TGA Recall Notices: What You Need to Do if You Have Received One

The TGA

The Therapeutic Goods Administration, otherwise known as the TGA, is the medical regulatory body in Australia that regulates the supply and use of therapeutic goods and medical products in Australia.

These goods and devices include: -

• medical devices and products such as implants;
• prescription medication;
• vaccines;
• vitamins and minerals;
• blood and blood products;
• sunscreen

From time to time the TGA is notified of a therapeutic good or product that does not meet the required standard in Australia. When this occurs, the therapeutic good or product is recalled.

The recall is aimed to keep the community safe by withdrawing the good or product from the market and notifying those that may have already been affected by its use.

What is a TGA recall?

A recall occurs when a problem is identified with a product already on the market and in use.

Some of the reasons why a product is recalled included, but is not limited to circumstances where the product is: -

• deficient;
• defective;
• not safe;
• of poor quality;
• not effective (does not perform);
• of poor presentation (quality control)

For a therapeutic good or product to be recalled by the TGA significant investigation and testing must have been undertaken prior to its withdrawal from the market. Therefore, all therapeutic goods and product recalls should be taken seriously and acted upon by affected patients immediately.

What do you do if you've received a recall notice?

You may receive a recall notice, or you may be notified by your GP or specialist that a therapeutic good prescribed or a product utilised in your care is subject to a recall.

If you receive a recall notice or are advised of a recall you should: -

• Immediately consult your treating GP or specialist for advice;
• Provide details of any symptoms you have experienced or are experiencing;
• Investigate: blood tests, scans, referrals to specialists;
• Continue to monitor for symptoms and report any changes urgently;
• Call the TGA for further information if required

McInnes Wilson Lawyers has been made aware of TGA investigations into the link between textured breast implants and breast implant associated anaplastic large cell lymphoma (BIA-ALCL) and will provide further information on the developments of the investigation and impact on patients in our next article.

If you believe you have textured implants, you should urgently consult your treating GP or specialist for advice.

For further information consult the TGA website: https://www.tga.gov.au/