TGA Breast Implant Recall

Patient Information and Concerns about  textured or polyurethane implants.

As with all medical alerts it is important that you are informed of the facts, the risks to you personally and what the authorised medical authorities are recommending. Me Clinic has always prided itself on putting the patient first and therefore it is important that you understand we are on your side and here to help you through these uncertain times.

What is the alert about?

It is very important you understand that this alert only refers to textured or polyurethane implants. Medically referred to as BIA-ALCL, this usually involves a swelling of the breast, typically 3 to 14 years after the operation to insert the breast implant. This swelling is due to an accumulation of fluid. Less commonly, BIA-ALCL can take the form of a lump in the breast or a lump in the armpit.

According to the TGA this is considered a rare condition with expert opinions estimating the published risk of BIA-ALCL at between 1-in-1,000 and 1-in-10,000. Although fatalities have been recorded, the vast majority of BIA- ALCL are cured by removal of the implant and the capsule surrounding the implant.

It is important that you understand this is a RARE condition and can be treated through early detection and treatment. Because this is a rare condition, experts do not recommend removal of breast implants where there are no problems with the implant.

Information for consumers about this condition (BIA-ALCL), its symptoms and treatments is available on the TGA's breast implant hub. This can be accessed by visiting: https://www.tga.gov.au/hubs/breast-implants.

Is this Cancer associated with all textured breast implants?

Once again it is important to note this is considered a rare condition. Other facts you should be aware of is that since 8 of April 2019 there has been 76 reports of BIA-ALCL in Australian women, noting that there is between 13,000 to 17,000 breast implant procedures performed every year in Australia. This gives a clear indication to how rare this condition is.

At Me Clinic we will continue to monitor the reported results and actions that are needed to be taken as indicated by the TGA. As part of our 'Patient First' policy we will ensure, where practically possible, you have all the facts necessary to make an informed decision about what the steps are if you feel concerned.

I am a me clinic Patient, what should I do?

The first thing we would like to tell you is that we have developed an approved approach that contains a series of steps to deal with this issue and associated condition. Please continue to keep in mind this is considered a rare condition to date and there is no need to feel concerned. However, if you have concerns or feel anxious we encourage you to book an appointment with Me Clinic (1300 852 525) and we will give you a priority appointment so we can address your concerns. Please read the approach we have outlined below first.

Not a me clinic patient?

We can still help you. Even if you are not a me clinic patient we can assist you. Simply call our office on 1300 852 525 and speak to one of our staff.

me clinic Approach

Step 1:

Through either direct contact or via email we provide the necessary information to alert all at risk patients of the TGA warning and actions.

Step 2:

As this is an acknowledged rare condition we provide the information necessary to allow patients to make a self assessment.

Step 3:

Priority appointments. We have set aside some priority appointments to address any concerns from patients who either present with the described symptoms or feel overly anxious or concerned. We may in the first instance assess you via the phone to ensure we understand what the situation is and then determine whether an appointment is necessary.

Step 4:

If symptoms are identified prior to your appointment then we will arrange a time to meet your surgeon and have an MRI so that we could determine the situation further.

If concerned at all then please come to see your surgeon for examination and information.

The next steps

BIA-ALCL is more likely to occur in rougher surfaced implants, and the TGA is proposing to either cancel or suspend particular products. There are alternative smooth implants available and these have not been associated with known cases of ALCL in Australia.
Because the risk to women who already have these implants is very low, experts do not recommend that women who already have them need to have them removed unless there is a confirmed diagnosis of ALCL.

The proposed action by the TGA does not change this advice. If you have concerns you should speak to your surgeon.

The expert group confirmed that the breast implant associated cancer is rare. Since the 8 April 2019 the TGA has received 76 reports for BIA-ALCL in Australian women, noting that between 13,000-17,000 breast implant procedures are performed in Australia each year

How do I find out more ?

Please contact the me clinic by our contact us page, email or by telephone. One of our staff will talk you through the issue. Our aim is to ensure you will be fully informed and understand your risks and options.

Frequently Asked Questions (TGA Website):

Why hasn't the TGA immediately banned these breast implants?

There are a range of types of textured breast implants supplied in Australian. By compelling suppliers to provide additional information specific to the Australian market, the TGA can make well informed decisions about safety of particular types of implants. Suppliers have 10 working days to respond to the request for information. After receiving this information the TGA will consider action to suspend or cancel particular products.

The decision by the French regulator appears to be based on events described to them from patients and doctors as well as data published about three implants, which has been extrapolated to other products. Other regulators, including those in the US, Germany and the UK are also seeking additional evidence on the risk of BIA-ALCL, and we are working closely with these regulators.

Patients who have breast implants should expect that the regulator makes decisions based on sound scientific and medical evidence.

Textured implants of varying roughness are used in 82% of operations in Australia. They play an important role in reconstructive surgery. Smooth implants are an alternative but they may require a higher rate of replacement reoperation due to greater rates of contracture of these implant.

The international consensus is that there is no evidence supporting the removal of breast implants in the absence of properly diagnosed BIA-ALCL.

Should breast implants be removed just incase?

Because breast implant-associated ALCL is rare, experts do not recommend removal of breast implants for women who have no problems with the implant. If you are concerned you should discuss your options with your doctor.

Generally, breast implants are not lifetime devices regardless of breast implant-associated ALCL. Typically they are removed after 10-15 years. The longer you have the implant, the more likely it will need to be removed. Common reasons for removal are contracture (hard or painful implants) or movement of the implant.

What is the prognosis and treatment of breast implant-associated ALCL?

Most cases are cured by removal of the implant and capsule surrounding the implant. Usually your doctor will remove both implants, even if breast implant-associated ALCL has only occurred in one breast. This is because there is a small but real risk that breast implant-associated ALCL can develop in the opposite breast. Sometimes there is a solid lump (not just fluid). In these cases, chemotherapy or radiotherapy may be required.

Over the last 10 years, three Australian women have died from breast implant-associated ALCL.

The management of breast implant-associated-ALCL is multidisciplinary with all patients requiring a referral to a surgeon experienced with breast implants and the involvement of a haematologist who specialises in lymphoma, for initial and ongoing investigations and management.

Important references and links

All our information is based on the details, research and requirements of the TGA and its associated bodies. Listed below are the sources of information and regulatory requirements that have been made available to us via the TGA, which we have used for this article. We will endeavour to update this information on a regular basis.

SOURCE: Therapeutic Good Administration Website dated 11 July 2019.

LINK: Therapeutic Goods Administration official warning and information

DEFINITION: BIA-ALCL = Breast implants and anaplastic large cell lymphoma

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