ATGA to Consider Regulatory Action Around Breast Implants

BIA-ALCL is a rare and highly treatable type of lymphoma that can develop around breast implants. BIA-ALCL occurs most frequently in patients who have breast implants with textured surfaces. This is a cancer of the immune system, not a type of breast cancer.  When caught early, BIA-ALCL is usually curable.

Dr Barnouti

The Australian Therapeutic Goods Association has announced it is considering regulatory action regarding breast implants – which could include cancelling, suspending or recalling certain types of breast implants following an extensive review of an apparent association between Anaplastic large cell lymphoma and some implants.

The TGA’s proposal to ban certain implant products will cause significant concern and panic across the community.

Anyone with breast implants needs to ensure they have their implants checked regularly regardless of the latest announcement by the TGA.

All implants fail at some point.  Now the concern many will have is around breast implant associated sickness.

While many implants are safe, and many women live full and rewarding lives with implants, the latest news will cause worry – and for many unnecessary worry as the risks of developing Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) are very low.

Around 35 million women (60 million implants) in the world with textured breast implants. There are around 700 confirmed cases of BIA-ALCL worldwide. 123 of them in Australia. There are 23 death from late diagnosis of the disease world wide, 5 of them are in Australia. The current lifetime risk of BIA-ALCL is estimated to be 1:1000 – 1:10,000 women with coarse textured implants based upon current confirmed cases and implant sales data over the past two decades.

The majority of the implants that Dr Barnouti uses, that is around 99.5% of the time, are soft textured and considered to be the safest implants in the market. It is also important to put things into perspective by stating the fact that the incidence of breast Cancer of women who do not have breast implants is 1 in 8. Therefore the incidence of BIA ALCL considered to be rare.


One of the main caused of the ALCL is bacterial contamination. We follow strict protocol in minimizing such contamination such as scrubbed the skin with Betadine, use of protective sleeve, IV Antibiotics, change gloves, no touch techniques, wash the pocket with Saline, minimize time of exposure, minimal tissue injuries, careful hemostasis, layered closure and careful atraumatic dissection to minimize devascularised tissue. Our Clinic has not had a reported case of ALCL.

The government  needs to review legislation around breast implants to require people to have annual check-ups from the moment they receive their implants.  Given the latest announcement by the TGA, I feel checkups will also need to be government funded to ensure people are able to meet the cost of the checkups and where treatment is required, such as removal of implants surgery, the cost of such surgery should be covered by health funds and medicare.

Women who received coarse textured round or anatomical implants should have an annual check by their plastic surgeons until more evidence become available. Some women may need to have the implants removed, and or possibly replaced with smooth implants, if they experienced symptoms such as excessive swelling around the breast implants, pain, major asymmetry, breast enlargement, pain, lump in the breast or armpit, overlying skin rash and hardening of the breast.

My advice to women with breast implants is to see their specialist plastic surgeon immediately if they experienced any of the symptoms. If the breast feels normal and asymptomatic, an annual check is recommended.