Eight breast implant models have been suspended from supply in Australia for six months and conditions have been placed on supply of all other breast implants and tissue expanders.
The Therapeutic Goods Administration has imposed the regulations following reports of about 100 cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in Australia, including four deaths.
The TGA on Thursday released the findings of its review into breast implants and tissue expanders and has imposed the suspensions while safety and performance concerns are addressed.
As well as the suspensions, the TGA says two industry sponsors have cancelled supply of their highly textured implants and tissue expanders since the review was initiated.
Unused stock of the implants suspended from supply is being recalled, but the TGA says removal of implants is not required in a person who has no symptoms or concerns of the “very rare” BIA-ALCL.
The suspensions and cancellations affect 13 per cent of the supply of breast implant devices on the Australian market by volume.
No tissue expanders, which are used for breast reconstruction surgery following mastectomy, have been suspended.
The TGA conditions placed on expanders and non-suspended implants include providing written information to patients and clinicians about the potential risk of BIA-ALCL and mandatory reporting of any new cases.
The Australian Society of Plastic Surgeons says the TGA’s stance is in line with the society’s recommendations.
“These actions balance minimising risk for women seeking breast implants, while also ensuring women who require reconstructive surgery following breast cancer aren’t restricted in their options,” society president Gazi Hussain said in a statement.
The suspended products are:
* Nagor Mammary Implants Gel-filled-textured
* 9-cell CoGel gel-filled Nagor mammary implant range – textured
* Impleo gel-filled Nagor mammary implant range – textured
* Anatomical Breast Implants – Textured – High Cohesive Gel
* Cristaline I Aptex/Vertex Paragel Natural Cohesive Gel Implant
* Cristaline Paragel Cohesive Gel Implant
* Sublime Line, Microthane, Silicone gel filled Mammary Implants
* 4Two Line, Single Lumen, Micro Polyurethane, Silicone gel filled Mammary Implants.