Therapeutic Goods Administration

Allergan textured Breast Implants no longer to be used

25 July 2019

Textured breast implants and tissue expanders made by Allergan are being recalled from sale globally.

These implants have been linked to anaplastic large-cell lymphoma (ALCL), which is a rare cancer of the immune system.  It is not breast cancer, but can develop adjacent to a breast implant.  In most cases, removing the implant and the capsule around it cures the disease.  The main symptoms patients should be aware of are an unusual swelling and/or fluid accumulation in the breast or around the implant.  If any of these symptoms occur please see your Specialist Plastic Surgeon.  Your surgeon knows the details of your implants and will assess you and if appropriate perform tests which may include a biopsy or draining the fluid and sending it for specific testing.  A delay in diagnosis has been shown to have poorer long term outcomes.

ALCL has occurred associated with implants placed both for cosmetic breast enlargement and with those used for reconstruction after mastectomy for breast cancer.  It has also occurred in implants that are filled with silicone or saline.  Whilst there are several hypotheses, why this texturing leads to cancer in some patients is not known.

The lymphoma is rare, given that millions of women have breast implants.

Women who have these implants, but no symptoms, do not need to have them removed. The recall means that doctors and hospitals should not implant any more of the devices and should return any on their shelves to Allergan.

“Patient safety is a priority for Allergan,” the company said in a statement, “and patients are advised to speak with their plastic surgeon about the risk and benefits of their implant type should they have any concerns.”

Although several companies make textured implants, a great majority of the lymphoma cases have occurred in women with the Allergan products and the Australian Society of Plastic Surgery supports their withdrawal from the market.

GA consulatation on definition of cosmetic Oct 2013

ASPS commented on a proposal to include definitions, such as cosmetic use and/or personal care use, in the Poisons Standard (SUSMP) to better define these terms and their intent and purpose. Dowload ASPS letter to the TGA.

The consultation is open until 1 November 2013.

 

Feasibility of a new to market risk communication scheme submissions

The TGA has concluded a round of consultation on the feasibility of a new to market risk communication scheme. Read more about the outcomes of the consultation.

Visit the TGA website to view other submissions.

 

Report adverse events to the TGA

The TGA’s new reporting system makes it easier to tell the TGA about problems with medical devices. The new reporting system consists of a number of forms with easy-to-follow instructions.

Visit the TGA website to download forms.

Once an Adverse Event Report (AER) is submitted, it is placed in the Incident Reporting and Investigation Scheme (IRIS) database. A risk assessment is then conducted and a decision made on what level of investigation is needed. The most serious adverse events are given the highest priority.

Contact IRIS on 1800 809 361 or by email iris@tga.gov.au.

 

Anaplastic Large Cell Lymphoma

Anaplastic Large Cell Lymphoma (ALCL) is a rare cancer of the immune system that can occur anywhere in the body. Since 2009, ASPS has been in discussion with TGA, FDA and the American Society of Plastic Surgeons to monitor the incidence of ALCL.

Visit the TGA website for further information.

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