Thursday, July 18
I've heard in the media that textured breast implants may be banned in Australia? I'm worried about the safety of my own breast implants!! What should I do?
It's likely you have seen or heard recent media reports about a proposed ban or cancellation of some implants and a 6 month suspension on other textured breast implants announced by the TGA or Therapeutic Goods Administration on 11 July 2019.
What do I need to know?
As of today's date 18 July there is currently no ban on textured implants, rather a notice of intent to manufacturers of textured breast implants that they have until the 24th of July to respond to the TGA proposal.
How can I find out what type of breast implants I have?
- If you are a patient of Dr Eddie Cheng's please contact our rooms and we can provide this information to you from your patient record.
- Other patients should contact their original surgeon
- If your Australian surgeon is no longer in practice, contact The Australian Breast Device Registry via the link here.
- If you can recall the hospital where your surgery was performed you can also try the Health Information Records Department at the relevant hospital.
- If you can recall the brand of breast implant you have, let your plastic surgeon know and they can also try to track this information down via the breast implant manufacturer.
How many cases of BIA ALCL have been found in Australia and Worldwide?
While still alarming and important that patients be well informed, the risk of BIA ALCL is still considered rare. As of February 2019 the current statistics are:
- 99 total cases of BIA ALCL in Australia
- Of those 99, there have been 4 deaths.
- 688cases of BIA ALCL world wide with 17 confirmed deaths.
Why is the TGA cancelling or suspending texturing implant?
Studies have found a link between textured implants and the increased risk of developing Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA: ALCL). Here are some of the facts we do know:
BIA-ALCL is not breast cancer—it is a type of non-Hodgkin’s lymphoma (cancer of the immune system), that affects lymphocytes (immune cells), typically taking between 8-10 years to develop.
Individuals who have been implanted with textured breast implants at some point during their clinical history have a risk of developing BIA-ALCL. Other factors that may contribute to a diagnosis of BIA ALCL include:
- patient factors such as genetics
- bacterial contamination (Dr Cheng uses the 14 point plan to reduce bacterial contamination during surgery)
- chronic irritation
Currently all breast implant manufacturers have until the 24 of July 2019 to submit their position for the continued use of textured breast implants. Until this time textured implants and tissue expanders are still available for use in Australia.
Does Dr Cheng Use Textured Breast Implants?
Where possible Dr Cheng uses smooth breast implants, however, in certain cases such as breast reconstruction and other situations textured implants may be more suitable to achieve an adequate result. In this instance Dr Cheng will discuss the options and risks and if necessary he will utilise the least textured breast implant option available.
What are the different breast implant surfaces in order of most textured to least textured?
- Polyurethane more commonly known as furry brazilians - highest level of texturing and therefore highest risk of BIA ALCL.
- Macro-textured (heavily textured silicone surface) for example some brands of Allergan breast implants.
- Mirco-textured (less textured silicone surface) (eg. mentor siltex)
- Smooth (eg. mentor smooth round, motiva ergonomix and motiva progressive) thought to carry little or no risk of BIA ALCL.
You can find a comprehensive list of textured implants that may be included in this cancellation or suspension via the TGA website here.
Should I have my textured breast implants removed?
If you don't have any signs or symptoms the TGA and other international experts are NOT advising removal of textured breast implants.
What symptoms should I watch for?
- Any swelling or changes in size of the breast
- Breast lumps
Where is BIA ALCL found?
You can learn more about BIA ALCL assessment and treatment in a previous article here.
Typically the majority (85%) of BIA-ALCL cases have been found in a collection of fluid called a seroma. The fluid is commonly contained within the cavity between the breast implant itself and the scar tissue or capsule that forms around the breast implant. Occasionally a mass or tumour can grow which may indicate a more advanced case and which may require more extensive combinations of treatments.
Image Credit: https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl
How is BIA ALCL Treated?
- In most cases treatment involves removal of the breast implant and surrounding fluid and capsule.
- A small number of more advanced cases may require multi-modality treatment involving surgery and oncological treatments such as chemotherapy and or radiotherapy.
How often should I have my breast implants checked?
More regular monitoring is suggested if you have polyurethane or textured implants. Further information about monitoring will be updated in the future once there is a recommended protocol. For now Dr Cheng would advise:
- Texture breast implants - annual check ups
- Smooth breast implants - every 2 years
What about other countries?
Other countries like France and Canada have not restricted minimally textured breast implants or tissue expanders.
What should I do now?
It is best to make an appointment with your original surgeon (preferably a Specialist Plastic Surgeon) to discuss concerns relevant to your specific breast implants.
Does Dr Cheng see patients who have had their surgery elsewhere?
Dr Cheng and our team do see patients who have had their surgery elsewhere, however you do require all of your breast implant information and surgery notes. We recommend obtaining a referral from your GP and possibly an Ultrasound Scan prior to your appointment. Our friendly team can guide your through what is needed.
Where can I find more information?
You can read more information about textured breast implants and BIA ALCL via the TGA Breast Implant Hub link here.
The Australian Society of Plastic Surgeons also have a patient information sheet you can read - you can read it here.
The Australian Society of Aesthetic Plastic Surgeons statement is here.
Or visit our Breast Augmentation and Implant page
Dr Eddie Cheng is a board certified Specialist Plastic Surgeon in Brisbane, Australia. Socialise with us @arplasticsurgery to learn more about Dr Eddie Cheng and our Team.