PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is taking regulatory action in relation to all un-implanted breast implants and tissue expanders sold in that country.
Those actions include suspension and recall of products, removal from the market and additional requirements for supply of products.
The TGA reviewed information from extensive laboratory testing and statistical review of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) cases in Australia. The agency considered evidence submitted by sponsors and manufacturers of breast implants and tissue expanders, advice from the Breast Implant Expert Working Group, and submissions and information from other stakeholders and patients.
The report comes on the heels of roughly 100 cases of BIA-ALCL in Australia.
The TGA stressed that these actions apply to all un-implanted breast implants. It does not recommend removal of devices if patients don't have symptoms of BIA-ALCL, because the risk of undergoing surgery could exceed that of developing the disease.
Effective Oct. 25, the agency has suspended eight models of breast implants from the market for six months. No models of breast tissue expanders were suspended.
The affected manufacturers include Allied Scientific Products Pty. Ltd., Emagin Pty. Ltd., Euro Implants Pty. Ltd. and Jt Medical Pty. Ltd. These suspended implants are all macrotextured grade 3 and 4 and some microtextured implants associated with higher incidences of BIA-ALCL and other clinical concerns.
The move means these devices will not be able to be imported, exported or supplied within Australia while the TGA works with sponsors to ensure the devices meet all the necessary requirements for patient safety.
"A suspension can be withdrawn early if the sponsor can address concerns to the TGA's satisfaction," the agency said. However, if concerns persist, the suspension may be extended or the entries of the device on the Australian Register of Therapeutic Goods may be canceled. No new patients will be implanted with these devices.
Any stock of these un-implanted devices will be recalled during the suspension period.
The suspensions represent roughly 13% of the supply of breast implants on the Australian market.
In addition to these suspensions, some sponsors elected to remove their implants from the market. These include the Allergan Biocell macrotextured breast implants and tissue expanders and the Emergo Airxpanders Aeroform tissue expanders.
In addition, the TGA has put in place new conditions on supply that sponsors and manufacturers are required to meet for all breast implants and tissue expanders. These new requirements of supply include:
- All cases of BIA-ALCL must be reported to the TGA by sponsors within 10 working days of becoming aware of the adverse event;
- Sponsors must submit reports every six months that include supply data and detail all adverse events and complaints received regarding breast implants and tissue expander devices, both in Australia and worldwide, including BIA-ALCL, capsular contracture or rupture of the implant;
- To promote clinician awareness, the risk of BIA-ALCL must be included in the instructions for use of all breast implants and tissue expander devices; and
- All breast implants and tissue expander devices must have a patient information leaflet that includes information about warnings and risks associated with the product; in addition, information relating to the Australian Breast Device Registry also must be included to support ongoing reporting and monitoring.
The TGA said that based on its reports, available evidence indicates that while causes are likely to be multi-factoral, BIA-ALCL is more likely to occur in implants with a greater surface area and roughness of their wall. The degree of texturing in the surface is a result of the materials used in the production of the device or the manufacturing processes.
The TGA said it is "taking are a precautionary approach and suspending particular breast implant devices which have a higher degree of texturing, or a higher risk of BIA-ALCL, or deficiencies in evidence to demonstrate the manufacturer has adequate risk detection and mitigation measures in place."
Over the past few years, there has been a change in the type of breast implants used in Australia with a decrease in macrotextured implants and an increase in supply of microtextured and smooth implants. The suspensions imposed by the TGA do not affect the supply of the smooth implants available. To date, there are no known cases of BIA-ALCL in Australia when only smooth devices were implanted.