With so many women in our community concerned about the recent news cycle regarding textured implants and the subsequent Therapeutic Goods Administration (TGA) action, we thought it appropriate to provide an update on the latest developments with regards to the potential ban of textured breast implants and tissue expanders.
The TGA called for a review into textured implants back in July. The review is a result of what the medical professionals deem to be an apparent link between some textured implants and a very rare form of lymphoma called Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
Across the industry – including manufacturers, industry bodies including the many breast oncology surgeons and plastic surgeons’ associations and patient advocacy groups, submissions have been put forward to the TGA to consider in light of the suspension of many key products, including the only tissue expander currently used in Australia.
Broadly speaking, every submission covered the same key issues:
- Readdressing need for breast reconstruction surgery not to be categorised as cosmetic surgery
- Highlight that a ban on all textured implants would seriously impact upon a woman’s options for immediate breast reconstruction
- Highlight that the risk of BIA-ALCL is lower with micro textured expanders and implants than we macro textured options
- Advocate for the use of micro-textured devices to be available so that women with breast cancer or prophylactic needs have appropriate implant reconstruction options available
- Consider and address the implications for women who currently already have textured expanders or implants in place as a result of prophylactic or reconstructive surgery following cancer treatment
- Strong call for the TGA to carefully consider its messaging to the broader public if and when bans are implemented to ensure women feel safe, secure and well educated about their options both should they require future reconstruction as well as for patients who currently have the potentially banned implants or tissue expanders
Where to from here?
The TGA has prioritised the review and is expected to provide a response to all submissions received and consider what best next steps will be taken, as well as if further regulatory action is required.
- BIA-ALCL is most likely to occur in rougher surfaced implants, and the TGA is proposing to cancel or suspend particular products
- Smooth implants are available and there are no known cases associated with these and BIA-ALCL
- Breast implant associated cancer is rare. The TGA advises that between one in 1000 and one in 10,000 people with breast implants are diagnosed with the condition. Your risk is dependent on the type and texture of your implant
What should women do?
- Due to the low risk of developing BIA-ALCL, it is not recommended that women with textured breast implants who have no symptoms have them removed
- Pink Hope recommends that women who do have a textured breast implant speak with their breast surgeon or plastic surgeon about the implications for them.
- If you are unsure of what brand and texture grade of implant you may have, you can contact your surgeon or the hospital where your surgery was performed to find out. More information is available from the TGA’s website.
- Should you notice any sudden changes around your implant including swelling or a lump, notify your doctor immediately.
- The TGA has advised that any scans required to investigate for suspected BIA-ALCL will be eligible for a Medicare rebate.
- It is also important to note that implants are not designed to last forever and will need to be replaced after about 10 – 15 years.
- Pink Hope recently hosted an implant-based reconstruction webinar, with Dr Jane O’Brien. Dr O’Brien discusses the recent TGA findings as well as BIA-ALCL within. You can watch it here.
- Should you be concerned about your implants and are looking for advice and support, please contact firstname.lastname@example.org