16 Jul TGA moves to finalise the decision on the sale of textured implants in Australia
The Sale of textured Implants In Australia
The Therapeutic Goods Association (TGA) has proposed regulatory action in relation to a number of textured implants.
“Textured Implants are associated with a very rare form of cancer known as Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL),” advises Dr Rohit Kumar (MBBS,MMedSci, FRACS), Specialist Plastic Surgeon at Sydney Cosmetic Surgery. “However the TGA findings currently propose regulatory actions – and they are just that, proposed. No decision has been made to suspend or cancel the relevant products at this time.”
Dr Rohit, an expert in Breast and Body Surgery, and Implant Removal Surgery and regularly featured as a health expert in Channel 7, Foxtel and Netflix programs, as well as in Vogue, Harper’s Bazaar, Woman’s Day and Who magazines, assures current and future patients considering breast implants there is no need for concern unless you have experienced swelling or a lump around the implant or in the armpit.
BIA-ALCL is a rare condition, with expert opinions estimating the published risk at between 1-in-1,000 and 1-in-10,000. As such, experts do not recommend removal of breast implants where there are no problems. It’s also important to note that BIA-ALCL is different and unrelated to breast cancer.
If you notice any swelling or lumps, or you have any other concerns with your implants, please call Sydney Cosmetic Sanctuary rooms for a Free Breast Implant Check.
Further details will follow after the TGA has had an opportunity to finalise its deliberations, so check back in here soon. More information for consumers about breast implants, risks, BIA-ALCL and treatments is available on the TGA’s breast implant hub.
More about Breast Implant Associated Anaplastic Large Cell Lymphoma BIA-ALCL
What is BIA-ALCL?
Breast implant associated cancer, which is also known as Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), is a rare cancer of the immune system. It is not breast cancer, which forms from cells in the breast, but instead a cancer that grows in the fluid and scar tissue that forms around a breast implant. Less commonly, BIA-ALCL can take the form of a lump in the breast or a lump in the armpit.
BIA-ALCL has been known to occur as soon as one year after the operation and as late as 37 years after the operation. The average time to diagnosis is within eight years of the operation.
Who can get breast implant associated cancer?
All reported cases of breast implant associated cancer in Australia involve patients who have had a textured implant at some point in their life. Based on current evidence, experts do not think breast implant associated cancer is related to either the contents (saline/silicone) or shape (round/teardrop) of the implant.
Breast implant associated cancer is rare. Between one in 1000 and one in 10,000 people with breast implants are diagnosed with the condition. In comparison, breast cancer has a risk of approximately 1 in 12 in Australia. Breast implant associated cancer can occur after both cosmetic and reconstruction surgery, with 95% of cases occurring between three and 14 years after the insertion of an implant.
What is the treatment and prognosis for breast implant associated cancer?
In about 80% of cases, the disease is detected in the early stage, with cancer cells found only in the fluid surrounding the implant. Most of these cases are cured by removal of the implant and surrounding capsule. Over the last 10 years, four Australian women have died from breast implant-associated lymphoma.
Usually, both implants are removed 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. If there is a solid lump or the cancer has spread, the patient may require additional treatment such as chemotherapy, radiotherapy or additional surgery. Follow up monitoring may require additional CT scans.
How do I spot the symptoms?
The most common symptom is swelling of a breast caused by fluid build-up around the implant, but in some cases it may appear as a lump in the breast or armpit.
As this is a rare disease, changes in your breast are unlikely to be breast implant associated cancer. For example, swelling immediately after your breast implant surgery is normal. But you should raise all concerns with your surgeon, including the possibility of breast implant associated cancer. surgeon.
What implants are involved?
Textured Implant branded from Allergan, Nagor, Groupe Sebbin, Air Expanders, Eurosilicone, Polytech and Mentor are all currently being considered for cancellation or suspension.
What if I have implants from one of these brands?
Get to know the normal look and feel of your breasts. Self-examine your breasts regularly, such as in the bath or shower, and include your armpits and up to your collarbone.
If you think there are any changes, or if you have any concerns, see your doctor. Discuss with your surgeon whether in your case there should be any longer term monitoring.
Should my implants be removed even though I have no symptoms?
Breast implants are not lifetime devices, regardless of breast implant associated cancer. 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.
Breast implant associated cancer is rare, but the risk is higher with certain types of breast implants. If you do not remember whether your implants are smooth or textured, or what brand they are, your surgeon or the clinic that holds your operation record should be able to advise you on these details.
It is best to discuss with your surgeon what they would recommend in their clinical opinion given the type of implant you have and the benefits versus risks of removal of implants in a healthy person with no symptoms. You can seek a second opinion to help you decide on options, or if you are unsure or concerned about the advice you receive from your surgeon.
What if I am currently undergoing Breast Cancer Reconstruction with an expander?
BIA-ALCL appears to present after long term placement of textured implants. The average time being eight years. Air Expanders (or breast expanders in general) usually stay inside a patient for between 3-6 months. There are currently no reported cases of BIA-ALCL arising from someone using a breast expander.
If you are currently using an expander, continue to do so until you have reached your goal size etc. You will need to discuss with your surgeon, your options following this as these options may now be more limited or different to when you started the expansion process.
What if I had surgery planned in the next month?
Discuss your choice of implants with your surgeon. You may find that the implants recommended for you may be in the proposed suspension category or the cancellation category. You will need to discuss with your surgeon what this means for your personal circumstance. In some situations, you may choose to delay your surgery until definitive decisions by the TGA have been made.
I have a lump in my breast, should I get investigated for BIA-ALCL?
All breast lumps should be investigated irrespective of whether you have implants or not.
If you develop swelling of an implanted breast your doctor will send you for an ultrasound scan to see if this is due to a fluid collection. If fluid is present it will be removed and sent to the laboratory for analysis.
Most fluid collections are not ALCL, but the laboratory test will be able to tell for sure. Mammograms are not helpful for diagnosing ALCL. Other investigations such as MRI and CT-scans would typically be done if the laboratory analysis of the fluid confirms a diagnosis of ALCL.
I had my surgery overseas or by a non-plastic surgeon or I can’t contact my surgeon, what can I do?
If the surgeon or clinic which performed your original implant operation is no longer available, you should see your GP for referral to another surgeon.
Dr Kumar and his team offer a free breast implant check for women who may be concerned and not have a potential referral source.
How can I know more?
Call Sydney Cosmetic Sanctuary rooms on 1300 267 726 to make an appointment with Dr Kumar. Email an enquiry to [email protected]. Send us a message via our website or through our social media channels on Facebook and Instagram.