Name: Anatomical Breast Implants – Textured – High Cohesive Gel

Sponsor (Manufacturer)

Emergo Asia Pacific Pty Ltd T/a Emergo Australia (AirXpanders)

ARTG Number:216704
Product Name: Aeroform Patient Controlled Tissue Expander

Sponsor (Manufacturer)
Euro Implants Pty Ltd (Eurosilicone SAS)

ARTG Number:132040
Product Name: Cristaline I Aptex/Vertex Paragel Natural Cohesive Gel Implant

ARTG Number:132037
Product Name: Cristaline Paragel Cohesive Gel Implant

Sponsor (Manufacturer)

JT Medical Pty Ltd (Polytech Health & Aesthetics GmbH)

ARTG Number:171782
Product Name: Sublime Line, Microthane, Silicone gel filled Mammary Implants

ARTG Number:185060
Product Name: 4Two Line, Single Lumen, Micro Polyurethane, Silicone gel filled Mammary Implants

Sponsor (Manufacturer)

Johnson & Johnson Medical Pty Ltd (Mentor Medical Systems BV)

ARTG Number:110588
Product Name: Siltex Round Cohesive I

ARTG Number:110589
Product Name: Siltex Round Cohesive II

ARTG Number:110592
Product Name: Siltex Round Becker Cohesive I

ARTG Number:119809
Product Name: Siltex Contour Becker Cohesive II

ARTG Number:130678
Product Name:Siltex Contour Gel Breast Implants Cohesive III

ARTG Number:226977
Product Name:Mentor® CPX™4 Breast Tissue Expander

ARTG Number:226982
Product Name:Mentor® CPX™4 with Suture Tabs Breast Tissue Expander

If the entries of the above products are suspended, the products would no longer be able to be imported, manufactured or exported from Australia by the sponsor for the duration of the suspension. A suspension can be revoked if concerns about the products are addressed to the TGA’s satisfaction. Alternatively, where concerns persist the duration of the suspension may be extended or the entries of the products may be cancelled. If any of the products are suspended, it is proposed to recall all remaining product to remove it from the market. The recall would only apply to product that is waiting to be implanted surgically.

There is not a recommendation to surgeons to remove implants in the absence of a BIA-ALCL diagnosis.


 

Reminder: next steps

The TGA is required by law to provide the sponsors of affected implants with an opportunity to make submissions in response to proposed regulatory action. The TGA will then take into consideration each sponsor’s submission  when deciding what, if any, regulatory action should be taken in relation to particular sponsor’s device(s). 

Sponsors were notified of the TGA’s preliminary view on 9 July 2019 and have been given until 24 July to respond. The TGA will then evaluate the submissions as a priority, and more information on regulatory actions will follow.

At this time relevant products will continue to be included on the ARTG (i.e. approved by TGA) and available for use in Australia.

BIA-ALCL is more likely to occur in rougher surfaced implants, and the TGA is proposing to either cancel or suspend particular products. There are alternative smooth implants available and these have not been associated with known cases of ALCL in Australia.

Because the risk to women who already have these implants is very low, experts do not recommend that women who already have them need to have them removed unless there is a confirmed diagnosis of ALCL. The proposed action by the TGA does not change this advice. If you have concerns you should speak to your surgeon.

Consumers with concerns about their breast implants can access information about BIA-ALCL, its symptoms and treatments through the TGA’s breast implant hub.


FAQ

What is breast implant-associated ALCL

Breast implant-associated ALCL is a rare type of cancer. It usually involves a swelling of the breast, typically 3 to 14 years after the operation to insert the breast implant. This swelling is due to an accumulation of fluid. Breast implant-associated ALCL has been known to occur as soon as 1 year after the operation and as late as 37 years after the operation.
Less commonly, breast implant-associated ALCL can take the form of a lump in the breast or a lump in the armpit. If you notice any of these problems (swelling or a lump), or have any other concerns with your implants, you should seek medical attention.
Most cases of breast implant-associated ALCL are cured by removal of the implant and the capsule surrounding the implant.

What is the risk?

Based on the currently available data, it is not possible to provide an accurate estimate of risk. Current expert opinion puts the risk of ALCL at between 1-in-1,000 and 1-in-10,000. Based on currently available data, most (95%) of cases of breast implant-associated ALCL occur between 3 and 14 years after the implant (median: 8 years; range: 1-37 years).
It can be difficult to express this risk in a concrete way, such that you can make a fully informed decision about whether or not to have a breast implant. Some different ways of expressing the risk are given below:

  • One woman will be diagnosed with breast implant-associated ALCL for every 1000 to 10,000 women with breast implants.
  • Suppose we took 1-in-5000 women, the middle of the experts’ range, as the best estimate of risk of ALCL in women who have breast implants. This would mean that, of 5000 women with implants, one woman will develop ALCL over a period of about 3-14 years following an implant; the other 4999 women will not develop ALCL.

Should implants be removed, just in case?

Because breast implant-associated ALCL is rare, experts do not recommend removal of breast implants for women who have no problems with the implant. If you are concerned you should discuss your options with your doctor. Generally, breast implants are not lifetime devices regardless of breast implant-associated ALCL. Typically they are removed after 10-15 years. The longer you have the implant, the more likely it will need to be removed. Common reasons for removal are contracture (hard or painful implants) or movement of the implant.

How is breast implant-associated ALCL diagnosed?

If you develop swelling of an implanted breast your doctor will send you for an ultrasound scan to see if this is due to a fluid collection. If fluid is present it will be removed and sent to the laboratory for analysis. Most fluid collections are not ALCL, but the laboratory test will be able to tell for sure. Mammograms are not helpful for diagnosing ALCL. Other investigations such as MRI and CT-scans would typically be done if the laboratory analysis of the fluid confirms a diagnosis of ALCL.

Should women with implants be screened for ALCL?

Based on external expert clinical advice received by the TGA, regular screening is not recommended at this time. If you notice enlargement or swelling of one or both breasts, or a lump, you should seek medical advice as soon as possible.

Are some women more at risk of breast implant-associated ALCL than others?

Breast implant-associated ALCL can develop regardless of whether the implant is inserted for cosmetic reasons or for reconstruction of the breast following breast cancer.
It can occur with both saline and silicone gel filled implants.

To date:

  • No Australian cases have been reported in women who have only had smooth implants.
  • All Australian cases have occurred in women who have had textured or polyurethane implants.

Based on the currently available data:

  • It is uncertain whether textured (either micro or macro) and polyurethane implants carry different risks.
  • It is uncertain whether different brands of textured and polyurethane implants carry different risks.
  • It is not possible to predict which women with textured or polyurethane implants will develop breast implant-associated ALCL.

What is the prognosis and treatment of ALCL?

Most cases are cured by removal of the implant and capsule surrounding the implant. Usually your doctor will remove both implants, even if breast implant-associated ALCL has only occurred in one breast. This is because there is a small but real risk that breast implant-associated ALCL can develop in the opposite breast. Sometimes there is a solid lump (not just fluid). In these cases, chemotherapy or radiotherapy may be required. Over the last 10 years, three Australian women have died from breast implant-associated ALCL.
The management of breast implant-associated-ALCL is multidisciplinary with all patients requiring a referral to a surgeon experienced with breast implants and the involvement of a haematologist who specialises in lymphoma, for initial and ongoing investigations and management.

What has the TGA been going to monitor BIA-ALCL?

The TGA has been monitoring BIA-ALCL since 2011 after receiving the first adverse event report in 2009. It established an expert working group in 2016 to seek advice on BIA-ALCL. The working group includes plastic surgeons, cosmetic surgeons, breast-cancer surgeons, cancer epidemiologists, data analysts, public -health practitioners and consumers. The TGA has worked with this group to develop targeted information for consumers and health professionals. The introduction of a new requirement for Patient Information Leaflets for implantable devices commencing in 2018 enhances patient access to information.

Why hasn’t the TGA immediately banned these products?

There are a range of types of textured breast implants supplied in Australian. By compelling suppliers to provide additional information specific to the Australian market, the TGA can make well informed decisions about safety of particular types of implants. Suppliers have 10 working days to respond to the request for information. After receiving this information the TGA will consider action to suspend or cancel particular products.
The decision by the French regulator appears to be based on events described to them from patients and doctors as well as data published about three implants, which has been extrapolated to other products. Other regulators, including those in the US, Germany and the UK are also seeking additional evidence on the risk of BIA-ALCL, and we are working closely with these regulators.
Patients who have breast implants should expect that the regulator makes decisions based on sound scientific and medical evidence. Textured implants of varying roughness are used in 82% of operations in Australia. They play an important role in reconstructive surgery. Smooth implants are an alternative but they may require a higher rate of replacement reoperation due to greater rates of contracture of these implant.

The international consensus is that there is no evidence supporting the removal of breast implants in the absence of properly diagnosed BIA-ALCL.


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