*UPDATED* TGA breast implant review and worldwide Allergan recall of “Natrelle” textured breast implants
December 20, 2022
September 29, 2019
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By Dr. Andrew Campbell-Lloyd

*UPDATED* TGA breast implant review and worldwide Allergan recall of “Natrelle” textured breast implants

The headlines are pretty scary: “WORLDWIDE ALLERGAN RECALL” and the like. Well, it was only a matter of time I guess before this happened. I am sure that any woman with an Allergan Natrelle macrotextured breast implant must be feeling a significant degree of anxiety, knowing that the very device they have in their breast has now been recalled.

This update hopefully will serve two purposes: firstly, to help allay those anxieties, and secondly, let you know what you can do if you are concerned.

Who could be affected?

I think the first thing to highlight is the fact that for quite some time, the Allergan range of implants were the most widely used in Australia. Many plastic surgeons trained with, and learned the art of aesthetic breast surgery with Allergan “style 410” anatomical breast implants. In some ways, they came to define what “teardrop” or anatomical breast implants were! What this means, obviously, is that there are MANY women with these devices in-situ, so this is not something affecting only a small proportion of Australian women with breast implants. This is a pretty big deal.

The devices in question have been used extensively for both cosmetic and reconstructive procedures. This potentially means that women of all ages, and both women with and without their own breast tissue.

Having said that, we also have to be clear that just because you have an Allergan breast implant, does NOT mean that you are at immediate risk. Please remember that ALCL remains a very rare condition that remains incompletely understood.

Just because you have Allergan implants does not mean that you have, or ever will develop ALCL.

The questions:

I have made a quick list of responses to common questions. There is a huge amount of information circulating already online, and a significant amount of that information is either inaccurate or pure hyperbole. Please, be selective about where you obtain your information.

  1. Please remember that the implants alone are not responsible for ALCL. Other factors in conjunction with highly textured devices are required. Just because you have Allergan implants does not mean that you have, or ever will develop ALCL.
  2. You DO NOT need to have your existing implants removed if there are no findings to support a possible diagnosis of ALCL.
  3. You can however CHOOSE to have your implants removed, or revised. This can be done with, or without a capsulectomy. Should you choose to do so, there may be an item number applicable (provided the capsule is removed), which means that you will have some coverage from private health insurance.
  4. For patients who have implants after breast reconstruction, there are ALWAYS applicable item numbers should you require revision of your existing implants.
  5. If you are experiencing any symptoms that you attribute to “breast implant illness”, it is very important to understand that those symptoms may not in any way be changed/resolved by having your implants removed.
  6. Your first port of call should be your original treating surgeon. We are of course aware that many Australian women have had their breast implants placed either by cosmetic doctors with no recognised specialist qualifications or overseas, and therefore, follow-up is either not possible or not desirable. In that case, ask your GP to refer you to a local plastic surgeon.
  7. Please understand that you will have to cover the costs of any necessary investigations (such as ultrasound or MRI) or consultations if you are uninsured and wish to see a private plastic surgeon (that includes us). These costs will vary from surgeon to surgeon.

I am fortunate that since establishing my own private practice, I have had sufficient awareness of the looming challenge of ALCL. As such, I have never used textured Allergan implants in any form in my own consultant practise.

*UPDATE*

The TGA review has been finalised, and we have seen a range macrotextured devices now withdrawn from the market by the regulator. In addition, there are increased reporting requirements for all implant companies operating in Australia. Importantly however, the regulator has seen fit not to interfere with the sale or use of textured tissue expanders commonly used for breast reconstruction surgery, and a range of microtextured devices remain in use. We have previously, and continue to use nanotextured devices. The breast implants that I choose to use for my patients have no cases of ALCL attributed them worldwide.

We are here to help. For any woman with new onset swelling of the breast after previous cosmetic breast augmentation, seek assistance promptly. If you have concerns, either contact us directly or via your GP.