Three types of highly textured implants can no longer be supplied or imported to, or exported from, Australia. On October 29, the Therapeutic Goods Administration (TGA) had dropped the following three breast implant entries from the Australian Register of Therapeutic Goods (ARTG), effective October 27, 2020:
- Sublime Line, Microthane, Silicone gel filled Mammary Implants: ARTG/Device Number 171782, manufactured by JT Medical Pty Ltd (Polytech Health & Aesthetics GmbH)
- 4Two Line, Single Lumen, Micro Polyurethane, Silicone gel filled Mammary Implants: ARTG/Device Number 185060, manufactured by JT Medical Pty Ltd (Polytech Health & Aesthetics GmbH)
- Cristaline Paragel Cohesive Gel Implant: ARTG/Device Number 132037, Manufactured by Euro Implants Pty Ltd (Eurosilicone SAS)
The Basis for the TGA’s Decision
According to The Sydney Morning Herald, links to breast implant-associated anaplastic large cell lymphoma (BIA ALCL) have prompted Australia’s medical device watchdog to wipe these implants from the ARTG. This database houses names of all therapeutic goods that can be legally supplied across the continent.
Since October 2019, the affected implants had been suspended pending proof of the safety and performance of the medical devices, as well as proof that manufacturers had resolved the issues that had prompted the implants’ suspension. Based on the information the device sponsors supplied, TGA moved to cancel the implants from the ARTG, rather than revoke their suspension.
TGA advises individuals who have received the cancelled implants to maintain an acute awareness of the symptoms associated with BIA-ALCL. If recipients note they are experiencing any of the symptoms, they should talk to their doctors about any recommended next steps.
BIA-ALCL is a rare cancer of the immune system. It is not breast cancer, but rather a form of non-Hodgkin’s lymphoma that manifests in scar tissue around the implant.
According to TGA, fluid can accumulate around the implant in the fibrous scar capsule, causing the breast to swell. This can happen any time between three to 14 years after the individual receives a breast implant. In the rarest of cases, the cancer can appear as early as one year after implantation and as late as 37 years after the procedure. Sometimes, rather than swelling, an implant recipient will detect a lump in their breast or armpit. If either swelling or a lump are detected, the individual should seek prompt medical attention.
The United States Food & Drug Administration also has taken action on breast implants it has linked to incidents of BIA-ALCL. On September 28, 2020, the agency issued its strongest warning for all breast implant products.
The warning was issued in a guidance document, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication, which details labeling specifications to help potential implant recipients understand the scope of the risks of these medical devices.
Breast Implant BIA-ALCL Lawsuits
As of August 2020, the FDA had documented 733 unique cases of BIA-ALCL, including 36 deaths. Many of hundreds of women who have suffered BIA-ALCL from their implants have filed lawsuits to collect compensation for their injury-related costs, including pain and suffering. Many of these lawsuits target Allergan, maker of the BIOCELL brand of textured breast implants.