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@esteemstudio
Liposuction surgery can be extremely expensive so before handing your money over, step back and get an understanding if Liposuction surgery is actually for you. Let this sink it. Liposuction surgery is NOT a weight loss procedure. Liposuction is primarily a body reshaping procedure. It is suitable for patients who are close to their ideal […]
Breaking News: There is no standardize cup sizing in Australia. A “b” cup is a Berlei bra would not necessarily be a “B” cup in a Triumph bra !! Implant size range is determined by YOUR anatomical measurements first and foremost and taking into account the answers to the questions of the surgeon to ascertain […]
Interested in Breast Augmentation Surgery in Brisbane? Here’s something to decipher your bill.
Please do not hesitate to contact a member of our team should you want to have a frank , open, honest consultation with Dr Pedro Valente. Call 1300 ESTEEM / 1300 378 336 or email [email protected]
Interested in Breast Augmentation Surgery in Sydney? Here’s something to decipher your bill.
Please do not hesitate to contact a member of our team should you want to have a frank , open, honest consultation with Dr Pedro Valente. Call 1300 ESTEEM / 1300 378 336 or email [email protected]
Be informed before proceeding with Breast Augmentation Surgery. This is after all surgery and it does come with risks and complications. Whilst the procedure is fairly straight forward and the risks are low, there is absolutely nothing to say that it won’t happen to you ! No fluff, No Puff – no at Esteem Cosmetic […]
What are the complications and side effects of a breast augmentation surgery? Read here to find the side effects and risks involving breast implant surgery.
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.
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.
Once again, thank you very much for reading our blog. If you have questions, feel free to fill up the form at the bottom to drop us an email. One of our staff will respond to you shortly.
Explant surgery... 1) Should they stay or should they go❓ 2) What are the most common reasons for removing implants❓ 3) Where are the incisions❓ 4) Do I need a lift when I explant❓ 5) Is enbloc technique… https://t.co/SiocQGIWMN
Explant surgery... 1) Should they stay or should they go❓ 2) What are the most common reasons for removing implants❓ 3) Where are the incisions❓ 4) Do I need a lift when I explant❓ 5) Is enbloc technique… https://t.co/SiocQGIWMN
— ESTEEM (@esteemstudio1) July 24, 2019
from Twitter https://twitter.com/esteemstudio1
Explant surgery... 1) Should they stay or should they go❓ 2) What are the most common reasons for removing implants❓ 3) Where are the incisions❓ 4) Do I need a lift when I explant❓ 5) Is enbloc technique suitable for everyone❓ You are curious, right? 🧐 Have a listen to @dr.pedrovalente 👍🏻 Jump onto IG stories and watch clips or watch it easily on our feed now! 😍 Considering Breast Surgery? Implants? Explants? Replacement? Breast Lift? 🤔 Call us on 1300 378 336 and let’s get the conversation started 📳 . . #ESTEEM #cosmetic #affordable #EMPOWERING #clinic #aestheticsurgery #breastexplant #breastimplantillness #womenempowerment #biaalcl #womeninspiringwomen #bodygoals #womensupportwomen #slay #bodytransformation #summerbody #dr_pedro_valente #breastsurgery #australiaclinic #breastsurgery #aestheticsurgery #explant #removalandreplacment #capsularcontracture #esteem_aesthetics_aus #transformation #breastreplacement #breastremoval #breastwithimplants #inspiring (at Australia) https://www.instagram.com/p/B0SoFVfj9dV/?igshid=4nae1gxr3nmi
Look at this Before & After photo of breast augmentation 👀😻 ✅ 295cc Implants ✅ Placement: Dual Plane 1 Fantastic Result of Breast Augmentation surgery performed by dr.pedrovalente 👌🏻👨⚕️ Implants can be… https://t.co/5yyvJOnntl
Look at this Before & After photo of breast augmentation 👀😻 ✅ 295cc Implants ✅ Placement: Dual Plane 1 Fantastic Result of Breast Augmentation surgery performed by dr.pedrovalente 👌🏻👨⚕️ Implants can be… https://t.co/5yyvJOnntl
— ESTEEM (@esteemstudio1) July 23, 2019
from Twitter https://twitter.com/esteemstudio1
Look at this Before & After photo of breast augmentation 👀😻 ✅ 295cc Implants ✅ Placement: Dual Plane 1 Fantastic Result of Breast Augmentation surgery performed by @dr.pedrovalente 👌🏻👨⚕️ Implants can be placed above the muscle, underneath the muscle or Dual Plane. With regards to Dual Plane, there are Dual Plane 1, Dual Plane 2 and Dual Plane 3 – what are the differences between the 3? 🤔 💖 Dual Plane I or "Partial Submuscular": the bottom attachments of the pectoral muscle are released from the chest and minimal breast tissue released from the "top plane" of the muscle. This is synonymous with the classic "partial submuscular" placement and is the most commonly performed option for patients who do not need to address sagging. 💖 Dual Plane II: the pectoral muscle is released from the chest and from the overlying muscle, partially up to the nipple. This greater degree of top plane muscle release places the implant in the optimal position while also slightly raising the nipple/areola complex, allowing for correction of extremely minor sagging without any form of the breast lift. 💖 Dual Plane III: the pectoral muscle is released from the chest and from the overlying muscle up to the nipple, allowing a surgeon to correct for a slightly greater degree of sagging than the Dual Plane II technique. Are you interested in learning more about the following? 😉 👉🏼Breast Augmentation surgery 👉🏼Breast Lift surgery 👉🏼Explant surgery Call the Esteem Cosmetic Studio team at 1300 378 336 and schedule an appointment 📲 Clinics are located in Canberra✨ Sydney ✨ Brisbane ✨ . . . #ESTEEM #cosmetic #affordable #EMPOWERING #clinic #aestheticsurgery #beautycounter #australiangirl #womenempowerment #roundimplants #womeninspiringwomen #bodygoals #womensupportwomen #slay #bodytransformation #summerbody #bikinibody #australianbeautyclinic #breastlift #medical #breastsurgery #breastsimplants #breastaugmentation #hellogorgeous #australiaclinic #breastsurgery #aestheticsurgery #confidenceissexy #esteem_aesthetics_aus #dr_pedro_valente (at Australia) https://www.instagram.com/p/BzKfFudD7-R/?igshid=x2ppxgav2ewo
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 […]
If you're considering a breast implant surgery, here are some of the frequently asked questions, recovery, post-op and more answered here.
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 […]
Despite the popularity of breast augmentation surgery, the procedure comes with a number of notable risks. Be fully informed. Learn here.
Women are made of steel. You can bend them, 💪 but they will never break. 😎 Check out this amazing before and after photo of one brave soul. 😊 She had 385cc high profile round implants in our clinic, looking great, right?! if this is something you w… https://t.co/RjiDN9bLLI
Women are made of steel. You can bend them, 💪 but they will never break. 😎 Check out this amazing before and after photo of one brave soul. 😊 She had 385cc high profile round implants in our clinic, looking great, right?! if this is something you w… https://t.co/RjiDN9bLLI
— ESTEEM (@esteemstudio1) April 24, 2019
from Twitter https://twitter.com/esteemstudio1
Looking healthy, stunning and fit. 💪 What a wonderful vibe this post surgery picture gives us! 😍 Thank you @ccmae88 for trusting ESTEEM Cosmetic Studio. ☺️ Our pretty client had 470cc round extra high profile implants. We know that this is j… https://t.co/maeX8t1DeE
Looking healthy, stunning and fit. 💪 What a wonderful vibe this post surgery picture gives us! 😍 Thank you @ccmae88 for trusting ESTEEM Cosmetic Studio. ☺️ Our pretty client had 470cc round extra high profile implants. We know that this is j… https://t.co/maeX8t1DeE
— ESTEEM (@esteemstudio1) April 18, 2019
from Twitter https://twitter.com/esteemstudio1
When a woman gets the support she needs 🤩 incredible things happen! 👍🏽 . An amazing transformation with breast augmentation. 345cc high profile round implants . Improvement is a choice :) DM or call us now for more information 👇 Brisbane all inclu… https://t.co/ggZQmIlo0Z
When a woman gets the support she needs 🤩 incredible things happen! 👍🏽 . An amazing transformation with breast augmentation. 345cc high profile round implants . Improvement is a choice :) DM or call us now for more information 👇 Brisbane all inclu… https://t.co/ggZQmIlo0Z
— ESTEEM (@esteemstudio1) April 15, 2019
from Twitter https://twitter.com/esteemstudio1
If you have it why not flaunt it. Strikingly beautiful @kateeelizabeth_ 420cc extra high profile round implants. Dual plane approach. Been thinking about breast surgery? Call the team on 1300 378 336 and let’s start the journey together. Affordable surg… https://t.co/nHVohGYova
If you have it why not flaunt it. Strikingly beautiful @kateeelizabeth_ 420cc extra high profile round implants. Dual plane approach. Been thinking about breast surgery? Call the team on 1300 378 336 and let’s start the journey together. Affordable surg… https://t.co/nHVohGYova
— ESTEEM (@esteemstudio1) April 14, 2019
from Twitter https://twitter.com/esteemstudio1
There are a number of problems that we can prevent with effective decision-making 🤔 Are YOU ready for an AWESOME TRANSFORMATION? 🤩 Thought of a life-changing Breast Augmentation surgery? 😏😍 . Read the questions and check out our Instagram stories … https://t.co/E9MpCTmNng
There are a number of problems that we can prevent with effective decision-making 🤔 Are YOU ready for an AWESOME TRANSFORMATION? 🤩 Thought of a life-changing Breast Augmentation surgery? 😏😍 . Read the questions and check out our Instagram stories … https://t.co/E9MpCTmNng
— ESTEEM (@esteemstudio1) April 9, 2019
from Twitter https://twitter.com/esteemstudio1