Home News & Resources Blog Uncategorised Textured Breast Implants No Longer Available in Europe & Under Scrutiny Worldwide

Textured Breast Implants No Longer Available in Europe & Under Scrutiny Worldwide

IF YOU ARE A PATIENT OF DR HODGKINSON THERE IS NO NEED FOR CONCERN AS HE DOES NOT USE TEXTURED IMPLANTS

France’s National Agency for the Safety of Medicines and Health Products (ANSM) has removed textured breast implants from the market in France & Europe. 1  The US Food and Drug Administration (FDA) has said in the wake of this move that it will further review the situation 1 while here in Australia our own Therapeutic Goods Administration (TGA) has advised surgeons via their “Information for Health Professionals” on the issue that, “The currently available data suggest that the risk might be reduced by using smooth implants.” 2

Textured implants have steadily declined in their usage in the United States, now constituting only 12% of the market according to a recent article in the journal Plastic and Reconstructive Surgery by Dr David Hidalgo.   Dr Hidalgo, a world acclaimed plastic surgeon and expert on breast implants from New York, noted that in the United states, “35% of the implants are smooth walled saline.” Dr Hidalgo continues to say, “it’s a shame it is only 35% because these devices work well despite the popular lay perception. They are ideal for young patients, especially if they want a trans axillary approach. They require no active monitoring and despite the rare premature deflation, our practice has witnessed that saline implants do not change with age and often decades will pass with persistent, durable results.” 3

To date, smooth walled implants have never been associated with the rare but occasionally fatal malignancy ALCL, only textured implants.  In fact, as previously stated the Australian TGA currently states, “…the risk might be reduced by using smooth implants.”4   So why are textured implants still being heavily marketed and used here in Australia?  An ABC article stated that it is estimated that 90% of breast implants used in Australia are textured implants and that an estimated 40,000 women per year are having breast surgeries. 5 Formerly, the risk rates were thought to be 1 in 100,000 implants, so with women each having 2 implants that would mean less than one diagnosis every year, but Australian statistics are now anticipated to be much higher and may even reach 1 in 1,000 implants according to Professor Anand Deva. 6   If Professor Deva is correct, then this will eventually result in 80 plus diagnoses per annum in Australia alone as the prevalence of the condition seems to increase over time post-operatively.

Dr Hodgkinson has never endorsed the use of textured implants and in fact wrote an article in 2011 when the textured implants known as the “furry Brazilians” were first being released called, “The Fuzzy Logic Behind Brazilian Breast Implants” 7  In this article he notes that the concept of textured foam implants was nothing new and that from past experience it was noted that,  “The foam is incorporated into the body. That is the problem. It degenerates with time and its by-products and the process of degeneration is chronic inflammation. There have been serious worries about the by-products of the implant in the past and whether it could have been carcinogenic or not.” 8

Dr Hodgkinson has only used smooth walled implants and while he prefers saline filled breast implants, he notes that patients who want to be quite large or who have a bony chest wall may be candidates for gel filled breast implants which give a less palpable result and are often better tolerated in this patient group.

Whilst there is no cause for alarm, or immediate need to have your implants removed if you have textured implants, no patient should be considering further textured implants until further evidence is available if the TGA is stating that the use of smooth implants might reduce the risk of cancer. 9 Patients with textured implants should be even more diligent about monitoring their implant health and be aware of the symptoms of ALCL so that they can react appropriately should they develop any difficulties.

Most importantly, all consumers in the end should be guided by their appropriate national authorities recognising that they too are aware of international data.  For Australians your authority is the TGA.

Learn more here

References:

  1. https://www.nbcnews.com/health/womens-health/allergan-s-textured-breast-implants-recalled-french-authorities-n949656 Accessed 29 January 2019
  2. https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma#hp Accessed 29 January 2019
  3. Hidalgo, Dr David, Plastic and Reconstructive Surgery Vol. 142, December 2018
  4. https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma#hp Accessed 29 January 2019
  5. https://www.abc.net.au/news/2018-12-20/france-recalls-breast-implants-after-implant-files-investigation/10635050 Accessed 29 January 2019
  6. https://www.abc.net.au/news/2018-11-27/implant-files-breast-implants-probe-exposes-tga-flaws/10496080 Accessed 29 January 2019
  7. https://www.drhodgkinson.com.au/news-resource/brazilian-breast-implants/ Accessed 29 January 2019
  8. https://www.drhodgkinson.com.au/news-resource/brazilian-breast-implants/ Accessed 29 January 2019
  9. https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma#hp Accessed 29 January 2019