As we have continued to monitor the situation of breast implants and their risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), textured implants have seemed to stay at the forefront of the issue. We know that several countries outside of the United States have banned this type of implant due to the conclusion that the risk is too high, but the FDA has not made that conclusion yet.
Textured Breast Implants Ban in Australia
We have previously been aware of bans on textured implants in France and Canada. Now, Australia is joining in. The article, “Australian ban on textured breast implants recommended over apparent cancer link“, gives us more information. Australia’s Therapeutic Goods Administration (TGA) has proposed regulatory action, similar to that of Health Canada, that prompts cancelling, suspending, or recalling implants. Reportedly, the Australian government is in support of this decision by the TGA, according to the health minister.
One of the manufacturers we often discuss, Allergan, used the TGA’s regulatory action in review with a type of their textured implants called Natrelle Biocell. This is the same type of implant that Canada so heavily warned about. You can read more about Canada’s ban on textured breast implants in our previous article, “Textured Breast Implants Ban: Will the FDA Reevaluate?“
There has apparently been no recommendations from health authorities in Australia suggesting that women should get their textured implants removed as a precaution.
Implants up for Suspension
From a recent article by The Sydney Morning Herald, “Breast implant ban, recall proposed by TGA“, there is a chart which provides us with the breast implants currently at proposed suspension from the TGA. Here are the brands, device numbers, and products that also appear in the U.S.:
Sponsor (Manufacturer): Johnson & Johnson Medical Pty Ltd (Mentor Medical Systems BV) Device Number: 110588 Product Name: Siltex Round Cohesive I
Sponsor (Manufacturer): Johnson & Johnson Medical Pty Ltd (Mentor Medical Systems BV) Device Number: 110589 Product Name: Siltex Round Cohesive II
Sponsor (Manufacturer): Johnson & Johnson Medical Pty Ltd (Mentor Medical Systems BV) Device Number: 110592 Product Name: Siltex Round Becker Cohesive I
Sponsor (Manufacturer): Johnson & Johnson Medical Pty Ltd (Mentor Medical Systems BV) Device Number: 119809 Product Name: Siltex Contour Becker Cohesive II
Sponsor (Manufacturer): Johnson & Johnson Medical Pty Ltd (Mentor Medical Systems BV) Device Number: 130678 Product Name: Siltex Contour Gel Breast Implants Cohesive III
Sponsor (Manufacturer): Johnson & Johnson Medical Pty Ltd (Mentor Medical Systems BV) Device Number: 226977 Product Name: Mentor® CPX™4 Breast Tissue Expander
Sponsor (Manufacturer): Johnson & Johnson Medical Pty Ltd (Mentor Medical Systems BV) Device Number: 226982 Product Name: Mentor® CPX™4 with Suture Tabs Breast Tissue Expander
Now that other countries are increasingly speaking out about the associated risk between textured breast implants and BIA-ALCL and studies are there to support these notions, maybe it’s time for the FDA to make some decisions to cut the leniency and ban these harmful products.
We encourage you to visit our Breast Implants Lymphoma Cancer page on our website for more information and submit a free case evaluation if you or someone you know has been diagnosed with BIA-ALCL.
Written by: Laura Beasley, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Breast Implants: Lymphoma / Blood Cancer Cases Overview
Free Breast Implants Case Evaluation
Previous articles on this topic:
- When Might The FDA Ban Textured Implants In The US?
- FDA Fails When It Comes To Banning Textured Breast Implants
- Textured Breast Implants Bans on the Rise
- March 2019 FDA Meeting On Breast Implants: A Summary Of What You Need To Know
- Breast Implants FDA March 2019 Meeting: Lymphoma Cancer Was A Main Topic
- 2019 Discoveries and Warnings on Breast Implant-Associated Lymphoma