Update on Mentor Implants / ALCL

Please find below updates announced by the TGA regarding textured implants.

Posted: July 12th, 2019

Posted In: Uncategorised

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BIA-ALCL back in the news

BIA-ALCL is back in the news following the TGA’s announcement yesterday. At the outset, it is important to state that there has been no new information and no changes to established investigation and treatment protocols.

Under section 42 of the Therapeutic Goods Act 1989 the TGA has formally requested textured implant suppliers provide detailed information and samples of the implants for analysis before considering whether to suspend or ban the products.  Suppliers have ten working days to respond.

After receiving information from suppliers, [the] TGA will consider whether to suspend or cancel particular products from the Australian Register of Therapeutic Goods.

Which implants are in question?

In France, macro-textured and polyurethane models of implants made by six manufacturers: Macro-textured Natrelle implants by Allergan; Monobloc textured implants by Arion; Silicone textured implants by SEBBIN; GFX, IMPLEO and COGEL implants by Nagor; MATRIX implants by Eurosilicone; and POLYtxt, Sublime Lime, Microthane and Diagon\Gel® 4Two implants by Polytech.

The ANSM (French regulator) banned these products following hearings in February. Canada Health (the Canadian Department of Health) issued a statement of its intent to ban Biocell implants which are the only macro-textured implant on this list available in Canada http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/69520a-eng.php.

In the Netherlands, the Dutch Plastic Surgery Association has advised members to suspend use of the macro-textured and polyurethane devices while the Dutch authorities complete further research into them. Other European countries have not followed the French.

Key Points on BIA – ALCL

  • To date, although there are hypotheses, no one can claim to know the exact cause of BIA-ALCL.  The hypotheses with most scientific support involve textured implants, the presence of bacteria, host genetic predisposition, chronic T-cell response with eventual monoclonal proliferation and transformation into lymphoma
  • The updated Australian and New Zealand figures due to be published next month:
    • Show that 70% of ANZ cases are diagnosed before any capsular invasion and a further 7.4% with tumour invading but not through the capsule. This is stage 1 disease.
    • In these cases, complete surgical removal is curative with enbloc capsulectomy and implant removal.
    • Shows the risk for Silimed polyurethane implants 1:2832, Allergan Biocell implants 1:3345 and Mentor Siltex 1:86000.

Posted: April 12th, 2019

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Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Australian Society of Plastic Surgeons FAQs on ALCL 191216 FAQs on ALCL 191216_2

The Therapeutic Goods Administration (TGA) has recently updated the public information on its website about breast implant associated anaplastic large cell lymphoma in consultation with other international regulatory agencies, scientific experts including plastic surgeons, breast surgeons, haematologists, and epidemiologists as well as breast implant manufacturers.

We have known about this disease for quite some time and the TGA has been providing updates since 2011. This most recent update gives a more completed picture of our current understanding of this disease. (more…)

Posted: January 18th, 2017

Posted In: TGA Alerts

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Malignant Melanoma Removal

This case is a malignant melanoma removal in front of woman’s ear.

The initial mark was a Congenital Naevus i.e. “birthmark”.

It is rare for these birthmarks to become malignant – but it does happen.

The woman was told by several doctors that it posed no problem, even though it had changed, because it was something she was born with.

The take home message is that any changing “mole” should be treated as suspicious and melanoma must be excluded.

Click on the link below to view the images from this procedure.

WARNING! This post contains images of a graphic nature.

Posted: November 14th, 2013

Posted In: Case of the Week

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Significant Breast Asymmetry Corrected

Significant breast asymmetry was corrected with a staged approach with repositioning of the left breast and nipple followed by bilateral breast augmentation. (more…)

Posted: May 23rd, 2012

Posted In: Case of the Week

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Lip Reconstruction

Defects in the lower lip involving more than 50% of the lip need something more complex than a few sutures. In this lip reconstruction case I have “borrowed” tissue (a flap) from the upper lip to repair the large lower lip defect following tumour excision. The bridge carrying the blood supply for the flap is left for 2 weeks. During this time the flap develops a new blood supply and the bridge can be safely divided.

Click on the link below to view the images from this procedure.

WARNING! This post contains images of a graphic nature.

Posted: April 19th, 2012

Posted In: Case of the Week


PIP Breast Implants

Gold Coast Plastic Surgeon Dr Stradwick would like to re-assure his patients that he only uses the highest quality breast implants for his patients. He keeps meticulous records so any patient can contact the clinic and find out exactly what breast implants they have – even if they made the decision not to participate in the breast implant register.

In Dr Stradwick’s opinion the current controversy regarding PIP breast implants is a salient reminder of the inherent risks of breast augmentation. All implants have a risk of rupture with an incidence of approximately 10% over a 10 year period. This is not just a problem confined to PIP breast implants. It does however highlight the vital importance of an ongoing relationship with your plastic surgeon. Plastic surgeon Dr Stradwick has written articles critical of “cosmetic tourism” and the the current PIP problem is yet another reason why the decision to have breast augmentation “on the cheap” is risky. Who knows what kind of breast implants these overseas clinics are using?

Posted: January 12th, 2012

Posted In: Breast Augmentation, Plastic Surgery, X Plastic Surgery Gone Wrong

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Botched Plastic Surgery Operations

The fallout of “Cosmetic Holidays”

As the head of the plastic surgery unit at the Gold Coast hospital, plastic surgeopn Dr Stradwick is increasingly seeing the fallout from “cosmetic holidays”. He has a number of patients waiting on the public hospital waiting list for corrective procedures after “botched plastic surgery”.

The overwhelming majority of problems following any cosmetic surgery but particularly breast augmentation occur in the weeks after plastic surgery. The only real problem that happens in the first few days is bleeding – and this is relatively simple to correct. The other complications are usually much more difficult. Ensuring your surgeon is an Australian trained Plastic Surgeon is your first defence against problems. Australia has some of the toughest training and examination programs in the world. Anyone who makes it through a plastic surgery training program in Australia has to have achieved a certain standard. Other parts of the world are just not like that. Putting your trust in the hands of someone with an uncertain level of training is a risk. (more…)

Posted: October 20th, 2010

Posted In: Breast Augmentation, Plastic Surgery, X Plastic Surgery Gone Wrong

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For Fracs Sake, Before Undergoing Plastic Surgery, Make Sure Your Surgeon is Qualified

Plastic surgery takes origin from the Greek word plastikos – meaning to shape or mould. Plastic surgeons dedicate themselves to the restoration of shape and form. Such loss of form may be a result of birth defects, removal of cancers or accidents. They train for years to do this. By necessity plastic surgeons have a finely honed appreciation of shape and form, combining science with artistry on a daily basis. This places them in a unique position to perform cosmetic or aesthetic procedures that, in essence, are an enhancement of features that already exist.

A perfect example is breast reconstruction. The ability to create a beautiful breast from literally nothing allows a plastic surgeon to use those same skills to improve an existing breast. Similarly, being trained to rebuild a face transfers naturally to rhinoplasty. The same knowledge, skills and appreciation of form are required if you are building a feature or enhancing it. It is therefore of critical importance when considering any type of surgery to ensure your plastic surgeon is appropriately qualified. An analogy I like to use is air travel. We all expect the person flying the plane is a trained pilot. After all, they are responsible for getting the passengers and the plane to the destination safely. How would it feel if we discovered the person at the pointy end was actually a bus driver having a bit of a go? The same applies for cosmetic surgery. You need to make sure that your plastic surgeon is qualified – not a ‘cowboy’. (more…)

Posted: October 26th, 2009

Posted In: Plastic Surgery

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