Urgent warning given because eight models of breast implants are withdrawn from the market due to the fear of causing CANCER
Eight models for breast implants have been suspended from delivery in Australia for six months and conditions have been imposed on the delivery of all other breast implants and tissue expanders.
The Therapeutic Goods Administration imposed the prescriptions following reports of approximately 100 cases of anaplastic large cell lymphoma associated with breast implants (BIA-ALCL) in Australia, including four deaths.
The TGA on Thursday published the findings of its research into breast implants and tissue enlargers and imposed the suspensions while addressing safety and performance concerns.
In addition to the suspensions, the TGA says that two industry sponsors have canceled the delivery of their highly structured implants and tissue extenders since the review was initiated.
Unused stock of implanted implants is recalled, but the TGA says that removal of implants is not required in a person who has no symptoms or concerns about the "very rare" BIA-ALCL.
The suspensions and cancellations affect 13% of the volume of breast implants on the Australian market.
No tissue expanders used for breast reconstruction after mastectomy are suspended.
The TGA conditions for expanders and non-suspended implants include providing written information to patients and clinicians about the potential risk of BIA-ALCL and mandatory reporting of new cases.
The Australian Society of Plastic Surgeons says the TGA position is in line with society's recommendations.
"These actions provide a balance between minimizing the risk for women looking for breast implants, and at the same time ensuring women who need reconstructive surgery after breast cancer are not limited in their options," President Gazi Hussain said in a statement.
Which implants have been suspended?
* Nagor breast implants Texture filled with gel
* 9-cell CoGel gel-filled Nagor breast implant range – texture
* Impleo gel-filled Nagor breast implant range – texture
* Anatomical breast implants – Textured – High cohesive gel
* Cristaline I Aptex / Vertex Paragel Natural Cohesive Gel implant
* Cristaline Paragel Cohesive Gel implant
* Sublime Line, Microthane, breast gel-filled breast implants
* 4 Two line, single lumen, micro-polyurethane, breast gel-filled breast implants
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