BIA-ALCL Controversy

Breast Implant associated Large Cell Lymphoma of the Breast (BIA-ALCL) has been in the news lately. There is a lot of misinformation regarding this condition and there is some confusion as to whether this is part of the Silicone Implant Disease spectrum. It is not thought to be related to silicone but to the texturing of the silicone shell.

ALCL presents as an unexplained swelling of the breast, typically 5-10 years following breast  augmentation. The seroma can be aspirated and if atypical cells are isolated then the diagnosis of ALCL can be made. Unexplained swelling of the breast following breast augmentation should always be followed up with ultrasound and aspiration if necessary. This can be done through your GP and specialist referral is only necessary if there is a positive finding. 

The treatment of ALCL involves removing the implant and associated capsule  and typically, a second opinion is sought from an Oncologist or Hematologist with an interest in ALCL. For the majority of patients no further treatment is necessary. Indeed, the patient may elect to have the implants replaced.

What are the facts regarding ALCL?

To date there have been 573 cases reported worldwide with 33 fatalities. 481 of these have been associated with Allergan Biocell implants which have subsequently been withdrawn from the market by the company. There have been 107 cases reported in Australia of which 5 have been fatal. 

What then are the risks of developing ALCL?

The disease appears to be related to the degree of texturing of the shell. Macrotextured implants have a reported risk of one in 2,800 to 3,300 breast augmentations. Microtextured implants such as Mentor products, have a much smaller risk profile of one in 80,000 augmentations. Smooth implants have never been reported in association with ALCL.

Why then use textured implants?

I still offer augmentation patients the choice of microtextured vs smooth implants. I believe the textured implants give a better result but that must be balanced by the very small risk of developing ALCL. Interestingly, tissue expanders used in breast reconstruction are all textured implants.

What is the postulated theory of the development of ALCL?

The currently accepted hypothesis is that textured implants encourage the development of a bacterial biofilm around the implant in patients with immune compromised status. 

What have the regulatory authorities recommended?

The TGA has proposed to cancel or suspend the use of a number of textured implants, following on from the Canadian and French regulatory bodies. They will be handing down their recommendations on August 15. None of the regulatory bodies have recommended that patients with any textured device have their implants removed.

Close Menu
×

Cart