TGA announcement on Textured Breast Implants
What is the proposed ban?
The TGA announced on 11th July 2019 completion of their review and laboratory assessment of textured breast implants available on the Australian market. TGA issued an updated announcement of proposed regulatory actions around all textured implants currently available in Australia(except Motiva), including:
- ceasing availability of all textured breast implants and expanders in Australia. This will not affect any device already implanted (however we are concerned that patients may request removal);
- cancellation of Allergan (Natrelle implants & expanders);
- suspension for six months of textured implants from Nagor, Emagin, Aeroform (AirXpanders), Eurosilicone (Cristaliine), Polytech, J&J (Siltex implants & Mentor expanders).
What is Breast Surganz, the Society for Australia and New Zealand Breast Surgeons, position on breast implants?
Our society supports the TGA ban on macrotexture and polyurethane implants (Grade 3 and 4 implants), following recent decisions in France and Canada – but not on microtexture expanders and implants, which have high volume use throughout Australia for immediate breast reconstruction post mastectomy.
Ultimately, we understand it is the role of the TGA to ensure the safety of the public, which is of paramount importance also to our Society. However we do not support the suspension of microtextured implant and expander options, including the following concerns:
- Detrimental impacts that the proposed suspension would have on patients needing a mastectomy and reconstruction during the 6 month suspension period, and the effect of this stop on implant supply on patients completing reconstructions that are in progress, or patients who develop ruptures and other complications in their existing anatomical implants;
- Reducing treatment options during the suspension period for immediate implant reconstruction, limiting results for the patient where implants allow skin and possibly nipple preservation for a staged reconstruction;
- Despite no recall currently being mandated, many patients are likely to request removal of the suspended implants. This would add a significant burden to the public and private hospital breast surgery sectors, and an increased risk to patients undergoing any unnecessary operations.
- If the suspension subsequently progresses to cancellation of the microtextured devices, serious longterm limitation of patient choice in breast cancer treatment choices may result, including alternate options which each carry their own significant risks. Considering the risk of ALCL solely is not taking into account the full risk profile of implants. ALCL is only one very rare risk of implants, and there are many other potential complications, which have been acknowledged and accepted by doctors and their patients making informed decisions on individual treatment plans based on best evidence practice.
- If people are worried following their breast implant surgery, they should see their GP or the surgeon who did the implant. This is particularly important if they notice swelling around their implant more than six months after having the breast implant (regardless of how many years later)
A check up and examination including ultrasound can assist.
There is no need for implants to be removed.
For any concerns, please book an appointment with our breast surgeon, Ms Ruth Bollard MBChB M.Sc FRCS FRACS, General Surgeon, Breast and Endocrine Specialist by calling (03) 5330 5900 or emailing firstname.lastname@example.org