UPDATE: TGA’s review of textured breast implants and preliminary outcomes

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.

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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.

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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.

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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.

What is my downtime post Breast Implant Surgery – Part 1

As straightforward as breast implant surgery is, post-surgery care and rest is of paramount importance to achieve a good result. Why would you want to compromise care and end up with post-surgery complications that will result in either revision surgery, more down time and of course financial implications such as loss of income. Here are some of the frequently asked questions by our patients.

When can I exercise? I feel fat not moving.

Light exercise (e.g. walking at a gentle pace) within your limits of comfort can be resumed after 2 weeks.  However, whatever you do, if it causes you discomfort, stop and try it again in another 2 weeks. You may only progress to more vigorous exercise after 6-8 weeks. Listen to your body and do not fight the pain. If you are hurting, stop what you are doing and relax.
During the first 6-8 weeks you must avoid potentially harmful activities such as heavy lifting and strenuous exercise such as jogging and gym workouts which would increase your pulse rate and raise your blood pressure.  However, walking at a gentle pace is permissible after the first two weeks.

How long do I have to wear my post surgery compression bra?

Check with your surgeon. Our general advise for our patients is that must wear your their compression bra day and night and yes even during sleep, for the first 8 weeks after their surgery. Once assessed at the 6 to 8 week mark, your surgeon will advise if you can move on to underwire bras, soft cup bras etc. The compression bra acts as an implant stabiliser to ensure implant is in pocket, there is sufficient compression to help reduce internal and external swelling and to ensure that implants are not displaced.

If the incisions have been placed under your breasts, you may be advised to refrain from wearing an underwire bra (one with wire supports under the cups) - the wire support may exert pressure on the incision sites and cause the scars to become permanently indented.  What bra to wear and for how long, the advice must come from the surgeon that operated on you. All our patients are advice to wear the Anna style post-surgery compression bra. This bra can be purchased from exquisite bodies.com.eu. Ignore the cup size component, it is based on your under bust measurements and solely based on that order a small, medium, large or extra-large. The size of the post-surgery bra has nothing to do with the cup size especially in the early post-surgery stage.

How long do I need to sleep on my back for?

Again check with the surgeon that operated on you. Our advice to our patients is to sleep on you back for a minimum of six week post op until advised otherwise. Sleeping on your back ensure that implants are not displaced. And for the first six months sleeping on your stomach is NO NO. Best to avoid direct pressure on the breasts.

When can I drive?

Again, this instruction should be from your surgeon. General advise is that you may be able to drive after a week. If you are not up to it and still feel sore, do not drive. Common sense will come in to play here. If you are taking meds that are making you feel drowsy, sleepy – PLEASE DO NOT DRIVE.

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Once again, thank you very much for reading our blog. If you have questions, feel free to call us 1300-ESTEEM / 1300-378336 or send us an enquiry here. One of our staff will respond to you shortly.

Risks and Complications associated with Breast Implant surgery – Part 2

Breast Augmentation surgery is purely an elective surgery. What does this mean? It simply means that this is not a life-saving surgery. The decision to undergo this surgery is purely based on the individual choice. Surgery always comes with risks even in the hands of the best and most experienced surgeons.

It is extremely important to comprehend the risks and its financial implications prior to saying “Yes, I am ready to proceed”.
Please see below some of the risks associated with the procedure:

Numbness

In cutting the skin small nerve endings are also cut that can result in numbness around or adjacent to the surgical area. Sensation usually returns in a matter of months or years as the small nerve endings regrow.  It may be unequal between the two sides. Most numbness goes away in time. Rarely does an area stay permanently numb. So whilst the possibility is low, the possibility is there.

Sagging of the Breasts

Many patients seem to think that they can go braless after breast implant surgery. This is not the case. In fact now with heavier weight on the chest, all the more you need support from a bra, While women with breast implants may sag no more than those women of the same breast size without implants, implants do have some weight and can over time cause some sagging of the breasts additional to that resulting from pregnancy, ageing and weight gain. Weight fluctuations post surgery can affect the results.

Symmastia (‘Uni-Breast”)

This refers to the loss of the normal midline separation of the two breasts.  In its most advanced form the pockets on each side merge to form a single pocket.  Further surgery is required to correct it. This can happen when you choose an implant larger than recommended.

Double Fold’ or ‘Double Bubble’

This refers to the persistence of the former crease under the breast along with the newly created crease thereby causing a double bubble appearance.  It may improve over time. Otherwise it will require further surgery to correct it.

Interference with Mammograms

The presence of breast implants of any type can interfere with mammography and the early detection of breast cancer.  Mammograms may also be more uncomfortable with implants since they require squeezing the breast with pressure. This pressure of mammography could rupture a silicone gel implant or cause deflation of a saline implant.

Muscle Weakness

Whenever the implants are placed under the muscle some weakness of the muscle usually results because of the partial detachment of the muscle from the ribs that is necessary to accommodate the implant. So be warned that you will not have the same muscle strength as you did before surgery.
One must accept and recognise that the practice of medicine and surgery is not an exact science and you paying for the performance of the surgery not a guaranteed result. This is extremely important to understand.


If you are considering breast augmentation surgery, call the team at Esteem Cosmetic Studio on 1300 378 336 and schedule an appointment with an experienced aesthetic breast surgeon. Surgery is not about the fluff and puff, we are committed in ensuring that you are fully informed of the procedure which includes its risks.

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Once again, thank you very much for reading our blog. If you have questions, feel free to call us 1300-ESTEEM / 1300-378336 or send us an enquiry here. One of our staff will respond to you shortly.

Risks and Complications Associated with Breast Implant Surgery – Part 1

Breast Augmentation surgery is purely an elective surgery. It simply means that this is not a life-saving surgery. The decision to undergo these type of procedures is purely based on the individual’s choice.
Surgery always comes with risks even in the hands of the best and most experienced surgeons. This makes it extremely important to comprehend the risks and its financial implications prior to saying, “Yes, I am ready to proceed”.
Please see below some of the risks associated with the procedure:

Hematoma

It is a collection of blood in the pocket around the implant which may require another surgery to drain it.

Infection

An infection may stem from the wound itself or within the pocket around the implant. This can be managed through proper wound care and antibiotics.  In contrast, when infection occurs around an implant two returns to the operating theatre will be necessary. The first is done to remove the implant while a second one is done to insert a new one, but it will be months after the infection has been resolved.

Capsular Contracture

A capsular contracture is one of the common causes of breast hardening after augmentation surgery which can be corrected through surgical revision. Cases of capsular contractures  vary based on the type of implants used and their placement.
Capsular contractures are graded based on their severity. Should this occur, you must decide whether to remove the implants only or have them replaced. However, it is also worth noting that there is a possibility of recurrence.

Scars  

Scarring is inevitable whenever surgical incisions are made on the skin.  While there are efforts to place incisions in areas where scarring may be minimal or inconspicuous, the process healing and scarring varies for each person. Healing may even vary for different areas of the body.  How well a person heals cannot be exactly predicted or controlled. Some are more prone to developing pigmented, wide or thickened scars (hypertrophic or keloid). If you can’t deal with the possibility of a scar it might be best to look at other options instead.

Asymmetry of the Breasts or Nipples

It is understood that both sides of our face and body may have some degree of asymmetry, and this is often evident in areas like the chest, breasts and nipples.  Although we may wish our two sides to be identical, it is understood that it is not possible to make them so. No two breasts are mirror images of each other and in some women they can be very different.  Breast implant surgery may correct those differences, but it can also magnify the problem especially when it is done poorly.

Rupture of Implant

Implants may rupture at any time after surgery even without apparent cause.  A ruptured silicone gel implant may result in gel migration, inflammation and the formation of silicone granulomas.  A ruptured saline implant will simply deflate and the saline solution is absorbed or expelled without any harmful effect on the body.

Stretch Marks

Stretch marks, such as those seen on the skin of the abdomen after pregnancy or a major weight loss, may also occur on the breasts. The more a person’s skin has to stretch to accommodate the implant, the higher the risk of developing stretch marks. They form gradually and if you are prone to getting them, it could still take shape even with conservative breast augmentation.

If you are considering breast augmentation surgery, you may call Esteem Cosmetic Studio at 1300 378 336 and schedule an appointment with an experienced aesthetic breast surgeon. Surgery is not about the fluff and puff, we are committed in ensuring that you are fully informed of the procedure and its risks.

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Once again, thank you very much for reading our blog. If you have questions, feel free to call us 1300-ESTEEM / 1300-378336 or send us an enquiry here. One of our staff will respond to you shortly.