Plastic Surgeons support TGA regulatory changes for breast implants and tissue expanders
The Australian Society of Plastic Surgeons has commended the TGA’s regulatory changes following its review of breast implants and breast tissue expanders as a sensible and measured response that will improve safety of women whilst preserving options for women, particularly those requiring reconstructive surgery following breast cancer treatment.
The TGA (Therapeutic Goods Administration) review followed reports of around 100 cases of Breast Implant-associated Anaplastic Large Cell Lymphoma in Australia (BIA ALCL) including four deaths.
Today the TGA announced it would take regulatory action on all breast implants and breast tissue expanders currently included in the Australian Register of Therapeutic Goods (ARTG). Eight models of implants have been suspended from supply.
Two industry sponsors have cancelled the supply of their highly textured implants and tissue expanders since the review was initiated. No tissue expanders, which are used for breast reconstruction surgery following mastectomy, will be suspended.
Conditions have been placed on all implants and expanders. These include written information to be provided to patients and clinicians regarding the potential risk of BIA ALCL, and mandatory reporting of any new cases.
“The TGA’s position is broadly in line with the Australian Society of Plastic Surgeons’ recommendations and we consider this a reasonable outcome”, says ASPS President, Associate Professor Gazi Hussain.
“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.
“We have not opposed the suspension of the macro-textured breast implants as emerging data shows these represent the most common association with ALCL.
“However, we are pleased that micro-textured, grade 2 breast implants remain available to women. The associated risk of ALCL with micro textured implants remains low and if detected early is typically curable.
“We support the TGA’s advice that it is not necessary for asymptomatic women to have implants removed. However, we remind women of the importance of monitoring their breasts for any changes such as swelling and to contact their doctor if this occurs,” says Associate Professor Hussain.
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